Toxicology Data Management System Page: 1 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. D. LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |A. D. LITTLE LABS 058806601 02/18/92 729 100(1) 51 (673) 61.7 POLYVINYL ALCOHOL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050510912 10/31/88 729 50(1) 46 (718) 50.8 TRIETHANOLAMINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050510912 10/31/88 729 50(1) 39 (669) 51.6 TRIETHANOLAMINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050510206 06/22/87 732 50(1) 43 (720) 51.5 BENZETHONIUM CHLORIDE | |BATTELLE COLUMBUS 055531204 01/20/93 727 50(1) 41 (704) 51.2 COCONUT OIL ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050516210 10/22/90 729 50(1) 40 (701) 52.1 DIETHANOLAMINE | |BATTELLE COLUMBUS 055532304 12/30/92 735 50(1) 40 (699) 52.2 LAURIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 059101404 05/10/93 729 49(1) 41 (706) 51.3 OLEIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050518806 12/20/90 733 50(1) 32 (704) 47.2 SODIUM XYLENESULFONATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050510206 06/22/87 732 52(1) 38 (704) 54.1 BENZETHONIUM CHLORIDE | |BATTELLE COLUMBUS 055531204 01/20/93 729 50(1) 35 (699) 58.0 COCONUT OIL ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050516210 10/22/90 731 50(1) 44 (720) 55.4 DIETHANOLAMINE | |BATTELLE COLUMBUS 055532304 12/30/92 736 50(1) 37 (704) 55.0 LAURIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 059101404 05/10/93 730 50(1) 34 (684) 55.9 OLEIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050518806 12/20/90 740 50(1) 31 (690) 50.6 SODIUM XYLENESULFONATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 4 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050508602 11/28/84 722 50(1) 45 (718) 52.0 O-BENZYL-P-CHLOROPHENOL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050508602 11/28/84 722 50(1) 37 (707) 49.8 O-BENZYL-P-CHLOROPHENOL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 5 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050518706 10/25/93 730 49(1) 38 (693) 53.7 METHYLEUGENOL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050518706 10/25/93 731 50(5) 31 (696) 63.2 METHYLEUGENOL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 6 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050512107 09/22/88 726 50(1) 40 (703) 52.4 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050512107 09/22/88 726 51(1) 33 (676) 56.0 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 7 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050516502 01/19/87 732 50(1) 41 (719) 48.8 4,4-THIOBIS-(6-TERT-BUTYL-M-CRESOL) | |BATTELLE COLUMBUS 058803604 10/31/94 729 50(1) 45 (709) 50.1 ANTHRAQUINONE | |BATTELLE COLUMBUS 050508502 10/08/84 729 50(5) 46 (722) 48.4 MANGANESE SULFATE | |BATTELLE COLUMBUS 050521203 06/22/89 729 50(1) 45 (709) 49.4 OXAZEPAM | |BATTELLE COLUMBUS 058803506 04/16/92 726 50(1) 35 (686) 51.2 PRIMACLONE | |BATTELLE COLUMBUS 050508702 09/17/84 729 50(1) 47 (723) 47.1 TRIAMTERENE | |BATTELLE COLUMBUS 050508703 08/26/85 729 50(1) 43 (716) 47.4 TRIAMTERENE | |BATTELLE COLUMBUS 050510004 10/09/86 739 52(1) 43 (686) 48.0 TRICRESYL PHOSPHATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050516502 01/19/87 732 51(1) 40 (695) 53.2 4,4-THIOBIS-(6-TERT-BUTYL-M-CRESOL) | |BATTELLE COLUMBUS 058803604 10/31/94 730 50(5) 35 (695) 56.8 ANTHRAQUINONE | |BATTELLE COLUMBUS 050508502 10/08/84 729 51(5) 42 (696) 53.8 MANGANESE SULFATE | |BATTELLE COLUMBUS 050521203 06/22/89 735 50(1) 39 (704) 56.0 OXAZEPAM | |BATTELLE COLUMBUS 058803506 04/16/92 727 50(5) 41 (704) 61.6 PRIMACLONE | |BATTELLE COLUMBUS 050508702 09/17/84 729 50(1) 38 (672) 51.6 TRIAMTERENE | |BATTELLE COLUMBUS 050508703 08/26/85 730 50(1) 40 (708) 49.9 TRIAMTERENE | |BATTELLE COLUMBUS 050510004 10/09/86 739 50(1) 41 (715) 50.9 TRICRESYL PHOSPHATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 8 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050513102 10/28/85 729 79(1) 58 (707) 51.3 SODIUM FLUORIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050513102 10/28/85 729 80(1) 53 (693) 57.4 SODIUM FLUORIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 9 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 050513402 01/23/86 736 50(1) 35 (690) 46.1 1,3-BUTADIENE | |BATTELLE NORTHWEST 050519712 07/26/93 729 50(1) 39 (697) 52.2 2-BUTOXYETHANOL | |BATTELLE NORTHWEST 050513304 04/07/88 733 50(1) 32 (690) 48.5 ACETONITRILE | |BATTELLE NORTHWEST 050513608 09/13/90 733 50(1) 27 (689) 49.4 CHLOROPRENE | |BATTELLE NORTHWEST 050515606 08/23/90 733 50(1) 22 (662) 47.1 COBALT SULFATE HEPTAHYDRATE | |BATTELLE NORTHWEST 050520106 11/21/91 733 50(1) 34 (688) 51.6 FURFURYL ALCOHOL | |BATTELLE NORTHWEST 050518007 09/16/93 733 50(1) 35 (687) 50.4 GALLIUM ARSENIDE | |BATTELLE NORTHWEST 050518406 07/07/94 733 50(1) 31 (686) 52.5 GLUTARALDEHYDE | |BATTELLE NORTHWEST 050511402 11/18/85 733 50(1) 35 (685) 43.9 HEXACHLOROCYCLOPENTADIENE (HCCPD) | |BATTELLE NORTHWEST 058807004 03/04/93 733 50(1) 28 (676) 51.0 ISOBUTENE | |BATTELLE NORTHWEST 056096802 08/09/90 733 50(1) 40 (712) 50.0 ISOBUTYRALDEHYDE | |BATTELLE NORTHWEST 050515804 03/22/90 733 50(1) 36 (689) 50.6 MOLYBDENUM TRIOXIDE | |BATTELLE NORTHWEST 050520006 08/31/89 734 50(1) 31 (681) 52.1 NITROMETHANE | |BATTELLE NORTHWEST 058803404 11/09/89 733 50(1) 30 (670) 50.9 OZONE | |BATTELLE NORTHWEST 050518104 12/07/89 733 50(1) 32 (689) 51.2 TETRAHYDROFURAN | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 10 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 050513402 01/23/86 737 50(1) 37 (706) 48.1 1,3-BUTADIENE | |BATTELLE NORTHWEST 050519712 07/26/93 731 50(1) 29 (688) 55.1 2-BUTOXYETHANOL | |BATTELLE NORTHWEST 050513304 04/07/88 735 49(1) 28 (692) 49.8 ACETONITRILE | |BATTELLE NORTHWEST 050513608 09/13/90 734 50(1) 35 (686) 56.2 CHLOROPRENE | |BATTELLE NORTHWEST 050515606 08/23/90 734 50(1) 34 (694) 48.9 COBALT SULFATE HEPTAHYDRATE | |BATTELLE NORTHWEST 050520106 11/21/91 734 50(1) 34 (690) 59.1 FURFURYL ALCOHOL | |BATTELLE NORTHWEST 050518007 09/16/93 735 50(1) 36 (699) 51.3 GALLIUM ARSENIDE | |BATTELLE NORTHWEST 050518406 07/07/94 735 50(1) 34 (699) 52.9 GLUTARALDEHYDE | |BATTELLE NORTHWEST 050511402 11/18/85 737 49(1) 31 (685) 46.9 HEXACHLOROCYCLOPENTADIENE (HCCPD) | |BATTELLE NORTHWEST 058807004 03/04/93 735 50(1) 32 (681) 58.1 ISOBUTENE | |BATTELLE NORTHWEST 056096802 08/09/90 735 50(1) 28 (668) 49.9 ISOBUTYRALDEHYDE | |BATTELLE NORTHWEST 050515804 03/22/90 733 50(1) 25 (683) 49.6 MOLYBDENUM TRIOXIDE | |BATTELLE NORTHWEST 050520006 08/31/89 734 50(1) 25 (662) 53.3 NITROMETHANE | |BATTELLE NORTHWEST 058803404 11/09/89 735 50(1) 29 (691) 54.2 OZONE | |BATTELLE NORTHWEST 050518104 12/07/89 733 50(1) 29 (615) 55.6 TETRAHYDROFURAN | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 11 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BIOASSAY SYS CORP 050509102 12/18/84 729 50(1) 42 (694) 53.1 3,4-DIHYDROCOUMARIN | |BIOASSAY SYS CORP 050509002 11/08/84 729 50(1) 43 (716) 54.4 COUMARIN | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BIOASSAY SYS CORP 050509102 12/18/84 729 51(1) 36 (669) 49.5 3,4-DIHYDROCOUMARIN | |BIOASSAY SYS CORP 050509002 11/08/84 729 52(1) 33 (618) 52.9 COUMARIN | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 12 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BROOKHAVEN 050510101 09/26/84 727 50(1) 40 (699) 48.6 METHYL BROMIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BROOKHAVEN 050510101 09/26/84 727 50(1) 36 (678) 49.5 METHYL BROMIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 13 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050506907 06/06/89 731 50(1) 39 (700) 53.9 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050506907 06/06/89 741 50(1) 34 (714) 57.0 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 14 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050511102 06/25/85 729 52(1) 42 (685) 45.9 1,2,3-TRICHLOROPROPANE | |E.G. & G. MASON 050510802 04/29/85 733 50(1) 39 (699) 44.7 PROMETHAZINE HYDROCHLORIDE | |E.G. & G. MASON 050521402 05/11/88 730 62(1) 50 (706) 53.4 TRANS-DELTA-9-TETRAHYDROCANNABINOL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050511102 06/25/85 733 50(1) 41 (701) 44.3 1,2,3-TRICHLOROPROPANE | |E.G. & G. MASON 050510802 04/29/85 743 50(1) 37 (721) 45.8 PROMETHAZINE HYDROCHLORIDE | |E.G. & G. MASON 050521402 05/11/88 737 60(1) 47 (702) 55.9 TRANS-DELTA-9-TETRAHYDROCANNABINOL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 15 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050515002 07/31/86 741 50(1) 45 (729) 46.2 METHYLPHENIDATE HYDROCHLORIDE | |E.G. & G. MASON 050508402 09/05/84 729 50(1) 43 (705) 48.4 TURMERIC, OLEORESIN (CURCUMIN) | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050515002 07/31/86 746 49(1) 37 (706) 45.1 METHYLPHENIDATE HYDROCHLORIDE | |E.G. & G. MASON 050508402 09/05/84 731 50(1) 37 (697) 47.4 TURMERIC, OLEORESIN (CURCUMIN) | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 16 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050512702 10/08/85 730 51(1) 45 (707) 48.2 BARIUM CHLORIDE DIHYDRATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |E.G. & G. MASON 050512702 10/08/85 737 50(1) 38 (704) 50.0 BARIUM CHLORIDE DIHYDRATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 17 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |HAZLETON 050510603 12/23/86 730 50(1) 43 (712) 39.5 DIETHYLPHTHALATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |HAZLETON 050510603 12/23/86 730 50(1) 41 (709) 37.9 DIETHYLPHTHALATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 18 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |I. I. T. RESEARCH I050521004 03/05/90 729 50(1) 28 (636) 48.1 ETHYLBENZENE | |I. I. T. RESEARCH I050518504 12/05/88 725 50(1) 37 (663) 48.4 ISOBUTYL NITRITE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |I. I. T. RESEARCH I050521004 03/05/90 730 50(1) 35 (689) 47.0 ETHYLBENZENE | |I. I. T. RESEARCH I050518504 12/05/88 729 51(1) 32 (676) 48.5 ISOBUTYL NITRITE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 19 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |LOVELACE RESEARCH 050512306 04/25/88 737 55(1) 19 (604) 42.6 NICKEL OXIDE | |LOVELACE RESEARCH 050510706 09/29/88 737 59(1) 26 (644) 42.6 NICKEL SUBSULFIDE | |LOVELACE RESEARCH 050512206 05/30/88 737 60(1) 26 (647) 43.9 NICKEL SULFATE HEXAHYDRATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |LOVELACE RESEARCH 050512306 04/25/88 729 60(1) 41 (657) 41.1 NICKEL OXIDE | |LOVELACE RESEARCH 050510706 09/29/88 733 58(1) 36 (677) 41.0 NICKEL SUBSULFIDE | |LOVELACE RESEARCH 050512206 05/30/88 730 60(1) 34 (673) 42.6 NICKEL SULFATE HEXAHYDRATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 20 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |MICROB. ASSOC. 050513002 08/13/85 739 50(1) 44 (708) 47.8 C. I. DIRECT BLUE 218 | |MICROB. ASSOC. 050506810 03/29/89 729 50(1) 41 (696) 50.7 CODEINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |MICROB. ASSOC. 050513002 08/13/85 744 49(1) 37 (692) 47.2 C. I. DIRECT BLUE 218 | |MICROB. ASSOC. 050506810 03/29/89 731 50(1) 36 (678) 53.2 CODEINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 21 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050509301 09/25/84 729 50(1) 33 (690) 53.8 P-NITROANILINE | |SOUTHERN RESEARCH 050509908 01/03/89 728 50(1) 40 (687) 54.4 SALICYLAZOSULFAPYRIDINE | |SOUTHERN RESEARCH 050506710 10/15/90 730 50(1) 36 (705) 53.6 THEOPHYLLINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050509301 09/25/84 729 50(1) 29 (662) 55.1 P-NITROANILINE | |SOUTHERN RESEARCH 050509908 01/03/89 735 50(1) 41 (680) 51.6 SALICYLAZOSULFAPYRIDINE | |SOUTHERN RESEARCH 050506710 10/15/90 731 50(1) 37 (700) 57.6 THEOPHYLLINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 22 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 058900606 07/09/90 729 50(1) 32 (683) 50.2 AZT | |SOUTHERN RESEARCH 058900602 10/08/90 731 50(1) 36 (694) 47.7 AZT/INTERFERON A/INTERFERON AD | |SOUTHERN RESEARCH 058900604 01/14/91 729 50(1) 31 (694) 48.1 AZT/INTERFERON A/INTERFERON AD | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 058900606 07/09/90 731 50(1) 34 (689) 58.0 AZT | |SOUTHERN RESEARCH 058900602 10/08/90 729 50(1) 33 (662) 51.1 AZT/INTERFERON A/INTERFERON AD | |SOUTHERN RESEARCH 058900604 01/14/91 730 50(1) 37 (703) 53.7 AZT/INTERFERON A/INTERFERON AD | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 23 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050510304 03/13/89 736 50(1) 42 (710) 49.8 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL | |SOUTHERN RESEARCH 050512004 08/25/86 729 50(1) 39 (705) 46.0 BENZYL ACETATE | |SOUTHERN RESEARCH 050521106 09/08/94 729 50(1) 41 (715) 51.1 EMODIN | |SOUTHERN RESEARCH 050509202 10/23/84 729 50(1) 35 (717) 49.2 O-NITROANISOLE | |SOUTHERN RESEARCH 050515504 05/25/88 730 50(1) 39 (709) 49.5 P-NITROBENZOIC ACID | |SOUTHERN RESEARCH 050521705 11/29/89 727 50(1) 39 (711) 52.7 T-BUTYLHYDROQUINONE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050510304 03/13/89 743 52(1) 37 (690) 54.5 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL | |SOUTHERN RESEARCH 050512004 08/25/86 729 50(1) 29 (681) 45.1 BENZYL ACETATE | |SOUTHERN RESEARCH 050521106 09/08/94 732 50(5) 37 (702) 58.7 EMODIN | |SOUTHERN RESEARCH 050509202 10/23/84 729 50(1) 38 (694) 51.7 O-NITROANISOLE | |SOUTHERN RESEARCH 050515504 05/25/88 735 50(1) 38 (704) 52.1 P-NITROBENZOIC ACID | |SOUTHERN RESEARCH 050521705 11/29/89 734 51(1) 38 (699) 56.2 T-BUTYLHYDROQUINONE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 24 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050508902 11/29/84 733 50(1) 34 (706) 50.9 CHLORAMINE | |SOUTHERN RESEARCH 050514204 11/19/86 729 60(1) 27 (676) 53.3 TERT-BUTYL ALCOHOL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050508902 11/29/84 733 50(1) 33 (683) 56.9 CHLORAMINE | |SOUTHERN RESEARCH 050514204 11/19/86 730 60(1) 36 (657) 60.5 TERT-BUTYL ALCOHOL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 25 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 058900608 09/05/90 728 50(1) 27 (679) 51.1 INTERFERON A/INTERFERON AD | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 058900608 09/05/90 729 50(1) 25 (684) 63.1 INTERFERON A/INTERFERON AD | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 26 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |TSI MASON RESEARCH 050518204 11/27/90 729 50(1) 40 (701) 52.0 PHENOLPHTHALEIN | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |TSI MASON RESEARCH 050518204 11/27/90 737 50(1) 39 (696) 56.5 PHENOLPHTHALEIN | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 27 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |TSI MASON RESEARCH 050516006 01/02/91 729 50(1) 40 (689) 53.1 1-CHLORO-2-PROPANOL | |TSI MASON RESEARCH 055530104 04/03/91 722 50(1) 35 (685) 55.4 PYRIDINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |TSI MASON RESEARCH 050516006 01/02/91 735 50(1) 32 (692) 60.1 1-CHLORO-2-PROPANOL | |TSI MASON RESEARCH 055530104 04/03/91 729 50(1) 32 (671) 63.3 PYRIDINE | |________________________________________________________________________________________________________________________________| This page intentionally left blank Toxicology Data Management System Page: 29 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. D. LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 72/100(72%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 42/100(42%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 82/100(82%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/100(0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 14/100(14%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 30 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/94 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/94 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/94 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/94 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/94 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 2/94 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/94 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/94 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 2/94 (2%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 31 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 32 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/99 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 33 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/87 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 9/100(9%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 11/100(11%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/94 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 36 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/94 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/94 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/98 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/98 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/98 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/98 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/98 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/98 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 56/99 (57%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 18/99 (18%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 18/99 (18%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 61/99 (62%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 61/99 (62%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 7/98 (7%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/98 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 10/98 (10%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/100(0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 42 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/100(0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 5/97 (5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 2/97 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 2/97 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 43 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 1/97 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 44 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 1/95 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/95 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/59 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 9/86 (10%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/86 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 9/86 (10%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 45 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/86 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/86 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/86 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/97 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 46 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/100(0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/100(0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 47 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/100(0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/100(0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/100(0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 48 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/100(0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/100(0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 49 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 2/100(2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/100(2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/100(0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/100(0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 50 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 51 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 52 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/93 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 1/96 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 1/96 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 9/96 (9%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/96 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 10/96 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 53 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 54 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 55 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: A. 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LITTLE LABS Route: VAGINAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 57 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 35/50 (70%) 34/50 (68%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 19/50 (38%) 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 39/50 (78%) 37/50 (74%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 2/50 (4%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 3/50 (6%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 4/50 (8%) 6/50 (12%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 58 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/50 (2%) 0/50 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 59 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 60 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 61 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 62 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 63 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 65 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 27/50 (54%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 15/50 (30%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 15/50 (30%) 1/50 (2%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 31/50 (62%) 23/50 (46%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 31/50 (62%) 23/50 (46%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 66 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 15/50 (30%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 16/50 (32%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 67 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 68 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 69 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 70 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 71 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 72 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/47 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 4/44 (9%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/44 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 4/44 (9%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 73 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 74 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 75 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 1/50 (2%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 76 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 1/50 (2%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 77 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 78 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 79 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 80 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 81 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 82 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 83 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 85 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 35/50 (70%) 26/50 (52%) 38/50 (76%) 28/52 (54%) 39/50 (78%) 40/50 (80%) | | 27/50 (54%) 28/49 (57%) 43/50 (86%) 34/50 (68%) 37/50 (74%) 29/50 (58%) | | Overall Incidence Total 197/299 (65.89%)Mean 65.86% SD 13.67% Total 207/302 (68.54%) Mean 68.64% SD 10.75% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 16/50 (32%) 22/50 (44%) 21/50 (42%) 27/52 (52%) 23/50 (46%) 22/50 (44%) | | 29/50 (58%) 24/49 (49%) 39/50 (78%) 30/50 (60%) 22/50 (44%) 25/50 (50%) | | Overall Incidence Total 151/299 (50.5%) Mean 50.5% SD 15.95% Total 149/302 (49.34%) Mean 49.32% SD 6.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 43/50 (86%) 35/50 (70%) 46/50 (92%) 41/52 (79%) 47/50 (94%) 47/50 (94%) | | 45/50 (90%) 42/49 (86%) 49/50 (98%) 44/50 (88%) 46/50 (92%) 45/50 (90%) | | Overall Incidence Total 260/299 (86.96%)Mean 86.95% SD 9.45% Total 270/302 (89.4%) Mean 89.47% SD 5.71% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/52 (6%) 2/50 (4%) 3/50 (6%) | | 1/50 (2%) 0/49 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 6/299 (2.01%) Mean 2% SD 2.53% Total 11/302 (3.64%) Mean 3.63% SD 2.29% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 6/50 (12%) 2/50 (4%) 3/52 (6%) 1/50 (2%) 2/50 (4%) | | 8/50 (16%) 4/49 (8%) 6/50 (12%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 30/299 (10.03%) Mean 10.03% SD 4.18% Total 10/302 (3.31%) Mean 3.29% SD 2.37% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 6/50 (12%) 6/50 (12%) 2/50 (4%) 6/52 (12%) 3/50 (6%) 5/50 (10%) | | 9/50 (18%) 4/49 (8%) 9/50 (18%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 36/299 (12.04%) Mean 12.03% SD 5.49% Total 21/302 (6.95%) Mean 6.92% SD 3.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/52 (6%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 11/302 (3.64%) Mean 3.63% SD 2.62% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 86 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 2/50 (4%) 0/50 (0%) 7/52 (13%) 13/50 (26%) 12/50 (24%) | | Lymphocytic, Mixed, NOS, or 4/50 (8%) 1/49 (2%) 5/50 (10%) 9/50 (18%) 3/50 (6%) 8/50 (16%) | | Undifferentiated Cell Type | | Overall Incidence Total 15/299 (5.02%) Mean 5.01% SD 3.74% Total 52/302 (17.22%) Mean 17.24% SD 7.28% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/302 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/302 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/50 (0%) 5/50 (10%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 2/49 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 9/299 (3.01%) Mean 3.01% SD 3.95% Total 3/302 (0.99%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 2/50 (4%) 2/50 (4%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 7/301 (2.33%) Mean 2.33% SD 1.97% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 87 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 2/50 (4%) 2/50 (4%) | | Complex, Malignant, NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 7/301 (2.33%) Mean 2.33% SD 1.97% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.03% Total 3/302 (0.99%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 88 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 89 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 90 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/52 (0%) 0/49 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) 0/49 (0%) | | Overall Incidence Total 0/283 (0%) Mean 0% SD 0% Total 0/292 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/52 (4%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 2/49 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 3/50 (6%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.68% SD 1.65% Total 10/302 (3.31%) Mean 3.31% SD 2.41% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/52 (4%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 5/302 (1.66%) Mean 1.64% SD 1.46% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 2/50 (4%) 0/50 (0%) 4/52 (8%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 2/49 (4%) 1/50 (2%) 2/50 (4%) 3/50 (6%) 4/50 (8%) | | Overall Incidence Total 9/299 (3.01%) Mean 3.01% SD 2.11% Total 15/302 (4.97%) Mean 4.95% SD 2.69% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 91 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 92 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.68% SD 1.67% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 93 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.68% SD 1.67% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.68% SD 1.67% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 3/298 (1.01%) Mean 1.01% SD 1.7% Total 3/301 (1%) Mean 1.01% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/298 (0.67%) Mean 0.67% SD 1.03% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 94 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/49 (4%) 1/50 (2%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 2/50 (4%) | | Overall Incidence Total 5/298 (1.68%) Mean 1.68% SD 1.53% Total 4/301 (1.33%) Mean 1.34% SD 1.64% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.03% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.63% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.33% SD 2.42% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 95 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.34% SD 0.83% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.63% Total 3/302 (0.99%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/50 (0%) | | 7/50 (14%) 1/49 (2%) 5/50 (10%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 18/299 (6.02%) Mean 6.01% SD 5.21% Total 4/302 (1.32%) Mean 1.32% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 24/50 (48%) 22/50 (44%) 31/50 (62%) 20/52 (38%) 32/50 (64%) 32/50 (64%) | | 19/50 (38%) 22/49 (45%) 37/50 (74%) 23/50 (46%) 26/50 (52%) 18/50 (36%) | | Overall Incidence Total 155/299 (51.84%)Mean 51.82% SD 13.49% Total 151/302 (50%) Mean 50.08% SD 12.17% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 10/50 (20%) 12/50 (24%) 12/50 (24%) 12/52 (23%) 3/50 (6%) 5/50 (10%) | | 11/50 (22%) 9/49 (18%) 35/50 (70%) 10/50 (20%) 5/50 (10%) 10/50 (20%) | | Overall Incidence Total 89/299 (29.77%) Mean 29.73% SD 19.85% Total 45/302 (14.9%) Mean 14.85% SD 7.02% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 13/50 (26%) 12/50 (24%) 12/52 (23%) 3/50 (6%) 5/50 (10%) | | Hepatoblastoma 11/50 (22%) 9/49 (18%) 35/50 (70%) 10/50 (20%) 6/50 (12%) 10/50 (20%) | | Overall Incidence Total 90/299 (30.1%) Mean 30.06% SD 19.75% Total 46/302 (15.23%) Mean 15.18% SD 6.78% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 96 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 29/50 (58%) 28/50 (56%) 39/50 (78%) 27/52 (52%) 33/50 (66%) 33/50 (66%) | | Hepatocellular Adenoma 28/50 (56%) 29/49 (59%) 46/50 (92%) 28/50 (56%) 28/50 (56%) 27/50 (54%) | | Overall Incidence Total 199/299 (66.56%)Mean 66.53% SD 15.03% Total 176/302 (58.28%) Mean 58.32% SD 6.14% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 29/50 (58%) 29/50 (58%) 39/50 (78%) 27/52 (52%) 33/50 (66%) 33/50 (66%) | | Hepatocellular Adenoma, or 28/50 (56%) 29/49 (59%) 46/50 (92%) 28/50 (56%) 28/50 (56%) 27/50 (54%) | | Hepatoblastoma | | Overall Incidence Total 200/299 (66.89%)Mean 66.86% SD 14.76% Total 176/302 (58.28%) Mean 58.32% SD 6.14% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 97 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 13/50 (26%) 11/50 (22%) 11/50 (22%) 1/52 (2%) 2/50 (4%) 4/50 (8%) | | 6/50 (12%) 7/49 (14%) 13/50 (26%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | | Overall Incidence Total 61/299 (20.4%) Mean 20.38% SD 5.93% Total 13/302 (4.3%) Mean 4.32% SD 2.96% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 4/50 (8%) 5/50 (10%) 1/52 (2%) 0/50 (0%) 2/50 (4%) | | 8/50 (16%) 7/49 (14%) 2/50 (4%) 7/50 (14%) 3/50 (6%) 2/50 (4%) | | Overall Incidence Total 27/299 (9.03%) Mean 9.05% SD 5.53% Total 15/302 (4.97%) Mean 4.99% SD 4.87% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 15/50 (30%) 15/50 (30%) 2/52 (4%) 2/50 (4%) 6/50 (12%) | | Alveolar/Bronchiolar Adenoma 14/50 (28%) 12/49 (24%) 15/50 (30%) 8/50 (16%) 4/50 (8%) 5/50 (10%) | | Overall Incidence Total 85/299 (28.43%) Mean 28.41% SD 2.16% Total 27/302 (8.94%) Mean 8.97% SD 4.72% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/302 (0.66%) Mean 0.65% SD 1.01% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 98 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 99 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 3/302 (0.99%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 3/302 (0.99%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 1/50 (2%) | | or Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 3/302 (0.99%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 100 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 101 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 102 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 3/52 (6%) 3/50 (6%) 2/49 (4%) | | 4/50 (8%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 15/301 (4.98%) Mean 4.98% SD 2.74% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Malignant, NOS 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/52 (0%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/301 (1%) Mean 1.02% SD 2.