Toxicology Data Management System Page: 1 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 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 050510911 11/14/88 729 50(1) 21 (651) 437.2 TRIETHANOLAMINE | |E.G. & G. MASON 050506908 09/12/89 729 50(1) 5 (619) 483.8 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050510911 11/14/88 729 50(1) 25 (678) 279.5 TRIETHANOLAMINE | |E.G. & G. MASON 050506908 09/12/89 736 50(1) 19 (667) 340.1 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 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 050510205 06/15/87 731 52(1) 15 (654) 496.6 BENZETHONIUM CHLORIDE | |BATTELLE COLUMBUS 055531203 02/01/93 729 50(1) 8 (594) 480.5 COCONUT OIL ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050516209 10/08/90 729 50(1) 14 (651) 467.0 DIETHANOLAMINE | |BATTELLE COLUMBUS 055532303 12/14/92 729 50(1) 12 (657) 471.8 LAURIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 059101403 05/19/93 728 50(1) 8 (622) 456.4 OLEIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050518805 11/29/90 735 50(1) 7 (637) 439.3 SODIUM XYLENESULFONATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050510205 06/15/87 731 51(1) 24 (671) 308.5 BENZETHONIUM CHLORIDE | |BATTELLE COLUMBUS 055531203 02/01/93 728 50(1) 28 (683) 311.9 COCONUT OIL ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050516209 10/08/90 730 50(1) 25 (669) 305.9 DIETHANOLAMINE | |BATTELLE COLUMBUS 055532303 12/14/92 729 50(1) 28 (653) 302.3 LAURIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 059101403 05/19/93 728 50(1) 15 (627) 297.1 OLEIC ACID DIETHANOLAMINE CONDENSATE | |BATTELLE COLUMBUS 050518805 11/29/90 736 50(1) 22 (647) 289.4 SODIUM XYLENESULFONATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 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 050510601 02/06/85 734 50(1) 4 (610) 464.5 DIETHYLPHTHALATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |HAZLETON 050510601 02/06/85 734 51(1) 30 (682) 305.0 DIETHYLPHTHALATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 4 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 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 050508601 10/29/84 729 50(5) 23 (641) 496.9 O-BENZYL-P-CHLOROPHENOL | |BIOASSAY SYS CORP 050509101 10/02/84 729 51(5) 28 (671) 529.1 3,4-DIHYDROCOUMARIN | |BIOASSAY SYS CORP 050509001 09/06/84 729 49(5) 28 (666) 526.9 COUMARIN | |E.G. & G. MASON 050511101 06/03/85 731 50(5) 34 (688) 488.8 1,2,3-TRICHLOROPROPANE | |E.G. & G. MASON 050510801 03/05/85 730 50(5) 23 (675) 482.3 PROMETHAZINE HYDROCHLORIDE | |E.G. & G. MASON 050521401 12/13/88 731 52(1) 22 (652) 464.8 TRANS-DELTA-9-TETRAHYDROCANNABINOL | |SOUTHERN RESEARCH 050509907 12/12/88 729 50(5) 35 (686) 477.3 SALICYLAZOSULFAPYRIDINE | |SOUTHERN RESEARCH 050506709 10/25/90 733 50(5) 23 (676) 491.2 THEOPHYLLINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050508601 10/29/84 729 50(5) 26 (652) 311.3 O-BENZYL-P-CHLOROPHENOL | |BIOASSAY SYS CORP 050509101 10/02/84 730 50(5) 31 (687) 322.9 3,4-DIHYDROCOUMARIN | |BIOASSAY SYS CORP 050509001 09/06/84 729 50(5) 29 (665) 339.1 COUMARIN | |E.G. & G. MASON 050511101 06/03/85 738 50(5) 31 (687) 313.7 1,2,3-TRICHLOROPROPANE | |E.G. & G. MASON 050510801 03/05/85 735 50(5) 30 (667) 335.0 PROMETHAZINE HYDROCHLORIDE | |E.G. & G. MASON 050521401 12/13/88 736 51(1) 23 (649) 316.9 TRANS-DELTA-9-TETRAHYDROCANNABINOL | |SOUTHERN RESEARCH 050509907 12/12/88 738 50(5) 34 (697) 295.0 SALICYLAZOSULFAPYRIDINE | |SOUTHERN RESEARCH 050506709 10/25/90 734 50(5) 31 (684) 320.7 THEOPHYLLINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 5 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 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 050512105 10/20/88 726 50(5) 20 (659) 485.0 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050512105 10/20/88 726 50(5) 34 (680) 334.6 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 6 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 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 050513303 03/31/88 733 48(1) 11 (639) 498.2 ACETONITRILE | |BATTELLE NORTHWEST 050513607 09/20/90 733 50(1) 13 (645) 529.2 CHLOROPRENE | |BATTELLE NORTHWEST 050515605 08/30/90 734 50(1) 17 (648) 497.6 COBALT SULFATE HEPTAHYDRATE | |BATTELLE NORTHWEST 050520105 11/26/91 735 50(1) 8 (618) 546.6 FURFURYL ALCOHOL | |BATTELLE NORTHWEST 050511401 12/02/85 733 50(1) 18 (661) 488.4 HEXACHLOROCYCLOPENTADIENE (HCCPD) | |BATTELLE NORTHWEST 058807003 03/11/93 733 50(1) 7 (630) 531.3 ISOBUTENE | |BATTELLE NORTHWEST 056096801 08/16/90 733 50(1) 12 (641) 530.8 ISOBUTYRALDEHYDE | |BATTELLE NORTHWEST 050513507 06/24/93 733 50(1) 18 (643) 513.1 ISOPRENE | |BATTELLE NORTHWEST 050515803 03/15/90 735 50(1) 17 (645) 518.7 MOLYBDENUM TRIOXIDE | |BATTELLE NORTHWEST 050520005 09/07/89 733 50(1) 13 (642) 533.0 NITROMETHANE | |BATTELLE NORTHWEST 058803403 01/25/90 733 50(1) 8 (620) 525.8 OZONE | |BATTELLE NORTHWEST 050513205 06/23/88 733 50(1) 17 (665) 485.7 TETRAFLUOROETHYLENE | |BATTELLE NORTHWEST 050518103 12/14/89 733 50(1) 12 (616) 542.0 TETRAHYDROFURAN | |I. I. T. RESEARCH I050521003 03/07/90 734 50(1) 15 (651) 507.1 ETHYLBENZENE | |I. I. T. RESEARCH I050518503 12/08/88 729 46(1) 17 (655) 465.8 ISOBUTYL NITRITE | |LOVELACE RESEARCH 050512305 04/04/88 733 54(1) 14 (648) 500.6 NICKEL OXIDE | |LOVELACE RESEARCH 050510705 10/31/88 733 53(1) 13 (635) 502.6 NICKEL SUBSULFIDE | |LOVELACE RESEARCH 050512205 06/20/88 733 54(1) 16 (641) 497.4 NICKEL SULFATE HEXAHYDRATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 7 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 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 050513303 03/31/88 734 48(1) 23 (649) 342.1 ACETONITRILE | |BATTELLE NORTHWEST 050513607 09/20/90 733 49(1) 29 (685) 365.7 CHLOROPRENE | |BATTELLE NORTHWEST 050515605 08/30/90 735 50(1) 28 (699) 334.1 COBALT SULFATE HEPTAHYDRATE | |BATTELLE NORTHWEST 050520105 11/26/91 735 50(1) 26 (667) 382.3 FURFURYL ALCOHOL | |BATTELLE NORTHWEST 050511401 12/02/85 733 50(1) 28 (689) 340.2 HEXACHLOROCYCLOPENTADIENE (HCCPD) | |BATTELLE NORTHWEST 058807003 03/11/93 733 50(1) 23 (667) 360.6 ISOBUTENE | |BATTELLE NORTHWEST 056096801 08/16/90 734 50(1) 27 (659) 360.1 ISOBUTYRALDEHYDE | |BATTELLE NORTHWEST 050513507 06/24/93 734 50(1) 29 (686) 359.3 ISOPRENE | |BATTELLE NORTHWEST 050515803 03/15/90 735 50(1) 28 (685) 363.0 MOLYBDENUM TRIOXIDE | |BATTELLE NORTHWEST 050520005 09/07/89 733 50(1) 28 (683) 358.0 NITROMETHANE | |BATTELLE NORTHWEST 058803403 01/25/90 733 50(1) 28 (676) 359.6 OZONE | |BATTELLE NORTHWEST 050513205 06/23/88 734 50(1) 28 (694) 335.5 TETRAFLUOROETHYLENE | |BATTELLE NORTHWEST 050518103 12/14/89 733 50(1) 25 (657) 373.8 TETRAHYDROFURAN | |I. I. T. RESEARCH I050521003 03/07/90 734 50(1) 31 (661) 347.4 ETHYLBENZENE | |I. I. T. RESEARCH I050518503 12/08/88 733 46(1) 29 (696) 306.2 ISOBUTYL NITRITE | |LOVELACE RESEARCH 050512305 04/04/88 729 53(1) 21 (659) 344.6 NICKEL OXIDE | |LOVELACE RESEARCH 050510705 10/31/88 729 53(1) 25 (658) 335.8 NICKEL SUBSULFIDE | |LOVELACE RESEARCH 050512205 06/20/88 729 53(1) 22 (676) 339.2 NICKEL SULFATE HEXAHYDRATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 8 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 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 050516501 12/22/86 731 50(5) 18 (648) 462.1 4,4-THIOBIS-(6-TERT-BUTYL-M-CRESOL) | |BATTELLE COLUMBUS 050508501 09/24/84 729 52(5) 25 (655) 510.0 MANGANESE SULFATE | |BATTELLE COLUMBUS 050521205 09/23/91 730 50(5) 17 (662) 509.2 OXAZEPAM | |BATTELLE COLUMBUS 058900202 11/23/92 736 50(5) 12 (656) 514.7 PENTACHLOROPHENOL | |BATTELLE COLUMBUS 058803505 04/06/92 723 50(5) 13 (639) 522.0 PRIMACLONE | |BATTELLE COLUMBUS 050508701 09/10/84 729 50(5) 25 (638) 489.9 TRIAMTERENE | |BATTELLE COLUMBUS 050510003 09/18/86 731 51(5) 31 (684) 466.8 TRICRESYL PHOSPHATE | |E.G. & G. MASON 050515001 08/27/86 735 50(5) 28 (678) 430.5 METHYLPHENIDATE HYDROCHLORIDE | |E.G. & G. MASON 050508401 07/24/84 732 50(5) 18 (649) 494.1 TURMERIC, OLEORESIN (CURCUMIN) | |MICROB. ASSOC. 050513003 05/15/86 733 50(5) 30 (676) 468.9 C. I. DIRECT BLUE 218 | |MICROB. ASSOC. 050506809 04/14/89 732 50(5) 29 (664) 478.2 CODEINE | |SOUTHERN RESEARCH 050510305 03/27/89 736 51(5) 26 (688) 462.5 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL | |SOUTHERN RESEARCH 050512003 09/09/86 729 50(5) 27 (684) 449.3 BENZYL ACETATE | |SOUTHERN RESEARCH 050509402 06/26/89 729 50(5) 28 (658) 451.2 BUTYL BENZYL PHTHALATE | |SOUTHERN RESEARCH 050512806 04/26/90 733 50(5) 19 (679) 476.9 D & C YELLOW NO. 11 | |SOUTHERN RESEARCH 050509201 09/11/84 728 50(5) 32 (695) 447.8 O-NITROANISOLE | |SOUTHERN RESEARCH 050515503 05/11/88 729 50(5) 12 (613) 484.4 P-NITROBENZOIC ACID | |TSI MASON RESEARCH 050518203 03/13/91 729 50(5) 21 (640) 470.3 PHENOLPHTHALEIN | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 9 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 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 COLUMBUS 050516501 12/22/86 731 50(5) 34 (706) 340.6 4,4-THIOBIS-(6-TERT-BUTYL-M-CRESOL) | |BATTELLE COLUMBUS 050508501 09/24/84 729 50(5) 37 (708) 339.6 MANGANESE SULFATE | |BATTELLE COLUMBUS 050521205 09/23/91 729 50(5) 32 (676) 348.2 OXAZEPAM | |BATTELLE COLUMBUS 058900202 11/23/92 738 50(5) 28 (680) 338.6 PENTACHLOROPHENOL | |BATTELLE COLUMBUS 058803505 04/06/92 722 50(5) 24 (673) 363.0 PRIMACLONE | |BATTELLE COLUMBUS 050508701 09/10/84 729 50(5) 29 (697) 343.8 TRIAMTERENE | |BATTELLE COLUMBUS 050510003 09/18/86 731 51(5) 34 (676) 328.4 TRICRESYL PHOSPHATE | |E.G. & G. MASON 050515001 08/27/86 747 50(5) 30 (699) 325.8 METHYLPHENIDATE HYDROCHLORIDE | |E.G. & G. MASON 050508401 07/24/84 734 50(5) 32 (691) 343.2 TURMERIC, OLEORESIN (CURCUMIN) | |MICROB. ASSOC. 050513003 05/15/86 734 50(5) 35 (689) 345.6 C. I. DIRECT BLUE 218 | |MICROB. ASSOC. 050506809 04/14/89 733 50(5) 28 (662) 348.6 CODEINE | |SOUTHERN RESEARCH 050510305 03/27/89 739 50(5) 36 (712) 329.5 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL | |SOUTHERN RESEARCH 050512003 09/09/86 731 50(5) 30 (693) 320.6 BENZYL ACETATE | |SOUTHERN RESEARCH 050509402 06/26/89 736 50(5) 25 (690) 334.9 BUTYL BENZYL PHTHALATE | |SOUTHERN RESEARCH 050512806 04/26/90 742 50(5) 22 (694) 356.7 D & C YELLOW NO. 11 | |SOUTHERN RESEARCH 050509201 09/11/84 728 50(5) 33 (694) 316.8 O-NITROANISOLE | |SOUTHERN RESEARCH 050515503 05/11/88 731 50(5) 27 (699) 341.0 P-NITROBENZOIC ACID | |TSI MASON RESEARCH 050518203 03/13/91 735 50(5) 30 (680) 351.2 PHENOLPHTHALEIN | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 10 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 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 050513101 10/07/85 729 80(5) 42 (668) 487.2 SODIUM FLUORIDE | |E.G. & G. MASON 050512701 09/09/85 733 50(5) 22 (685) 468.0 BARIUM CHLORIDE DIHYDRATE | |SOUTHERN RESEARCH 050508901 01/28/85 729 51(5) 14 (637) 495.7 CHLORAMINE | |SOUTHERN RESEARCH 050514203 11/12/86 729 50(1) 10 (618) 486.0 TERT-BUTYL ALCOHOL | |TSI MASON RESEARCH 050516005 02/05/91 729 50(5) 20 (659) 516.1 1-CHLORO-2-PROPANOL | |TSI MASON RESEARCH 055530105 04/23/91 722 50(5) 25 (663) 511.0 PYRIDINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 050513101 10/07/85 729 80(5) 59 (697) 335.8 SODIUM FLUORIDE | |E.G. & G. MASON 050512701 09/09/85 745 50(5) 30 (688) 335.5 BARIUM CHLORIDE DIHYDRATE | |SOUTHERN RESEARCH 050508901 01/28/85 730 50(5) 31 (694) 352.2 CHLORAMINE | |SOUTHERN RESEARCH 050514203 11/12/86 729 50(1) 28 (669) 336.8 TERT-BUTYL ALCOHOL | |TSI MASON RESEARCH 050516005 02/05/91 734 50(5) 25 (698) 348.1 1-CHLORO-2-PROPANOL | |TSI MASON RESEARCH 055530105 04/23/91 729 50(5) 32 (694) 344.2 PYRIDINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 11 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 44/50 (88%) 48/50 (96%) 43/50 (86%) 43/50 (86%) | | Overall Incidence Total 92/100 (92%) Mean 92% SD 5.66% Total 86/100 (86%) Mean 86% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 26/50 (52%) 27/50 (54%) 16/50 (32%) 30/50 (60%) | | Overall Incidence Total 53/100 (53%) Mean 53% SD 1.41% Total 46/100 (46%) Mean 46% SD 19.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 47/50 (94%) 48/50 (96%) 47/50 (94%) 49/50 (98%) | | Overall Incidence Total 95/100 (95%) Mean 95% SD 1.41% Total 96/100 (96%) Mean 96% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 24/50 (48%) 25/50 (50%) 13/50 (26%) 22/50 (44%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 49/100 (49%) Mean 49% SD 1.41% Total 35/100 (35%) Mean 35% SD 12.73% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% 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: 12 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | 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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 3/50 (6%) 5/50 (10%) 0/50 (0%) 4/50 (8%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 4/100 (4%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 3/50 (6%) 5/50 (10%) 0/50 (0%) 5/50 (10%) | | Complex, Malignant, NOS | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 5/100 (5%) Mean 5% SD 7.07% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | 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: | | Chondrosarcoma 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: 13 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 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: | | Chordoma 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: | | 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% | __________________________________________________________________________________________________________________________________ |#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 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 or 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: | | 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: | | Astrocytoma Malignant 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% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma 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: | | 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: 14 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma 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: | | Glioma Malignant, Mixed 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: | | Glioma 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: | | Granular 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% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular 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% | __________________________________________________________________________________________________________________________________ |*Brain: | | 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% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma 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% | __________________________________________________________________________________________________________________________________ |*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 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, Glioma, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% 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: 15 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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% | __________________________________________________________________________________________________________________________________ |*Brain: | | 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% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 1/50 (2%) 2/48 (4%) 4/49 (8%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 6/97 (6.19%) Mean 6.16% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 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% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 4/48 (8%) 5/49 (10%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 9/97 (9.28%) Mean 9.27% SD 1.32% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 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% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |#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: | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | 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% | __________________________________________________________________________________________________________________________________ |#Ear: | | 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% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | 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% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma 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% | __________________________________________________________________________________________________________________________________ |#Harderian 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% | __________________________________________________________________________________________________________________________________ |#Harderian 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% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | 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% | __________________________________________________________________________________________________________________________________ |*Heart: | | 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% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ |*Heart: | | 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% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | 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 Large: Colon/Rectum | | 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 | | 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: Colon/Rectum | | Fibroma 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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | 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 | | 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 | | 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 Large: Colon/Rectum | | 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: Colon/Rectum | | 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% | __________________________________________________________________________________________________________________________________ |#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 | | 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: Ileum | | 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: 18 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | 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 | | 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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | 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 Small: Jejunum | | 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 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 | | 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% | __________________________________________________________________________________________________________________________________ |#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%) 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 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 Small: Site Unspecified | | 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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | 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 Small: Site Unspecified | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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 | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 6/50 (12%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/100 (7%) Mean 7% SD 7.07% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | 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% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 6/50 (12%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/100 (7%) Mean 7% SD 7.07% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | 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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% 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: 20 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | 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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | 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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma 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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | 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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% 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: 21 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar 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% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 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% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | 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, Mediastinal: | | 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, 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 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%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 4/50 (8%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 4/100 (4%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 1/50 (2%) 0/50 (0%) 13/50 (26%) 25/50 (50%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 38/100 (38%) Mean 38% SD 16.97% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 1/50 (2%) 0/50 (0%) 13/50 (26%) 26/50 (52%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 39/100 (39%) Mean 39% SD 18.38% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 0/50 (0%) 13/50 (26%) 29/50 (58%) | | or Adenoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 42/100 (42%) Mean 42% SD 22.63% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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: | | 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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% | __________________________________________________________________________________________________________________________________ |*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: | | Chondroma 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: | | Chondrosarcoma 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: | | 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% | __________________________________________________________________________________________________________________________________ |*Nose: | | 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% | __________________________________________________________________________________________________________________________________ |*Nose: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 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: | | 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% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#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, 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | 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 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% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | 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% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence 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: 25 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) 0/50 (0%) | | Malignant, NOS | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed 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% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 1/48 (2%) 1/41 (2%) 0/44 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.04% SD 1.47% Total 1/85 (1.18%) Mean 1.22% SD 1.72% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 26 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | 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% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: 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% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | 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% | __________________________________________________________________________________________________________________________________ |#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 35/50 (70%) 25/49 (51%) 33/50 (66%) 30/49 (61%) | | Adenoma | | Overall Incidence Total 60/99 (60.61%) Mean 60.51% SD 13.42% Total 63/99 (63.64%) Mean 63.61% SD 3.38% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) | | Carcinoma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 35/50 (70%) 25/49 (51%) 33/50 (66%) 32/49 (65%) | | Carcinoma or Adenoma | | Overall Incidence Total 60/99 (60.61%) Mean 60.51% SD 13.42% Total 65/99 (65.66%) Mean 65.65% SD 0.49% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Craniopharyngioma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Ganglioneuroma | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | 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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | 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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 27 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | 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% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | 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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or 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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | 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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#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 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 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: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 8/50 (16%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 11/100 (11%) Mean 11% SD 7.07% 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 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: | | 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 5/50 (10%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/100 (7%) Mean 7% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 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: | | 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 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: | | Melanoma 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: 30 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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: | | 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: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 7/50 (14%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 10/100 (10%) Mean 10% SD 5.66% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 7/50 (14%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 10/100 (10%) Mean 10% SD 5.66% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#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 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 4/50 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 4.24% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 31 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 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: | | Neurofibroma or Schwannoma 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: | | Neurofibrosarcoma 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: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | (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%) 1/50 (2%) 0/50 (0%) | | 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 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: | | Schwannoma 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: | | 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% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | 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% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma 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: 32 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 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: | | Glioma 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% 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: 33 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid 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, Glandular: | | Carcinoid 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | 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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 31/50 (62%) 36/50 (72%) | | Overall Incidence Total 67/100 (67%) Mean 67% SD 7.07% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/46 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/46 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/46 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/46 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/46 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/46 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/91 (0%) Mean 0% SD 0% Total 0/96 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 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% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 6/50 (12%) 0/50 (0%) 1/50 (2%) 7/49 (14%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 8.49% Total 8/99 (8.08%) Mean 8.14% SD 8.69% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 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% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 6/50 (12%) 0/50 (0%) 1/50 (2%) 7/49 (14%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 8.49% Total 8/99 (8.08%) Mean 8.14% SD 8.69% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 3/99 (3.03%) Mean 3.02% SD 1.39% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/49 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 4/99 (4.04%) Mean 4.02% SD 2.8% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac 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: | | 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 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 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |#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: | | Adamantinoma 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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | 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% | __________________________________________________________________________________________________________________________________ |#Urethra: | | 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: 36 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 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: | | Leiomyoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 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: 37 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/50 (4%) 4/50 (8%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/50 (4%) 4/50 (8%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ACETONE Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 50/52 (96%) 48/50 (96%) 47/50 (94%) 38/51 (75%) 43/50 (86%) 38/50 (76%) | | 48/50 (96%) 47/50 (94%) 49/50 (98%) 33/50 (66%) 38/50 (76%) 40/50 (80%) | | Overall Incidence Total 289/302 (95.7%) Mean 95.69% SD 1.51% Total 230/301 (76.41%) Mean 76.42% SD 6.59% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 30/52 (58%) 25/50 (50%) 32/50 (64%) 22/51 (43%) 19/50 (38%) 17/50 (34%) | | 23/50 (46%) 21/50 (42%) 20/50 (40%) 18/50 (36%) 12/50 (24%) 23/50 (46%) | | Overall Incidence Total 151/302 (50%) Mean 49.95% SD 9.33% Total 111/301 (36.88%) Mean 36.86% SD 7.73% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 52/52 (100%) 49/50 (98%) 50/50 (100%) 43/51 (84%) 48/50 (96%) 46/50 (92%) | | 50/50 (100%) 49/50 (98%) 50/50 (100%) 40/50 (80%) 40/50 (80%) 45/50 (90%) | | Overall Incidence Total 300/302 (99.34%)Mean 99.33% SD 1.03% Total 262/301 (87.04%) Mean 87.05% SD 6.64% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.97% SD 1.62% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.97% SD 1.62% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 3/52 (6%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.96% SD 2.36% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 23/52 (44%) 16/50 (32%) 23/50 (46%) 18/51 (35%) 10/50 (20%) 11/50 (22%) | | Mononuclear, or Undifferentiated 6/50 (12%) 14/50 (28%) 12/50 (24%) 10/50 (20%) 5/50 (10%) 17/50 (34%) | | Overall Incidence Total 94/302 (31.13%) Mean 31.04% SD 12.81% Total 71/301 (23.59%) Mean 23.55% SD 9.57% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type | | Overall Incidence Total 2/302 (0.66%) 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: 40 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/52 (2%) 2/50 (4%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | NOS 6/50 (12%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 14/302 (4.64%) Mean 4.65% SD 3.73% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/52 (2%) 2/50 (4%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 6/50 (12%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 14/302 (4.64%) Mean 4.65% SD 3.73% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/52 (2%) 0/50 (0%) 2/50 (4%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.99% SD 1.66% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/52 (2%) 0/50 (0%) 2/50 (4%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.99% SD 1.66% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/0 (0%) 0/50 (0%) 0/50 (0%) 0/0 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 2/250 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/0 (0%) 0/50 (0%) 0/50 (0%) 0/0 (0%) 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 0/250 (0%) Mean 0% SD 0% Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/0 (0%) 0/50 (0%) 0/50 (0%) 0/0 (0%) 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 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/0 (0%) 6/50 (12%) 9/50 (18%) 0/0 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 12/50 (24%) 8/50 (16%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 37/250 (14.8%) Mean 14.8% SD 7.43% Total 3/249 (1.2%) Mean 1.2% SD 1.79% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/0 (0%) 0/50 (0%) 0/50 (0%) 0/0 (0%) 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 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/0 (0%) 0/50 (0%) 1/50 (2%) 0/0 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/0 (0%) 6/50 (12%) 10/50 (20%) 0/0 (0%) 0/50 (0%) 0/49 (0%) | | Complex, Malignant, NOS 4/50 (8%) 12/50 (24%) 8/50 (16%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 40/250 (16%) Mean 16% SD 6.32% Total 3/249 (1.2%) Mean 1.2% SD 1.79% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 42 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 1/52 (2%) 0/50 (0%) 2/50 (4%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.99% SD 1.66% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/52 (2%) 0/50 (0%) 2/50 (4%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.99% SD 1.66% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 43 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma NOS 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 44 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/52 (0%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 0/52 (0%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/52 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 8/49 (16%) 4/50 (8%) | | 4/50 (8%) 0/50 (0%) 1/50 (2%) 7/49 (14%) 10/49 (20%) 1/49 (2%) | | Overall Incidence Total 7/302 (2.32%) Mean 2.33% SD 2.94% Total 33/296 (11.15%) Mean 11.18% SD 6.95% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/49 (6%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 4/302 (1.32%) Mean 1.31% SD 2.03% Total 5/296 (1.69%) Mean 1.7% SD 2.71% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 2/52 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 9/49 (18%) 4/50 (8%) | | 6/50 (12%) 0/50 (0%) 1/50 (2%) 10/49 (20%) 10/49 (20%) 1/49 (2%) | | Overall Incidence Total 11/302 (3.64%) Mean 3.64% SD 4.27% Total 37/296 (12.5%) Mean 12.54% SD 8.14% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 45 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 3/52 (6%) 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%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.96% SD 2.36% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 46 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 47 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/52 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Leiomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 48 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/52 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/52 (2%) 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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.65% SD 1.01% 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: 49 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/52 (2%) 3/50 (6%) 3/50 (6%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 15/302 (4.97%) Mean 4.99% SD 3.05% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/52 (0%) 0/50 (0%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 4/50 (8%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 8/302 (2.65%) Mean 2.67% SD 3.27% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/52 (2%) 3/50 (6%) 5/50 (10%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 6/50 (12%) 3/50 (6%) 5/50 (10%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 23/302 (7.62%) Mean 7.65% SD 3.69% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% 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: 50 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (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% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/302 (1.99%) Mean 2% SD 2.53% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 4/50 (8%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/302 (2.32%) Mean 2.33% SD 3.2% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 0/52 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 51 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/52 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (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% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | Hepatocellular Adenoma 0/50 (0%) 1/50 (2%) 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% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | Hepatocellular Adenoma, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% Total 5/301 (1.66%) Mean 1.67% SD 1.51% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 52 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (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%) | | Overall Incidence Total 2/301 (0.66%) Mean 0.67% SD 1.63% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 3/301 (1%) Mean 1% SD 2.45% Total 5/301 (1.66%) Mean 1.67% SD 1.51% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrosarcoma 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/51 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 53 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/52 (2%) 1/50 (2%) 0/50 (0%) 3/51 (6%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.65% SD 1.01% Total 5/301 (1.66%) Mean 1.65% SD 2.29% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 4/301 (1.33%) Mean 1.33% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 1/52 (2%) 1/50 (2%) 0/50 (0%) 3/51 (6%) 3/50 (6%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.99% SD 1.08% Total 9/301 (2.99%) Mean 2.98% SD 2.42% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 1/52 (2%) 2/50 (4%) 1/50 (2%) 17/51 (33%) 18/50 (36%) 14/50 (28%) | | 2/50 (4%) 3/50 (6%) 1/50 (2%) 11/50 (22%) 9/50 (18%) 16/50 (32%) | | Overall Incidence Total 10/302 (3.31%) Mean 3.32% SD 1.65% Total 85/301 (28.24%) Mean 28.22% SD 6.99% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 3/52 (6%) 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%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.96% SD 2.36% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 5/52 (10%) 3/50 (6%) 1/50 (2%) 19/51 (37%) 18/50 (36%) 14/50 (28%) | | 2/50 (4%) 3/50 (6%) 1/50 (2%) 11/50 (22%) 9/50 (18%) 16/50 (32%) | | Overall Incidence Total 15/302 (4.97%) Mean 4.94% SD 2.91% Total 87/301 (28.9%) Mean 28.88% SD 7.71% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 5/52 (10%) 3/50 (6%) 1/50 (2%) 19/51 (37%) 20/50 (40%) 14/50 (28%) | | or Adenoma 2/50 (4%) 4/50 (8%) 1/50 (2%) 11/50 (22%) 10/50 (20%) 16/50 (32%) | | Overall Incidence Total 16/302 (5.3%) Mean 5.27% SD 3.16% Total 90/301 (29.9%) Mean 29.88% SD 8.06% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 54 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% 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: 55 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/52 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/302 (1.32%) Mean 1.32% SD 1.02% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 1/52 (2%) 0/50 (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%) 1/50 (2%) | | Overall Incidence Total 3/302 (0.99%) Mean 0.99% SD 1.08% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 2/52 (4%) 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 7/302 (2.32%) Mean 2.31% SD 0.75% 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: 56 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (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%) 1/50 (2%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/52 (0%) 1/50 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/51 (0%) 0/50 (0%) 0/50 (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 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/51 (0%) 0/50 (0%) 0/50 (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, 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence 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: 57 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/52 (0%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/52 (0%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 1/50 (2%) 0/48 (0%) 1/46 (2%) 0/47 (0%) 1/42 (2%) 0/43 (0%) | | 0/47 (0%) 0/45 (0%) 0/46 (0%) 0/47 (0%) 0/42 (0%) 0/48 (0%) | | Overall Incidence Total 2/282 (0.71%) Mean 0.7% SD 1.08% Total 1/269 (0.37%) Mean 0.4% SD 0.97% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 58 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 31/52 (60%) 37/50 (74%) 32/50 (64%) 28/51 (55%) 27/50 (54%) 27/49 (55%) | | Adenoma 48/50 (96%) 38/50 (76%) 44/50 (88%) 23/50 (46%) 29/50 (58%) 34/50 (68%) | | Overall Incidence Total 230/302 (76.16%)Mean 76.27% SD 13.86% Total 168/300 (56%) Mean 56% SD 7.13% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/52 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) 0/50 (0%) 2/49 (4%) | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 5/300 (1.67%) Mean 1.67% SD 1.97% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 31/52 (60%) 37/50 (74%) 32/50 (64%) 30/51 (59%) 27/50 (54%) 29/49 (59%) | | Carcinoma or Adenoma 48/50 (96%) 38/50 (76%) 45/50 (90%) 23/50 (46%) 29/50 (58%) 35/50 (70%) | | Overall Incidence Total 231/302 (76.49%)Mean 76.6% SD 14.21% Total 173/300 (57.67%) Mean 57.67% SD 7.82% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | Craniopharyngioma 0/50 (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% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/49 (0%) | | Ganglioneuroma 0/50 (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% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/52 (2%) 0/50 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% 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: 59 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/52 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/52 (2%) 0/50 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/52 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 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% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/52 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/52 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/52 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% 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: 60 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/52 (0%) 1/50 (2%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 1% SD 1.67% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.65% SD 1.01% 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: 61 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/52 (2%) 1/50 (2%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/302 (1.66%) Mean 1.65% SD 1.5% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Papilloma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.03% Total 1/301 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 3/302 (0.99%) Mean 1% SD 1.67% Total 1/301 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/52 (0%) 2/50 (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%) 0/50 (0%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.63% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/52 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 2/302 (0.66%) Mean 0.67% SD 1.63% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/52 (0%) 2/50 (4%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 5/302 (1.66%) Mean 1.67% SD 1.97% Total 1/301 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 2/52 (4%) 6/50 (12%) 2/50 (4%) 1/51 (2%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 7/50 (14%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 18/302 (5.96%) Mean 5.97% SD 5.67% Total 2/301 (0.66%) Mean 0.66% SD 1.02% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 62 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 1/301 (0.33%) Mean 0.33% SD 0.8% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/52 (2%) 3/50 (6%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/302 (3.97%) Mean 3.99% SD 3.59% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 2/301 (0.66%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 63 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/52 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 3/302 (0.99%) Mean 1% SD 1.67% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/52 (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%) 1/50 (2%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.65% SD 1.01% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/52 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/302 (0.66%) Mean 0.65% SD 1.01% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/52 (4%) 4/50 (8%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 14/302 (4.64%) Mean 4.64% SD 3.73% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/52 (4%) 4/50 (8%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 14/302 (4.64%) Mean 4.64% SD 3.73% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/52 (0%) 3/50 (6%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/302 (2.98%) Mean 3% SD 2.76% Total 2/301 (0.66%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/52 (0%) 3/50 (6%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Histiocytoma | | Overall Incidence Total 10/302 (3.31%) Mean 3.33% SD 3.27% Total 3/301 (1%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 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% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Histiocytoma | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | or NOS) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 65 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/52 (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%) 1/50 (2%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/52 (2%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Leiomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 66 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/52 (0%) 3/50 (6%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 1% SD 2.45% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/52 (0%) 3/50 (6%) 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%) 0/50 (0%) | | Overall Incidence Total 3/302 (0.99%) Mean 1% SD 2.45% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (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: 67 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 42/52 (81%) 23/50 (46%) 32/50 (64%) | | 20/50 (40%) 24/50 (48%) 24/50 (48%) | | Overall Incidence Total 165/302 (54.64%)Mean 54.46% SD 15.15% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/44 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/47 (0%) 0/49 (0%) | | 0/44 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/273 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/44 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/47 (0%) 0/49 (0%) | | 0/44 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/273 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/44 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/47 (0%) 0/49 (0%) | | 0/44 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/273 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/44 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/47 (0%) 0/49 (0%) | | 0/44 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/273 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/44 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/47 (0%) 0/49 (0%) | | 0/44 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/273 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/44 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/47 (0%) 0/49 (0%) | | 0/44 (0%) 0/45 (0%) 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/273 (0%) Mean 0% SD 0% Total 0/282 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/51 (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%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 7/51 (14%) 3/50 (6%) 6/50 (12%) 11/51 (22%) 4/50 (8%) 8/50 (16%) | | 2/50 (4%) 2/50 (4%) 9/50 (18%) 1/50 (2%) 4/50 (8%) 10/50 (20%) | | Overall Incidence Total 29/301 (9.63%) Mean 9.62% SD 5.81% Total 38/301 (12.62%) Mean 12.59% SD 7.76% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/301 (1%) Mean 1% SD 1.67% Total 3/301 (1%) Mean 0.99% SD 1.09% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 68 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 7/51 (14%) 3/50 (6%) 6/50 (12%) 11/51 (22%) 5/50 (10%) 8/50 (16%) | | 3/50 (6%) 3/50 (6%) 9/50 (18%) 2/50 (4%) 4/50 (8%) 10/50 (20%) | | Overall Incidence Total 31/301 (10.3%) Mean 10.29% SD 5.09% Total 40/301 (13.29%) Mean 13.26% SD 7.01% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/51 (2%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/301 (0.66%) Mean 0.66% SD 1.02% Total 4/301 (1.33%) Mean 1.33% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/51 (0%) 2/50 (4%) 1/50 (2%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/301 (1.33%) Mean 1.33% SD 1.63% Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/51 (2%) 2/50 (4%) 2/50 (4%) 0/51 (0%) 3/50 (6%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 6/301 (1.99%) Mean 1.99% SD 1.79% Total 5/301 (1.66%) Mean 1.67% SD 2.34% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 69 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 0/52 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 1/50 (2%) 0/50 (0%) 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% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/52 (0%) 0/50 (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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.33% SD 0.82% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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: 70 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Malignant 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 1/52 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 1/302 (0.33%) Mean 0.32% SD 0.79% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Urethra: | | Carcinoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/52 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/52 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 2/300 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 0/52 (0%) 0/50 (0%) 0/48 (0%) 0/51 (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 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/52 (0%) 0/50 (0%) 0/48 (0%) 0/51 (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 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/52 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% 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: 71 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 3/51 (6%) 6/50 (12%) 3/50 (6%) | | 2/50 (4%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 17/301 (5.65%) Mean 5.65% SD 3.44% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/51 (0%) 0/50 (0%) 0/50 (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: 72 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/301 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 3/51 (6%) 6/50 (12%) 4/50 (8%) | | 2/50 (4%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 18/301 (5.98%) Mean 5.98% SD 3.58% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/51 (0%) 0/50 (0%) 0/50 (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: 73 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: ETHANOL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (0%) Mean 0% SD 0% Total 0/301 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 2/52 (4%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/302 (1.32%) Mean 1.31% SD 1.58% Total 2/301 (0.66%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 2/52 (4%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/302 (1.32%) Mean 1.31% SD 1.58% Total 2/301 (0.66%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell Papilloma 0/52 (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%) 0/50 (0%) | | Overall Incidence Total 0/302 (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 This page intentionally left blank Toxicology Data Management System Page: 75 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 45/50 (90%) 47/51 (92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 32/51 (63%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 46/50 (92%) 51/51 (100%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 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, 9/50 (18%) 17/51 (33%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 0/51 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 2/50 (4%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 0/51 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 76 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 4/51 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 14/49 (29%) 3/50 (6%) | | 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, 14/49 (29%) 4/50 (8%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/49 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 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: 77 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 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%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | 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: 78 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*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 NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 1/50 (2%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 79 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/34 (0%) 5/44 (11%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/34 (3%) 2/44 (5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 1/34 (3%) 7/44 (16%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 0/34 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/34 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 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: 80 