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 103 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/52 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/52 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 104 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/47 (0%) 0/43 (0%) 0/41 (0%) 0/43 (0%) 0/37 (0%) 0/43 (0%) | | 0/40 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/38 (0%) 0/38 (0%) | | Overall Incidence Total 0/262 (0%) Mean 0% SD 0% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/45 (0%) 0/48 (0%) 6/52 (12%) 5/48 (10%) 7/50 (14%) | | Adenoma 0/48 (0%) 0/49 (0%) 1/49 (2%) 10/47 (21%) 9/50 (18%) 7/50 (14%) | | Overall Incidence Total 1/287 (0.35%) Mean 0.34% SD 0.83% Total 44/297 (14.81%) Mean 14.87% SD 4.08% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/45 (0%) 0/48 (0%) 0/52 (0%) 1/48 (2%) 0/50 (0%) | | Carcinoma 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/287 (0%) Mean 0% SD 0% Total 1/297 (0.34%) Mean 0.35% SD 0.85% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 105 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/45 (0%) 0/48 (0%) 6/52 (12%) 6/48 (13%) 7/50 (14%) | | Carcinoma or Adenoma 0/48 (0%) 0/49 (0%) 1/49 (2%) 10/47 (21%) 9/50 (18%) 7/50 (14%) | | Overall Incidence Total 1/287 (0.35%) Mean 0.34% SD 0.83% Total 45/297 (15.15%) Mean 15.22% SD 3.7% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 1/45 (2%) 1/48 (2%) 0/52 (0%) 0/48 (0%) 1/50 (2%) | | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/287 (0.7%) Mean 0.72% SD 1.11% Total 2/297 (0.67%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/45 (0%) 0/48 (0%) 0/52 (0%) 0/48 (0%) 0/50 (0%) | | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/287 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 1/45 (2%) 1/48 (2%) 0/52 (0%) 0/48 (0%) 1/50 (2%) | | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/287 (0.7%) Mean 0.72% SD 1.11% Total 2/297 (0.67%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 106 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 107 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 108 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.03% Total 2/302 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 109 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 110 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/52 (6%) 2/50 (4%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Histiocytoma | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.63% Total 9/302 (2.98%) Mean 2.96% SD 2.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/52 (4%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 6/302 (1.99%) Mean 1.97% SD 1.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/52 (6%) 2/50 (4%) 1/50 (2%) | | Myxosarcoma, or Fibrous 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Histiocytoma | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 9/302 (2.98%) Mean 2.96% SD 2.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 3/302 (0.99%) Mean 0.99% SD 1.08% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 111 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/52 (2%) 0/50 (0%) 2/50 (4%) | | 2/50 (4%) 3/49 (6%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/299 (3.68%) Mean 3.69% SD 2.36% Total 5/302 (1.66%) Mean 1.65% SD 1.96% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 112 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 1/50 (2%) 1/50 (2%) | | Papilloma Squamous 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.03% Total 6/302 (1.99%) Mean 2% SD 3.1% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 5/302 (1.66%) Mean 1.67% SD 2.34% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 113 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 3/299 (1%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 1/45 (2%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 1/238 (0.42%) Mean 0.37% SD 0.91% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 114 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/31 (0%) 0/43 (0%) 0/37 (0%) 0/41 (0%) 0/47 (0%) 0/48 (0%) | | 0/45 (0%) 0/45 (0%) 0/37 (0%) 0/50 (0%) 0/41 (0%) 0/38 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 0/265 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 3/52 (6%) 2/50 (4%) 4/50 (8%) | | 1/50 (2%) 2/49 (4%) 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 9/299 (3.01%) Mean 3.01% SD 3.04% Total 17/302 (5.63%) Mean 5.63% SD 1.96% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 1/302 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 4/50 (8%) 4/52 (8%) 2/50 (4%) 4/50 (8%) | | 1/50 (2%) 3/49 (6%) 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 11/299 (3.68%) Mean 3.69% SD 2.96% Total 18/302 (5.96%) Mean 5.95% SD 2.14% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 115 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 116 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.34% SD 0.83% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 117 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/52 (2%) 1/50 (2%) 3/50 (6%) | | 2/50 (4%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 11/302 (3.64%) Mean 3.65% SD 1.98% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/52 (2%) 1/50 (2%) 3/50 (6%) | | 2/50 (4%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 12/302 (3.97%) Mean 3.99% SD 1.81% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 118 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: DERMAL Date of Species: MICE Vehicle: ETHANOL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 119 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 30/50 (60%) 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 18/50 (36%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 38/50 (76%) 39/50 (78%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 6/50 (12%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 9/50 (18%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 120 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 1/50 (2%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/49 (2%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/49 (2%) 0/49 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 121 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 122 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 123 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/48 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 124 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 125 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 126 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 127 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 21/50 (42%) 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 7/50 (14%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 7/50 (14%) 2/50 (4%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 25/50 (50%) 13/50 (26%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 25/50 (50%) 13/50 (26%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 128 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 5/49 (10%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 129 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 130 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 131 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 132 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 2/49 (4%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 133 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 134 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/45 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 8/47 (17%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/47 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 8/47 (17%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 135 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/47 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 136 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 137 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 138 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 139 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 3/50 (6%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 1/50 (2%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 1/50 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 140 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 141 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 2/50 (4%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 142 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/42 (0%) 1/45 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/42 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/42 (0%) 1/45 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 143 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 144 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 145 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 147 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 33/49 (67%) 29/50 (58%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 23/49 (47%) 27/50 (54%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 41/49 (84%) 41/50 (82%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/49 (8%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 4/49 (8%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/49 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/49 (6%) 15/50 (30%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 148 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 0/50 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 149 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 150 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/49 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 151 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/48 (0%) 0/38 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 4/49 (8%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/49 (0%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 4/49 (8%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 152 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 153 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 154 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 155 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 26/49 (53%) 20/50 (40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 10/49 (20%) 7/50 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/49 (20%) 7/50 (14%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 31/49 (63%) 25/50 (50%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 31/49 (63%) 25/50 (50%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 156 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 11/49 (22%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 5/49 (10%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 15/49 (31%) 7/50 (14%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 157 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 158 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/49 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/49 (0%) 2/50 (4%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 159 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 160 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/49 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 161 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 162 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/43 (0%) 0/36 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 5/48 (10%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 0/48 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 5/48 (10%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 163 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/45 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/45 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/45 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 164 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/49 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 165 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/49 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/49 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 166 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/49 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/49 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/49 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/49 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 167 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/49 (0%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/49 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/49 (0%) 1/50 (2%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/49 (0%) 1/50 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 168 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 2/49 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 169 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/49 (0%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 170 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/37 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/49 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/49 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 171 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/49 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 1/49 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 172 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 173 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 175 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 36/50 (72%) 24/51 (47%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 26/51 (51%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 43/50 (86%) 40/51 (78%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 4/51 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/50 (4%) 4/51 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 3/50 (6%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 1/50 (2%) 0/51 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 4/50 (8%) 9/51 (18%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 176 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/51 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 1/51 (2%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 177 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 178 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/51 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 179 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/49 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 2/51 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 3/51 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 180 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 181 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 182 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/50 (6%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/51 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/51 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/51 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/51 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 2/50 (4%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 2/50 (4%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 183 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 26/50 (52%) 15/51 (29%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 6/50 (12%) 8/51 (16%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 6/50 (12%) 8/51 (16%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 30/50 (60%) 22/51 (43%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 30/50 (60%) 22/51 (43%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 184 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 3/51 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 15/50 (30%) 4/51 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 185 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 186 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/51 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 187 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 188 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/51 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 3/51 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/51 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 189 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 190 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 4/50 (8%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 4/50 (8%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 191 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 192 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/51 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/51 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 193 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/51 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/51 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/51 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 194 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/51 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/51 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/51 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/51 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 195 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/51 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/51 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/51 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/51 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 196 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 197 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/51 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 198 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/42 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 3/51 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 3/51 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 199 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/51 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 200 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 201 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/51 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 203 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 30/50 (60%) 27/50 (54%) 38/50 (76%) 27/51 (53%) 13/50 (26%) 21/51 (41%) | | 30/50 (60%) 26/50 (52%) 21/50 (42%) 29/50 (58%) 26/50 (52%) 22/50 (44%) | | 25/50 (50%) 26/52 (50%) 12/50 (24%) 27/50 (54%) | | Overall Incidence Total 223/402 (55.47%)Mean 55.5% SD 10.13% Total 177/402 (44.03%) Mean 44.01% SD 12.94% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 18/50 (36%) 20/50 (40%) 23/51 (45%) 21/50 (42%) 23/51 (45%) | | 17/50 (34%) 22/50 (44%) 17/50 (34%) 18/50 (36%) 20/50 (40%) 20/50 (40%) | | 25/50 (50%) 22/52 (42%) 23/50 (46%) 22/50 (44%) | | Overall Incidence Total 158/402 (39.3%) Mean 39.29% SD 5.87% Total 170/402 (42.29%) Mean 42.27% SD 3.43% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 38/50 (76%) 35/50 (70%) 46/50 (92%) 38/51 (75%) 28/50 (56%) 37/51 (73%) | | 37/50 (74%) 40/50 (80%) 32/50 (64%) 37/50 (74%) 34/50 (68%) 34/50 (68%) | | 37/50 (74%) 37/52 (71%) 29/50 (58%) 40/50 (80%) | | Overall Incidence Total 302/402 (75.12%)Mean 75.14% SD 8.26% Total 277/402 (68.91%) Mean 68.88% SD 8.29% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/51 (4%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/402 (0.75%) Mean 0.74% SD 1.02% Total 4/402 (1%) Mean 0.99% SD 1.49% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/51 (4%) 1/50 (2%) 2/51 (4%) | | 1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | 4/50 (8%) 5/52 (10%) 3/50 (6%) 4/50 (8%) | | Overall Incidence Total 18/402 (4.48%) Mean 4.45% SD 3.07% Total 17/402 (4.23%) Mean 4.23% SD 1.99% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/50 (4%) 2/50 (4%) 1/50 (2%) 4/51 (8%) 1/50 (2%) 3/51 (6%) | | 1/50 (2%) 4/50 (8%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | | 4/50 (8%) 6/52 (12%) 3/50 (6%) 4/50 (8%) | | Overall Incidence Total 21/402 (5.22%) Mean 5.19% SD 3.57% Total 21/402 (5.22%) Mean 5.22% SD 2.34% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 2/50 (4%) 0/51 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 5/402 (1.24%) Mean 1.25% SD 1.49% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 204 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Mononuclear, or Undifferentiated 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 3/50 (6%) 5/50 (10%) 13/51 (25%) 14/50 (28%) 15/51 (29%) | | Lymphocytic, Mixed, NOS, or 2/50 (4%) 7/50 (14%) 6/50 (12%) 3/50 (6%) 8/50 (16%) 12/50 (24%) | | Undifferentiated Cell Type 5/50 (10%) 3/52 (6%) 9/50 (18%) 4/50 (8%) | | Overall Incidence Total 33/402 (8.21%) Mean 8.22% SD 3.79% Total 78/402 (19.4%) Mean 19.36% SD 8.91% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 11/50 (22%) 0/50 (0%) 0/49 (0%) 1/51 (2%) 0/50 (0%) 0/51 (0%) | | 6/49 (12%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | 0/50 (0%) 2/52 (4%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 20/400 (5%) Mean 5.01% SD 8.03% Total 9/402 (2.24%) Mean 2.25% SD 2.71% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 205 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 1/50 (2%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/0 (0%) 10/50 (20%) 0/51 (0%) 0/0 (0%) 0/51 (0%) | | Adenoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/351 (3.13%) Mean 2.75% SD 7.01% Total 0/352 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/51 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | 0/50 (0%) 2/52 (4%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.74% SD 1.45% Total 3/396 (0.76%) Mean 0.75% SD 1.48% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/51 (2%) | | Complex, Malignant, NOS 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | 0/50 (0%) 2/52 (4%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.74% SD 1.45% Total 3/396 (0.76%) Mean 0.75% SD 1.48% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 206 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/402 (0.75%) Mean 0.75% SD 1.04% Total 1/402 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 2/402 (0.5%) Mean 0.5% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 207 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 208 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 209 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/50 (0%) 0/50 (0%) 0/42 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/47 (0%) 0/47 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 1/51 (2%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/383 (0.26%) Mean 0.25% SD 0.69% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 1/50 (2%) 3/50 (6%) 4/50 (8%) 0/51 (0%) 2/50 (4%) 2/51 (4%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 5/50 (10%) | | Overall Incidence Total 13/402 (3.23%) Mean 3.25% SD 2.82% Total 14/402 (3.48%) Mean 3.49% SD 3.34% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 210 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/51 (2%) 0/50 (0%) 1/51 (2%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/402 (1.49%) Mean 1.49% SD 1.41% Total 5/402 (1.24%) Mean 1.24% SD 1.48% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 3/50 (6%) 5/50 (10%) 1/51 (2%) 2/50 (4%) 3/51 (6%) | | 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 5/50 (10%) 1/50 (2%) | | 1/50 (2%) 1/52 (2%) 0/50 (0%) 5/50 (10%) | | Overall Incidence Total 19/402 (4.73%) Mean 4.74% SD 2.83% Total 19/402 (4.73%) Mean 4.73% SD 3.69% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 211 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 212 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 213 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 214 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 1/45 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/47 (0%) 1/52 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 3/393 (0.76%) Mean 0.77% SD 1.06% Total 2/399 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/47 (2%) 0/52 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 3/393 (0.76%) Mean 0.77% SD 1.06% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 1/45 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 1/47 (2%) 1/52 (2%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 6/393 (1.53%) Mean 1.53% SD 1.43% Total 3/399 (0.75%) Mean 0.76% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 215 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 216 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.24% SD 0.68% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/49 (0%) 1/51 (2%) | | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/401 (2%) Mean 2.01% SD 1.51% Total 2/401 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 17/50 (34%) 21/50 (42%) 30/50 (60%) 17/51 (33%) 6/49 (12%) 12/51 (24%) | | 17/49 (35%) 22/50 (44%) 17/50 (34%) 25/50 (50%) 15/50 (30%) 10/50 (20%) | | 21/50 (42%) 18/52 (35%) 7/50 (14%) 12/50 (24%) | | Overall Incidence Total 163/401 (40.65%)Mean 40.66% SD 8.86% Total 104/401 (25.94%) Mean 25.89% SD 12.1% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 11/50 (22%) 8/50 (16%) 9/50 (18%) 4/51 (8%) 2/49 (4%) 3/51 (6%) | | 9/49 (18%) 12/50 (24%) 5/50 (10%) 9/50 (18%) 3/50 (6%) 4/50 (8%) | | 9/50 (18%) 15/52 (29%) 5/50 (10%) 10/50 (20%) | | Overall Incidence Total 78/401 (19.45%) Mean 19.4% SD 5.63% Total 40/401 (9.98%) Mean 9.98% SD 5.86% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 11/50 (22%) 9/50 (18%) 9/50 (18%) 4/51 (8%) 2/49 (4%) 3/51 (6%) | | Hepatoblastoma 9/49 (18%) 12/50 (24%) 5/50 (10%) 9/50 (18%) 4/50 (8%) 4/50 (8%) | | 9/50 (18%) 15/52 (29%) 5/50 (10%) 10/50 (20%) | | Overall Incidence Total 79/401 (19.7%) Mean 19.65% SD 5.5% Total 41/401 (10.22%) Mean 10.23% SD 5.71% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 25/50 (50%) 25/50 (50%) 34/50 (68%) 20/51 (39%) 6/49 (12%) 13/51 (25%) | | Hepatocellular Adenoma 23/49 (47%) 31/50 (62%) 20/50 (40%) 28/50 (56%) 16/50 (32%) 13/50 (26%) | | 25/50 (50%) 28/52 (54%) 10/50 (20%) 21/50 (42%) | | Overall Incidence Total 211/401 (52.62%)Mean 52.6% SD 8.77% Total 127/401 (31.67%) Mean 31.62% SD 13.83% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 25/50 (50%) 26/50 (52%) 34/50 (68%) 20/51 (39%) 6/49 (12%) 13/51 (25%) | | Hepatocellular Adenoma, or 23/49 (47%) 31/50 (62%) 20/50 (40%) 28/50 (56%) 16/50 (32%) 13/50 (26%) | | Hepatoblastoma 25/50 (50%) 28/52 (54%) 10/50 (20%) 21/50 (42%) | | Overall Incidence Total 212/401 (52.87%)Mean 52.85% SD 8.71% Total 127/401 (31.67%) Mean 31.62% SD 13.83% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 217 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/49 (2%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 218 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 6/50 (12%) 11/50 (22%) 7/50 (14%) 2/51 (4%) 1/50 (2%) 2/51 (4%) | | 11/50 (22%) 7/50 (14%) 3/50 (6%) 4/50 (8%) 4/50 (8%) 4/50 (8%) | | 6/50 (12%) 7/52 (13%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 58/402 (14.43%) Mean 14.43% SD 5.33% Total 21/402 (5.22%) Mean 5.23% SD 2.39% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 8/50 (16%) 5/50 (10%) 0/51 (0%) 3/50 (6%) 4/51 (8%) | | 2/50 (4%) 4/50 (8%) 6/50 (12%) 1/50 (2%) 4/50 (8%) 0/50 (0%) | | 7/50 (14%) 1/52 (2%) 1/50 (2%) 4/50 (8%) | | Overall Incidence Total 36/402 (8.96%) Mean 8.99% SD 4.91% Total 17/402 (4.23%) Mean 4.23% SD 3.59% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 8/50 (16%) 17/50 (34%) 12/50 (24%) 2/51 (4%) 4/50 (8%) 6/51 (12%) | | Alveolar/Bronchiolar Adenoma 13/50 (26%) 11/50 (22%) 9/50 (18%) 5/50 (10%) 7/50 (14%) 4/50 (8%) | | 13/50 (26%) 8/52 (15%) 3/50 (6%) 5/50 (10%) | | Overall Incidence Total 91/402 (22.64%) Mean 22.67% SD 6.24% Total 36/402 (8.96%) Mean 8.96% SD 3.19% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 219 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 220 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 221 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/51 (0%) | | or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 222 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 223 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 1/50 (2%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 1/391 (0.26%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 224 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 2/45 (4%) 2/51 (4%) | | 1/50 (2%) 3/49 (6%) 1/48 (2%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 9/391 (2.3%) Mean 2.32% SD 2.33% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 1/50 (2%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 1/48 (2%) | | Overall Incidence Total 2/391 (0.51%) Mean 0.51% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/45 (0%) 0/51 (0%) | | Malignant, NOS 1/50 (2%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 1/48 (2%) | | Overall Incidence Total 2/391 (0.51%) Mean 0.51% SD 0.95% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 225 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 1/50 (2%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 1/391 (0.26%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 2/50 (4%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 2/391 (0.51%) Mean 0.5% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 1/391 (0.26%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 1/50 (2%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 1/391 (0.26%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 226 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 1/48 (2%) | | Overall Incidence Total 1/391 (0.26%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 1/50 (2%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 1/391 (0.26%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) 0/45 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/391 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 227 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/395 (0.25%) Mean 0.27% SD 0.77% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/49 (0%) 0/41 (0%) 0/46 (0%) 0/46 (0%) 0/39 (0%) 0/47 (0%) | | 0/48 (0%) 0/31 (0%) 0/47 (0%) 0/46 (0%) 0/45 (0%) 0/41 (0%) | | 0/44 (0%) 0/52 (0%) 0/47 (0%) 0/46 (0%) | | Overall Incidence Total 0/358 (0%) Mean 0% SD 0% Total 0/357 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/48 (0%) 0/46 (0%) 6/48 (13%) 4/47 (9%) 2/48 (4%) | | Adenoma 1/48 (2%) 0/45 (0%) 0/49 (0%) 2/50 (4%) 3/49 (6%) 7/49 (14%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 6/46 (13%) | | Overall Incidence Total 1/383 (0.26%) Mean 0.26% SD 