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | 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 Toxicology Data Management System Page: 81 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 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 | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 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: Ileum | | 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: 82 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 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: 83 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 6/49 (12%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 6/49 (12%) 5/50 (10%) | | 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%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 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: 84 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 85 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 0/50 (0%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | 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: 86 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 5/51 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 6/51 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 0/50 (0%) 21/51 (41%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 2/50 (4%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 22/51 (43%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 25/51 (49%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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: 87 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 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 | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 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: | | Chondroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 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: 88 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 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 | __________________________________________________________________________________________________________________________________ |#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: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 89 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/47 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 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: 90 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 39/44 (89%) 38/50 (76%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/44 (0%) 2/50 (4%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 39/44 (89%) 40/50 (80%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/44 (0%) 0/50 (0%) | | Craniopharyngioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/44 (0%) 0/50 (0%) | | Ganglioneuroma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/44 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/44 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/44 (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: 91 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/44 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 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: 92 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 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 Papilloma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/51 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/51 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 93 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/51 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 2/50 (4%) 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 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma 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: 94 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 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, 1/50 (2%) 0/51 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 0/51 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#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%) 0/51 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | 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: 95 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/51 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 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 | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma 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: 96 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 2/50 (4%) 0/51 (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: 97 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 2/50 (4%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/35 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/35 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/35 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/35 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/35 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/35 (0%) 0/44 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/48 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 2/48 (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: 98 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/48 (0%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 2/48 (4%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/48 (2%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/48 (4%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 1/50 (2%) 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 1/50 (2%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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: 99 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 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: | | Adamantinoma Malignant 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Urethra: | | Carcinoma 1/50 (2%) 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: 100 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/48 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/48 (0%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 0/48 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/48 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/48 (0%) 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 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: 101 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/51 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/51 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 1/51 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/51 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | 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: 102 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: DERMAL Date of Species: RATS Vehicle: NEAT Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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 | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell 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: 103 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 45/50 (90%) 48/51 (94%) 45/49 (92%) 36/50 (72%) 41/50 (82%) 37/50 (74%) | | 49/50 (98%) 48/50 (96%) 50/52 (96%) 41/50 (82%) 39/50 (78%) 40/51 (78%) | | 49/50 (98%) 49/50 (98%) 41/50 (82%) 37/50 (74%) | | Overall Incidence Total 383/402 (95.27%)Mean 95.26% SD 3.04% Total 312/401 (77.81%) Mean 77.8% SD 4.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 24/50 (48%) 16/51 (31%) 17/49 (35%) 24/50 (48%) 15/50 (30%) 10/50 (20%) | | 22/50 (44%) 28/50 (56%) 22/52 (42%) 20/50 (40%) 19/50 (38%) 18/51 (35%) | | 23/50 (46%) 23/50 (46%) 21/50 (42%) 18/50 (36%) | | Overall Incidence Total 175/402 (43.53%)Mean 43.55% SD 7.7% Total 145/401 (36.16%) Mean 36.16% SD 8.39% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 45/50 (90%) 48/51 (94%) 46/49 (94%) 44/50 (88%) 46/50 (92%) 41/50 (82%) | | 50/50 (100%) 48/50 (96%) 51/52 (98%) 48/50 (96%) 46/50 (92%) 44/51 (86%) | | 49/50 (98%) 49/50 (98%) 44/50 (88%) 44/50 (88%) | | Overall Incidence Total 386/402 (96.02%)Mean 96.01% SD 3.22% Total 357/401 (89.03%) Mean 89.03% SD 4.25% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (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%) 1/51 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 1.41% Total 2/401 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 104 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 10/50 (20%) 10/51 (20%) 8/49 (16%) 14/50 (28%) 10/50 (20%) 6/50 (12%) | | Mononuclear, or Undifferentiated 16/50 (32%) 22/50 (44%) 14/52 (27%) 13/50 (26%) 17/50 (34%) 9/51 (18%) | | 13/50 (26%) 15/50 (30%) 14/50 (28%) 10/50 (20%) | | Overall Incidence Total 108/402 (26.87%)Mean 26.86% SD 8.79% Total 93/401 (23.19%) Mean 23.21% SD 7.04% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Undifferentiated Cell Type 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 4/50 (8%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/402 (1%) Mean 1% SD 2.83% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/50 (8%) 0/51 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | NOS 3/50 (6%) 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/402 (2.99%) Mean 2.99% SD 2.82% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/402 (1.74%) Mean 1.73% SD 2.23% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% 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: 105 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/49 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 4/400 (1%) Mean 1.01% SD 1.07% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | 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%) 0/52 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 1/400 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 13/50 (26%) 17/50 (34%) 9/49 (18%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | 10/50 (20%) 14/50 (28%) 9/52 (17%) 5/49 (10%) 4/50 (8%) 2/51 (4%) | | 15/50 (30%) 7/50 (14%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 94/401 (23.44%) Mean 23.46% SD 7.03% Total 18/400 (4.5%) Mean 4.52% SD 3.39% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/401 (0.5%) Mean 0.5% SD 0.93% Total 1/400 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 1/52 (2%) 2/49 (4%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/401 (2%) Mean 1.99% SD 1.85% Total 3/400 (0.75%) Mean 0.76% SD 1.51% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 14/50 (28%) 18/50 (36%) 9/49 (18%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | Complex, Malignant, NOS 11/50 (22%) 16/50 (32%) 9/52 (17%) 7/49 (14%) 4/50 (8%) 2/51 (4%) | | 16/50 (32%) 8/50 (16%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 101/401 (25.19%)Mean 25.21% SD 7.75% Total 22/400 (5.5%) Mean 5.53% SD 4.33% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/50 (0%) 0/47 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (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: 106 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/51 (0%) 1/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.26% SD 0.72% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% 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: 107 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 1/50 (2%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/397 (0.76%) Mean 0.75% SD 1.04% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Carcinoma 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (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: 108 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 0/50 (0%) 1/48 (2%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.26% SD 0.74% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 1/48 (2%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.26% SD 0.74% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (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: 109 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma NOS 0/50 (0%) 0/48 (0%) 0/47 (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%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 1/50 (2%) 0/48 (0%) 0/47 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Astrocytoma 1/50 (2%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 2/51 (4%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 4/397 (1.01%) Mean 1% SD 1.07% Total 4/401 (1%) Mean 0.99% SD 1.49% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 0/50 (0%) 0/48 (0%) 0/47 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 6/49 (12%) 8/47 (17%) 2/45 (4%) 8/49 (16%) 3/47 (6%) 0/48 (0%) | | 5/49 (10%) 2/48 (4%) 2/52 (4%) 5/46 (11%) 3/46 (7%) 4/48 (8%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 4/49 (8%) | | Overall Incidence Total 26/390 (6.67%) Mean 6.74% SD 5.81% Total 29/383 (7.57%) Mean 7.57% SD 4.8% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 2/49 (4%) 3/47 (6%) 1/45 (2%) 5/49 (10%) 2/47 (4%) 0/48 (0%) | | 0/49 (0%) 0/48 (0%) 0/52 (0%) 0/46 (0%) 0/46 (0%) 0/48 (0%) | | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 11/390 (2.82%) Mean 2.84% SD 2.67% Total 8/383 (2.09%) Mean 2.06% SD 3.63% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 8/49 (16%) 11/47 (23%) 3/45 (7%) 13/49 (27%) 5/47 (11%) 0/48 (0%) | | 5/49 (10%) 2/48 (4%) 2/52 (4%) 5/46 (11%) 3/46 (7%) 4/48 (8%) | | 3/50 (6%) 3/50 (6%) 3/50 (6%) 4/49 (8%) | | Overall Incidence Total 37/390 (9.49%) Mean 9.58% SD 6.9% Total 37/383 (9.66%) Mean 9.63% SD 7.63% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 110 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 0/49 (0%) 0/47 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) 0/48 (0%) | | 0/49 (0%) 0/48 (0%) 0/52 (0%) 0/46 (0%) 0/46 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/390 (0%) Mean 0% SD 0% Total 0/383 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) 0/47 (0%) 0/45 (0%) 0/49 (0%) 0/47 (0%) 0/48 (0%) | | 0/49 (0%) 0/48 (0%) 0/52 (0%) 0/46 (0%) 0/46 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/390 (0%) Mean 0% SD 0% Total 0/383 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 111 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (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: 112 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 3/401 (0.75%) Mean 0.75% SD 2.12% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 0/50 (0%) 0/50 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 113 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 114 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 115 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 116 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/49 (0%) 4/49 (8%) 4/47 (9%) 0/50 (0%) 2/50 (4%) 1/49 (2%) | | 9/50 (18%) 4/50 (8%) 5/52 (10%) 2/50 (4%) 2/50 (4%) 1/51 (2%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 28/397 (7.05%) Mean 7.04% SD 5.85% Total 9/400 (2.25%) Mean 2.25% SD 1.67% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 2/49 (4%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/397 (1.76%) Mean 1.76% SD 2.26% Total 2/400 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/49 (4%) 4/49 (8%) 4/47 (9%) 0/50 (0%) 2/50 (4%) 1/49 (2%) | | 10/50 (20%) 4/50 (8%) 5/52 (10%) 3/50 (6%) 2/50 (4%) 2/51 (4%) | | 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 35/397 (8.82%) Mean 8.8% SD 4.86% Total 11/400 (2.75%) Mean 2.75% SD 2.11% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (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%) 0/49 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (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%) 0/49 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/400 (0.75%) Mean 0.75% SD 1.03% Total 1/400 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 2/50 (4%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/400 (0.5%) Mean 0.5% SD 1.41% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 2/50 (4%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/400 (1.25%) Mean 1.25% SD 1.49% Total 1/400 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 1/400 (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: 118 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/49 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/49 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/400 (0.25%) Mean 0.24% SD 0.68% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 0/50 (0%) 0/49 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/400 (0%) Mean 0% SD 0% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 4/50 (8%) 3/52 (6%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/400 (3%) Mean 2.97% SD 2.99% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/49 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/400 (1%) Mean 0.99% SD 1.84% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/49 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/400 (1%) Mean 0.99% SD 1.84% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma 1/50 (2%) 4/50 (8%) 5/52 (10%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 16/400 (4%) Mean 3.96% SD 3.45% 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: 119 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 1/50 (2%) 4/50 (8%) 5/52 (10%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | Hepatoblastoma 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 16/400 (4%) Mean 3.96% SD 3.45% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 1/50 (2%) 1/52 (2%) 2/50 (4%) 1/50 (2%) 0/51 (0%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/401 (2.74%) Mean 2.75% SD 1.49% Total 4/401 (1%) Mean 1% SD 1.51% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 0/50 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/401 (0.75%) Mean 0.75% SD 1.49% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 2/50 (4%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 1/50 (2%) 1/52 (2%) 2/50 (4%) 1/50 (2%) 0/51 (0%) | | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 14/401 (3.49%) Mean 3.5% SD 1.42% Total 4/401 (1%) Mean 1% SD 1.51% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.26% SD 0.72% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 120 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 1/51 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/52 (0%) 1/50 (2%) 3/50 (6%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.92% Total 5/401 (1.25%) Mean 1.25% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.49% SD 0.91% Total 8/401 (2%) Mean 2% SD 1.51% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/51 (2%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 1/50 (2%) 1/52 (2%) 2/50 (4%) 3/50 (6%) 1/51 (2%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 4/402 (1%) Mean 0.99% SD 1.05% Total 13/401 (3.24%) Mean 3.25% SD 1.84% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 121 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 3/51 (6%) 3/49 (6%) 13/50 (26%) 14/50 (28%) 17/50 (34%) | | 2/50 (4%) 4/50 (8%) 3/52 (6%) 15/50 (30%) 14/50 (28%) 15/51 (29%) | | 3/50 (6%) 3/50 (6%) 22/50 (44%) 22/50 (44%) | | Overall Incidence Total 23/402 (5.72%) Mean 5.72% SD 1.28% Total 132/401 (32.92%) Mean 32.93% SD 7.21% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 4/51 (8%) 3/49 (6%) 13/50 (26%) 14/50 (28%) 18/50 (36%) | | 2/50 (4%) 5/50 (10%) 3/52 (6%) 16/50 (32%) 15/50 (30%) 15/51 (29%) | | 3/50 (6%) 3/50 (6%) 22/50 (44%) 22/50 (44%) | | Overall Incidence Total 25/402 (6.22%) Mean 6.22% SD 1.97% Total 135/401 (33.67%) Mean 33.68% SD 7.01% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 4/51 (8%) 3/49 (6%) 14/50 (28%) 14/50 (28%) 19/50 (38%) | | or Adenoma 2/50 (4%) 5/50 (10%) 4/52 (8%) 17/50 (34%) 15/50 (30%) 16/51 (31%) | | 3/50 (6%) 3/50 (6%) 24/50 (48%) 23/50 (46%) | | Overall Incidence Total 26/402 (6.47%) Mean 6.46% SD 2.02% Total 142/401 (35.41%) Mean 35.42% SD 7.88% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 122 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Nose: | | 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%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | 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%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 123 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | 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%) 1/52 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/401 (0.5%) Mean 0.49% SD 0.91% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/51 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/402 (0.75%) Mean 0.76% SD 1.49% Total 2/401 (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: 124 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 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%) 0/49 (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%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 2/401 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/51 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 1/50 (2%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 4/402 (1%) Mean 1.01% SD 1.52% Total 4/401 (1%) Mean 1% SD 1.06% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 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% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/401 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 125 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/49 (2%) 2/49 (4%) 1/47 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 5/50 (10%) 2/50 (4%) 8/52 (15%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 12/50 (24%) 10/50 (20%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 41/397 (10.33%) Mean 10.2% SD 8.63% Total 1/398 (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: 126 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.25% SD 0.71% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/49 (2%) 2/49 (4%) 1/47 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 5/50 (10%) 2/50 (4%) 8/52 (15%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 13/50 (26%) 10/50 (20%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 42/397 (10.58%) Mean 10.45% SD 9.1% Total 1/398 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.25% SD 0.71% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/397 (0.5%) Mean 0.49% SD 0.91% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/47 (0%) 0/47 (0%) 1/41 (2%) 0/46 (0%) 0/42 (0%) 0/46 (0%) | | 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/47 (0%) 0/48 (0%) 0/48 (0%) | | 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 1/374 (0.27%) Mean 0.3% SD 0.86% Total 0/374 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 127 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.26% SD 0.72% Total 2/401 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 16/48 (33%) 24/49 (49%) 19/48 (40%) 19/50 (38%) 31/49 (63%) 30/49 (61%) | | Adenoma 9/48 (19%) 16/50 (32%) 21/52 (40%) 28/50 (56%) 26/49 (53%) 23/51 (45%) | | 14/50 (28%) 19/50 (38%) 26/50 (52%) 22/47 (47%) | | Overall Incidence Total 138/395 (34.94%)Mean 34.88% SD 9.1% Total 205/395 (51.9%) Mean 51.93% SD 8.45% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 2/48 (4%) 0/49 (0%) 0/48 (0%) 2/50 (4%) 0/49 (0%) 1/49 (2%) | | Carcinoma 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 2/395 (0.51%) Mean 0.52% SD 1.47% Total 3/395 (0.76%) Mean 0.76% SD 1.49% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 18/48 (38%) 24/49 (49%) 19/48 (40%) 21/50 (42%) 31/49 (63%) 31/49 (63%) | | Carcinoma or Adenoma 9/48 (19%) 16/50 (32%) 21/52 (40%) 28/50 (56%) 26/49 (53%) 23/51 (45%) | | 14/50 (28%) 19/50 (38%) 26/50 (52%) 22/47 (47%) | | Overall Incidence Total 140/395 (35.44%)Mean 35.4% SD 9.11% Total 208/395 (52.66%) Mean 52.69% SD 7.94% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) 0/48 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | | Craniopharyngioma 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 1/395 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Ganglioneuroma 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 1/395 (0.25%) Mean 0.25% SD 0.71% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% 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: 128 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/395 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/45 (0%) 0/45 (0%) | | 0/48 (0%) 0/48 (0%) 0/52 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/388 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) 0/45 (0%) 0/45 (0%) | | 0/48 (0%) 0/48 (0%) 0/52 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/388 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/45 (0%) 0/45 (0%) | | 0/48 (0%) 0/48 (0%) 0/52 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/388 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 129 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.24% SD 0.68% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 130 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/51 (0%) 1/49 (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%) 1/51 (2%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/402 (0.75%) Mean 0.76% SD 1.49% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 1/51 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/402 (1%) Mean 1% SD 1.51% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 131 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 1/51 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | Trichoepithelioma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/402 (1.24%) Mean 1.25% SD 1.49% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | NOS) 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 1/51 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 1/50 (2%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | (benign, malignant or NOS), or 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 6/402 (1.49%) Mean 1.5% SD 1.41% Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 7/50 (14%) 5/51 (10%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 3/50 (6%) 3/50 (6%) 4/52 (8%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | B), Basal Cell Adenoma, Adenoma, 6/50 (12%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 32/402 (7.96%) Mean 7.95% SD 3.68% Total 7/401 (1.75%) Mean 1.75% SD 1.98% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/50 (0%) 1/51 (2%) 0/49 (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%) 0/51 (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% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 132 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 6/50 (12%) 2/51 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 3/52 (6%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 18/402 (4.48%) Mean 4.46% SD 3.81% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.49% SD 0.91% Total 3/401 (0.75%) Mean 0.75% SD 1.04% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 133 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 1/50 (2%) 0/51 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 1/50 (2%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 3/402 (0.75%) Mean 0.74% SD 1.02% Total 3/401 (0.75%) Mean 0.75% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 2/51 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 6/402 (1.49%) Mean 1.5% SD 1.76% Total 3/401 (0.75%) Mean 0.75% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 2/51 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 2/50 (4%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 6/402 (1.49%) Mean 1.5% SD 1.76% Total 3/401 (0.75%) Mean 0.75% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 6/50 (12%) 4/51 (8%) 1/49 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell 2/50 (4%) 3/50 (6%) 4/52 (8%) 1/50 (2%) 0/50 (0%) 0/51 (0%) | | Carcinoma or Keratoacanthoma 4/50 (8%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 26/402 (6.47%) Mean 6.45% SD 3.12% Total 6/401 (1.5%) Mean 1.5% SD 2.07% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 6/50 (12%) 4/51 (8%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 2/50 (4%) 2/50 (4%) 3/52 (6%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 4/50 (8%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 24/402 (5.97%) Mean 5.96% SD 3.19% Total 3/401 (0.75%) Mean 0.75% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) 1/51 (2%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 3/50 (6%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) | | 2/50 (4%) 6/50 (12%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 17/402 (4.23%) Mean 4.26% SD 3.62% Total 4/401 (1%) Mean 1% SD 1.51% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 2/50 (4%) 2/51 (4%) 3/49 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous 3/50 (6%) 3/50 (6%) 1/52 (2%) 1/50 (2%) 1/50 (2%) 1/51 (2%) | | Histiocytoma 2/50 (4%) 6/50 (12%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 22/402 (5.47%) Mean 5.5% SD 3% Total 8/401 (2%) Mean 2% SD 1.51% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 134 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 1/51 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/402 (0.75%) Mean 0.75% SD 1.04% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 1/51 (2%) 1/49 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Myxosarcoma, or Fibrous 1/50 (2%) 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/402 (1.24%) Mean 1.24% SD 1.03% Total 4/401 (1%) Mean 1% SD 1.06% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | or NOS) 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 135 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.49% SD 0.91% Total 3/401 (0.75%) Mean 0.75% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/398 (0.5%) Mean 0.5% SD 1.41% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 136 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/398 (0.25%) Mean 0.26% SD 0.72% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Leiomyosarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/400 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 137 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 2/401 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/51 (0%) 0/49 (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%) 1/51 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.5% SD 0.93% Total 2/401 (0.5%) Mean 0.5% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 38/50 (76%) 43/49 (88%) 38/45 (84%) | | 47/50 (94%) 47/50 (94%) 46/52 (88%) | | 45/50 (90%) 46/50 (92%) | | Overall Incidence Total 350/396 (88.38%)Mean 88.33% SD 5.95% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/45 (0%) 0/46 (0%) 1/47 (2%) 0/48 (0%) 0/44 (0%) 0/48 (0%) | | 0/49 (0%) 0/42 (0%) 0/51 (0%) 0/46 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/376 (0.27%) Mean 0.27% SD 0.75% Total 0/375 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 138 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/45 (0%) 0/46 (0%) 0/47 (0%) 0/48 (0%) 0/44 (0%) 0/48 (0%) | | 0/49 (0%) 0/42 (0%) 0/51 (0%) 0/46 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/376 (0%) Mean 0% SD 0% Total 0/375 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/45 (0%) 0/46 (0%) 0/47 (0%) 1/48 (2%) 0/44 (0%) 0/48 (0%) | | 0/49 (0%) 0/42 (0%) 0/51 (0%) 0/46 (0%) 0/45 (0%) 0/46 (0%) | | 1/47 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/376 (0.27%) Mean 0.27% SD 0.75% Total 1/375 (0.27%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/45 (0%) 0/46 (0%) 0/47 (0%) 0/48 (0%) 0/44 (0%) 0/48 (0%) | | 0/49 (0%) 0/42 (0%) 0/51 (0%) 0/46 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/376 (0%) Mean 0% SD 0% Total 0/375 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/45 (0%) 0/46 (0%) 0/47 (0%) 0/48 (0%) 0/44 (0%) 0/48 (0%) | | 0/49 (0%) 0/42 (0%) 0/51 (0%) 0/46 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/376 (0%) Mean 0% SD 0% Total 0/375 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/45 (0%) 0/46 (0%) 0/47 (0%) 1/48 (2%) 0/44 (0%) 0/48 (0%) | | 0/49 (0%) 0/42 (0%) 0/51 (0%) 0/46 (0%) 0/45 (0%) 0/46 (0%) | | 1/47 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/376 (0.27%) Mean 0.27% SD 0.75% Total 1/375 (0.27%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 9/49 (18%) 1/50 (2%) 1/47 (2%) 9/50 (18%) 1/49 (2%) 0/49 (0%) | | 4/50 (8%) 4/49 (8%) 3/52 (6%) 4/50 (8%) 4/49 (8%) 3/51 (6%) | | 3/50 (6%) 5/50 (10%) 3/50 (6%) 3/50 (6%) | | Overall Incidence Total 30/397 (7.56%) Mean 7.55% SD 5.2% Total 27/398 (6.78%) Mean 6.76% SD 5.34% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 3/49 (6%) 0/50 (0%) 1/47 (2%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 1/51 (2%) | | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/397 (1.76%) Mean 1.78% SD 2.29% Total 2/398 (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: 139 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 11/49 (22%) 1/50 (2%) 2/47 (4%) 10/50 (20%) 1/49 (2%) 0/49 (0%) | | 4/50 (8%) 4/49 (8%) 3/52 (6%) 4/50 (8%) 4/49 (8%) 4/51 (8%) | | 5/50 (10%) 6/50 (12%) 3/50 (6%) 3/50 (6%) | | Overall Incidence Total 36/397 (9.07%) Mean 9.08% SD 6.26% Total 29/398 (7.29%) Mean 7.26% SD 5.94% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/49 (4%) 1/50 (2%) 0/47 (0%) 3/50 (6%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 1/49 (2%) 1/52 (2%) 0/50 (0%) 2/49 (4%) 1/51 (2%) | | 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 10/397 (2.52%) Mean 2.51% SD 2.57% Total 6/398 (1.51%) Mean 1.51% SD 2.34% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/49 (2%) 1/50 (2%) 1/47 (2%) 0/50 (0%) 0/49 (0%) 1/49 (2%) | | 0/50 (0%) 0/49 (0%) 1/52 (2%) 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/397 (1.26%) Mean 1.26% SD 1.05% Total 2/398 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 3/49 (6%) 2/50 (4%) 1/47 (2%) 3/50 (6%) 0/49 (0%) 1/49 (2%) | | 1/50 (2%) 1/49 (2%) 2/52 (4%) 0/50 (0%) 2/49 (4%) 1/51 (2%) | | 5/50 (10%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 15/397 (3.78%) Mean 3.77% SD 3.1% Total 8/398 (2.01%) Mean 2.01% SD 2.15% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 0/50 (0%) 0/51 (0%) 1/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.26% SD 0.72% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/402 (0%) Mean 0% SD 0% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 1/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.26% SD 0.72% 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: 140 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 141 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/402 (0.25%) Mean 0.25% SD 0.71% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Malignant 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 142 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Urethra: | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/393 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/50 (2%) 0/49 (0%) 0/45 (0%) 1/50 (2%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/393 (0.25%) Mean 0.25% SD 0.71% Total 1/396 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/393 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/49 (0%) 0/45 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/393 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/50 (2%) 0/49 (0%) 0/45 (0%) 1/50 (2%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/51 (0%) 0/49 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/393 (0.25%) Mean 0.25% SD 0.71% Total 1/396 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence 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: 143 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 5/50 (10%) 9/50 (18%) 7/50 (14%) | | 9/50 (18%) 10/50 (20%) 8/51 (16%) | | 6/50 (12%) 9/50 (18%) | | Overall Incidence Total 63/401 (15.71%) Mean 15.71% SD 3.45% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence 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: 144 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 1/50 (2%) 1/51 (2%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 8/401 (2%) Mean 2% SD 2.14% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 6/50 (12%) 9/50 (18%) 7/50 (14%) | | 12/50 (24%) 11/50 (22%) 8/51 (16%) | | 6/50 (12%) 10/50 (20%) | | Overall Incidence Total 69/401 (17.21%) Mean 17.21% SD 4.54% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence 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: 145 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.49% SD 0.91% Total 0/401 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/51 (0%) 0/49 (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%) 0/51 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/402 (0.5%) Mean 0.49% SD 0.91% Total 1/401 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (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% | __________________________________________________________________________________________________________________________________ *: 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 48/50 (96%) 37/50 (74%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 38/50 (76%) 23/50 (46%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 48/50 (96%) | | 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%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 33/50 (66%) 20/50 (40%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/50 (2%) 0/50 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 148 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/50 (2%) 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 Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 11/50 (22%) 1/50 (2%) | | 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, 11/50 (22%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 