0.74% Total 31/386 (8.03%) Mean 8.08% SD 4.71% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/48 (0%) 0/46 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) | | Carcinoma 0/48 (0%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 0/383 (0%) Mean 0% SD 0% Total 0/386 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 228 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/48 (0%) 0/46 (0%) 6/48 (13%) 4/47 (9%) 2/48 (4%) | | Carcinoma or Adenoma 1/48 (2%) 0/45 (0%) 0/49 (0%) 2/50 (4%) 3/49 (6%) 7/49 (14%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 6/46 (13%) | | Overall Incidence Total 1/383 (0.26%) Mean 0.26% SD 0.74% Total 31/386 (8.03%) Mean 8.08% SD 4.71% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/48 (0%) 0/46 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) | | 0/48 (0%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 0/383 (0%) Mean 0% SD 0% Total 0/386 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/47 (0%) 0/48 (0%) 0/46 (0%) 1/48 (2%) 0/47 (0%) 0/48 (0%) | | 0/48 (0%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 0/383 (0%) Mean 0% SD 0% Total 1/386 (0.26%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/48 (0%) 0/46 (0%) 1/48 (2%) 0/47 (0%) 0/48 (0%) | | 0/48 (0%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 0/383 (0%) Mean 0% SD 0% Total 1/386 (0.26%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 229 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 230 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 231 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Carcinoma, Basosq. Tumor (M or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 232 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.49% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.24% SD 0.68% Total 2/402 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 233 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma, Squamous Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Keratoacanthoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma, or Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 234 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) 2/50 (4%) 2/51 (4%) | | Myxoma, Myxosarcoma, or Fibrous 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | | Histiocytoma 0/50 (0%) 0/52 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 17/402 (4.23%) Mean 4.23% SD 1.29% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) 2/50 (4%) 2/51 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 16/402 (3.98%) Mean 3.98% SD 1.85% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) 2/50 (4%) 2/51 (4%) | | Myxosarcoma, or Fibrous 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | | Histiocytoma 0/50 (0%) 0/52 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 17/402 (4.23%) Mean 4.23% SD 1.29% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/51 (2%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 235 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/51 (2%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 2/402 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 1/51 (2%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 1/395 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/51 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/51 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/396 (0.25%) Mean 0.25% SD 0.71% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 236 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/51 (4%) 0/45 (0%) 0/51 (0%) | | 0/49 (0%) 2/48 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 2/47 (4%) 4/52 (8%) 3/49 (6%) 3/50 (6%) | | Overall Incidence Total 11/396 (2.78%) Mean 2.76% SD 2.76% Total 10/395 (2.53%) Mean 2.51% SD 2.58% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/51 (0%) | | 0/49 (0%) 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/396 (0.25%) Mean 0.26% SD 0.74% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/51 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.49% SD 0.91% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/51 (4%) 3/50 (6%) 1/51 (2%) | | Papilloma Squamous 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/402 (1.24%) Mean 1.24% SD 1.48% Total 7/402 (1.74%) Mean 1.74% SD 2.24% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 237 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/51 (4%) 3/50 (6%) 1/51 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/402 (0.75%) Mean 0.75% SD 1.04% Total 7/402 (1.74%) Mean 1.74% SD 2.24% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 238 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 1/49 (2%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 1/364 (0.27%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 0/50 (0%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/364 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 239 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 0/49 (0%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 1/50 (2%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 1/364 (0.27%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/47 (0%) 0/45 (0%) 0/39 (0%) 0/46 (0%) 0/44 (0%) 1/49 (2%) | | 0/43 (0%) 0/42 (0%) 0/36 (0%) 1/50 (2%) 0/45 (0%) 0/38 (0%) | | 0/40 (0%) 0/45 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 2/364 (0.55%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/400 (0.25%) Mean 0.25% SD 0.71% Total 0/394 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/394 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/400 (0.25%) Mean 0.25% SD 0.71% Total 0/394 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/45 (2%) 2/50 (4%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 1/400 (0.25%) Mean 0.25% SD 0.71% Total 6/394 (1.52%) Mean 1.54% SD 1.43% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/45 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 1/394 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/45 (2%) 2/50 (4%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 1/50 (2%) 0/52 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 1/400 (0.25%) Mean 0.25% SD 0.71% Total 7/394 (1.78%) Mean 1.79% SD 1.69% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 240 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 241 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.48% SD 1.36% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/44 (0%) 0/51 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/392 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/44 (0%) 0/51 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/392 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/44 (0%) 0/51 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/392 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 242 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/44 (0%) 0/51 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/392 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/44 (0%) 0/51 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/392 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/51 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 243 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/51 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/51 (4%) 0/50 (0%) 1/51 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 7/402 (1.74%) Mean 1.74% SD 1.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/51 (4%) 0/50 (0%) 1/51 (2%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 9/402 (2.24%) Mean 2.24% SD 1.66% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 244 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 0/402 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 245 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 57/79 (72%) 65/80 (81%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 41/79 (52%) 34/80 (43%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 71/79 (90%) 72/80 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/79 (0%) 4/80 (5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/79 (4%) 3/80 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 3/79 (4%) 7/80 (9%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/79 (1%) 5/80 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/79 (0%) 0/80 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 4/79 (5%) 11/80 (14%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 246 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/79 (0%) 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 9/79 (11%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/79 (0%) 0/79 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/76 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/76 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/76 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/76 (0%) 0/76 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 247 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/79 (0%) 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 248 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/79 (0%) 0/80 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 249 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/76 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 7/79 (9%) 4/80 (5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/79 (1%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 8/79 (10%) 5/80 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 250 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 251 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/78 (0%) 1/79 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 252 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/78 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/78 (0%) 1/79 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/80 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/80 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/80 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/80 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 253 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 2/79 (3%) 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 50/79 (63%) 49/80 (61%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 25/79 (32%) 14/80 (18%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 25/79 (32%) 14/80 (18%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 62/79 (78%) 55/80 (69%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 62/79 (78%) 55/80 (69%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 254 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 11/79 (14%) 5/80 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 12/79 (15%) 3/80 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 23/79 (29%) 8/80 (10%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 255 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 256 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/79 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/79 (0%) 1/80 (1%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 257 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 258 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/79 (0%) 0/80 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 3/78 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/78 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/78 (1%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 259 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/78 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 260 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/78 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/78 (0%) 1/80 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/70 (0%) 0/73 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/71 (0%) 25/80 (31%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/71 (0%) 0/80 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/71 (0%) 25/80 (31%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 261 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/71 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/71 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/71 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/78 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/78 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 262 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/79 (0%) 0/80 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/79 (0%) 0/80 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 263 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/79 (0%) 0/80 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/79 (0%) 0/80 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/79 (0%) 0/80 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/79 (1%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 264 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/79 (0%) 0/80 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/79 (0%) 0/80 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/79 (0%) 0/80 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/79 (0%) 0/80 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 265 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/79 (0%) 2/80 (3%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/79 (0%) 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/79 (0%) 2/80 (3%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/79 (0%) 0/80 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/79 (0%) 0/80 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 266 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/79 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 267 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/79 (0%) 3/80 (4%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/79 (0%) 3/80 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 268 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/67 (0%) 0/76 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 1/79 (1%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 1/79 (1%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/79 (1%) 4/80 (5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/79 (1%) 4/80 (5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 269 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/79 (0%) 0/80 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 270 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/78 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 271 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/80 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/79 (0%) 0/80 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 273 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 36/50 (72%) 30/50 (60%) 24/50 (48%) 28/50 (56%) 31/50 (62%) 29/49 (59%) | | 31/50 (62%) 30/50 (60%) 31/50 (62%) 22/50 (44%) 25/50 (50%) 23/50 (46%) | | 30/50 (60%) 27/50 (54%) 29/50 (58%) 22/50 (44%) 32/50 (64%) 23/49 (47%) | | 30/50 (60%) 22/50 (44%) 28/50 (56%) 29/50 (58%) 26/50 (52%) 25/50 (50%) | | 31/50 (62%) 27/50 (54%) 36/50 (72%) 31/50 (62%) 33/50 (66%) 21/50 (42%) | | Overall Incidence Total 442/750 (58.93%)Mean 58.93% SD 7.44% Total 400/748 (53.48%) Mean 53.47% SD 8.06% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 19/50 (38%) 19/50 (38%) 18/50 (36%) 15/50 (30%) 27/50 (54%) 23/49 (47%) | | 34/50 (68%) 33/50 (66%) 23/50 (46%) 20/50 (40%) 27/50 (54%) 20/50 (40%) | | 23/50 (46%) 33/50 (66%) 11/50 (22%) 26/50 (52%) 24/50 (48%) 21/49 (43%) | | 21/50 (42%) 28/50 (56%) 20/50 (40%) 29/50 (58%) 25/50 (50%) 28/50 (56%) | | 22/50 (44%) 25/50 (50%) 24/50 (48%) 26/50 (52%) 31/50 (62%) 21/50 (42%) | | Overall Incidence Total 353/750 (47.07%)Mean 47.07% SD 12.67% Total 363/748 (48.53%) Mean 48.52% SD 8.36% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 44/50 (88%) 42/50 (84%) 32/50 (64%) 35/50 (70%) 43/50 (86%) 35/49 (71%) | | 48/50 (96%) 49/50 (98%) 43/50 (86%) 34/50 (68%) 42/50 (84%) 36/50 (72%) | | 40/50 (80%) 44/50 (88%) 35/50 (70%) 36/50 (72%) 41/50 (82%) 34/49 (69%) | | 41/50 (82%) 40/50 (80%) 40/50 (80%) 43/50 (86%) 38/50 (76%) 40/50 (80%) | | 40/50 (80%) 40/50 (80%) 47/50 (94%) 38/50 (76%) 47/50 (94%) 34/50 (68%) | | Overall Incidence Total 625/750 (83.33%)Mean 83.33% SD 9.06% Total 576/748 (77.01%) Mean 76.99% SD 7.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/49 (4%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 7/750 (0.93%) Mean 0.93% SD 1.49% Total 12/748 (1.6%) Mean 1.61% SD 2.3% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) 3/49 (6%) | | 3/50 (6%) 3/50 (6%) 1/50 (2%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | | 3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/49 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 23/750 (3.07%) Mean 3.07% SD 2.12% Total 31/748 (4.14%) Mean 4.14% SD 2.57% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/50 (4%) 1/50 (2%) 3/50 (6%) 5/50 (10%) 5/50 (10%) 5/49 (10%) | | 3/50 (6%) 5/50 (10%) 1/50 (2%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | | 5/50 (10%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/49 (2%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 7/50 (14%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 30/750 (4%) Mean 4% SD 3.12% Total 43/748 (5.75%) Mean 5.75% SD 3.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 274 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/49 (4%) | | 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | | 3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 4/49 (8%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 18/750 (2.4%) Mean 2.4% SD 2.53% Total 27/748 (3.61%) Mean 3.62% SD 2.19% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Mononuclear, or Undifferentiated 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 4/50 (8%) 1/50 (2%) 3/50 (6%) 6/50 (12%) 7/50 (14%) 11/49 (22%) | | Lymphocytic, Mixed, NOS, or 2/50 (4%) 1/50 (2%) 3/50 (6%) 7/50 (14%) 4/50 (8%) 6/50 (12%) | | Undifferentiated Cell Type 1/50 (2%) 4/50 (8%) 2/50 (4%) 3/50 (6%) 12/50 (24%) 13/49 (27%) | | 4/50 (8%) 1/50 (2%) 2/50 (4%) 16/50 (32%) 12/50 (24%) 3/50 (6%) | | 3/50 (6%) 4/50 (8%) 2/50 (4%) 9/50 (18%) 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 37/750 (4.93%) Mean 4.93% SD 2.37% Total 123/748 (16.44%) Mean 16.47% SD 7.79% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 275 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 5/748 (0.67%) Mean 0.67% SD 1.23% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 5/748 (0.67%) Mean 0.67% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 2/50 (4%) 2/50 (4%) 2/48 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/49 (0%) 6/50 (12%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/47 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 2/49 (4%) 2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 5/49 (10%) 0/50 (0%) 3/48 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 28/739 (3.79%) Mean 3.8% SD 3.58% Total 3/747 (0.4%) Mean 0.4% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 1/747 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 276 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/0 (0%) 0/47 (0%) 0/49 (0%) 0/0 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/689 (0%) Mean 0% SD 0% Total 0/697 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) 3/50 (6%) 2/48 (4%) | | 0/50 (0%) 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/48 (2%) | | 1/50 (2%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 4/50 (8%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | | Overall Incidence Total 4/738 (0.54%) Mean 0.55% SD 0.94% Total 15/741 (2.02%) Mean 2.02% SD 2.52% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/738 (0%) Mean 0% SD 0% Total 0/741 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) | | 1/50 (2%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/738 (0.14%) Mean 0.13% SD 0.52% Total 1/741 (0.13%) Mean 0.14% SD 0.54% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) 3/50 (6%) 3/48 (6%) | | Complex, Malignant, NOS 1/50 (2%) 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/48 (2%) | | 1/50 (2%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 4/50 (8%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | | Overall Incidence Total 5/738 (0.68%) Mean 0.68% SD 1% Total 16/741 (2.16%) Mean 2.16% SD 2.7% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/742 (0%) Mean 0% SD 0% Total 0/745 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 277 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/742 (0%) Mean 0% SD 0% Total 0/745 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 0/49 (0%) 1/48 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | | Overall Incidence Total 3/742 (0.4%) Mean 0.41% SD 0.85% Total 10/745 (1.34%) Mean 1.34% SD 1.24% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/742 (0%) Mean 0% SD 0% Total 1/745 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/742 (0.13%) Mean 0.13% SD 0.52% Total 0/745 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/742 (0%) Mean 0% SD 0% Total 0/745 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 278 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/750 (0.27%) Mean 0.27% SD 0.7% Total 3/748 (0.4%) Mean 0.4% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 4/748 (0.53%) Mean 0.53% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 4/748 (0.53%) Mean 0.53% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 1/747 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 279 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 1/747 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/749 (0%) Mean 0% SD 0% Total 0/747 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 280 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 281 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/746 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 282 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/44 (0%) 0/42 (0%) 0/45 (0%) 0/46 (0%) 0/43 (0%) 0/42 (0%) | | 0/41 (0%) 0/37 (0%) 0/45 (0%) 0/45 (0%) 0/43 (0%) 0/43 (0%) | | 0/42 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) | | 0/46 (0%) 0/47 (0%) 0/43 (0%) 0/46 (0%) 0/46 (0%) 0/40 (0%) | | 0/43 (0%) 0/46 (0%) 0/42 (0%) 0/40 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/653 (0%) Mean 0% SD 0% Total 0/669 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 6/50 (12%) 3/50 (6%) 5/50 (10%) 8/50 (16%) 4/50 (8%) 3/49 (6%) | | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | 0/0 (0%) 3/50 (6%) 7/50 (14%) 0/0 (0%) 1/50 (2%) 4/49 (8%) | | 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 0/0 (0%) 1/50 (2%) 1/50 (2%) 0/0 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 40/650 (6.15%) Mean 5.33% SD 4.25% Total 32/648 (4.94%) Mean 4.29% SD 4.08% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/0 (0%) 1/50 (2%) 0/50 (0%) 0/0 (0%) 2/50 (4%) 1/49 (2%) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 0/0 (0%) 0/50 (0%) 3/50 (6%) 0/0 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 10/650 (1.54%) Mean 1.33% SD 1.95% Total 10/648 (1.54%) Mean 1.34% SD 1.45% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 6/50 (12%) 3/50 (6%) 5/50 (10%) 8/50 (16%) 5/50 (10%) 3/49 (6%) | | 2/50 (4%) 4/50 (8%) 4/50 (8%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | | 0/0 (0%) 4/50 (8%) 7/50 (14%) 0/0 (0%) 3/50 (6%) 5/49 (10%) | | 4/50 (8%) 3/50 (6%) 3/50 (6%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | | 0/0 (0%) 1/50 (2%) 4/50 (8%) 0/0 (0%) 3/50 (6%) 2/50 (4%) | | Overall Incidence Total 50/650 (7.69%) Mean 6.67% SD 3.98% Total 42/648 (6.48%) Mean 5.62% SD 4.03% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 283 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/750 (0.27%) Mean 0.27% SD 0.7% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 284 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 285 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 3/748 (0.4%) Mean 0.4% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/750 (0.8%) Mean 0.8% SD 1.26% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 286 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/750 (0.8%) Mean 0.8% SD 1.26% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/750 (0.93%) Mean 0.93% SD 1.49% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 287 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 3/748 (0.4%) Mean 0.4% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 2/50 (4%) 0/47 (0%) 0/49 (0%) 2/50 (4%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/47 (2%) 1/50 (2%) 1/50 (2%) | | 1/49 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 6/737 (0.81%) Mean 0.8% SD 1.48% Total 8/739 (1.08%) Mean 1.08% SD 1.29% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/737 (0%) Mean 0% SD 0% Total 0/739 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 288 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 2/50 (4%) 0/47 (0%) 0/49 (0%) 2/50 (4%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/47 (2%) 1/50 (2%) 1/50 (2%) | | 1/49 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 6/737 (0.81%) Mean 0.8% SD 1.48% Total 8/739 (1.08%) Mean 1.08% SD 1.29% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/744 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/744 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/744 (0.13%) Mean 0.14% SD 0.53% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/744 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/744 (0.4%) Mean 0.4% SD 0.83% Total 1/746 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 289 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/744 (0.13%) Mean 0.13% SD 0.52% Total 2/746 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/744 (0.54%) Mean 0.54% SD 1.19% Total 2/746 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/744 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/744 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/744 (0%) Mean 0% SD 0% Total 1/746 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 290 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/748 (0.13%) Mean 0.14% SD 0.53% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/47 (0%) 1/49 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/748 (1.6%) Mean 1.61% SD 1.56% Total 6/743 (0.81%) Mean 0.81% SD 1.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/748 (0.67%) Mean 0.67% SD 2.09% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 13/50 (26%) 22/50 (44%) 13/50 (26%) 11/49 (22%) 16/50 (32%) 4/49 (8%) | | 22/50 (44%) 22/50 (44%) 13/50 (26%) 17/50 (34%) 8/50 (16%) 7/50 (14%) | | 16/50 (32%) 19/49 (39%) 19/50 (38%) 11/50 (22%) 11/50 (22%) 5/49 (10%) | | 20/50 (40%) 12/49 (24%) 20/50 (40%) 20/47 (43%) 9/49 (18%) 9/50 (18%) | | 17/50 (34%) 23/50 (46%) 24/50 (48%) 14/50 (28%) 20/50 (40%) 12/50 (24%) | | Overall Incidence Total 275/748 (36.76%)Mean 36.75% SD 8.12% Total 174/743 (23.42%) Mean 23.45% SD 10.21% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 291 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 11/50 (22%) 10/50 (20%) 7/50 (14%) 4/49 (8%) 10/50 (20%) 7/49 (14%) | | 24/50 (48%) 23/50 (46%) 15/50 (30%) 4/50 (8%) 12/50 (24%) 9/50 (18%) | | 13/50 (26%) 15/49 (31%) 7/50 (14%) 12/50 (24%) 4/50 (8%) 4/49 (8%) | | 13/50 (26%) 17/49 (35%) 12/50 (24%) 5/47 (11%) 6/49 (12%) 19/50 (38%) | | 16/50 (32%) 12/50 (24%) 14/50 (28%) 10/50 (20%) 15/50 (30%) 6/50 (12%) | | Overall Incidence Total 209/748 (27.94%)Mean 27.95% SD 9.74% Total 127/743 (17.09%) Mean 17.03% SD 9.03% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 11/50 (22%) 10/50 (20%) 7/50 (14%) 4/49 (8%) 10/50 (20%) 7/49 (14%) | | Hepatoblastoma 24/50 (48%) 27/50 (54%) 15/50 (30%) 4/50 (8%) 12/50 (24%) 9/50 (18%) | | 13/50 (26%) 15/49 (31%) 7/50 (14%) 12/50 (24%) 4/50 (8%) 4/49 (8%) | | 13/50 (26%) 17/49 (35%) 12/50 (24%) 5/47 (11%) 6/49 (12%) 19/50 (38%) | | 16/50 (32%) 12/50 (24%) 14/50 (28%) 10/50 (20%) 15/50 (30%) 6/50 (12%) | | Overall Incidence Total 213/748 (28.48%)Mean 28.49% SD 10.94% Total 127/743 (17.09%) Mean 17.03% SD 9.03% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 21/50 (42%) 30/50 (60%) 19/50 (38%) 15/49 (31%) 22/50 (44%) 9/49 (18%) | | Hepatocellular Adenoma 43/50 (86%) 38/50 (76%) 28/50 (56%) 20/50 (40%) 18/50 (36%) 14/50 (28%) | | 26/50 (52%) 32/49 (65%) 24/50 (48%) 21/50 (42%) 14/50 (28%) 9/49 (18%) | | 30/50 (60%) 27/49 (55%) 30/50 (60%) 23/47 (49%) 12/49 (24%) 23/50 (46%) | | 29/50 (58%) 30/50 (60%) 35/50 (70%) 19/50 (38%) 27/50 (54%) 17/50 (34%) | | Overall Incidence Total 442/748 (59.09%)Mean 59.09% SD 12.27% Total 263/743 (35.4%) Mean 35.38% SD 10.76% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 21/50 (42%) 30/50 (60%) 19/50 (38%) 15/49 (31%) 22/50 (44%) 9/49 (18%) | | Hepatocellular Adenoma, or 43/50 (86%) 40/50 (80%) 28/50 (56%) 20/50 (40%) 18/50 (36%) 14/50 (28%) | | Hepatoblastoma 26/50 (52%) 32/49 (65%) 24/50 (48%) 21/50 (42%) 14/50 (28%) 9/49 (18%) | | 30/50 (60%) 27/49 (55%) 30/50 (60%) 23/47 (49%) 12/49 (24%) 23/50 (46%) | | 29/50 (58%) 30/50 (60%) 35/50 (70%) 19/50 (38%) 27/50 (54%) 17/50 (34%) | | Overall Incidence Total 444/748 (59.36%)Mean 59.36% SD 12.7% Total 263/743 (35.4%) Mean 35.38% SD 10.76% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/47 (2%) 2/49 (4%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 7/748 (0.94%) Mean 0.93% SD 1.67% Total 12/743 (1.62%) Mean 1.61% SD 1.73% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 292 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/747 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 293 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 18/50 (36%) 9/50 (18%) 6/50 (12%) 4/50 (8%) 7/50 (14%) 7/49 (14%) | | 8/50 (16%) 9/50 (18%) 16/50 (32%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | | 13/50 (26%) 8/48 (17%) 11/49 (22%) 6/50 (12%) 2/50 (4%) 4/48 (8%) | | 12/50 (24%) 5/50 (10%) 9/50 (18%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | 11/50 (22%) 6/50 (12%) 18/50 (36%) 3/50 (6%) 4/50 (8%) 1/50 (2%) | | Overall Incidence Total 159/747 (21.29%)Mean 21.27% SD 8.28% Total 48/746 (6.43%) Mean 6.45% SD 4.33% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 5/50 (10%) 5/50 (10%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 6/50 (12%) 4/50 (8%) 4/50 (8%) 2/50 (4%) 1/50 (2%) 4/50 (8%) | | 3/50 (6%) 10/48 (21%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 3/48 (6%) | | 6/50 (12%) 7/50 (14%) 2/50 (4%) 4/49 (8%) 3/50 (6%) 2/50 (4%) | | 2/50 (4%) 8/50 (16%) 6/50 (12%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 72/747 (9.64%) Mean 9.66% SD 5.21% Total 25/746 (3.35%) Mean 3.36% SD 2.73% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 21/50 (42%) 14/50 (28%) 10/50 (20%) 4/50 (8%) 7/50 (14%) 8/49 (16%) | | Alveolar/Bronchiolar Adenoma 13/50 (26%) 11/50 (22%) 20/50 (40%) 4/50 (8%) 4/50 (8%) 6/50 (12%) | | 15/50 (30%) 18/48 (38%) 11/49 (22%) 7/50 (14%) 3/50 (6%) 7/48 (15%) | | 17/50 (34%) 12/50 (24%) 11/50 (22%) 6/49 (12%) 3/50 (6%) 3/50 (6%) | | 13/50 (26%) 14/50 (28%) 21/50 (42%) 3/50 (6%) 6/50 (12%) 2/50 (4%) | | Overall Incidence Total 221/747 (29.59%)Mean 29.6% SD 7.65% Total 73/746 (9.79%) Mean 9.81% SD 3.94% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/747 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/747 (0%) Mean 0% SD 0% Total 1/746 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/747 (0.13%) Mean 0.13% SD 0.52% Total 2/746 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 294 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/747 (0%) Mean 0% SD 0% Total 1/746 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/747 (0%) Mean 0% SD 0% Total 0/746 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 295 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 296 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 18/748 (2.41%) Mean 2.41% SD 2.31% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 297 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 18/748 (2.41%) Mean 2.41% SD 2.31% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | | or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 18/748 (2.41%) Mean 2.41% SD 2.31% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 298 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/750 (0.27%) Mean 0.27% SD 1.03% Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 299 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/745 (0.13%) Mean 0.13% SD 0.52% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/745 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/745 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 300 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/745 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 2/748 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 2/49 (4%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 1/49 (2%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 3/734 (0.41%) Mean 0.41% SD 1.14% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 301 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 1/48 (2%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/734 (0.14%) Mean 0.14% SD 0.54% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/49 (0%) 0/50 (0%) 1/48 (2%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/734 (0.14%) Mean 0.14% SD 0.54% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/49 (0%) 2/50 (4%) 1/48 (2%) | | 1/48 (2%) 2/48 (4%) 2/50 (4%) | | 2/49 (4%) 1/49 (2%) 0/49 (0%) | | 0/48 (0%) 1/50 (2%) 1/50 (2%) | | 2/47 (4%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 16/734 (2.18%) Mean 2.18% SD 1.64% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/49 (2%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 1/48 (2%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 1/49 (2%) | | 1/48 (2%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 4/734 (0.54%) Mean 0.55% SD 0.94% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 302 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/49 (2%) 0/50 (0%) 0/48 (0%) | | Malignant, NOS 0/48 (0%) 1/48 (2%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 1/49 (2%) | | 1/48 (2%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 4/734 (0.54%) Mean 0.55% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 1/49 (2%) 1/50 (2%) 1/48 (2%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 3/734 (0.41%) Mean 0.41% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 303 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) 0/50 (0%) 1/48 (2%) | | 0/48 (0%) 1/48 (2%) 1/50 (2%) | | 0/49 (0%) 2/49 (4%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 1/50 (2%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 6/734 (0.82%) Mean 0.82% SD 1.29% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 1/48 (2%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 1/48 (2%) 1/50 (2%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 3/734 (0.41%) Mean 0.41% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 1/50 (2%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/734 (0.14%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/734 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 1/49 (2%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/734 (0.14%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 304 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 1/49 (2%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 1/50 (2%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/734 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/49 (0%) 0/50 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 1/48 (2%) 1/50 (2%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/734 (0.27%) Mean 0.27% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/739 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 1/739 (0.14%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 1/739 (0.14%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/739 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 305 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/739 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/739 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 1/739 (0.14%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/739 (0%) Mean 0% SD 0% Total 0/739 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/39 (0%) 0/26 (0%) 0/39 (0%) 0/40 (0%) 0/31 (0%) 0/24 (0%) | | 0/35 (0%) 0/19 (0%) 0/32 (0%) 0/35 (0%) 0/25 (0%) 0/32 (0%) | | 0/34 (0%) 0/21 (0%) 0/31 (0%) 0/39 (0%) 0/27 (0%) 0/34 (0%) | | 0/41 (0%) 0/43 (0%) 0/36 (0%) 0/35 (0%) 0/44 (0%) 0/31 (0%) | | 0/41 (0%) 0/47 (0%) 0/39 (0%) 1/33 (3%) 0/44 (0%) 0/30 (0%) | | Overall Incidence Total 0/523 (0%) Mean 0% SD 0% Total 1/504 (0.2%) Mean 0.2% SD 0.78% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 306 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/50 (2%) 0/49 (0%) 0/46 (0%) 7/50 (14%) 5/50 (10%) 14/48 (29%) | | Adenoma 1/49 (2%) 0/48 (0%) 0/50 (0%) 4/49 (8%) 11/48 (23%) 7/48 (15%) | | 0/48 (0%) 1/46 (2%) 0/49 (0%) 3/46 (7%) 20/49 (41%) 8/49 (16%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 8/49 (16%) 10/50 (20%) 9/49 (18%) | | 1/47 (2%) 0/47 (0%) 1/45 (2%) 9/50 (18%) 17/50 (34%) 10/47 (21%) | | Overall Incidence Total 5/720 (0.69%) Mean 0.7% SD 1.03% Total 142/732 (19.4%) Mean 19.36% SD 9.4% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/49 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) | | Carcinoma 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) | | 0/48 (0%) 0/46 (0%) 1/49 (2%) 0/46 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/47 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 1/720 (0.14%) Mean 0.14% SD 0.53% Total 2/732 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/50 (2%) 0/49 (0%) 0/46 (0%) 7/50 (14%) 6/50 (12%) 14/48 (29%) | | Carcinoma or Adenoma 1/49 (2%) 0/48 (0%) 0/50 (0%) 4/49 (8%) 11/48 (23%) 7/48 (15%) | | 0/48 (0%) 1/46 (2%) 1/49 (2%) 3/46 (7%) 21/49 (43%) 8/49 (16%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 8/49 (16%) 10/50 (20%) 9/49 (18%) | | 1/47 (2%) 0/47 (0%) 1/45 (2%) 9/50 (18%) 17/50 (34%) 10/47 (21%) | | Overall Incidence Total 6/720 (0.83%) Mean 0.84% SD 1.07% Total 144/732 (19.67%) Mean 19.63% SD 9.62% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/49 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) 1/48 (2%) | | 0/48 (0%) 1/46 (2%) 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 1/47 (2%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 3/720 (0.42%) Mean 0.43% SD 0.89% Total 2/732 (0.27%) Mean 0.27% SD 0.73% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 0/47 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/720 (0%) Mean 0% SD 0% Total 0/732 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) 1/48 (2%) | | 0/48 (0%) 1/46 (2%) 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/47 (0%) 1/47 (2%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 3/720 (0.42%) Mean 0.43% SD 0.89% Total 2/732 (0.27%) Mean 0.27% SD 0.73% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 307 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/47 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/725 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/47 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/725 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/47 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/725 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/743 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/743 (0%) Mean 0% SD 0% Total 0/743 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 308 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 309 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 310 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 311 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma, Basosq. Tumor (M or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Papilloma, Sq Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Keratoacanthoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 4/748 (0.53%) Mean 0.53% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/750 (0.4%) Mean 0.4% SD 0.83% Total 5/748 (0.67%) Mean 0.67% SD 1.23% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 312 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 313 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Papilloma, Squamous Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Carcinoma or Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 3/748 (0.4%) Mean 0.4% SD 0.83% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 314 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Papilloma, or Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) | | Myxoma, Myxosarcoma, or Fibrous 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) | | Histiocytoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 4/50 (8%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 8/750 (1.07%) Mean 1.07% SD 1.28% Total 23/748 (3.07%) Mean 3.07% SD 3.53% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/750 (0.27%) Mean 0.27% SD 0.7% Total 2/748 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) | | Myxosarcoma, or Fibrous 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) | | Histiocytoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 4/50 (8%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 8/750 (1.07%) Mean 1.07% SD 1.28% Total 23/748 (3.07%) Mean 3.07% SD 3.53% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 315 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 6/750 (0.8%) Mean 0.8% SD 1.01% Total 21/748 (2.81%) Mean 2.8% SD 3.53% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 316 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/740 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/740 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/740 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 317 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) 2/49 (4%) | | 0/50 (0%) 1/47 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 1/48 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/49 (6%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) 1/49 (2%) | | Overall Incidence Total 7/740 (0.95%) Mean 0.95% SD 1.3% Total 12/744 (1.61%) Mean 1.62% SD 1.92% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/740 (0%) Mean 0% SD 0% Total 1/744 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/740 (0%) Mean 0% SD 0% Total 0/744 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 318 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Papilloma Squamous 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 6/750 (0.8%) Mean 0.8% SD 1.01% Total 6/748 (0.8%) Mean 0.8% SD 1.02% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 6/750 (0.8%) Mean 0.8% SD 1.01% Total 5/748 (0.67%) Mean 0.67% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/750 (0.27%) Mean 0.27% SD 0.7% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 319 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/747 (0.54%) Mean 0.53% SD 1.19% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/747 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 320 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/47 (0%) 0/43 (0%) 1/44 (2%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 1/572 (0.17%) Mean 0.15% SD 0.59% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 1/43 (2%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 1/658 (0.15%) Mean 0.16% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 1/43 (2%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 1/658 (0.15%) Mean 0.16% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 321 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 0/43 (0%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/47 (0%) 0/43 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) 0/44 (0%) | | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/44 (0%) 0/41 (0%) 0/42 (0%) | | 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) 0/49 (0%) | | 0/41 (0%) 0/39 (0%) 0/30 (0%) 0/47 (0%) 0/41 (0%) 0/40 (0%) | | 0/33 (0%) 0/39 (0%) 0/35 (0%) 1/43 (2%) 0/47 (0%) 0/40 (0%) | | Overall Incidence Total 0/572 (0%) Mean 0% SD 0% Total 1/658 (0.15%) Mean 0.16% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/742 (0.13%) Mean 0.14% SD 0.53% Total 1/746 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/742 (0%) Mean 0% SD 0% Total 1/746 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/742 (0.13%) Mean 0.14% SD 0.53% Total 2/746 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 2/50 (4%) 2/49 (4%) 1/50 (2%) 1/50 (2%) 2/49 (4%) | | 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 3/50 (6%) | | 1/50 (2%) 1/48 (2%) 1/48 (2%) 1/50 (2%) 4/50 (8%) 1/49 (2%) | | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/48 (2%) 3/50 (6%) 2/50 (4%) | | 1/50 (2%) 0/49 (0%) 4/49 (8%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 20/742 (2.7%) Mean 2.69% SD 2.25% Total 31/746 (4.16%) Mean 4.15% SD 2.19% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 322 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 1/48 (2%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | | Overall Incidence Total 4/742 (0.54%) Mean 0.54% SD 0.93% Total 5/746 (0.67%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 2/50 (4%) 2/49 (4%) 1/50 (2%) 1/50 (2%) 2/49 (4%) | | 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 4/50 (8%) 3/50 (6%) | | 2/50 (4%) 2/48 (4%) 1/48 (2%) 1/50 (2%) 4/50 (8%) 1/49 (2%) | | 0/50 (0%) 4/50 (8%) 2/50 (4%) 1/48 (2%) 3/50 (6%) 2/50 (4%) | | 1/50 (2%) 0/49 (0%) 4/49 (8%) 4/50 (8%) 5/50 (10%) 3/50 (6%) | | Overall Incidence Total 24/742 (3.23%) Mean 3.23% SD 2.51% Total 36/746 (4.83%) Mean 4.81% SD 2.8% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 323 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 2/748 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 324 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 1/748 (0.13%) Mean 0.14% SD 0.53% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/750 (0.4%) Mean 0.4% SD 0.83% Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 1/736 (0.14%) Mean 0.13% SD 0.52% Total 0/720 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/736 (0%) Mean 0% SD 0% Total 0/720 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/736 (0%) Mean 0% SD 0% Total 0/720 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 325 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/736 (0%) Mean 0% SD 0% Total 0/720 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 1/736 (0.14%) Mean 0.13% SD 0.52% Total 0/720 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/748 (0.27%) Mean 0.27% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/748 (0.13%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 326 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 1/50 (2%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/748 (0.67%) Mean 0.67% SD 1.24% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 2/49 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/748 (0.27%) Mean 0.27% SD 1.05% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/748 (0.27%) Mean 0.27% SD 0.7% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/50 (4%) 1/50 (2%) 2/49 (4%) | | 2/50 (4%) 0/50 (0%) 2/50 (4%) | | 1/50 (2%) 3/50 (6%) 0/49 (0%) | | 3/50 (6%) 2/50 (4%) 4/50 (8%) | | 4/50 (8%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 28/748 (3.74%) Mean 3.74% SD 2.49% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 327 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 2/748 (0.27%) Mean 0.27% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/50 (4%) 1/50 (2%) 2/49 (4%) | | 2/50 (4%) 0/50 (0%) 2/50 (4%) | | 1/50 (2%) 3/50 (6%) 0/49 (0%) | | 3/50 (6%) 2/50 (4%) 4/50 (8%) | | 4/50 (8%) 3/50 (6%) 1/50 (2%) | | Overall Incidence Total 30/748 (4.01%) Mean 4.01% SD 2.51% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 328 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/750 (0%) Mean 0% SD 0% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/750 (0.13%) Mean 0.13% SD 0.52% Total 0/748 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 329 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 35/50 (70%) 38/50 (76%) 17/51 (33%) 20/52 (38%) | | Overall Incidence Total 73/100 (73%) Mean 73% SD 4.24% Total 37/103 (35.92%) Mean 35.9% SD 3.63% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 15/50 (30%) 9/51 (18%) 8/52 (15%) | | Overall Incidence Total 32/100 (32%) Mean 32% SD 2.83% Total 17/103 (16.5%) Mean 16.52% SD 1.6% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 42/50 (84%) 42/50 (84%) 24/51 (47%) 25/52 (48%) | | Overall Incidence Total 84/100 (84%) Mean 84% SD 0% Total 49/103 (47.57%) Mean 47.57% SD 0.72% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/50 (6%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 3/50 (6%) 0/50 (0%) 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 1/51 (2%) 1/52 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/103 (1.94%) Mean 1.94% SD 0.03% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 4/51 (8%) 5/52 (10%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 9/103 (8.74%) Mean 8.73% SD 1.25% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 330 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Adenoma | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 1/49 (2%) 0/47 (0%) 2/49 (4%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.02% SD 1.44% Total 2/96 (2.08%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 1/49 (2%) 0/47 (0%) 2/49 (4%) | | Complex, Malignant, NOS | | Overall Incidence Total 1/98 (1.02%) Mean 1.02% SD 1.44% Total 2/96 (2.08%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 331 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 332 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Astrocytoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 333 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/45 (0%) 0/40 (0%) 0/45 (0%) 0/41 (0%) | | Overall Incidence Total 0/85 (0%) Mean 0% SD 0% Total 0/86 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 5/50 (10%) 3/50 (6%) 1/51 (2%) 1/52 (2%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 2/103 (1.94%) Mean 1.94% SD 0.03% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 5/50 (10%) 3/50 (6%) 1/51 (2%) 1/52 (2%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 2/103 (1.94%) Mean 1.94% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 334 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 335 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 2/50 (4%) 2/50 (4%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 3/50 (6%) 2/50 (4%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 4/50 (8%) 2/50 (4%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 336 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 1/49 (2%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/49 (2%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 337 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 2/50 (4%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 29/50 (58%) 26/50 (52%) 10/51 (20%) 8/50 (16%) | | Overall Incidence Total 55/100 (55%) Mean 55% SD 4.24% Total 18/101 (17.82%) Mean 17.8% SD 2.55% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 11/50 (22%) 11/50 (22%) 3/51 (6%) 0/50 (0%) | | Overall Incidence Total 22/100 (22%) Mean 22% SD 0% Total 3/101 (2.97%) Mean 2.94% SD 4.16% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 11/50 (22%) 11/50 (22%) 3/51 (6%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 22/100 (22%) Mean 22% SD 0% Total 3/101 (2.97%) Mean 2.94% SD 4.16% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 36/50 (72%) 35/50 (70%) 13/51 (25%) 8/50 (16%) | | Hepatocellular Adenoma | | Overall Incidence Total 71/100 (71%) Mean 71% SD 1.41% Total 21/101 (20.79%) Mean 20.75% SD 6.71% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 36/50 (72%) 35/50 (70%) 13/51 (25%) 8/50 (16%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 71/100 (71%) Mean 71% SD 1.41% Total 21/101 (20.79%) Mean 20.75% SD 6.71% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 338 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 8/50 (16%) 14/50 (28%) 2/51 (4%) 2/51 (4%) | | Overall Incidence Total 22/100 (22%) Mean 22% SD 8.49% Total 4/102 (3.92%) Mean 3.92% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 9/50 (18%) 14/50 (28%) 2/51 (4%) 2/51 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 23/100 (23%) Mean 23% SD 7.07% Total 4/102 (3.92%) Mean 3.92% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 339 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 340 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 341 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 342 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/50 (2%) 2/51 (4%) | | Overall Incidence Total 3/101 (2.97%) Mean 2.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) 0/51 (0%) | | Malignant, NOS | | Overall Incidence Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 343 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 344 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/39 (0%) 0/38 (0%) 0/38 (0%) 0/35 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/73 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/42 (0%) 9/47 (19%) 4/45 (9%) | | Adenoma | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 13/92 (14.13%) Mean 14.02% SD 7.25% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/42 (0%) 0/47 (0%) 0/45 (0%) | | Carcinoma | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/92 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/42 (0%) 9/47 (19%) 4/45 (9%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 13/92 (14.13%) Mean 14.02% SD 7.25% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 345 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/42 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/92 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/47 (0%) 0/42 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/92 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/42 (0%) 0/47 (0%) 0/45 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/92 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/102 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 346 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 347 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 348 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 349 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/51 (0%) 2/52 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/103 (1.94%) Mean 1.92% SD 2.72% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/52 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 350 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/49 (2%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.02% SD 1.44% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 351 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 3/50 (6%) 2/50 (4%) 2/51 (4%) 1/52 (2%) | | Papilloma Squamous | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 3/103 (2.91%) Mean 2.92% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 2/50 (4%) 2/50 (4%) 2/51 (4%) 1/52 (2%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 3/103 (2.91%) Mean 2.92% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/49 (2%) 3/49 (6%) | | Overall Incidence Total 4/98 (4.08%) Mean 4.08% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 352 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/41 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/88 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/47 (2%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/95 (1.05%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/47 (2%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/95 (1.05%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 353 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/45 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 354 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/45 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/45 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/45 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/45 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 1/103 (0.97%) Mean 0.96% SD 1.36% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 355 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BIOASSAY SYS CORP Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/51 (2%) 0/52 (0%) | | Overall Incidence Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/51 (2%) 0/52 (0%) | | Overall Incidence Total 1/103 (0.97%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/103 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 357 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 29/50 (58%) 16/50 (32%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 16/50 (32%) 16/50 (32%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 37/50 (74%) 27/50 (54%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 4/50 (8%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 358 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 359 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 360 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 361 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/44 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 362 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 363 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 364 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 365 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 17/50 (34%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 14/50 (28%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 14/50 (28%) 4/50 (8%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 28/50 (56%) 10/50 (20%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 28/50 (56%) 10/50 (20%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 366 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 4/50 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 367 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 368 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 1/50 (2%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 369 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 370 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 371 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 372 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/43 (0%) 5/49 (10%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/43 (0%) 1/49 (2%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/43 (0%) 6/49 (12%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 373 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/43 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/43 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/43 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 374 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 375 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 376 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 377 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 378 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 379 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 380 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/41 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/49 (2%) 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/49 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/49 (2%) 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 381 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 382 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 383 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BROOKHAVEN Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 385 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 35/50 (70%) 34/50 (68%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 22/50 (44%) 31/50 (62%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 42/50 (84%) 46/50 (92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 6/50 (12%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 10/50 (20%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 386 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 2/48 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/49 (0%) 0/48 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/48 (2%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/48 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/48 (0%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/48 (2%) 2/48 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 387 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 2/49 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 388 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 389 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/46 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 390 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 391 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/49 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 392 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/49 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 393 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 3/50 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 24/50 (48%) 30/50 (60%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 8/50 (16%) 13/50 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 8/50 (16%) 13/50 (26%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 27/50 (54%) 33/50 (66%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 27/50 (54%) 33/50 (66%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 394 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 7/50 (14%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 18/50 (36%) 4/50 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 395 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 396 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 397 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 398 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 399 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 400 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/37 (0%) 0/40 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 5/44 (11%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 0/44 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 5/44 (11%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 401 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/45 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/45 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/45 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 402 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 403 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 404 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 405 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 406 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 2/48 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 407 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 2/50 (4%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 408 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/39 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 1/39 (3%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 1/39 (3%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/49 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/49 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/49 (0%) 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/49 (2%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/49 (2%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 409 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 410 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 411 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 413 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 19/52 (37%) 25/50 (50%) 36/62 (58%) 17/50 (34%) 24/50 (48%) 30/60 (50%) | | Overall Incidence Total 80/164 (48.78%) Mean 48.2% SD 10.88% Total 71/160 (44.38%) Mean 44% SD 8.72% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 15/52 (29%) 15/50 (30%) 25/62 (40%) 23/50 (46%) 16/50 (32%) 23/60 (38%) | | Overall Incidence Total 55/164 (33.54%) Mean 33.06% SD 6.32% Total 62/160 (38.75%) Mean 38.78% SD 7.01% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 29/52 (56%) 31/50 (62%) 45/62 (73%) 36/50 (72%) 32/50 (64%) 46/60 (77%) | | Overall Incidence Total 105/164 (64.02%)Mean 63.45% SD 8.5% Total 114/160 (71.25%) Mean 70.89% SD 6.