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: 149 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 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 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/50 (2%) 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: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | 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: 150 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*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 NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 151 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 3/50 (6%) 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 3/50 (6%) 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 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: 152 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | 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 Toxicology Data Management System Page: 153 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 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 | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 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: Ileum | | 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: 154 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 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 | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 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: 155 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*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%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 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: 156 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 157 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 2/50 (4%) 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 2/50 (4%) 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 1/50 (2%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | 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: 158 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 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: | | Fibroadenoma 3/50 (6%) 29/50 (58%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 29/50 (58%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 3/50 (6%) 29/50 (58%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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: 159 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 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 | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 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: | | Chondroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 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: 160 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 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 | __________________________________________________________________________________________________________________________________ |#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: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 161 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/46 (0%) 0/41 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 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: 162 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 19/49 (39%) 20/50 (40%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 19/49 (39%) 20/50 (40%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/50 (0%) | | Craniopharyngioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/50 (0%) | | Ganglioneuroma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | 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 Toxicology Data Management System Page: 163 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 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: 164 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Papilloma 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 | __________________________________________________________________________________________________________________________________ |#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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 165 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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, 4/50 (8%) 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 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma 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: 166 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 1/50 (2%) 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, 4/50 (8%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 5/50 (10%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 6/50 (12%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | 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: 167 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 1/50 (2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 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 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma 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: 168 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 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: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (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: 169 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 43/50 (86%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/46 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 1/50 (2%) 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: 170 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 2/50 (4%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 3/50 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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: 171 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 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: | | Adamantinoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Urethra: | | 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: 172 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 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: | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | 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: 174 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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 | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell 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: 175 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 45/48 (94%) 50/50 (100%) 48/50 (96%) 38/48 (79%) 44/49 (90%) 45/50 (90%) | | 47/50 (94%) 46/50 (92%) 48/50 (96%) 48/50 (96%) 44/50 (88%) 42/50 (84%) | | 47/50 (94%) 49/50 (98%) 50/50 (100%) 44/50 (88%) 43/50 (86%) 45/50 (90%) | | 50/50 (100%) 48/50 (96%) 49/50 (98%) 44/50 (88%) 41/50 (82%) 46/50 (92%) | | 47/50 (94%) 48/50 (96%) 42/46 (91%) 42/50 (84%) 37/50 (74%) 32/46 (70%) | | 52/54 (96%) 49/53 (92%) 49/54 (91%) 39/53 (74%) 37/53 (70%) 35/53 (66%) | | Overall Incidence Total 864/905 (95.47%)Mean 95.47% SD 2.94% Total 746/902 (82.71%) Mean 82.78% SD 8.77% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 36/48 (75%) 40/50 (80%) 38/50 (76%) 29/48 (60%) 26/49 (53%) 25/50 (50%) | | 35/50 (70%) 36/50 (72%) 31/50 (62%) 31/50 (62%) 29/50 (58%) 30/50 (60%) | | 40/50 (80%) 34/50 (68%) 40/50 (80%) 21/50 (42%) 28/50 (56%) 28/50 (56%) | | 40/50 (80%) 33/50 (66%) 39/50 (78%) 28/50 (56%) 26/50 (52%) 21/50 (42%) | | 37/50 (74%) 33/50 (66%) 30/46 (65%) 27/50 (54%) 20/50 (40%) 21/46 (46%) | | 37/54 (69%) 33/53 (62%) 37/54 (69%) 32/53 (60%) 24/53 (45%) 35/53 (66%) | | Overall Incidence Total 649/905 (71.71%)Mean 71.75% SD 6.31% Total 481/902 (53.33%) Mean 53.27% SD 7.65% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 48/48 (100%) 50/50 (100%) 50/50 (100%) 47/48 (98%) 47/49 (96%) 48/50 (96%) | | 50/50 (100%) 50/50 (100%) 50/50 (100%) 49/50 (98%) 47/50 (94%) 50/50 (100%) | | 50/50 (100%) 50/50 (100%) 50/50 (100%) 48/50 (96%) 49/50 (98%) 48/50 (96%) | | 50/50 (100%) 49/50 (98%) 49/50 (98%) 49/50 (98%) 48/50 (96%) 49/50 (98%) | | 48/50 (96%) 49/50 (98%) 46/46 (100%) 46/50 (92%) 42/50 (84%) 40/46 (87%) | | 53/54 (98%) 52/53 (98%) 53/54 (98%) 52/53 (98%) 48/53 (91%) 49/53 (92%) | | Overall Incidence Total 897/905 (99.12%)Mean 99.13% SD 1.21% Total 856/902 (94.9%) Mean 94.88% SD 4.24% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 1/50 (2%) 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%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.23% SD 0.68% Total 3/902 (0.33%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 176 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.23% SD 0.68% Total 4/902 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 2/50 (4%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.44% SD 0.84% Total 4/902 (0.44%) Mean 0.44% SD 1.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 29/48 (60%) 33/50 (66%) 30/50 (60%) 18/48 (38%) 18/49 (37%) 15/50 (30%) | | Mononuclear, or Undifferentiated 29/50 (58%) 29/50 (58%) 21/50 (42%) 21/50 (42%) 16/50 (32%) 18/50 (36%) | | 33/50 (66%) 24/50 (48%) 35/50 (70%) 12/50 (24%) 14/50 (28%) 18/50 (36%) | | 35/50 (70%) 27/50 (54%) 34/50 (68%) 22/50 (44%) 17/50 (34%) 16/50 (32%) | | 30/50 (60%) 27/50 (54%) 27/46 (59%) 17/50 (34%) 13/50 (26%) 14/46 (30%) | | 31/54 (57%) 28/53 (53%) 31/54 (57%) 22/53 (42%) 19/53 (36%) 25/53 (47%) | | Overall Incidence Total 533/905 (58.9%) Mean 58.93% SD 7.4% Total 315/902 (34.92%) Mean 34.84% SD 6.18% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type 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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 177 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 5/905 (0.55%) Mean 0.56% SD 1.65% Total 1/902 (0.11%) Mean 0.11% SD 0.48% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 3/48 (6%) 0/50 (0%) 3/50 (6%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | NOS 3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 5/50 (10%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 34/905 (3.76%) Mean 3.79% SD 3.3% Total 1/902 (0.11%) Mean 0.11% SD 0.48% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/48 (0%) 0/50 (0%) 3/50 (6%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 25/905 (2.76%) Mean 2.78% SD 3.08% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 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%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 3/905 (0.33%) Mean 0.34% SD 0.79% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/48 (2%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 1/53 (2%) 1/54 (2%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 7/905 (0.77%) Mean 0.76% SD 0.98% Total 5/902 (0.55%) Mean 0.55% SD 0.92% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 178 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/48 (2%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 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%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/46 (2%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 1/53 (2%) 1/54 (2%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 10/905 (1.1%) Mean 1.1% SD 1.02% Total 5/902 (0.55%) Mean 0.55% SD 0.92% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/48 (0%) 2/50 (4%) 0/50 (0%) 0/48 (0%) 2/49 (4%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) 2/50 (4%) 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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.67% SD 1.19% Total 9/898 (1%) Mean 1.01% SD 1.58% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (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%) 0/49 (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%) | | 1/50 (2%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.47% Total 2/898 (0.22%) Mean 0.22% SD 0.63% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (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%) 0/49 (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%) | | 0/48 (0%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/51 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% Total 0/889 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 4/48 (8%) 19/50 (38%) 14/50 (28%) 1/48 (2%) 3/49 (6%) 2/48 (4%) | | 19/50 (38%) 15/50 (30%) 23/50 (46%) 4/50 (8%) 6/47 (13%) 3/50 (6%) | | 11/49 (22%) 18/50 (36%) 15/50 (30%) 1/49 (2%) 1/50 (2%) 5/49 (10%) | | 16/50 (32%) 17/50 (34%) 19/50 (38%) 1/49 (2%) 6/50 (12%) 4/50 (8%) | | 18/48 (38%) 13/50 (26%) 8/45 (18%) 0/50 (0%) 2/50 (4%) 0/45 (0%) | | 27/54 (50%) 13/53 (25%) 16/54 (30%) 4/51 (8%) 2/53 (4%) 2/51 (4%) | | Overall Incidence Total 285/901 (31.63%)Mean 31.46% SD 9.85% Total 47/889 (5.29%) Mean 5.28% SD 3.86% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 179 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/48 (0%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 2/45 (4%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/51 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 2/901 (0.22%) Mean 0.22% SD 0.63% Total 5/889 (0.56%) Mean 0.58% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/47 (0%) 0/50 (0%) | | 3/49 (6%) 3/50 (6%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/48 (0%) 0/50 (0%) 1/45 (2%) 2/50 (4%) 0/50 (0%) 0/45 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/51 (0%) 1/53 (2%) 0/51 (0%) | | Overall Incidence Total 17/901 (1.89%) Mean 1.91% SD 2.13% Total 5/889 (0.56%) Mean 0.55% SD 1.14% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 4/48 (8%) 19/50 (38%) 15/50 (30%) 1/48 (2%) 3/49 (6%) 2/48 (4%) | | Complex, Malignant, NOS 19/50 (38%) 16/50 (32%) 23/50 (46%) 5/50 (10%) 6/47 (13%) 4/50 (8%) | | 14/49 (29%) 20/50 (40%) 15/50 (30%) 1/49 (2%) 2/50 (4%) 6/49 (12%) | | 17/50 (34%) 17/50 (34%) 20/50 (40%) 2/49 (4%) 6/50 (12%) 4/50 (8%) | | 18/48 (38%) 13/50 (26%) 8/45 (18%) 2/50 (4%) 2/50 (4%) 2/45 (4%) | | 27/54 (50%) 14/53 (26%) 16/54 (30%) 4/51 (8%) 3/53 (6%) 2/51 (4%) | | Overall Incidence Total 295/901 (32.74%)Mean 32.57% SD 9.72% Total 57/889 (6.41%) Mean 6.41% SD 3.45% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (0%) 0/49 (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%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 180 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 181 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.65% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 1/48 (2%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 5/905 (0.55%) Mean 0.55% SD 0.91% Total 4/902 (0.44%) Mean 0.45% SD 0.86% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/48 (2%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 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%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 7/905 (0.77%) Mean 0.77% SD 0.99% Total 4/902 (0.44%) Mean 0.45% SD 0.86% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 2/900 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 182 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.65% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/900 (0.11%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |*Brain: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.23% SD 0.66% Total 1/900 (0.11%) Mean 0.12% SD 0.51% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 183 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 1/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/900 (0.11%) Mean 0.11% SD 0.48% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 184 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 185 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 1/48 (2%) 0/50 (0%) 1/50 (2%) 1/48 (2%) 1/49 (2%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 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%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 1/46 (2%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 6/905 (0.66%) Mean 0.66% SD 1.18% Total 5/900 (0.56%) Mean 0.57% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/47 (0%) 3/50 (6%) 0/50 (0%) 1/46 (2%) 2/46 (4%) 5/50 (10%) | | 2/49 (4%) 0/50 (0%) 4/50 (8%) 4/44 (9%) 0/49 (0%) 3/50 (6%) | | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/48 (2%) 3/47 (6%) 2/44 (5%) | | 4/50 (8%) 3/49 (6%) 1/50 (2%) 7/47 (15%) 5/43 (12%) 6/49 (12%) | | 2/49 (4%) 3/49 (6%) 3/44 (7%) 1/48 (2%) 2/47 (4%) 1/44 (2%) | | 1/54 (2%) 1/53 (2%) 2/54 (4%) 1/53 (2%) 0/52 (0%) 4/51 (8%) | | Overall Incidence Total 33/898 (3.67%) Mean 3.7% SD 2.75% Total 48/858 (5.59%) Mean 5.65% SD 4.42% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 5/47 (11%) 3/50 (6%) 3/50 (6%) 4/46 (9%) 0/46 (0%) 2/50 (4%) | | 3/49 (6%) 6/50 (12%) 1/50 (2%) 3/44 (7%) 5/49 (10%) 1/50 (2%) | | 2/50 (4%) 3/50 (6%) 3/50 (6%) 4/48 (8%) 2/47 (4%) 1/44 (2%) | | 0/50 (0%) 1/49 (2%) 3/50 (6%) 0/47 (0%) 0/43 (0%) 1/49 (2%) | | 3/49 (6%) 0/49 (0%) 0/44 (0%) 1/48 (2%) 1/47 (2%) 1/44 (2%) | | 0/54 (0%) 2/53 (4%) 1/54 (2%) 2/53 (4%) 1/52 (2%) 0/51 (0%) | | Overall Incidence Total 39/898 (4.34%) Mean 4.36% SD 3.52% Total 29/858 (3.38%) Mean 3.38% SD 3.16% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 186 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 5/47 (11%) 6/50 (12%) 3/50 (6%) 5/46 (11%) 2/46 (4%) 7/50 (14%) | | 4/49 (8%) 6/50 (12%) 5/50 (10%) 7/44 (16%) 5/49 (10%) 4/50 (8%) | | 2/50 (4%) 5/50 (10%) 5/50 (10%) 5/48 (10%) 5/47 (11%) 3/44 (7%) | | 4/50 (8%) 4/49 (8%) 4/50 (8%) 7/47 (15%) 5/43 (12%) 7/49 (14%) | | 5/49 (10%) 3/49 (6%) 3/44 (7%) 2/48 (4%) 3/47 (6%) 2/44 (5%) | | 1/54 (2%) 3/53 (6%) 3/54 (6%) 3/53 (6%) 1/52 (2%) 4/51 (8%) | | Overall Incidence Total 71/898 (7.91%) Mean 7.95% SD 2.77% Total 77/858 (8.97%) Mean 9.03% SD 4.14% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/46 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/44 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/44 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 0/44 (0%) 0/48 (0%) 0/47 (0%) 0/44 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/52 (0%) 0/51 (0%) | | Overall Incidence Total 0/898 (0%) Mean 0% SD 0% Total 0/858 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/46 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/44 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/44 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 0/44 (0%) 0/48 (0%) 0/47 (0%) 0/44 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/52 (0%) 0/51 (0%) | | Overall Incidence Total 0/898 (0%) Mean 0% SD 0% Total 0/858 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 187 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.12% SD 0.49% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 188 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 189 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 1/53 (2%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 2/902 (0.22%) Mean 0.22% SD 0.63% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 190 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 191 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 192 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 193 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (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%) 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%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 3/905 (0.33%) Mean 0.34% SD 0.79% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.12% SD 0.49% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 194 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 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%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.45% SD 0.87% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 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%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.45% SD 0.87% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 195 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.12% SD 0.49% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 196 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/48 (2%) 3/50 (6%) 2/50 (4%) 0/48 (0%) 2/49 (4%) 4/49 (8%) | | 3/50 (6%) 7/50 (14%) 4/50 (8%) 1/49 (2%) 2/50 (4%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/49 (2%) 1/49 (2%) | | 8/50 (16%) 4/50 (8%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 4/50 (8%) 3/50 (6%) 3/45 (7%) 1/48 (2%) 1/50 (2%) 5/46 (11%) | | 2/54 (4%) 2/53 (4%) 2/52 (4%) 1/52 (2%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 56/902 (6.21%) Mean 6.23% SD 3.77% Total 23/894 (2.57%) Mean 2.62% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 1/48 (2%) 3/50 (6%) 3/50 (6%) 0/48 (0%) 1/49 (2%) 2/49 (4%) | | 1/50 (2%) 4/50 (8%) 4/50 (8%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 1/45 (2%) 1/48 (2%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 0/52 (0%) 0/52 (0%) 1/53 (2%) 0/52 (0%) | | Overall Incidence Total 31/902 (3.44%) Mean 3.45% SD 2.45% Total 6/894 (0.67%) Mean 0.67% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/48 (4%) 6/50 (12%) 5/50 (10%) 0/48 (0%) 3/49 (6%) 6/49 (12%) | | 4/50 (8%) 11/50 (22%) 8/50 (16%) 1/49 (2%) 2/50 (4%) 1/50 (2%) | | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/50 (4%) 1/49 (2%) 1/49 (2%) | | 9/50 (18%) 7/50 (14%) 4/50 (8%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 5/50 (10%) 5/50 (10%) 4/45 (9%) 2/48 (4%) 1/50 (2%) 5/46 (11%) | | 3/54 (6%) 2/53 (4%) 2/52 (4%) 1/52 (2%) 1/53 (2%) 0/52 (0%) | | Overall Incidence Total 87/902 (9.65%) Mean 9.68% SD 5.07% Total 29/894 (3.24%) Mean 3.3% SD 3.39% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 1/899 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 197 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (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%) 0/50 (0%) 0/50 (0%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 1/899 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (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%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 10/903 (1.11%) Mean 1.11% SD 1.41% Total 1/899 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/49 (2%) | | 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%) 0/49 (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%) 0/50 (0%) 0/45 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.11% SD 0.47% Total 5/899 (0.56%) Mean 0.56% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 1/49 (2%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/45 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 11/903 (1.22%) Mean 1.22% SD 1.39% Total 6/899 (0.67%) Mean 0.67% SD 0.97% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 198 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 1/50 (2%) 0/45 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 2/903 (0.22%) Mean 0.22% SD 0.65% Total 2/899 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 1/53 (2%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 1/899 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 199 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.11% SD 0.47% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.21% SD 0.62% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/45 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 3/54 (6%) 4/53 (8%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 18/904 (1.99%) Mean 1.95% SD 2.37% Total 4/900 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 200 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 2/50 (4%) 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%) | | 1/50 (2%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 2/54 (4%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 8/904 (0.88%) Mean 0.87% SD 1.37% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 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%) | | 1/50 (2%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 2/54 (4%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 8/904 (0.88%) Mean 0.87% SD 1.37% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | Hepatocellular Adenoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 2/50 (4%) 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/45 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 5/54 (9%) 4/53 (8%) 2/54 (4%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 26/904 (2.88%) Mean 2.82% SD 2.85% Total 4/900 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 2/50 (4%) 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/45 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 5/54 (9%) 4/53 (8%) 2/54 (4%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 26/904 (2.88%) Mean 2.82% SD 2.85% Total 4/900 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/48 (2%) 2/50 (4%) 1/50 (2%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | 0/50 (0%) 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 1/50 (2%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 2/53 (4%) 0/52 (0%) | | Overall Incidence Total 16/904 (1.77%) Mean 1.78% SD 2.56% Total 12/900 (1.33%) Mean 1.32% SD 1.35% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 201 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 1/49 (2%) 0/50 (0%) 1/49 (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%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.67% SD 0.98% Total 2/900 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/48 (4%) 2/50 (4%) 1/50 (2%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 1/49 (2%) 0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 1/46 (2%) 1/50 (2%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 1/53 (2%) 2/53 (4%) 0/52 (0%) | | Overall Incidence Total 22/904 (2.43%) Mean 2.46% SD 2.62% Total 14/900 (1.56%) Mean 1.54% SD 1.45% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 202 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (0%) 0/50 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.32% SD 0.73% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 203 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 2/50 (4%) | | 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 1/50 (2%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 1/53 (2%) 1/53 (2%) 1/53 (2%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 13/902 (1.44%) Mean 1.43% SD 1.33% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/48 (4%) 4/49 (8%) 3/50 (6%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 9/50 (18%) 3/50 (6%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) 3/50 (6%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 5/50 (10%) 3/50 (6%) 3/46 (7%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 1/53 (2%) 1/53 (2%) 4/53 (8%) | | Overall Incidence Total 3/905 (0.33%) Mean 0.33% SD 0.75% Total 55/902 (6.1%) Mean 6.12% SD 3.85% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/48 (4%) 4/49 (8%) 5/50 (10%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 10/50 (20%) 3/50 (6%) 3/50 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) 5/50 (10%) 4/50 (8%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 5/50 (10%) 4/50 (8%) 3/46 (7%) | | 0/54 (0%) 1/53 (2%) 1/54 (2%) 2/53 (4%) 2/53 (4%) 5/53 (9%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.43% SD 0.83% Total 67/902 (7.43%) Mean 7.44% SD 4.09% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 0/48 (0%) 2/50 (4%) 3/50 (6%) 16/48 (33%) 24/49 (49%) 22/50 (44%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 19/50 (38%) 12/50 (24%) 22/50 (44%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 27/50 (54%) 19/50 (38%) 22/50 (44%) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) 19/50 (38%) 20/50 (40%) 22/50 (44%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 23/50 (46%) 19/50 (38%) 11/46 (24%) | | 2/54 (4%) 0/53 (0%) 0/54 (0%) 12/53 (23%) 22/53 (42%) 17/53 (32%) | | Overall Incidence Total 20/905 (2.21%) Mean 2.21% SD 2.03% Total 348/902 (38.58%) Mean 38.58% SD 8.68% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 204 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/48 (0%) 2/50 (4%) 3/50 (6%) 16/48 (33%) 24/49 (49%) 23/50 (46%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 20/50 (40%) 12/50 (24%) 22/50 (44%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 27/50 (54%) 19/50 (38%) 22/50 (44%) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) 20/50 (40%) 21/50 (42%) 23/50 (46%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 24/50 (48%) 20/50 (40%) 11/46 (24%) | | 2/54 (4%) 1/53 (2%) 0/54 (0%) 13/53 (25%) 23/53 (43%) 18/53 (34%) | | Overall Incidence Total 21/905 (2.32%) Mean 2.31% SD 1.96% Total 358/902 (39.69%) Mean 39.67% SD 8.74% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/48 (0%) 2/50 (4%) 3/50 (6%) 17/48 (35%) 28/49 (57%) 25/50 (50%) | | or Adenoma 3/50 (6%) 0/50 (0%) 2/50 (4%) 25/50 (50%) 14/50 (28%) 23/50 (46%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 27/50 (54%) 20/50 (40%) 23/50 (46%) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) 21/50 (42%) 23/50 (46%) 24/50 (48%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 27/50 (54%) 22/50 (44%) 13/46 (28%) | | 2/54 (4%) 1/53 (2%) 1/54 (2%) 13/53 (25%) 24/53 (45%) 22/53 (42%) | | Overall Incidence Total 24/905 (2.65%) Mean 2.64% SD 2.05% Total 391/902 (43.35%) Mean 43.34% SD 9.23% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 1/45 (2%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 1/900 (0.11%) Mean 0.12% SD 0.52% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/48 (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%) 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 0/894 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 1/49 (2%) 1/50 (2%) | | 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%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 3/50 (6%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 2/54 (4%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 9/905 (0.99%) Mean 0.98% SD 1.68% Total 11/902 (1.22%) Mean 1.23% SD 1.22% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 3/53 (6%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.65% Total 6/902 (0.67%) Mean 0.66% SD 1.47% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 1/49 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 3/50 (6%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 1/53 (2%) 2/54 (4%) 0/53 (0%) 0/53 (0%) 3/53 (6%) | | Overall Incidence Total 11/905 (1.22%) Mean 1.2% SD 1.8% Total 17/902 (1.88%) Mean 1.89% SD 1.56% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 209 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 1/50 (2%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 3/53 (6%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 4/902 (0.44%) Mean 0.43% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/49 (2%) 1/50 (2%) | | 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%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 2/54 (4%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 5/905 (0.55%) Mean 0.54% SD 1.29% Total 4/902 (0.44%) Mean 0.45% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 210 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/48 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 2/53 (4%) 1/52 (2%) | | Overall Incidence Total 7/900 (0.78%) Mean 0.76% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 2/900 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/48 (0%) 0/49 (0%) 1/50 (2%) | | Malignant, NOS 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 2/53 (4%) 1/52 (2%) | | Overall Incidence Total 9/900 (1%) Mean 0.98% SD 1.38% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/53 (2%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/900 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 211 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 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%) 0/45 (0%) 0/48 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 10/903 (1.11%) Mean 1.1% SD 1.71% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/50 (0%) 0/45 (0%) 0/48 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 0/53 (0%) 1/52 (2%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 1/893 (0.11%) Mean 0.11% SD 0.45% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 212 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 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%) 0/45 (0%) 0/48 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/52 (0%) 0/53 (0%) 1/52 (2%) | | Overall Incidence Total 10/903 (1.11%) Mean 1.1% SD 1.71% Total 1/893 (0.11%) Mean 0.11% SD 0.45% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (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%) 0/50 (0%) 0/45 (0%) 0/48 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 1/50 (2%) 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%) 0/50 (0%) 0/45 (0%) 0/48 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.11% SD 0.47% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/47 (0%) 1/48 (2%) 0/48 (0%) 0/44 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/46 (0%) 0/42 (0%) 0/48 (0%) | | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/46 (0%) 0/48 (0%) 0/50 (0%) | | 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/46 (0%) 0/45 (0%) 0/39 (0%) 0/43 (0%) 0/48 (0%) 0/41 (0%) | | 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 3/856 (0.35%) Mean 0.34% SD 0.78% Total 1/845 (0.12%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 25/48 (52%) 40/50 (80%) 43/49 (88%) 24/48 (50%) 36/48 (75%) 40/50 (80%) | | Adenoma 36/50 (72%) 23/50 (46%) 43/50 (86%) 38/50 (76%) 31/50 (62%) 39/50 (78%) | | 41/50 (82%) 39/50 (78%) 37/49 (76%) 34/48 (71%) 33/50 (66%) 43/49 (88%) | | 38/50 (76%) 41/50 (82%) 39/50 (78%) 33/50 (66%) 34/50 (68%) 43/50 (86%) | | 33/49 (67%) 25/49 (51%) 25/45 (56%) 33/49 (67%) 30/49 (61%) 25/46 (54%) | | 24/53 (45%) 20/53 (38%) 13/54 (24%) 20/52 (38%) 24/52 (46%) 22/52 (42%) | | Overall Incidence Total 585/899 (65.07%)Mean 65.35% SD 18.79% Total 582/893 (65.17%) Mean 65.3% SD 14.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 214 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (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%) 0/49 (0%) 0/48 (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%) | | 0/49 (0%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 1/46 (2%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 1/52 (2%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 3/893 (0.34%) Mean 0.34% SD 0.78% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 25/48 (52%) 40/50 (80%) 43/49 (88%) 24/48 (50%) 36/48 (75%) 40/50 (80%) | | Carcinoma or Adenoma 36/50 (72%) 23/50 (46%) 43/50 (86%) 38/50 (76%) 31/50 (62%) 39/50 (78%) | | 41/50 (82%) 39/50 (78%) 37/49 (76%) 34/48 (71%) 34/50 (68%) 43/49 (88%) | | 38/50 (76%) 41/50 (82%) 39/50 (78%) 33/50 (66%) 34/50 (68%) 43/50 (86%) | | 33/49 (67%) 25/49 (51%) 25/45 (56%) 33/49 (67%) 30/49 (61%) 26/46 (57%) | | 24/53 (45%) 20/53 (38%) 13/54 (24%) 21/52 (40%) 24/52 (46%) 22/52 (42%) | | Overall Incidence Total 585/899 (65.07%)Mean 65.35% SD 18.79% Total 585/893 (65.51%) Mean 65.64% SD 14.19% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Craniopharyngioma 0/50 (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%) 0/48 (0%) 0/50 (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%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Ganglioneuroma 0/50 (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%) 0/48 (0%) 0/50 (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%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/48 (2%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (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%) 0/49 (0%) 0/48 (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%) | | 0/49 (0%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 2/899 (0.22%) Mean 0.23% SD 0.66% Total 2/893 (0.22%) Mean 0.22% SD 0.94% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 215 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (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%) 0/48 (0%) 0/50 (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%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (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%) 0/49 (0%) 0/48 (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%) | | 0/49 (0%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 2/899 (0.22%) Mean 0.23% SD 0.66% Total 2/893 (0.22%) Mean 0.22% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (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%) 0/48 (0%) 0/50 (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%) 0/49 (0%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/52 (0%) 0/52 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/48 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) | | Overall Incidence Total 3/903 (0.33%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/48 (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%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 216 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/54 (0%) | | Overall Incidence Total 4/903 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% Total 0/898 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% Total 0/898 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% Total 0/898 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% Total 0/898 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 217 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 218 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/48 (0%) 1/50 (2%) 1/50 (2%) 0/48 (0%) 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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.44% SD 