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/52 (2%) 0/50 (0%) 0/62 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/52 (8%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 5/164 (3.05%) Mean 3.1% SD 4.06% Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 4/52 (8%) 0/50 (0%) 1/62 (2%) 1/50 (2%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 5/164 (3.05%) Mean 3.1% SD 4.06% Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/52 (2%) 1/50 (2%) 2/62 (3%) 2/50 (4%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 4/164 (2.44%) Mean 2.38% SD 0.73% Total 3/160 (1.88%) Mean 1.89% SD 2.01% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 5/52 (10%) 3/50 (6%) 6/62 (10%) 15/50 (30%) 8/50 (16%) 11/60 (18%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 14/164 (8.54%) Mean 8.43% SD 2.11% Total 34/160 (21.25%) Mean 21.44% SD 7.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 414 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/52 (0%) 2/48 (4%) 1/62 (2%) 0/50 (0%) 2/50 (4%) 0/59 (0%) | | Overall Incidence Total 3/162 (1.85%) Mean 1.93% SD 2.1% Total 2/159 (1.26%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/52 (0%) 0/48 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/52 (0%) 0/48 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/52 (0%) 0/48 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/52 (0%) 0/48 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Adenoma | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/51 (0%) 0/46 (0%) 1/61 (2%) 0/49 (0%) 0/46 (0%) 1/59 (2%) | | Overall Incidence Total 1/158 (0.63%) Mean 0.55% SD 0.95% Total 1/154 (0.65%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/51 (0%) 0/46 (0%) 0/61 (0%) 0/49 (0%) 0/46 (0%) 0/59 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% Total 0/154 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/51 (0%) 0/46 (0%) 0/61 (0%) 0/49 (0%) 0/46 (0%) 0/59 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% Total 0/154 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/51 (0%) 0/46 (0%) 1/61 (2%) 0/49 (0%) 0/46 (0%) 1/59 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 1/158 (0.63%) Mean 0.55% SD 0.95% Total 1/154 (0.65%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 415 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/52 (2%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/163 (0.61%) Mean 0.64% SD 1.11% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 416 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Astrocytoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 417 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/47 (0%) 0/48 (0%) 0/57 (0%) 0/49 (0%) 0/46 (0%) 0/53 (0%) | | Overall Incidence Total 0/152 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 1/52 (2%) 0/50 (0%) 2/62 (3%) 2/50 (4%) 2/50 (4%) 3/60 (5%) | | Overall Incidence Total 3/164 (1.83%) Mean 1.72% SD 1.62% Total 7/160 (4.38%) Mean 4.33% SD 0.58% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/52 (0%) 1/50 (2%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.67% SD 1.15% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 1/52 (2%) 1/50 (2%) 2/62 (3%) 2/50 (4%) 3/50 (6%) 3/60 (5%) | | Overall Incidence Total 4/164 (2.44%) Mean 2.38% SD 0.73% Total 8/160 (5%) Mean 5% SD 1% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 418 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/52 (0%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.54% SD 0.93% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 419 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/52 (0%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.54% SD 0.93% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/52 (0%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.54% SD 0.93% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/52 (2%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 2/164 (1.22%) Mean 1.18% SD 1.03% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/52 (0%) 1/50 (2%) 0/62 (0%) 0/49 (0%) 1/49 (2%) 0/59 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.67% SD 1.15% Total 1/157 (0.64%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 420 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/52 (0%) 1/50 (2%) 0/62 (0%) 0/49 (0%) 1/49 (2%) 0/59 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.67% SD 1.15% Total 1/157 (0.64%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Carcinoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Hemangioma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/52 (0%) 1/50 (2%) 1/62 (2%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 2/164 (1.22%) Mean 1.2% SD 1.06% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/52 (0%) 1/50 (2%) 1/62 (2%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 2/164 (1.22%) Mean 1.2% SD 1.06% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 421 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 3/52 (6%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 4/164 (2.44%) Mean 2.46% SD 2.98% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/52 (0%) 0/50 (0%) 2/62 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 2/164 (1.22%) Mean 1.08% SD 1.86% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 11/52 (21%) 16/50 (32%) 25/62 (40%) 6/50 (12%) 3/50 (6%) 17/60 (28%) | | Overall Incidence Total 52/164 (31.71%) Mean 31.16% SD 9.61% Total 26/160 (16.25%) Mean 15.44% SD 11.56% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 4/52 (8%) 8/50 (16%) 10/62 (16%) 1/50 (2%) 1/50 (2%) 6/60 (10%) | | Overall Incidence Total 22/164 (13.41%) Mean 13.27% SD 4.83% Total 8/160 (5%) Mean 4.67% SD 4.62% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 4/52 (8%) 8/50 (16%) 12/62 (19%) 1/50 (2%) 1/50 (2%) 6/60 (10%) | | Hepatoblastoma | | Overall Incidence Total 24/164 (14.63%) Mean 14.35% SD 6% Total 8/160 (5%) Mean 4.67% SD 4.62% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 13/52 (25%) 18/50 (36%) 31/62 (50%) 7/50 (14%) 4/50 (8%) 22/60 (37%) | | Hepatocellular Adenoma | | Overall Incidence Total 62/164 (37.8%) Mean 37% SD 12.53% Total 33/160 (20.63%) Mean 19.56% SD 15.12% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 13/52 (25%) 18/50 (36%) 31/62 (50%) 7/50 (14%) 4/50 (8%) 22/60 (37%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 62/164 (37.8%) Mean 37% SD 12.53% Total 33/160 (20.63%) Mean 19.56% SD 15.12% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 422 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 7/52 (13%) 9/50 (18%) 11/62 (18%) 4/50 (8%) 6/50 (12%) 1/59 (2%) | | Overall Incidence Total 27/164 (16.46%) Mean 16.4% SD 2.55% Total 11/159 (6.92%) Mean 7.23% SD 5.2% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/52 (2%) 2/50 (4%) 4/62 (6%) 3/50 (6%) 2/50 (4%) 2/59 (3%) | | Overall Incidence Total 7/164 (4.27%) Mean 4.12% SD 2.27% Total 7/159 (4.4%) Mean 4.46% SD 1.37% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 8/52 (15%) 11/50 (22%) 14/62 (23%) 7/50 (14%) 8/50 (16%) 2/59 (3%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 33/164 (20.12%) Mean 19.99% SD 4% Total 17/159 (10.69%) Mean 11.13% SD 6.78% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 423 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 424 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 1/60 (2%) | | or Adenoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 425 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/47 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/156 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/47 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/156 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/50 (0%) 0/47 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/156 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/52 (0%) 1/49 (2%) 0/62 (0%) 0/50 (0%) 0/47 (0%) 0/59 (0%) | | Overall Incidence Total 1/163 (0.61%) Mean 0.68% SD 1.18% Total 0/156 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/52 (0%) 0/50 (0%) 0/62 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 426 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/52 (0%) 0/50 (0%) 0/62 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/49 (0%) 0/49 (0%) 1/59 (2%) | | Overall Incidence Total 1/157 (0.64%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/49 (0%) 0/49 (0%) 1/59 (2%) | | Overall Incidence Total 1/157 (0.64%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/49 (0%) 0/49 (0%) 1/59 (2%) | | Malignant, NOS | | Overall Incidence Total 1/157 (0.64%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 427 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 1/49 (2%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 1/157 (0.64%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 428 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/36 (0%) 0/43 (0%) 0/50 (0%) 0/36 (0%) 0/40 (0%) 0/49 (0%) | | Overall Incidence Total 0/129 (0%) Mean 0% SD 0% Total 0/125 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/52 (0%) 0/50 (0%) 0/62 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/46 (0%) 0/48 (0%) 1/59 (2%) 3/48 (6%) 5/46 (11%) 9/55 (16%) | | Adenoma | | Overall Incidence Total 1/153 (0.65%) Mean 0.56% SD 0.98% Total 17/149 (11.41%) Mean 11.16% SD 5.06% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/46 (0%) 0/48 (0%) 0/59 (0%) 0/48 (0%) 0/46 (0%) 0/55 (0%) | | Carcinoma | | Overall Incidence Total 0/153 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/46 (0%) 0/48 (0%) 1/59 (2%) 3/48 (6%) 5/46 (11%) 9/55 (16%) | | Carcinoma or Adenoma | | Overall Incidence Total 1/153 (0.65%) Mean 0.56% SD 0.98% Total 17/149 (11.41%) Mean 11.16% SD 5.06% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 429 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/46 (0%) 0/48 (0%) 0/59 (0%) 0/48 (0%) 0/46 (0%) 0/55 (0%) | | Overall Incidence Total 0/153 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/46 (0%) 0/48 (0%) 0/59 (0%) 0/48 (0%) 0/46 (0%) 0/55 (0%) | | Overall Incidence Total 0/153 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/46 (0%) 0/48 (0%) 0/59 (0%) 0/48 (0%) 0/46 (0%) 0/55 (0%) | | Overall Incidence Total 0/153 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/51 (0%) 0/45 (0%) 0/62 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/51 (0%) 0/45 (0%) 0/62 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/51 (0%) 0/45 (0%) 0/62 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/52 (0%) 0/48 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/52 (0%) 0/48 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 430 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 431 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 432 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/52 (2%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 1/164 (0.61%) Mean 0.64% SD 1.11% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 433 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/52 (0%) 0/50 (0%) 0/62 (0%) 2/50 (4%) 2/50 (4%) 2/60 (3%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 6/160 (3.75%) Mean 3.78% SD 0.38% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/52 (0%) 0/50 (0%) 0/62 (0%) 2/50 (4%) 2/50 (4%) 2/60 (3%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 6/160 (3.75%) Mean 3.78% SD 0.38% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 2/50 (4%) 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 4/160 (2.5%) Mean 2.56% SD 1.26% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 434 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 1/52 (2%) 0/49 (0%) 0/62 (0%) 1/49 (2%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 1/163 (0.61%) Mean 0.64% SD 1.11% Total 1/157 (0.64%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 2/52 (4%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 2/163 (1.23%) Mean 1.28% SD 2.22% Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 435 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 3/52 (6%) 1/50 (2%) 3/62 (5%) 0/50 (0%) 1/50 (2%) 3/60 (5%) | | Papilloma Squamous | | Overall Incidence Total 7/164 (4.27%) Mean 4.2% SD 1.96% Total 4/160 (2.5%) Mean 2.33% SD 2.52% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 3/52 (6%) 1/50 (2%) 3/62 (5%) 0/50 (0%) 1/50 (2%) 3/60 (5%) | | Overall Incidence Total 7/164 (4.27%) Mean 4.2% SD 1.96% Total 4/160 (2.5%) Mean 2.33% SD 2.52% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/52 (0%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.54% SD 0.93% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/52 (0%) 0/50 (0%) 1/62 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.54% SD 0.93% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/52 (0%) 1/50 (2%) 0/62 (0%) | | Overall Incidence Total 1/164 (0.61%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 436 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 1/59 (2%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 1/147 (0.68%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/47 (0%) 0/38 (0%) 0/58 (0%) 0/46 (0%) 0/42 (0%) 0/59 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/48 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/48 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/48 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 0/48 (0%) 0/62 (0%) 0/49 (0%) 4/50 (8%) 4/60 (7%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 8/159 (5.03%) Mean 4.89% SD 4.29% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/48 (0%) 1/62 (2%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.54% SD 0.93% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 0/48 (0%) 1/62 (2%) 0/49 (0%) 4/50 (8%) 4/60 (7%) | | Overall Incidence Total 2/160 (1.25%) Mean 1.2% SD 1.06% Total 8/159 (5.03%) Mean 4.89% SD 4.29% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 437 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 438 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/52 (0%) 0/49 (0%) 0/62 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/163 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 439 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/52 (0%) 0/50 (0%) 0/62 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/164 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 441 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 31/50 (62%) 33/50 (66%) 19/49 (39%) 14/50 (28%) | | Overall Incidence Total 64/100 (64%) Mean 64% SD 2.83% Total 33/99 (33.33%) Mean 33.39% SD 7.62% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 19/50 (38%) 17/50 (34%) 22/49 (45%) 21/50 (42%) | | Overall Incidence Total 36/100 (36%) Mean 36% SD 2.83% Total 43/99 (43.43%) Mean 43.45% SD 2.05% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 41/50 (82%) 38/50 (76%) 34/49 (69%) 31/50 (62%) | | Overall Incidence Total 79/100 (79%) Mean 79% SD 4.24% Total 65/99 (65.66%) Mean 65.69% SD 5.22% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 2/50 (4%) 3/49 (6%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 4/99 (4.04%) Mean 4.06% SD 2.92% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 4/50 (8%) 2/50 (4%) 4/49 (8%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 5/99 (5.05%) Mean 5.08% SD 4.36% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 1/50 (2%) 12/49 (24%) 9/50 (18%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 21/99 (21.21%) Mean 21.24% SD 4.59% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 442 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 2/49 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.04% SD 1.47% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/48 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/48 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/48 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 443 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 444 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 445 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/46 (0%) 0/43 (0%) 0/44 (0%) 0/45 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 4/50 (8%) 4/50 (8%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 5/50 (10%) 4/50 (8%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 9/100 (9%) Mean 9% SD 1.41% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 446 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 447 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 1/50 (2%) 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 448 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 449 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 3/50 (6%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 18/50 (36%) 25/50 (50%) 6/49 (12%) 7/50 (14%) | | Overall Incidence Total 43/100 (43%) Mean 43% SD 9.9% Total 13/99 (13.13%) Mean 13.12% SD 1.24% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 10/50 (20%) 12/50 (24%) 5/49 (10%) 7/50 (14%) | | Overall Incidence Total 22/100 (22%) Mean 22% SD 2.83% Total 12/99 (12.12%) Mean 12.1% SD 2.68% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 12/50 (24%) 5/49 (10%) 7/50 (14%) | | Hepatoblastoma | | Overall Incidence Total 22/100 (22%) Mean 22% SD 2.83% Total 12/99 (12.12%) Mean 12.1% SD 2.68% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 24/50 (48%) 30/50 (60%) 9/49 (18%) 13/50 (26%) | | Hepatocellular Adenoma | | Overall Incidence Total 54/100 (54%) Mean 54% SD 8.49% Total 22/99 (22.22%) Mean 22.18% SD 5.4% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 24/50 (48%) 30/50 (60%) 9/49 (18%) 13/50 (26%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 54/100 (54%) Mean 54% SD 8.49% Total 22/99 (22.22%) Mean 22.18% SD 5.4% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 450 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 14/50 (28%) 11/50 (22%) 1/48 (2%) 4/50 (8%) | | Overall Incidence Total 25/100 (25%) Mean 25% SD 4.24% Total 5/98 (5.1%) Mean 5.04% SD 4.18% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 4/50 (8%) 4/50 (8%) 0/48 (0%) 1/50 (2%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 0% Total 1/98 (1.02%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 16/50 (32%) 14/50 (28%) 1/48 (2%) 5/50 (10%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 30/100 (30%) Mean 30% SD 2.83% Total 6/98 (6.12%) Mean 6.04% SD 5.6% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 451 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 452 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 453 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 454 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/46 (2%) 1/50 (2%) | | Overall Incidence Total 2/96 (2.08%) Mean 2.09% SD 0.12% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/46 (0%) 1/50 (2%) | | Overall Incidence Total 1/96 (1.04%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/46 (0%) 1/50 (2%) | | Malignant, NOS | | Overall Incidence Total 1/96 (1.04%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 455 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 1/46 (2%) 0/50 (0%) | | Overall Incidence Total 1/96 (1.04%) Mean 1.09% SD 1.54% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 456 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/39 (0%) 0/38 (0%) 0/39 (0%) 0/33 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/72 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) 7/48 (15%) 0/46 (0%) | | Adenoma | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 7/94 (7.45%) Mean 7.29% SD 10.31% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Carcinoma | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) 7/48 (15%) 0/46 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 7/94 (7.45%) Mean 7.29% SD 10.31% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 457 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/50 (0%) 1/48 (2%) 0/46 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/94 (1.06%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 1/48 (2%) 0/46 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/94 (1.06%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 458 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 459 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 460 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 461 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 462 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 2/48 (4%) 1/49 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 3/97 (3.09%) Mean 3.1% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 463 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 464 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/38 (0%) 0/39 (0%) 0/47 (0%) 0/44 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/91 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 465 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/48 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 466 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/48 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/48 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/49 (4%) 1/50 (2%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.04% SD 1.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 467 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/49 (4%) 1/50 (2%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 469 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 36/51 (71%) 25/50 (50%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 16/51 (31%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 45/51 (88%) 35/50 (70%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/51 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 3/51 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/51 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 8/51 (16%) 15/50 (30%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 470 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/48 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/48 (0%) 1/49 (2%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 471 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 472 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/51 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 473 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/44 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 5/51 (10%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/51 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 6/51 (12%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 474 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 475 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 476 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 477 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 2/51 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 24/51 (47%) 13/50 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 5/51 (10%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 5/51 (10%) 4/50 (8%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 27/51 (53%) 16/50 (32%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 27/51 (53%) 16/50 (32%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 478 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 14/51 (27%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 15/51 (29%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 479 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 480 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/51 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 481 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/51 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/51 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/51 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/51 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 482 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/51 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/49 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 483 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 484 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/35 (0%) 0/29 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/47 (2%) 9/48 (19%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/48 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/47 (2%) 9/48 (19%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 485 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/47 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 486 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/51 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/51 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 487 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/51 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/51 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/51 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 488 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/51 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/51 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/51 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/51 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 489 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/51 (2%) 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/51 (0%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/51 (0%) 3/50 (6%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/51 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/51 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 490 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 491 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/51 (0%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 492 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/39 (0%) 0/43 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/51 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/51 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 493 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/51 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 494 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 495 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: E.G. & G. MASON Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/51 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 497 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 16/50 (32%) 20/50 (40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 19/50 (38%) 17/50 (34%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 27/50 (54%) 31/50 (62%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 10/50 (20%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 1/50 (2%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 6/50 (12%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 498 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 8/50 (16%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/0 (0%) 0/38 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/0 (0%) 0/38 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 4/50 (8%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 499 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 500 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 501 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/44 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 502 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 503 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 504 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 505 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 6/50 (12%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 4/50 (8%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 4/50 (8%) 4/50 (8%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 9/50 (18%) 7/50 (14%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 9/50 (18%) 7/50 (14%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 506 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 5/50 (10%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 5/50 (10%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 8/50 (16%) 4/50 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 507 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 508 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 1/50 (2%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 509 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 510 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/49 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 511 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 512 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 6/49 (12%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 6/49 (12%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 513 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 514 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 515 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 516 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 517 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 518 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 6/50 (12%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 519 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 1/29 (3%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 520 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/29 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 521 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 522 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 523 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: HAZLETON Route: DERMAL Date of Species: MICE Vehicle: ACETONE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 525 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 20/50 (40%) 24/50 (48%) 20/50 (40%) 27/51 (53%) | | Overall Incidence Total 44/100 (44%) Mean 44% SD 5.66% Total 47/101 (46.53%) Mean 46.47% SD 9.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 21/50 (42%) 16/50 (32%) 13/50 (26%) 17/51 (33%) | | Overall Incidence Total 37/100 (37%) Mean 37% SD 7.07% Total 30/101 (29.7%) Mean 29.67% SD 5.19% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 35/50 (70%) 33/50 (66%) 29/50 (58%) 37/51 (73%) | | Overall Incidence Total 68/100 (68%) Mean 68% SD 2.83% Total 66/101 (65.35%) Mean 65.27% SD 10.29% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/51 (4%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 2/101 (1.98%) Mean 1.96% SD 2.77% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 3/50 (6%) 0/50 (0%) 3/51 (6%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 3/101 (2.97%) Mean 2.94% SD 4.16% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/101 (1.98%) Mean 1.96% SD 2.77% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 1/50 (2%) 3/50 (6%) 7/51 (14%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 10/101 (9.9%) Mean 9.86% SD 5.46% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 526 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/47 (2%) 0/49 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/96 (1.04%) Mean 1.06% SD 1.5% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/47 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) | | Complex, Malignant, NOS | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 527 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 528 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 529 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/33 (0%) 0/41 (0%) 0/44 (0%) 0/46 (0%) | | Overall Incidence Total 0/74 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 1/50 (2%) 4/50 (8%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 5/100 (5%) Mean 5% SD 4.24% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 1/50 (2%) 4/50 (8%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 5/100 (5%) Mean 5% SD 4.24% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 530 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 531 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 2/99 (2.02%) Mean 2% SD 2.83% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 532 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 2/99 (2.02%) Mean 2% SD 2.83% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Hemangioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 533 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 12/50 (24%) 14/50 (28%) 6/50 (12%) 6/51 (12%) | | Overall Incidence Total 26/100 (26%) Mean 26% SD 2.83% Total 12/101 (11.88%) Mean 11.88% SD 0.17% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 17/50 (34%) 12/50 (24%) 7/50 (14%) 4/51 (8%) | | Overall Incidence Total 29/100 (29%) Mean 29% SD 7.07% Total 11/101 (10.89%) Mean 10.92% SD 4.35% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 17/50 (34%) 12/50 (24%) 7/50 (14%) 4/51 (8%) | | Hepatoblastoma | | Overall Incidence Total 29/100 (29%) Mean 29% SD 7.07% Total 11/101 (10.89%) Mean 10.92% SD 4.35% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 27/50 (54%) 24/50 (48%) 13/50 (26%) 10/51 (20%) | | Hepatocellular Adenoma | | Overall Incidence Total 51/100 (51%) Mean 51% SD 4.24% Total 23/101 (22.77%) Mean 22.8% SD 4.52% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 27/50 (54%) 24/50 (48%) 13/50 (26%) 10/51 (20%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 51/100 (51%) Mean 51% SD 4.24% Total 23/101 (22.77%) Mean 22.8% SD 4.52% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 534 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 5/50 (10%) 7/50 (14%) 4/50 (8%) 4/51 (8%) | | Overall Incidence Total 12/100 (12%) Mean 12% SD 2.83% Total 8/101 (7.92%) Mean 7.92% SD 0.11% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/51 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/101 (1.98%) Mean 1.96% SD 2.77% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 7/50 (14%) 8/50 (16%) 4/50 (8%) 6/51 (12%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 15/100 (15%) Mean 15% SD 1.41% Total 10/101 (9.9%) Mean 9.88% SD 2.66% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 535 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 536 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 537 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 538 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 2/49 (4%) 1/49 (2%) | | Overall Incidence Total 3/98 (3.06%) Mean 3.06% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/49 (2%) 0/49 (0%) | | Malignant, NOS | | Overall Incidence Total 1/98 (1.02%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 539 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 540 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/22 (0%) 0/29 (0%) 0/26 (0%) 0/21 (0%) | | Overall Incidence Total 0/51 (0%) Mean 0% SD 0% Total 0/47 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/44 (0%) 0/47 (0%) 4/48 (8%) 12/48 (25%) | | Adenoma | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 16/96 (16.67%) Mean 16.67% SD 11.79% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/44 (0%) 0/47 (0%) 0/48 (0%) 0/48 (0%) | | Carcinoma | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/44 (0%) 0/47 (0%) 4/48 (8%) 12/48 (25%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 16/96 (16.67%) Mean 16.67% SD 11.79% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 541 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/44 (0%) 0/47 (0%) 0/48 (0%) 2/48 (4%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 2/96 (2.08%) Mean 2.08% SD 2.95% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/44 (0%) 0/47 (0%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/44 (0%) 0/47 (0%) 0/48 (0%) 2/48 (4%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 2/96 (2.08%) Mean 2.08% SD 2.95% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 542 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 543 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 544 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 545 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 546 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 547 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 548 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/37 (0%) 0/45 (0%) 0/42 (0%) 0/47 (0%) | | Overall Incidence Total 0/82 (0%) Mean 0% SD 0% Total 0/89 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 3/50 (6%) 1/50 (2%) 5/50 (10%) 4/51 (8%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 9/101 (8.91%) Mean 8.92% SD 1.53% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 3/50 (6%) 1/50 (2%) 5/50 (10%) 4/51 (8%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 9/101 (8.91%) Mean 8.92% SD 1.53% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 549 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 550 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/50 (4%) 3/51 (6%) | | Overall Incidence Total 5/101 (4.95%) Mean 4.94% SD 1.33% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 551 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: I. I. T. RESEARCH INSTITUTE Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 1/101 (0.99%) Mean 0.98% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/50 (4%) 4/51 (8%) | | Overall Incidence Total 6/101 (5.94%) Mean 5.92% SD 2.72% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/101 (0.99%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/101 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 553 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 18/55 (33%) 27/59 (46%) 21/60 (35%) 20/60 (33%) 27/58 (47%) 27/60 (45%) | | Overall Incidence Total 66/174 (37.93%) Mean 37.83% SD 6.96% Total 74/178 (41.57%) Mean 41.63% SD 7.23% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 14/55 (25%) 20/59 (34%) 20/60 (33%) 30/60 (50%) 26/58 (45%) 26/60 (43%) | | Overall Incidence Total 54/174 (31.03%) Mean 30.9% SD 4.72% Total 82/178 (46.07%) Mean 46.05% SD 3.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 28/55 (51%) 39/59 (66%) 37/60 (62%) 36/60 (60%) 42/58 (72%) 41/60 (68%) | | Overall Incidence Total 104/174 (59.77%)Mean 59.56% SD 7.81% Total 119/178 (66.85%) Mean 66.92% SD 6.33% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 2/55 (4%) 1/59 (2%) 2/60 (3%) 3/60 (5%) 3/58 (5%) 1/60 (2%) | | Overall Incidence Total 5/174 (2.87%) Mean 2.89% SD 1.04% Total 7/178 (3.93%) Mean 3.95% SD 1.98% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/55 (4%) 2/59 (3%) 2/60 (3%) 3/60 (5%) 4/58 (7%) 1/60 (2%) | | Overall Incidence Total 6/174 (3.45%) Mean 3.45% SD 0.16% Total 8/178 (4.49%) Mean 4.52% SD 2.65% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/55 (0%) 0/59 (0%) 1/60 (2%) 2/60 (3%) 2/58 (3%) 1/60 (2%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.96% Total 5/178 (2.81%) Mean 2.82% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/55 (4%) 1/59 (2%) 2/60 (3%) 13/60 (22%) 5/58 (9%) 7/60 (12%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 5/174 (2.87%) Mean 2.89% SD 1.04% Total 25/178 (14.04%) Mean 13.98% SD 6.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 554 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 4/55 (7%) 2/59 (3%) 1/60 (2%) 0/60 (0%) 1/58 (2%) 1/59 (2%) | | Overall Incidence Total 7/174 (4.02%) Mean 4.11% SD 2.87% Total 2/177 (1.13%) Mean 1.14% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Adenoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/55 (0%) 0/58 (0%) 0/60 (0%) 1/60 (2%) 1/58 (2%) 1/59 (2%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 3/177 (1.69%) Mean 1.7% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/55 (0%) 1/58 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.57% SD 1% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/55 (0%) 0/58 (0%) 0/60 (0%) 2/60 (3%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 2/177 (1.13%) Mean 1.11% SD 1.92% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/55 (0%) 1/58 (2%) 0/60 (0%) 3/60 (5%) 1/58 (2%) 1/59 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 1/173 (0.58%) Mean 0.57% SD 1% Total 5/177 (2.82%) Mean 2.81% SD 1.9% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/57 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 555 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/57 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/57 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/57 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/57 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/57 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 1/60 (2%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.96% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 556 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Astrocytoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 1/60 (2%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.96% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/54 (0%) 1/59 (2%) 0/60 (0%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/54 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 557 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/54 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 1/54 (2%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.62% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/45 (0%) 0/56 (0%) 0/55 (0%) 0/57 (0%) 0/53 (0%) 0/59 (0%) | | Overall Incidence Total 0/156 (0%) Mean 0% SD 0% Total 0/169 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 558 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 559 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/52 (0%) 1/59 (2%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 2/59 (3%) | | Overall Incidence Total 1/171 (0.58%) Mean 0.56% SD 0.98% Total 2/176 (1.14%) Mean 1.13% SD 1.96% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 560 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 1/58 (2%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 1/176 (0.57%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/52 (0%) 1/59 (2%) 0/60 (0%) 0/59 (0%) 1/58 (2%) 2/59 (3%) | | Overall Incidence Total 1/171 (0.58%) Mean 0.56% SD 0.98% Total 3/176 (1.7%) Mean 1.7% SD 1.69% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Carcinoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Hemangioma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Hemangiosarcoma | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 561 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/55 (2%) 0/59 (0%) 1/60 (2%) 0/60 (0%) 2/58 (3%) 0/60 (0%) | | Overall Incidence Total 2/174 (1.15%) Mean 1.16% SD 1.01% Total 2/178 (1.12%) Mean 1.15% SD 1.99% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 8/55 (15%) 13/59 (22%) 17/60 (28%) 6/60 (10%) 13/58 (22%) 13/60 (22%) | | Overall Incidence Total 38/174 (21.84%) Mean 21.64% SD 6.9% Total 32/178 (17.98%) Mean 18.03% SD 6.96% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 6/55 (11%) 10/59 (17%) 11/60 (18%) 8/60 (13%) 11/58 (19%) 7/60 (12%) | | Overall Incidence Total 27/174 (15.52%) Mean 15.4% SD 3.95% Total 26/178 (14.61%) Mean 14.66% SD 3.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 6/55 (11%) 10/59 (17%) 11/60 (18%) 8/60 (13%) 11/58 (19%) 7/60 (12%) | | Hepatoblastoma | | Overall Incidence Total 27/174 (15.52%) Mean 15.4% SD 3.95% Total 26/178 (14.61%) Mean 14.66% SD 3.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 12/55 (22%) 23/59 (39%) 26/60 (43%) 14/60 (23%) 20/58 (34%) 18/60 (30%) | | Hepatocellular Adenoma | | Overall Incidence Total 61/174 (35.06%) Mean 34.71% SD 11.38% Total 52/178 (29.21%) Mean 29.27% SD 5.61% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 12/55 (22%) 23/59 (39%) 26/60 (43%) 14/60 (23%) 20/58 (34%) 18/60 (30%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 61/174 (35.06%) Mean 34.71% SD 11.38% Total 52/178 (29.21%) Mean 29.27% SD 5.61% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 562 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 7/55 (13%) 6/59 (10%) 5/60 (8%) 2/60 (3%) 3/58 (5%) 3/60 (5%) | | Overall Incidence Total 18/174 (10.34%) Mean 10.41% SD 2.21% Total 8/178 (4.49%) Mean 4.5% SD 1.02% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 4/55 (7%) 7/59 (12%) 9/60 (15%) 4/60 (7%) 7/58 (12%) 4/60 (7%) | | Overall Incidence Total 20/174 (11.49%) Mean 11.38% SD 3.89% Total 15/178 (8.43%) Mean 8.47% SD 3.12% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 9/55 (16%) 13/59 (22%) 13/60 (22%) 6/60 (10%) 9/58 (16%) 7/60 (12%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 35/174 (20.11%) Mean 20.02% SD 3.17% Total 22/178 (12.36%) Mean 12.39% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 563 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 2/178 (1.12%) Mean 1.13% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 564 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 2/60 (3%) 1/58 (2%) 2/60 (3%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 5/178 (2.81%) Mean 2.8% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 2/60 (3%) 1/58 (2%) 2/60 (3%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 5/178 (2.81%) Mean 2.8% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/55 (0%) 0/59 (0%) 0/60 (0%) 2/60 (3%) 1/58 (2%) 2/60 (3%) | | or Adenoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 5/178 (2.81%) Mean 2.8% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 565 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 1/55 (2%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.61% SD 1.05% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 566 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/57 (2%) 2/58 (3%) 2/58 (3%) | | Overall Incidence Total 5/173 (2.89%) Mean 2.88% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/57 (0%) 0/58 (0%) 1/58 (2%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/57 (0%) 0/58 (0%) 1/58 (2%) | | Malignant, NOS | | Overall Incidence Total 1/173 (0.58%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 567 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/57 (2%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.58% SD 1.01% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 1/57 (2%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.58% SD 1.01% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/57 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 568 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/52 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/171 (0%) Mean 0% SD 0% Total 0/177 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/36 (0%) 0/54 (0%) 0/48 (0%) 0/49 (0%) 0/52 (0%) 0/40 (0%) | | Overall Incidence Total 0/138 (0%) Mean 0% SD 0% Total 0/141 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/54 (0%) 0/56 (0%) 0/52 (0%) 6/59 (10%) 8/58 (14%) 8/58 (14%) | | Adenoma | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 22/175 (12.57%) Mean 12.59% SD 2.09% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/54 (0%) 0/56 (0%) 0/52 (0%) 1/59 (2%) 0/58 (0%) 0/58 (0%) | | Carcinoma | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 1/175 (0.57%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/54 (0%) 0/56 (0%) 0/52 (0%) 7/59 (12%) 8/58 (14%) 8/58 (14%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 23/175 (13.14%) Mean 13.15% SD 1.11% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 569 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/54 (0%) 0/56 (0%) 0/52 (0%) 0/59 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/54 (0%) 0/56 (0%) 0/52 (0%) 0/59 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/54 (0%) 0/56 (0%) 0/52 (0%) 0/59 (0%) 0/58 (0%) 0/58 (0%) | | Overall Incidence Total 0/162 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/51 (0%) 0/59 (0%) 0/59 (0%) | | Overall Incidence Total 0/169 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/51 (0%) 0/59 (0%) 0/59 (0%) | | Overall Incidence Total 0/169 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/51 (0%) 0/59 (0%) 0/59 (0%) | | Overall Incidence Total 0/169 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 570 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 571 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 1/60 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 1/60 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 1/60 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 1/60 (2%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 572 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 1/60 (2%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Papilloma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 573 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 2/58 (3%) 5/60 (8%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 7/178 (3.93%) Mean 3.93% SD 4.19% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 2/58 (3%) 5/60 (8%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 7/178 (3.93%) Mean 3.93% SD 4.19% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/55 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) 2/58 (3%) 5/60 (8%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% Total 7/178 (3.93%) Mean 3.93% SD 4.19% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 574 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/54 (2%) 0/59 (0%) 0/60 (0%) 2/60 (3%) 0/58 (0%) 1/60 (2%) | | Overall Incidence Total 1/173 (0.58%) Mean 0.62% SD 1.07% Total 3/178 (1.69%) Mean 1.67% SD 1.67% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/54 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/173 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 575 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/55 (2%) 0/59 (0%) 0/60 (0%) 2/60 (3%) 1/58 (2%) 0/60 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/174 (0.57%) Mean 0.61% SD 1.05% Total 3/178 (1.69%) Mean 1.69% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/55 (2%) 0/59 (0%) 0/60 (0%) 1/60 (2%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.61% SD 1.05% Total 2/178 (1.12%) Mean 1.13% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/55 (0%) 1/59 (2%) 0/60 (0%) | | Overall Incidence Total 1/174 (0.57%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 576 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/43 (0%) 0/46 (0%) 0/54 (0%) 0/56 (0%) 0/58 (0%) 0/57 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 0/171 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/176 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/176 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/59 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 0/176 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/53 (4%) 4/59 (7%) 0/60 (0%) 2/59 (3%) 2/58 (3%) 1/59 (2%) | | Overall Incidence Total 6/172 (3.49%) Mean 3.52% SD 3.4% Total 5/176 (2.84%) Mean 2.84% SD 1% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/53 (0%) 0/59 (0%) 0/60 (0%) 1/59 (2%) 1/58 (2%) 0/59 (0%) | | Overall Incidence Total 0/172 (0%) Mean 0% SD 0% Total 2/176 (1.14%) Mean 1.14% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/53 (4%) 4/59 (7%) 0/60 (0%) 3/59 (5%) 3/58 (5%) 1/59 (2%) | | Overall Incidence Total 6/172 (3.49%) Mean 3.52% SD 3.4% Total 7/176 (3.98%) Mean 3.98% SD 1.98% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 577 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/52 (0%) 0/59 (0%) 0/59 (0%) 0/60 (0%) 0/56 (0%) 0/59 (0%) | | Overall Incidence Total 0/170 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 578 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/52 (0%) 0/59 (0%) 0/59 (0%) 0/60 (0%) 0/56 (0%) 0/59 (0%) | | Overall Incidence Total 0/170 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/52 (0%) 0/59 (0%) 0/59 (0%) 0/60 (0%) 0/56 (0%) 0/59 (0%) | | Overall Incidence Total 0/170 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/52 (0%) 1/59 (2%) 0/59 (0%) 0/60 (0%) 0/56 (0%) 0/59 (0%) | | Overall Incidence Total 1/170 (0.59%) Mean 0.56% SD 0.98% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/52 (0%) 0/59 (0%) 0/59 (0%) 0/60 (0%) 0/56 (0%) 0/59 (0%) | | Overall Incidence Total 0/170 (0%) Mean 0% SD 0% Total 0/175 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/60 (0%) 1/58 (2%) 0/60 (0%) | | Overall Incidence Total 1/178 (0.56%) Mean 0.57% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/60 (2%) 0/58 (0%) 1/60 (2%) | | Overall Incidence Total 2/178 (1.12%) Mean 1.11% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/60 (3%) 1/58 (2%) 2/60 (3%) | | Overall Incidence Total 5/178 (2.81%) Mean 2.8% SD 0.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 579 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: LOVELACE RESEARCH Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/60 (2%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 1/178 (0.56%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 3/60 (5%) 1/58 (2%) 2/60 (3%) | | Overall Incidence Total 6/178 (3.37%) Mean 3.35% SD 1.64% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/55 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | | Overall Incidence Total 0/174 (0%) Mean 0% SD 0% Total 0/178 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 581 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 25/50 (50%) 34/50 (68%) 20/49 (41%) 26/50 (52%) | | Overall Incidence Total 59/100 (59%) Mean 59% SD 12.73% Total 46/99 (46.46%) Mean 46.41% SD 7.91% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 14/50 (28%) 20/50 (40%) 14/49 (29%) 15/50 (30%) | | Overall Incidence Total 34/100 (34%) Mean 34% SD 8.49% Total 29/99 (29.29%) Mean 29.29% SD 1.01% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 31/50 (62%) 41/50 (82%) 29/49 (59%) 34/50 (68%) | | Overall Incidence Total 72/100 (72%) Mean 72% SD 14.14% Total 63/99 (63.64%) Mean 63.59% SD 6.23% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 2/50 (4%) 2/49 (4%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 3/99 (3.03%) Mean 3.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/99 (2.02%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 7/50 (14%) 7/49 (14%) 7/50 (14%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 9/100 (9%) Mean 9% SD 7.07% Total 14/99 (14.14%) Mean 14.14% SD 0.2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 582 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Complex, Malignant, NOS | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 583 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 584 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 585 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. 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Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/45 (0%) 0/34 (0%) 0/47 (0%) 0/43 (0%) | | Overall Incidence Total 0/79 (0%) Mean 0% SD 0% Total 0/90 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 3/50 (6%) 3/49 (6%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 0% Total 4/99 (4.04%) Mean 4.06% SD 2.92% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 3/50 (6%) 3/49 (6%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 0% Total 4/99 (4.04%) Mean 4.06% SD 2.92% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 586 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. 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Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 587 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. 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Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/49 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/99 (2.02%) Mean 2% SD 2.83% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 588 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/49 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/99 (2.02%) Mean 2% SD 2.83% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 589 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 16/50 (32%) 23/50 (46%) 7/49 (14%) 12/50 (24%) | | Overall Incidence Total 39/100 (39%) Mean 39% SD 9.9% Total 19/99 (19.19%) Mean 19.14% SD 6.87% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 7/50 (14%) 13/50 (26%) 5/49 (10%) 5/50 (10%) | | Overall Incidence Total 20/100 (20%) Mean 20% SD 8.49% Total 10/99 (10.1%) Mean 10.1% SD 0.14% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 7/50 (14%) 13/50 (26%) 5/49 (10%) 5/50 (10%) | | Hepatoblastoma | | Overall Incidence Total 20/100 (20%) Mean 20% SD 8.49% Total 10/99 (10.1%) Mean 10.1% SD 0.14% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 21/50 (42%) 29/50 (58%) 10/49 (20%) 16/50 (32%) | | Hepatocellular Adenoma | | Overall Incidence Total 50/100 (50%) Mean 50% SD 11.31% Total 26/99 (26.26%) Mean 26.2% SD 8.2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 21/50 (42%) 29/50 (58%) 10/49 (20%) 16/50 (32%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 50/100 (50%) Mean 50% SD 11.31% Total 26/99 (26.26%) Mean 26.2% SD 8.2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 590 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 13/50 (26%) 15/50 (30%) 5/49 (10%) 1/50 (2%) | | Overall Incidence Total 28/100 (28%) Mean 28% SD 2.83% Total 6/99 (6.06%) Mean 6.1% SD 5.8% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 15/50 (30%) 5/49 (10%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 29/100 (29%) Mean 29% SD 1.41% Total 7/99 (7.07%) Mean 7.1% SD 4.39% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 591 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 592 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 593 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 594 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/47 (0%) 2/49 (4%) | | Overall Incidence Total 2/96 (2.08%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 2/47 (4%) 0/49 (0%) | | Overall Incidence Total 2/96 (2.08%) Mean 2.13% SD 3.01% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/47 (0%) 1/49 (2%) | | Overall Incidence Total 1/96 (1.04%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/47 (0%) 1/49 (2%) | | Malignant, NOS | | Overall Incidence Total 1/96 (1.04%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 595 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/47 (2%) 0/49 (0%) | | Overall Incidence Total 1/96 (1.04%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 596 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/41 (0%) 0/36 (0%) 0/33 (0%) 0/36 (0%) | | Overall Incidence Total 0/77 (0%) Mean 0% SD 0% Total 0/69 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/46 (0%) 2/48 (4%) 11/48 (23%) | | Adenoma | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 13/96 (13.54%) Mean 13.54% SD 13.26% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/46 (0%) 0/48 (0%) 0/48 (0%) | | Carcinoma | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/46 (0%) 2/48 (4%) 11/48 (23%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 13/96 (13.54%) Mean 13.54% SD 13.26% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 597 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/49 (0%) 0/46 (0%) 0/48 (0%) 1/48 (2%) | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 1/96 (1.04%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/49 (0%) 1/46 (2%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.09% SD 1.54% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/49 (0%) 1/46 (2%) 0/48 (0%) 1/48 (2%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.09% SD 1.54% Total 1/96 (1.04%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/46 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/46 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/46 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 598 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 599 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 600 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 601 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 602 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/49 (0%) 1/50 (2%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 1/49 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 603 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 604 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/49 (0%) 0/43 (0%) 0/46 (0%) 0/38 (0%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 0/84 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 1/49 (2%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.02% SD 1.39% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 1/49 (2%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.02% SD 1.39% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 605 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 606 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/49 (0%) 4/50 (8%) | | Overall Incidence Total 4/99 (4.04%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 607 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: MICROB. ASSOC. Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/49 (2%) 4/50 (8%) | | Overall Incidence Total 5/99 (5.05%) Mean 5.02% SD 4.21% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 609 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 27/50 (54%) 26/50 (52%) 29/50 (58%) 23/50 (46%) 22/50 (44%) 33/50 (66%) | | Overall Incidence Total 82/150 (54.67%) Mean 54.67% SD 3.06% Total 78/150 (52%) Mean 52% SD 12.17% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 23/50 (46%) 25/50 (50%) 32/50 (64%) 21/50 (42%) 19/50 (38%) 26/50 (52%) | | Overall Incidence Total 80/150 (53.33%) Mean 53.33% SD 9.45% Total 66/150 (44%) Mean 44% SD 7.21% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 33/50 (66%) 40/50 (80%) 44/50 (88%) 35/50 (70%) 34/50 (68%) 46/50 (92%) | | Overall Incidence Total 117/150 (78%) Mean 78% SD 11.14% Total 115/150 (76.67%) Mean 76.67% SD 13.32% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 3/50 (6%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 10/150 (6.67%) Mean 6.67% SD 1.15% Total 4/150 (2.67%) Mean 2.67% SD 3.06% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 5/50 (10%) 4/50 (8%) 3/50 (6%) 1/50 (2%) 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 12/150 (8%) Mean 8% SD 2% Total 5/150 (3.33%) Mean 3.33% SD 4.16% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 4/50 (8%) 5/50 (10%) 5/50 (10%) 9/50 (18%) 13/50 (26%) 11/50 (22%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 14/150 (9.33%) Mean 9.33% SD 1.15% Total 33/150 (22%) Mean 22% SD 4% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 610 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 1/50 (2%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 5/150 (3.33%) Mean 3.33% SD 4.16% Total 1/149 (0.67%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Adenoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% Total 3/150 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 611 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 612 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 613 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/47 (0%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 0/141 (0%) Mean 0% SD 0% Total 0/144 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 4/50 (8%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) 6/50 (12%) | | Overall Incidence Total 7/150 (4.67%) Mean 4.67% SD 3.06% Total 11/150 (7.33%) Mean 7.33% SD 4.16% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 4/50 (8%) 3/50 (6%) 1/50 (2%) 4/50 (8%) 2/50 (4%) 6/50 (12%) | | Overall Incidence Total 8/150 (5.33%) Mean 5.33% SD 3.06% Total 12/150 (8%) Mean 8% SD 4% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 614 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 615 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 616 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 617 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 4/150 (2.67%) Mean 2.67% SD 2.31% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 19/50 (38%) 13/50 (26%) 21/50 (42%) 13/50 (26%) 12/50 (24%) 20/50 (40%) | | Overall Incidence Total 53/150 (35.33%) Mean 35.33% SD 8.33% Total 45/150 (30%) Mean 30% SD 8.72% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 10/50 (20%) 13/50 (26%) 19/50 (38%) 7/50 (14%) 2/50 (4%) 11/50 (22%) | | Overall Incidence Total 42/150 (28%) Mean 28% SD 9.17% Total 20/150 (13.33%) Mean 13.33% SD 9.02% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 13/50 (26%) 19/50 (38%) 7/50 (14%) 2/50 (4%) 11/50 (22%) | | Hepatoblastoma | | Overall Incidence Total 42/150 (28%) Mean 28% SD 9.17% Total 20/150 (13.33%) Mean 13.33% SD 9.02% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 25/50 (50%) 24/50 (48%) 34/50 (68%) 17/50 (34%) 14/50 (28%) 29/50 (58%) | | Hepatocellular Adenoma | | Overall Incidence Total 83/150 (55.33%) Mean 55.33% SD 11.02% Total 60/150 (40%) Mean 40% SD 15.87% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 25/50 (50%) 24/50 (48%) 34/50 (68%) 17/50 (34%) 14/50 (28%) 29/50 (58%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 83/150 (55.33%) Mean 55.33% SD 11.02% Total 60/150 (40%) Mean 40% SD 15.87% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 618 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 7/50 (14%) 11/50 (22%) 8/50 (16%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 26/150 (17.33%) Mean 17.33% SD 4.16% Total 7/150 (4.67%) Mean 4.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 5/50 (10%) 3/50 (6%) 6/50 (12%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 14/150 (9.33%) Mean 9.33% SD 3.06% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 9/50 (18%) 14/50 (28%) 13/50 (26%) 2/50 (4%) 3/50 (6%) 4/50 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 36/150 (24%) Mean 24% SD 5.29% Total 9/150 (6%) Mean 6% SD 2% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 619 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 620 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 621 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 622 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 1/47 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/146 (0.68%) Mean 0.71% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/47 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/146 (0.68%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/47 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/146 (0.68%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/47 (0%) 1/49 (2%) 0/50 (0%) | | Malignant, NOS | | Overall Incidence Total 1/146 (0.68%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 623 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/47 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/146 (0.68%) Mean 0.71% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 624 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/42 (0%) 0/49 (0%) | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/138 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 1/44 (2%) 0/49 (0%) 4/48 (8%) 7/49 (14%) 9/49 (18%) | | Adenoma | | Overall Incidence Total 1/141 (0.71%) Mean 0.76% SD 1.31% Total 20/146 (13.7%) Mean 13.66% SD 5.05% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | Carcinoma | | Overall Incidence Total 0/141 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 1/44 (2%) 0/49 (0%) 4/48 (8%) 7/49 (14%) 9/49 (18%) | | Carcinoma or Adenoma | | Overall Incidence Total 1/141 (0.71%) Mean 0.76% SD 1.31% Total 20/146 (13.7%) Mean 13.66% SD 5.05% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 625 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/44 (0%) 0/49 (0%) 1/48 (2%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 0/141 (0%) Mean 0% SD 0% Total 2/146 (1.37%) Mean 1.37% SD 1.19% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 1/44 (2%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/141 (0.71%) Mean 0.76% SD 1.31% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 1/44 (2%) 0/49 (0%) 1/48 (2%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 1/141 (0.71%) Mean 0.76% SD 1.31% Total 2/146 (1.37%) Mean 1.37% SD 1.19% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 626 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 627 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 628 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 629 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 4/150 (2.67%) Mean 2.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 3/150 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 4/150 (2.67%) Mean 2.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 630 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 4/50 (8%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/150 (4.67%) Mean 4.67% SD 3.06% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 631 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 4/50 (8%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 5/50 (10%) 4/50 (8%) | | Papilloma Squamous | | Overall Incidence Total 8/150 (5.33%) Mean 5.33% SD 3.06% Total 12/150 (8%) Mean 8% SD 2% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 3/50 (6%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 5/50 (10%) 4/50 (8%) | | Overall Incidence Total 7/150 (4.67%) Mean 4.67% SD 2.31% Total 12/150 (8%) Mean 8% SD 2% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 632 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/46 (0%) 0/45 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/134 (0%) Mean 0% SD 0% Total 0/146 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 5/150 (3.33%) Mean 3.33% SD 4.16% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 5/150 (3.33%) Mean 3.33% SD 4.16% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 633 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 634 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 635 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: CORN OIL Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 637 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 33/50 (66%) 26/50 (52%) 28/50 (56%) 30/50 (60%) 23/50 (46%) 36/50 (72%) | | Overall Incidence Total 87/150 (58%) Mean 58% SD 7.21% Total 89/150 (59.33%) Mean 59.33% SD 13.01% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 28/50 (56%) 30/50 (60%) 28/50 (56%) 26/50 (52%) 23/50 (46%) 32/50 (64%) | | Overall Incidence Total 86/150 (57.33%) Mean 57.33% SD 2.31% Total 81/150 (54%) Mean 54% SD 9.17% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 43/50 (86%) 40/50 (80%) 41/50 (82%) 41/50 (82%) 35/50 (70%) 44/50 (88%) | | Overall Incidence Total 124/150 (82.67%)Mean 82.67% SD 3.06% Total 120/150 (80%) Mean 80% SD 9.17% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 2.31% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 7/50 (14%) 3/50 (6%) 5/50 (10%) 1/50 (2%) 0/50 (0%) 5/50 (10%) | | Overall Incidence Total 15/150 (10%) Mean 10% SD 4% Total 6/150 (4%) Mean 4% SD 5.29% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 9/50 (18%) 3/50 (6%) 5/50 (10%) 1/50 (2%) 1/50 (2%) 7/50 (14%) | | Overall Incidence Total 17/150 (11.33%) Mean 11.33% SD 6.11% Total 9/150 (6%) Mean 6% SD 6.93% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 7/150 (4.67%) Mean 4.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 7/50 (14%) 2/50 (4%) 5/50 (10%) 13/50 (26%) 8/50 (16%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 10/150 (6.67%) Mean 6.67% SD 6.43% Total 26/150 (17.33%) Mean 17.33% SD 8.08% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 638 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 5/50 (10%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 7/149 (4.7%) Mean 4.69% SD 5.03% Total 1/149 (0.67%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 1/148 (0.68%) Mean 0.69% SD 1.2% Total 2/149 (1.34%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 1/148 (0.68%) Mean 0.67% SD 1.15% Total 1/149 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 1/50 (2%) 1/48 (2%) 0/50 (0%) 0/49 (0%) 3/50 (6%) | | Complex, Malignant, NOS | | Overall Incidence Total 2/148 (1.35%) Mean 1.36% SD 1.18% Total 3/149 (2.01%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 639 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 640 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 641 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/41 (0%) 0/50 (0%) 0/44 (0%) 0/48 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 0/135 (0%) Mean 0% SD 0% Total 0/143 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 3/50 (6%) 3/50 (6%) 4/50 (8%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 9/150 (6%) Mean 6% SD 0% Total 7/150 (4.67%) Mean 4.67% SD 4.16% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 3/50 (6%) 3/50 (6%) 5/50 (10%) 0/50 (0%) 4/50 (8%) | | Overall Incidence Total 9/150 (6%) Mean 6% SD 0% Total 9/150 (6%) Mean 6% SD 5.29% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 642 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 643 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) 1/48 (2%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 2/147 (1.36%) Mean 1.36% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 644 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/147 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) 1/48 (2%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 2/147 (1.36%) Mean 1.36% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 645 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 2.31% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 6/50 (12%) 3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 11/150 (7.33%) Mean 7.33% SD 4.16% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 25/50 (50%) 16/50 (32%) 19/50 (38%) 20/50 (40%) 11/50 (22%) 19/50 (38%) | | Overall Incidence Total 60/150 (40%) Mean 40% SD 9.17% Total 50/150 (33.33%) Mean 33.33% SD 9.87% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 21/50 (42%) 13/50 (26%) 19/50 (38%) 12/50 (24%) 13/50 (26%) 14/50 (28%) | | Overall Incidence Total 53/150 (35.33%) Mean 35.33% SD 8.33% Total 39/150 (26%) Mean 26% SD 2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 21/50 (42%) 13/50 (26%) 20/50 (40%) 13/50 (26%) 13/50 (26%) 14/50 (28%) | | Hepatoblastoma | | Overall Incidence Total 54/150 (36%) Mean 36% SD 8.72% Total 40/150 (26.67%) Mean 26.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 36/50 (72%) 24/50 (48%) 35/50 (70%) 27/50 (54%) 20/50 (40%) 24/50 (48%) | | Hepatocellular Adenoma | | Overall Incidence Total 95/150 (63.33%) Mean 63.33% SD 13.32% Total 71/150 (47.33%) Mean 47.33% SD 7.02% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 36/50 (72%) 24/50 (48%) 36/50 (72%) 27/50 (54%) 20/50 (40%) 24/50 (48%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 96/150 (64%) Mean 64% SD 13.86% Total 71/150 (47.33%) Mean 47.33% SD 7.02% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 646 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 10/49 (20%) 6/50 (12%) 3/49 (6%) 1/50 (2%) 4/50 (8%) | | Overall Incidence Total 28/149 (18.79%) Mean 18.8% SD 6.16% Total 8/149 (5.37%) Mean 5.37% SD 3.07% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 4/50 (8%) 6/49 (12%) 2/50 (4%) 3/49 (6%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 12/149 (8.05%) Mean 8.08% SD 4.12% Total 5/149 (3.36%) Mean 3.37% SD 3.11% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 16/49 (33%) 8/50 (16%) 6/49 (12%) 1/50 (2%) 6/50 (12%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 38/149 (25.5%) Mean 25.55% SD 8.59% Total 13/149 (8.72%) Mean 8.75% SD 5.85% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 647 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 648 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 649 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 650 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 2/50 (4%) 0/49 (0%) 3/50 (6%) | | Overall Incidence Total 5/149 (3.36%) Mean 3.33% SD 3.06% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Malignant, NOS | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 651 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 652 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 1/148 (0.68%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 1/148 (0.68%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/46 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/43 (0%) | | Overall Incidence Total 0/144 (0%) Mean 0% SD 0% Total 0/135 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/40 (0%) 0/48 (0%) 0/47 (0%) 2/46 (4%) 7/50 (14%) 8/49 (16%) | | Adenoma | | Overall Incidence Total 0/135 (0%) Mean 0% SD 0% Total 17/145 (11.72%) Mean 11.56% SD 6.35% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/46 (0%) 1/50 (2%) 0/49 (0%) | | Carcinoma | | Overall Incidence Total 0/135 (0%) Mean 0% SD 0% Total 1/145 (0.69%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/40 (0%) 0/48 (0%) 0/47 (0%) 2/46 (4%) 8/50 (16%) 8/49 (16%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/135 (0%) Mean 0% SD 0% Total 18/145 (12.41%) Mean 12.22% SD 6.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 653 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/40 (0%) 1/48 (2%) 0/47 (0%) 0/46 (0%) 0/50 (0%) 2/49 (4%) | | Overall Incidence Total 1/135 (0.74%) Mean 0.69% SD 1.2% Total 2/145 (1.38%) Mean 1.36% SD 2.36% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/46 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/135 (0%) Mean 0% SD 0% Total 0/145 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/40 (0%) 1/48 (2%) 0/47 (0%) 0/46 (0%) 0/50 (0%) 2/49 (4%) | | Overall Incidence Total 1/135 (0.74%) Mean 0.69% SD 1.2% Total 2/145 (1.38%) Mean 1.36% SD 2.36% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 654 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 655 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 3/150 (2%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 656 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 657 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 658 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 2/50 (4%) 0/50 (0%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 3/49 (6%) | | Overall Incidence Total 3/148 (2.03%) Mean 2.03% SD 2% Total 4/148 (2.7%) Mean 2.72% SD 3.12% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 659 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 4/150 (2.67%) Mean 2.67% SD 3.06% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 4/150 (2.67%) Mean 2.67% SD 3.06% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/41 (0%) 1/45 (2%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 1/128 (0.78%) Mean 0.74% SD 1.28% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 660 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/41 (0%) 0/45 (0%) 0/42 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) | | Overall Incidence Total 0/128 (0%) Mean 0% SD 0% Total 0/142 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/148 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 4/50 (8%) 6/50 (12%) 3/49 (6%) 1/50 (2%) 2/49 (4%) | | Overall Incidence Total 12/150 (8%) Mean 8% SD 4% Total 6/148 (4.05%) Mean 4.07% SD 2.06% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/148 (0.68%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 4/50 (8%) 6/50 (12%) 4/49 (8%) 1/50 (2%) 2/49 (4%) | | Overall Incidence Total 12/150 (8%) Mean 8% SD 4% Total 7/148 (4.73%) Mean 4.75% SD 3.14% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 661 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 662 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 5/150 (3.33%) Mean 3.33% SD 4.16% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 663 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: MICE Vehicle: METHYL CELLULOSE Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 5/150 (3.33%) Mean 3.33% SD 4.16% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 665 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 30/50 (60%) 28/50 (56%) 24/50 (48%) 26/52 (50%) 29/50 (58%) 21/50 (42%) | | 29/50 (58%) 20/50 (40%) 33/50 (66%) 31/50 (62%) 22/50 (44%) 22/51 (43%) | | Overall Incidence Total 164/300 (54.67%)Mean 54.67% SD 9.27% Total 151/303 (49.83%) Mean 49.86% SD 8.43% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 24/50 (48%) 31/50 (62%) 16/52 (31%) 17/50 (34%) 22/50 (44%) | | 16/50 (32%) 18/50 (36%) 21/50 (42%) 20/50 (40%) 23/50 (46%) 18/51 (35%) | | Overall Incidence Total 127/300 (42.33%)Mean 42.33% SD 11.27% Total 116/303 (38.28%) Mean 38.34% SD 5.98% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 37/50 (74%) 42/50 (84%) 43/50 (86%) 35/52 (67%) 35/50 (70%) 34/50 (68%) | | 38/50 (76%) 33/50 (66%) 39/50 (78%) 39/50 (78%) 36/50 (72%) 32/51 (63%) | | Overall Incidence Total 232/300 (77.33%)Mean 77.33% SD 7.23% Total 211/303 (69.64%) Mean 69.68% SD 5.12% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/52 (2%) 2/50 (4%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 4/300 (1.33%) Mean 1.33% SD 1.63% Total 5/303 (1.65%) Mean 1.65% SD 1.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 2/50 (4%) 2/50 (4%) 3/50 (6%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 3/50 (6%) 6/50 (12%) 7/50 (14%) 1/50 (2%) 4/50 (8%) 2/51 (4%) | | Overall Incidence Total 23/300 (7.67%) Mean 7.67% SD 4.27% Total 8/303 (2.64%) Mean 2.65% SD 3% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/50 (4%) 2/50 (4%) 4/50 (8%) 1/52 (2%) 2/50 (4%) 1/50 (2%) | | 4/50 (8%) 6/50 (12%) 9/50 (18%) 3/50 (6%) 4/50 (8%) 2/51 (4%) | | Overall Incidence Total 27/300 (9%) Mean 9% SD 5.33% Total 13/303 (4.29%) Mean 4.31% SD 2.36% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/51 (4%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 7/303 (2.31%) Mean 2.31% SD 1.49% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 666 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 2/50 (4%) 5/50 (10%) 5/52 (10%) 8/50 (16%) 9/50 (18%) | | Lymphocytic, Mixed, NOS, or 4/50 (8%) 2/50 (4%) 4/50 (8%) 5/50 (10%) 9/50 (18%) 3/51 (6%) | | Undifferentiated Cell Type | | Overall Incidence Total 19/300 (6.33%) Mean 6.33% SD 2.66% Total 39/303 (12.87%) Mean 12.92% SD 5.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/303 (0.99%) Mean 0.99% SD 1.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/303 (0.99%) Mean 0.99% SD 1.66% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/48 (2%) 4/50 (8%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 7/50 (14%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 14/298 (4.7%) Mean 4.68% SD 5.31% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/48 (0%) 0/50 (0%) 0/0 (0%) 0/51 (0%) 0/50 (0%) 0/0 (0%) | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/251 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/51 (2%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.03% Total 4/301 (1.33%) Mean 1.33% SD 1.03% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 667 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/51 (0%) 1/50 (2%) 1/50 (2%) | | Complex, Malignant, NOS 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/51 (2%) | | Overall Incidence Total 3/299 (1%) Mean 1% SD 1.1% Total 5/301 (1.66%) Mean 1.67% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/301 (0.33%) Mean 0.32% SD 0.79% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/48 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.63% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 668 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/303 (0.99%) Mean 0.99% SD 1.66% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/303 (0.99%) Mean 0.99% SD 1.66% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 669 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 670 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/48 (0%) 0/47 (0%) 1/48 (2%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | | 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/288 (0.35%) Mean 0.35% SD 0.85% Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 4/50 (8%) 4/50 (8%) 2/52 (4%) 3/50 (6%) 0/50 (0%) | | 0/0 (0%) 1/50 (2%) 3/50 (6%) 0/0 (0%) 3/50 (6%) 0/51 (0%) | | Overall Incidence Total 15/250 (6%) Mean 5% SD 3.29% Total 8/253 (3.16%) Mean 2.64% SD 3% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 1/50 (2%) | | 0/0 (0%) 0/50 (0%) 0/50 (0%) 0/0 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.33% SD 0.82% Total 2/253 (0.79%) Mean 0.65% SD 1.01% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 4/50 (8%) 4/50 (8%) 4/50 (8%) 3/52 (6%) 3/50 (6%) 1/50 (2%) | | 0/0 (0%) 1/50 (2%) 3/50 (6%) 0/0 (0%) 3/50 (6%) 0/51 (0%) | | Overall Incidence Total 16/250 (6.4%) Mean 5.33% SD 3.5% Total 10/253 (3.95%) Mean 3.29% SD 2.97% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 671 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 672 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 5/300 (1.67%) Mean 1.67% SD 2.66% Total 3/303 (0.99%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 673 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 6/300 (2%) Mean 2% SD 2.53% Total 4/303 (1.32%) Mean 1.33% SD 2.42% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 6/300 (2%) Mean 2% SD 2.53% Total 4/303 (1.32%) Mean 1.33% SD 2.42% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/49 (2%) 0/50 (0%) 0/49 (0%) 1/51 (2%) 3/50 (6%) 0/48 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 4/298 (1.34%) Mean 1.34% SD 1.64% Total 7/300 (2.33%) Mean 2.32% SD 2.34% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 674 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/49 (2%) 0/50 (0%) 0/49 (0%) 1/51 (2%) 3/50 (6%) 0/48 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 4/298 (1.34%) Mean 1.34% SD 1.64% Total 7/300 (2.33%) Mean 2.32% SD 2.34% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 675 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 1/49 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/49 (2%) 0/50 (0%) 3/50 (6%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/51 (2%) | | Overall Incidence Total 9/299 (3.01%) Mean 3.01% SD 2.75% Total 3/302 (0.99%) Mean 0.99% SD 1.09% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 18/49 (37%) 10/50 (20%) 9/50 (18%) 16/51 (31%) 6/50 (12%) 9/50 (18%) | | 14/50 (28%) 17/50 (34%) 28/50 (56%) 14/50 (28%) 11/50 (22%) 9/51 (18%) | | Overall Incidence Total 96/299 (32.11%) Mean 32.12% SD 13.84% Total 65/302 (21.52%) Mean 21.5% SD 7.17% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 11/49 (22%) 12/50 (24%) 20/50 (40%) 5/51 (10%) 10/50 (20%) 4/50 (8%) | | 7/50 (14%) 8/50 (16%) 8/50 (16%) 5/50 (10%) 4/50 (8%) 8/51 (16%) | | Overall Incidence Total 66/299 (22.07%) Mean 22.07% SD 9.64% Total 36/302 (11.92%) Mean 11.92% SD 4.87% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 11/49 (22%) 12/50 (24%) 21/50 (42%) 5/51 (10%) 10/50 (20%) 4/50 (8%) | | Hepatoblastoma 7/50 (14%) 8/50 (16%) 8/50 (16%) 6/50 (12%) 4/50 (8%) 8/51 (16%) | | Overall Incidence Total 67/299 (22.41%) Mean 22.41% SD 10.38% Total 37/302 (12.25%) Mean 12.25% SD 4.78% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 676 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 27/49 (55%) 22/50 (44%) 28/50 (56%) 20/51 (39%) 14/50 (28%) 13/50 (26%) | | Hepatocellular Adenoma 21/50 (42%) 22/50 (44%) 31/50 (62%) 17/50 (34%) 15/50 (30%) 17/51 (33%) | | Overall Incidence Total 151/299 (50.5%) Mean 50.52% SD 8.25% Total 96/302 (31.79%) Mean 31.76% SD 4.76% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 27/49 (55%) 22/50 (44%) 29/50 (58%) 20/51 (39%) 14/50 (28%) 13/50 (26%) | | Hepatocellular Adenoma, or 21/50 (42%) 22/50 (44%) 31/50 (62%) 17/50 (34%) 15/50 (30%) 17/51 (33%) | | Hepatoblastoma | | Overall Incidence Total 152/299 (50.84%)Mean 50.85% SD 8.55% Total 96/302 (31.79%) Mean 31.76% SD 4.76% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 677 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 9/50 (18%) 9/50 (18%) 3/52 (6%) 1/50 (2%) 4/50 (8%) | | 5/50 (10%) 6/50 (12%) 12/50 (24%) 4/50 (8%) 3/50 (6%) 3/51 (6%) | | Overall Incidence Total 53/300 (17.67%) Mean 17.67% SD 5.85% Total 18/303 (5.94%) Mean 5.94% SD 2.19% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 5/50 (10%) 10/50 (20%) 2/52 (4%) 0/50 (0%) 2/50 (4%) | | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) 2/51 (4%) | | Overall Incidence Total 23/300 (7.67%) Mean 7.67% SD 6.74% Total 8/303 (2.64%) Mean 2.63% SD 2.04% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 15/50 (30%) 14/50 (28%) 18/50 (36%) 5/52 (10%) 1/50 (2%) 6/50 (12%) | | Alveolar/Bronchiolar Adenoma 6/50 (12%) 7/50 (14%) 15/50 (30%) 6/50 (12%) 3/50 (6%) 5/51 (10%) | | Overall Incidence Total 75/300 (25%) Mean 25% SD 9.7% Total 26/303 (8.58%) Mean 8.57% SD 3.9% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 678 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 679 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 680 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 681 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 2/51 (4%) 0/49 (0%) 0/45 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/294 (1.02%) Mean 0.99% SD 1.65% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 682 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/51 (0%) 0/49 (0%) 1/45 (2%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 5/294 (1.7%) Mean 1.71% SD 1.52% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/51 (0%) 1/49 (2%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/294 (0.34%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/51 (0%) 1/49 (2%) 0/45 (0%) | | Malignant, NOS 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/294 (0.34%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 683 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/294 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/51 (0%) 0/49 (0%) 0/45 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 1/50 (2%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 684 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 1/50 (2%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/47 (0%) 0/42 (0%) 0/44 (0%) 0/44 (0%) 0/48 (0%) 0/44 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/40 (0%) 0/46 (0%) | | Overall Incidence Total 0/282 (0%) Mean 0% SD 0% Total 0/272 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 3/48 (6%) 0/40 (0%) 4/50 (8%) 9/48 (19%) 4/46 (9%) | | Adenoma 0/47 (0%) 0/46 (0%) 1/46 (2%) 7/49 (14%) 7/48 (15%) 5/49 (10%) | | Overall Incidence Total 4/275 (1.45%) Mean 1.4% SD 2.53% Total 36/290 (12.41%) Mean 12.42% SD 4.16% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/48 (0%) 0/40 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Carcinoma 0/47 (0%) 0/46 (0%) 0/46 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/275 (0%) Mean 0% SD 0% Total 1/290 (0.34%) Mean 0.35% SD 0.85% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 685 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 3/48 (6%) 0/40 (0%) 4/50 (8%) 9/48 (19%) 4/46 (9%) | | Carcinoma or Adenoma 0/47 (0%) 0/46 (0%) 1/46 (2%) 7/49 (14%) 8/48 (17%) 5/49 (10%) | | Overall Incidence Total 4/275 (1.45%) Mean 1.4% SD 2.53% Total 37/290 (12.76%) Mean 12.77% SD 4.45% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/48 (0%) 0/40 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | 0/47 (0%) 0/46 (0%) 0/46 (0%) 1/49 (2%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/275 (0%) Mean 0% SD 0% Total 1/290 (0.34%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/48 (0%) 0/40 (0%) 0/50 (0%) 0/48 (0%) 1/46 (2%) | | 0/47 (0%) 0/46 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/275 (0%) Mean 0% SD 0% Total 1/290 (0.34%) Mean 0.36% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/48 (0%) 0/40 (0%) 0/50 (0%) 0/48 (0%) 1/46 (2%) | | 0/47 (0%) 0/46 (0%) 0/46 (0%) 1/49 (2%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/275 (0%) Mean 0% SD 0% Total 2/290 (0.69%) Mean 0.7% SD 1.09% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 686 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.67% SD 1.03% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 687 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/303 (0.66%) Mean 0.65% SD 1.01% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/52 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 2/303 (0.66%) Mean 0.65% SD 1.01% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | NOS) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 688 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 2/300 (0.67%) Mean 0.67% SD 1.03% Total 2/303 (0.66%) Mean 0.66% SD 1.02% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/303 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 5/300 (1.67%) Mean 1.67% SD 1.51% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 689 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 690 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/51 (4%) | | Histiocytoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 5/303 (1.65%) Mean 1.65% SD 1.95% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 2/303 (0.66%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 2/50 (4%) | | Myxosarcoma, or Fibrous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/51 (4%) | | Histiocytoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 5/303 (1.65%) Mean 1.65% SD 1.95% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | or NOS) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/51 (4%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/303 (0.99%) Mean 0.99% SD 1.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 691 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 1/50 (2%) 4/50 (8%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 9/299 (3.01%) Mean 3% SD 3.95% Total 1/300 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 692 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 2/50 (4%) | | Papilloma Squamous 3/50 (6%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/51 (2%) | | Overall Incidence Total 6/300 (2%) Mean 2% SD 3.1% Total 7/303 (2.31%) Mean 2.33% SD 2.34% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 3/50 (6%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/51 (2%) | | Overall Incidence Total 6/300 (2%) Mean 2% SD 3.1% Total 6/303 (1.98%) Mean 1.99% SD 2.19% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 693 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 1/45 (2%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 1/282 (0.35%) Mean 0.37% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 694 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 0/45 (0%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/44 (0%) 0/42 (0%) 0/42 (0%) 0/46 (0%) 1/45 (2%) 0/49 (0%) | | 0/47 (0%) 0/45 (0%) 0/44 (0%) 0/47 (0%) 0/50 (0%) 0/45 (0%) | | Overall Incidence Total 0/264 (0%) Mean 0% SD 0% Total 1/282 (0.35%) Mean 0.37% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 0/302 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) 2/50 (4%) 1/50 (2%) 3/51 (6%) 1/50 (2%) 2/50 (4%) | | 2/49 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 7/298 (2.35%) Mean 2.35% SD 1.52% Total 8/302 (2.65%) Mean 2.64% SD 2.03% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 2/298 (0.67%) Mean 0.67% SD 1.04% Total 1/302 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/49 (2%) 2/50 (4%) 2/50 (4%) 3/51 (6%) 1/50 (2%) 2/50 (4%) | | 2/49 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/51 (2%) | | Overall Incidence Total 9/298 (3.02%) Mean 3.02% SD 1.1% Total 9/302 (2.98%) Mean 2.97% SD 1.64% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 695 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.33% SD 0.82% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 696 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.34% SD 0.83% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 1/49 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.34% SD 0.83% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 2/303 (0.66%) Mean 0.66% SD 1.02% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 697 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 2/303 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 3/52 (6%) 8/50 (16%) 2/50 (4%) | | 3/50 (6%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 16/303 (5.28%) Mean 5.29% SD 5.88% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 3/52 (6%) 8/50 (16%) 2/50 (4%) | | 3/50 (6%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 17/303 (5.61%) Mean 5.63% SD 5.57% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 698 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/303 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 699 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 39/50 (78%) 47/60 (78%) 26/50 (52%) 38/60 (63%) | | Overall Incidence Total 86/110 (78.18%) Mean 78.17% SD 0.24% Total 64/110 (58.18%) Mean 57.67% SD 8.01% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 22/50 (44%) 41/60 (68%) 23/50 (46%) 41/60 (68%) | | Overall Incidence Total 63/110 (57.27%) Mean 56.17% SD 17.21% Total 64/110 (58.18%) Mean 57.17% SD 15.79% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 42/50 (84%) 56/60 (93%) 35/50 (70%) 54/60 (90%) | | Overall Incidence Total 98/110 (89.09%) Mean 88.67% SD 6.6% Total 89/110 (80.91%) Mean 80% SD 14.14% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 3/50 (6%) 0/60 (0%) 3/50 (6%) 0/60 (0%) | | Overall Incidence Total 3/110 (2.73%) Mean 3% SD 4.24% Total 3/110 (2.73%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/50 (6%) 4/60 (7%) 3/50 (6%) 5/60 (8%) | | Overall Incidence Total 7/110 (6.36%) Mean 6.33% SD 0.47% Total 8/110 (7.27%) Mean 7.17% SD 1.65% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 6/50 (12%) 4/60 (7%) 5/50 (10%) 5/60 (8%) | | Overall Incidence Total 10/110 (9.09%) Mean 9.33% SD 3.77% Total 10/110 (9.09%) Mean 9.17% SD 1.18% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 2/60 (3%) 0/50 (0%) 3/60 (5%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.67% SD 2.36% Total 3/110 (2.73%) Mean 2.5% SD 3.54% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 7/60 (12%) 9/50 (18%) 17/60 (28%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 7/110 (6.36%) Mean 5.83% SD 8.25% Total 26/110 (23.64%) Mean 23.17% SD 7.31% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 700 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 5/50 (10%) 4/60 (7%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 9/110 (8.18%) Mean 8.33% SD 2.36% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Adenoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/49 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/109 (0.92%) Mean 1.02% SD 1.44% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/49 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Complex, Malignant, NOS | | Overall Incidence Total 1/109 (0.92%) Mean 1.02% SD 1.44% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 701 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/60 (0%) 0/49 (0%) 1/60 (2%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 0.83% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 702 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/60 (0%) 0/49 (0%) 1/60 (2%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 0.83% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Astrocytoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 703 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/44 (0%) 0/55 (0%) 0/47 (0%) 0/58 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 8/60 (13%) 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 11/110 (10%) Mean 9.67% SD 5.19% Total 2/110 (1.82%) Mean 1.83% SD 0.24% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.67% SD 2.36% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 10/60 (17%) 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 13/110 (11.82%) Mean 11.33% SD 7.54% Total 2/110 (1.82%) Mean 1.83% SD 0.24% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 704 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 705 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 2/60 (3%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 2/110 (1.82%) Mean 1.67% SD 2.36% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 1/60 (2%) 0/50 (0%) 2/60 (3%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% Total 2/110 (1.82%) Mean 1.67% SD 2.36% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 1/60 (2%) 0/50 (0%) 2/60 (3%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% Total 2/110 (1.82%) Mean 1.67% SD 2.36% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 1/59 (2%) 0/50 (0%) 1/59 (2%) | | Overall Incidence Total 1/109 (0.92%) Mean 0.85% SD 1.2% Total 1/109 (0.92%) Mean 0.85% SD 1.2% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 706 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 1/59 (2%) 0/50 (0%) 1/59 (2%) | | Overall Incidence Total 1/109 (0.92%) Mean 0.85% SD 1.2% Total 1/109 (0.92%) Mean 0.85% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Carcinoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Hemangioma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 707 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 1/59 (2%) 0/50 (0%) 1/59 (2%) | | Overall Incidence Total 1/109 (0.92%) Mean 0.85% SD 1.2% Total 1/109 (0.92%) Mean 0.85% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/59 (0%) 1/50 (2%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 3/59 (5%) 1/50 (2%) 2/59 (3%) | | Overall Incidence Total 4/109 (3.67%) Mean 3.54% SD 2.18% Total 3/109 (2.75%) Mean 2.69% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 1/50 (2%) 2/59 (3%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 3/109 (2.75%) Mean 2.69% SD 0.98% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 30/50 (60%) 40/59 (68%) 19/50 (38%) 29/59 (49%) | | Overall Incidence Total 70/109 (64.22%) Mean 63.9% SD 5.51% Total 48/109 (44.04%) Mean 43.58% SD 7.89% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 12/50 (24%) 25/59 (42%) 6/50 (12%) 25/59 (42%) | | Overall Incidence Total 37/109 (33.94%) Mean 33.19% SD 12.99% Total 31/109 (28.44%) Mean 27.19% SD 21.48% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 13/50 (26%) 27/59 (46%) 6/50 (12%) 25/59 (42%) | | Hepatoblastoma | | Overall Incidence Total 40/109 (36.7%) Mean 35.88% SD 13.97% Total 31/109 (28.44%) Mean 27.19% SD 21.48% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 35/50 (70%) 47/59 (80%) 20/50 (40%) 41/59 (69%) | | Hepatocellular Adenoma | | Overall Incidence Total 82/109 (75.23%) Mean 74.83% SD 6.83% Total 61/109 (55.96%) Mean 54.75% SD 20.85% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 35/50 (70%) 48/59 (81%) 20/50 (40%) 41/59 (69%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 83/109 (76.15%) Mean 75.68% SD 8.03% Total 61/109 (55.96%) Mean 54.75% SD 20.85% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 708 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 1/50 (2%) 0/59 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/109 (0.92%) Mean 1% SD 1.41% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 15/50 (30%) 12/60 (20%) 4/50 (8%) 2/59 (3%) | | Overall Incidence Total 27/110 (24.55%) Mean 25% SD 7.07% Total 6/109 (5.5%) Mean 5.69% SD 3.26% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 8/50 (16%) 4/60 (7%) 1/50 (2%) 3/59 (5%) | | Overall Incidence Total 12/110 (10.91%) Mean 11.33% SD 6.6% Total 4/109 (3.67%) Mean 3.54% SD 2.18% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 21/50 (42%) 15/60 (25%) 5/50 (10%) 4/59 (7%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 36/110 (32.73%) Mean 33.5% SD 12.02% Total 9/109 (8.26%) Mean 8.39% SD 2.28% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 709 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 710 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | or Adenoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 711 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 712 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 2/46 (4%) 0/58 (0%) | | Overall Incidence Total 2/104 (1.92%) Mean 2.17% SD 3.07% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/46 (0%) 2/58 (3%) | | Overall Incidence Total 2/104 (1.92%) Mean 1.72% SD 2.44% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/46 (0%) 0/58 (0%) | | Malignant, NOS | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 713 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 1/46 (2%) 0/58 (0%) | | Overall Incidence Total 1/104 (0.96%) Mean 1.09% SD 1.54% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/46 (0%) 1/58 (2%) | | Overall Incidence Total 1/104 (0.96%) Mean 0.86% SD 1.22% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/46 (2%) 0/58 (0%) | | Overall Incidence Total 1/104 (0.96%) Mean 1.09% SD 1.54% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/46 (0%) 0/58 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 714 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/58 (0%) 1/50 (2%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/58 (0%) 1/50 (2%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 1/109 (0.92%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/59 (0%) | | Overall Incidence Total 0/108 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/49 (0%) 0/55 (0%) 0/47 (0%) 0/48 (0%) | | Overall Incidence Total 0/104 (0%) Mean 0% SD 0% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/52 (0%) 5/48 (10%) 11/56 (20%) | | Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 16/104 (15.38%) Mean 15.03% SD 6.52% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/52 (0%) 0/48 (0%) 0/56 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/52 (0%) 5/48 (10%) 11/56 (20%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 16/104 (15.38%) Mean 15.03% SD 6.52% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 715 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/52 (0%) 1/48 (2%) 0/56 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/104 (0.96%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/52 (0%) 0/48 (0%) 0/56 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/104 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/52 (0%) 1/48 (2%) 0/56 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/104 (0.96%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 1/50 (2%) 0/60 (0%) 0/49 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/109 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 716 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 717 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 0.83% SD 1.18% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 718 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 719 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/60 (2%) 2/50 (4%) 0/60 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 2/110 (1.82%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/60 (2%) 2/50 (4%) 0/60 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 2/110 (1.82%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 720 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/59 (0%) 1/49 (2%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 1/108 (0.93%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 1/50 (2%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 1/109 (0.92%) Mean 1% SD 1.41% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 3/50 (6%) 1/59 (2%) 1/49 (2%) 1/59 (2%) | | Overall Incidence Total 4/109 (3.67%) Mean 3.85% SD 3.04% Total 2/108 (1.85%) Mean 1.87% SD 0.24% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 721 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) 1/60 (2%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/47 (0%) 0/53 (0%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/47 (0%) 0/53 (0%) 1/48 (2%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/105 (0.95%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 1/47 (2%) 0/53 (0%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1.06% SD 1.5% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/47 (0%) 1/53 (2%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 1/100 (1%) Mean 0.94% SD 1.33% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 722 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/47 (0%) 0/53 (0%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/47 (0%) 0/53 (0%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/47 (0%) 0/53 (0%) 1/48 (2%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/105 (0.95%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/47 (0%) 0/53 (0%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/47 (0%) 0/53 (0%) 0/48 (0%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/105 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/47 (0%) 0/53 (0%) 1/48 (2%) 0/57 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/105 (0.95%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/58 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/58 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/58 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 1/60 (2%) 2/50 (4%) 2/58 (3%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% Total 4/108 (3.7%) Mean 3.72% SD 0.39% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/58 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/60 (2%) 2/50 (4%) 2/58 (3%) | | Overall Incidence Total 2/110 (1.82%) Mean 1.83% SD 0.24% Total 4/108 (3.7%) Mean 3.72% SD 0.39% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 723 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 724 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/59 (0%) | | Overall Incidence Total 0/109 (0%) Mean 0% SD 0% Total 0/108 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 725 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 1/50 (2%) 0/60 (0%) | | Overall Incidence Total 1/110 (0.91%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) 1/60 (2%) | | Overall Incidence Total 1/110 (0.91%) Mean 0.83% SD 1.18% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/60 (0%) | | Overall Incidence Total 0/110 (0%) Mean 0% SD 0% Total 0/110 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 727 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 22/50 (44%) 34/50 (68%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 32/50 (64%) 35/50 (70%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 42/50 (84%) 48/50 (96%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 4/50 (8%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 4/50 (8%) 11/50 (22%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 728 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 1/49 (2%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 729 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 730 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 731 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/45 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 2/50 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 4/50 (8%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 732 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 733 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 734 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 735 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 4/50 (8%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 2/50 (4%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 14/50 (28%) 24/49 (49%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 18/50 (36%) 16/49 (33%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 20/50 (40%) 16/49 (33%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 28/50 (56%) 33/49 (67%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 30/50 (60%) 33/49 (67%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 1/50 (2%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 736 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 9/50 (18%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 5/50 (10%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 13/50 (26%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 737 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 738 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 739 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 740 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 4/46 (9%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/46 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/46 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 741 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/46 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 742 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/49 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 11/46 (24%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 0/46 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/45 (0%) 11/46 (24%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 743 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/45 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/45 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/45 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 744 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 745 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 2/50 (4%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 746 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 1/50 (2%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 747 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 748 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/49 (0%) 1/47 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 749 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 750 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/38 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 751 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 752 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 753 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SUBCUTANEOUS Date of Species: MICE Vehicle: BUFFERED SERUM Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 755 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 29/50 (58%) 26/50 (52%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 19/50 (38%) 25/50 (50%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 40/50 (80%) 40/50 (80%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 3/50 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 6/50 (12%) 15/50 (30%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 756 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/49 (0%) 0/50 (0%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 0/50 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 757 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 758 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 759 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/50 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 3/50 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 760 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 761 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 762 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Hemangiosarcoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 763 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 22/50 (44%) 17/50 (34%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 8/50 (16%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 8/50 (16%) 6/50 (12%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 27/50 (54%) 21/50 (42%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 27/50 (54%) 21/50 (42%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 764 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 8/50 (16%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 11/50 (22%) 6/50 (12%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 765 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 766 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 767 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 768 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 769 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 770 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/46 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 3/49 (6%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 3/49 (6%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 771 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/48 (2%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/48 (2%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 772 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 773 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 774 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 775 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 776 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 777 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/43 (0%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 778 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/43 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/49 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 779 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 780 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 781 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 783 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 41/50 (82%) 35/50 (70%) 42/50 (84%) 40/50 (80%) | | Overall Incidence Total 76/100 (76%) Mean 76% SD 8.49% Total 82/100 (82%) Mean 82% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 32/50 (64%) 22/50 (44%) 28/50 (56%) 26/50 (52%) | | Overall Incidence Total 54/100 (54%) Mean 54% SD 14.14% Total 54/100 (54%) Mean 54% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 48/50 (96%) 43/50 (86%) 46/50 (92%) 47/50 (94%) | | Overall Incidence Total 91/100 (91%) Mean 91% SD 7.07% Total 93/100 (93%) Mean 93% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 5/50 (10%) 2/50 (4%) 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 7/100 (7%) Mean 7% SD 4.24% Total 4/100 (4%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 7/50 (14%) 2/50 (4%) 5/50 (10%) 0/50 (0%) | | Overall Incidence Total 9/100 (9%) Mean 9% SD 7.07% Total 5/100 (5%) Mean 5% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 2/50 (4%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 4/100 (4%) Mean 4% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Erythrocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 3/50 (6%) 10/50 (20%) 6/50 (12%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 16/100 (16%) Mean 16% SD 5.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 784 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 3/49 (6%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.06% SD 4.33% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Gland: Non-medullary, | | Non-cortical 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Adenoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/48 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/48 (0%) 1/50 (2%) 0/49 (0%) | | Complex, Malignant, NOS | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 785 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 786 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 787 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/45 (0%) 0/43 (0%) 0/42 (0%) 0/37 (0%) | | Overall Incidence Total 0/88 (0%) Mean 0% SD 0% Total 0/79 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 1/50 (2%) 5/50 (10%) 5/50 (10%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 5.66% Total 6/100 (6%) Mean 6% SD 5.66% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 788 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 789 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/49 (2%) | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 790 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/49 (2%) | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Hemangioma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Hemangiosarcoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 791 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 6/50 (12%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 5.66% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 35/50 (70%) 29/50 (58%) 40/50 (80%) 37/49 (76%) | | Overall Incidence Total 64/100 (64%) Mean 64% SD 8.49% Total 77/99 (77.78%) Mean 77.76% SD 3.17% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 13/50 (26%) 15/50 (30%) 6/50 (12%) 13/49 (27%) | | Overall Incidence Total 28/100 (28%) Mean 28% SD 2.83% Total 19/99 (19.19%) Mean 19.27% SD 10.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 18/50 (36%) 17/50 (34%) 6/50 (12%) 13/49 (27%) | | Hepatoblastoma | | Overall Incidence Total 35/100 (35%) Mean 35% SD 1.41% Total 19/99 (19.19%) Mean 19.27% SD 10.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 39/50 (78%) 37/50 (74%) 41/50 (82%) 41/49 (84%) | | Hepatocellular Adenoma | | Overall Incidence Total 76/100 (76%) Mean 76% SD 2.83% Total 82/99 (82.83%) Mean 82.84% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 40/50 (80%) 38/50 (76%) 41/50 (82%) 41/49 (84%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 78/100 (78%) Mean 78% SD 2.83% Total 82/99 (82.83%) Mean 82.84% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 792 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Ito Cell Tumor NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 12/50 (24%) 12/49 (24%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 24/99 (24.24%) Mean 24.24% SD 0.35% Total 6/100 (6%) Mean 6% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 4/50 (8%) 1/49 (2%) 5/50 (10%) 2/50 (4%) | | Overall Incidence Total 5/99 (5.05%) Mean 5.02% SD 4.21% Total 7/100 (7%) Mean 7% SD 4.24% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 16/50 (32%) 13/49 (27%) 9/50 (18%) 4/50 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 29/99 (29.29%) Mean 29.27% SD 3.87% Total 13/100 (13%) Mean 13% SD 7.07% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 793 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 794 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: Mesenteric | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 795 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 796 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma NOS 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Carcinoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/50 (2%) 4/47 (9%) | | Overall Incidence Total 5/97 (5.15%) Mean 5.26% SD 4.6% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Fibrous Histiocytoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) 1/47 (2%) | | Overall Incidence Total 2/97 (2.06%) Mean 2.06% SD 0.09% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) 1/47 (2%) | | Malignant, NOS | | Overall Incidence Total 2/97 (2.06%) Mean 2.06% SD 0.09% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 797 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 1/50 (2%) 0/47 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Liposarcoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Malignant 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma NOS 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Yolk Sac Carcinoma 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 798 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Carcinoma 0/48 (0%) 0/31 (0%) 0/49 (0%) 0/31 (0%) | | Overall Incidence Total 0/79 (0%) Mean 0% SD 0% Total 0/80 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/46 (0%) 6/49 (12%) 8/47 (17%) | | Adenoma | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 14/96 (14.58%) Mean 14.63% SD 3.38% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/47 (0%) | | Carcinoma | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/46 (0%) 6/49 (12%) 8/47 (17%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 14/96 (14.58%) Mean 14.63% SD 3.38% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 799 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Hemangioma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 800 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 801 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 802 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Paraganglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 803 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 804 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrous Histiocytoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 1/49 (2%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1.02% SD 1.44% Total 1/98 (1.02%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 805 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrosarcoma 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Fibrous Histiocytoma 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangiosarcoma 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 806 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Mast Cell Tumor Malignant 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/37 (0%) 0/46 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/83 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/99 (1.01%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 2/49 (4%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.04% SD 1.47% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 2/49 (4%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 3/99 (3.03%) Mean 3.04% SD 1.47% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 807 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 1/48 (2%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 808 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangioma 1/50 (2%) 0/48 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1% SD 1.41% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 0/98 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 1/48 (2%) 0/48 (0%) 0/45 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Deciduoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 809 Version: 01/12/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: TSI MASON RESEARCH Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 23-DEC-1999 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________