0.86% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.94% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 219 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/48 (0%) 1/50 (2%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 6/905 (0.66%) Mean 0.67% SD 1.19% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/48 (0%) 1/50 (2%) 2/50 (4%) 0/48 (0%) 0/49 (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%) 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%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 2/54 (4%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 6/905 (0.66%) Mean 0.65% SD 1.33% Total 1/902 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/48 (0%) 1/50 (2%) 2/50 (4%) 0/48 (0%) 0/49 (0%) 0/50 (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%) 1/50 (2%) 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%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 2/54 (4%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 8/905 (0.88%) Mean 0.87% SD 1.53% Total 1/902 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/48 (0%) 1/50 (2%) 2/50 (4%) 1/48 (2%) 0/49 (0%) 0/50 (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%) 1/50 (2%) 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%) | | 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 2/54 (4%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 9/905 (0.99%) Mean 0.98% SD 1.54% Total 2/902 (0.22%) Mean 0.22% SD 0.64% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 220 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.94% Total 2/902 (0.22%) Mean 0.23% SD 0.66% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 2/50 (4%) 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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.94% Total 2/902 (0.22%) Mean 0.23% SD 0.66% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/48 (0%) 1/50 (2%) 2/50 (4%) 1/48 (2%) 0/49 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 2/54 (4%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 11/905 (1.22%) Mean 1.21% SD 1.67% Total 3/902 (0.33%) Mean 0.33% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/48 (0%) 3/50 (6%) 4/50 (8%) 2/48 (4%) 0/49 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 7/50 (14%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | B), Basal Cell Adenoma, Adenoma, 2/50 (4%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Papilloma, Sq Papilloma, 7/50 (14%) 3/50 (6%) 7/50 (14%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Keratoacanthoma, 4/50 (8%) 5/50 (10%) 3/46 (7%) 2/50 (4%) 0/50 (0%) 1/46 (2%) | | Trichoepithelioma 3/54 (6%) 7/53 (13%) 4/54 (7%) 4/53 (8%) 0/53 (0%) 1/53 (2%) | | Overall Incidence Total 68/905 (7.51%) Mean 7.48% SD 4.14% Total 23/902 (2.55%) Mean 2.54% SD 1.97% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.94% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 221 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/48 (0%) 2/50 (4%) 2/50 (4%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 5/50 (10%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 6/50 (12%) 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 3/50 (6%) 3/50 (6%) 2/46 (4%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 5/53 (9%) 4/54 (7%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 46/905 (5.08%) Mean 5.06% SD 3.31% Total 7/902 (0.78%) Mean 0.77% SD 1.21% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/48 (0%) 2/50 (4%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 7/905 (0.77%) Mean 0.77% SD 1.21% Total 2/902 (0.22%) Mean 0.22% SD 0.94% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 222 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/49 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (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%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) | | Overall Incidence Total 6/905 (0.66%) Mean 0.68% SD 0.98% Total 3/902 (0.33%) Mean 0.33% SD 0.76% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 223 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/48 (4%) 0/49 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Carcinoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) | | Overall Incidence Total 8/905 (0.88%) Mean 0.9% SD 1.24% Total 5/902 (0.55%) Mean 0.56% SD 1.17% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 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%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 2/53 (4%) 0/54 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 7/905 (0.77%) Mean 0.77% SD 1.37% Total 10/902 (1.11%) Mean 1.11% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) | | Papilloma 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%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/46 (0%) 1/50 (2%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 2/53 (4%) 0/54 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 7/905 (0.77%) Mean 0.77% SD 1.37% Total 10/902 (1.11%) Mean 1.11% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/48 (0%) 2/50 (4%) 2/50 (4%) 1/48 (2%) 0/49 (0%) 1/50 (2%) | | Papilloma, Squamous Cell 5/50 (10%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma or Keratoacanthoma 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 7/50 (14%) 3/50 (6%) 5/50 (10%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | 3/50 (6%) 5/50 (10%) 3/46 (7%) 2/50 (4%) 0/50 (0%) 1/46 (2%) | | 1/54 (2%) 7/53 (13%) 4/54 (7%) 3/53 (6%) 0/53 (0%) 1/53 (2%) | | Overall Incidence Total 57/905 (6.3%) Mean 6.28% SD 3.87% Total 20/902 (2.22%) Mean 2.21% SD 1.62% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/48 (0%) 2/50 (4%) 2/50 (4%) 0/48 (0%) 0/49 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma 5/50 (10%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 6/50 (12%) 3/50 (6%) 4/50 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 3/50 (6%) 5/50 (10%) 2/46 (4%) 2/50 (4%) 0/50 (0%) 1/46 (2%) | | 1/54 (2%) 7/53 (13%) 4/54 (7%) 3/53 (6%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 52/905 (5.75%) Mean 5.71% SD 3.76% Total 17/902 (1.88%) Mean 1.88% SD 1.7% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 224 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 3/48 (6%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/50 (0%) | | 4/50 (8%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 3/50 (6%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 1/50 (2%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) | | 3/54 (6%) 3/53 (6%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 32/905 (3.54%) Mean 3.53% SD 2.77% Total 5/902 (0.55%) Mean 0.56% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/48 (6%) 2/50 (4%) 0/50 (0%) 2/48 (4%) 2/49 (4%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous 4/50 (8%) 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Histiocytoma 3/50 (6%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 6/50 (12%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 1/46 (2%) 0/50 (0%) 1/50 (2%) 1/46 (2%) | | 3/54 (6%) 4/53 (8%) 0/54 (0%) 0/53 (0%) 1/53 (2%) 1/53 (2%) | | Overall Incidence Total 41/905 (4.53%) Mean 4.53% SD 3.17% Total 17/902 (1.88%) Mean 1.9% SD 1.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 2/49 (4%) 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%) 1/50 (2%) 0/50 (0%) | | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 1/53 (2%) 0/53 (0%) | | Overall Incidence Total 6/905 (0.66%) Mean 0.66% SD 1.53% Total 5/902 (0.55%) Mean 0.56% SD 1.17% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/48 (0%) 2/50 (4%) 0/50 (0%) 1/48 (2%) 2/49 (4%) 0/50 (0%) | | Myxosarcoma, or Fibrous 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 1/53 (2%) 1/53 (2%) | | Overall Incidence Total 9/905 (0.99%) Mean 1% SD 1.72% Total 12/902 (1.33%) Mean 1.34% SD 1.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 225 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.22% SD 0.65% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | (malignant or NOS) 2/50 (4%) 0/50 (0%) 0/50 (0%) 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%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 5/905 (0.55%) Mean 0.55% SD 1.14% Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 226 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 2/50 (4%) 0/50 (0%) 1/50 (2%) 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%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 7/905 (0.77%) Mean 0.77% SD 1.21% Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/48 (0%) 1/50 (2%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 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%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) | | Overall Incidence Total 3/905 (0.33%) Mean 0.34% SD 0.79% Total 6/902 (0.67%) Mean 0.67% SD 0.97% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 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%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.44% SD 1.1% Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) 0/48 (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%) 0/49 (0%) 0/50 (0%) 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%) 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 3/905 (0.33%) Mean 0.33% SD 0.77% Total 0/895 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (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%) 0/49 (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%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/895 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (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%) 0/49 (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%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/895 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (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%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 2/905 (0.22%) Mean 0.23% SD 0.68% Total 2/895 (0.22%) Mean 0.23% SD 0.66% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (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%) 0/49 (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%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/895 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (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%) 0/49 (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%) 1/50 (2%) 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/895 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 0/48 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/48 (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%) 0/49 (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%) 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 2/895 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 229 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 33/48 (69%) 34/50 (68%) 35/50 (70%) | | 35/50 (70%) 38/50 (76%) 23/50 (46%) | | 30/50 (60%) 33/50 (66%) 39/50 (78%) | | 38/50 (76%) 27/50 (54%) 39/50 (78%) | | 23/50 (46%) 36/50 (72%) 31/46 (67%) | | 40/54 (74%) 39/53 (74%) 45/54 (83%) | | Overall Incidence Total 618/905 (68.29%)Mean 68.17% SD 10.54% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) 0/42 (0%) 0/45 (0%) 0/48 (0%) 0/43 (0%) 0/42 (0%) | | 0/43 (0%) 0/48 (0%) 0/40 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/45 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/47 (0%) | | 0/50 (0%) 0/46 (0%) 0/41 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | | 0/44 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/826 (0%) Mean 0% SD 0% Total 0/846 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/48 (0%) 0/42 (0%) 0/45 (0%) 0/48 (0%) 0/43 (0%) 0/42 (0%) | | 0/43 (0%) 0/48 (0%) 0/40 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/45 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/47 (0%) | | 0/50 (0%) 0/46 (0%) 0/41 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | | 0/44 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/826 (0%) Mean 0% SD 0% Total 0/846 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 1/42 (2%) 0/45 (0%) 0/48 (0%) 0/43 (0%) 0/42 (0%) | | 0/43 (0%) 0/48 (0%) 0/40 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/45 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/47 (0%) | | 1/50 (2%) 0/46 (0%) 0/41 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | | 0/44 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 2/826 (0.24%) Mean 0.24% SD 0.71% Total 0/846 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/48 (0%) 0/42 (0%) 0/45 (0%) 0/48 (0%) 0/43 (0%) 0/42 (0%) | | 0/43 (0%) 0/48 (0%) 0/40 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/45 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/47 (0%) | | 0/50 (0%) 0/46 (0%) 0/41 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | | 0/44 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/826 (0%) Mean 0% SD 0% Total 0/846 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/48 (0%) 0/42 (0%) 0/45 (0%) 0/48 (0%) 0/43 (0%) 0/42 (0%) | | 0/43 (0%) 0/48 (0%) 0/40 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/45 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/47 (0%) | | 0/50 (0%) 0/46 (0%) 0/41 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | | 0/44 (0%) 0/50 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/826 (0%) Mean 0% SD 0% Total 1/846 (0.12%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 1/42 (2%) 0/45 (0%) 0/48 (0%) 0/43 (0%) 0/42 (0%) | | 0/43 (0%) 0/48 (0%) 0/40 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/47 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | | 0/45 (0%) 0/44 (0%) 0/49 (0%) 0/48 (0%) 0/45 (0%) 0/47 (0%) | | 1/50 (2%) 0/46 (0%) 0/41 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | | 0/44 (0%) 0/50 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 2/826 (0.24%) Mean 0.24% SD 0.71% Total 1/846 (0.12%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 232 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/48 (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%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/46 (0%) | | 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 0/895 (0%) Mean 0% SD 0% Total 0/888 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 6/48 (13%) 3/50 (6%) 4/49 (8%) 3/48 (6%) 7/49 (14%) 6/49 (12%) | | 5/49 (10%) 5/49 (10%) 5/48 (10%) 7/49 (14%) 6/50 (12%) 7/50 (14%) | | 1/50 (2%) 3/49 (6%) 3/50 (6%) 1/49 (2%) 6/48 (13%) 3/49 (6%) | | 8/50 (16%) 1/49 (2%) 7/50 (14%) 8/50 (16%) 5/50 (10%) 5/50 (10%) | | 4/50 (8%) 3/50 (6%) 1/45 (2%) 2/48 (4%) 2/48 (4%) 1/46 (2%) | | 6/54 (11%) 4/52 (8%) 8/53 (15%) 1/52 (2%) 3/51 (6%) 1/52 (2%) | | Overall Incidence Total 77/895 (8.6%) Mean 8.54% SD 4.28% Total 74/888 (8.33%) Mean 8.33% SD 4.99% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 3/48 (6%) 2/50 (4%) 3/49 (6%) 0/48 (0%) 1/49 (2%) 3/49 (6%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/49 (2%) 0/50 (0%) 2/50 (4%) | | 3/50 (6%) 1/49 (2%) 4/50 (8%) 1/49 (2%) 2/48 (4%) 3/49 (6%) | | 0/50 (0%) 1/49 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | 2/50 (4%) 2/50 (4%) 1/45 (2%) 2/48 (4%) 0/48 (0%) 0/46 (0%) | | 1/54 (2%) 2/52 (4%) 0/53 (0%) 0/52 (0%) 0/51 (0%) 1/52 (2%) | | Overall Incidence Total 27/895 (3.02%) Mean 3.02% SD 2.52% Total 20/888 (2.25%) Mean 2.26% SD 2.2% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 9/48 (19%) 5/50 (10%) 7/49 (14%) 3/48 (6%) 8/49 (16%) 9/49 (18%) | | 5/49 (10%) 5/49 (10%) 5/48 (10%) 8/49 (16%) 6/50 (12%) 9/50 (18%) | | 4/50 (8%) 4/49 (8%) 7/50 (14%) 2/49 (4%) 8/48 (17%) 6/49 (12%) | | 8/50 (16%) 2/49 (4%) 8/50 (16%) 10/50 (20%) 5/50 (10%) 7/50 (14%) | | 6/50 (12%) 5/50 (10%) 2/45 (4%) 4/48 (8%) 2/48 (4%) 1/46 (2%) | | 7/54 (13%) 6/52 (12%) 8/53 (15%) 1/52 (2%) 3/51 (6%) 2/52 (4%) | | Overall Incidence Total 103/895 (11.51%)Mean 11.45% SD 3.91% Total 94/888 (10.59%) Mean 10.59% SD 6.16% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 1/49 (2%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/49 (0%) 0/48 (0%) 1/49 (2%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/45 (0%) 0/48 (0%) 0/48 (0%) 0/46 (0%) | | 1/54 (2%) 0/52 (0%) 0/53 (0%) 0/52 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 6/895 (0.67%) Mean 0.66% SD 1.18% Total 3/888 (0.34%) Mean 0.34% SD 0.78% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 233 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/48 (0%) 0/50 (0%) 1/49 (2%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/49 (2%) 0/48 (0%) 0/49 (0%) | | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 1/45 (2%) 0/48 (0%) 0/48 (0%) 0/46 (0%) | | 1/54 (2%) 0/52 (0%) 0/53 (0%) 0/52 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 9/895 (1.01%) Mean 1.02% SD 1.05% Total 4/888 (0.45%) Mean 0.45% SD 0.87% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 1/49 (2%) 1/48 (2%) 1/49 (2%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 2/49 (4%) 1/50 (2%) 1/49 (2%) 0/48 (0%) 1/49 (2%) | | 1/50 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 3/50 (6%) 1/50 (2%) 1/45 (2%) 0/48 (0%) 0/48 (0%) 0/46 (0%) | | 2/54 (4%) 0/52 (0%) 0/53 (0%) 0/52 (0%) 0/51 (0%) 0/52 (0%) | | Overall Incidence Total 15/895 (1.68%) Mean 1.68% SD 1.7% Total 7/888 (0.79%) Mean 0.79% SD 1.02% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 1/902 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 1/902 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.1% SD 0.44% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 235 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 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%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/905 (0.11%) Mean 0.11% SD 0.47% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 3/53 (6%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 3/902 (0.33%) Mean 0.31% SD 1.33% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.12% SD 0.51% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 236 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (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%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 1/50 (2%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.44% SD 0.84% Total 7/902 (0.78%) Mean 0.79% SD 1.23% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 1/50 (2%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 4/905 (0.44%) Mean 0.44% SD 0.84% Total 6/902 (0.67%) Mean 0.67% SD 1.19% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 237 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.1% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Urethra: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (0%) 0/50 (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%) 0/49 (0%) 1/46 (2%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.12% SD 0.51% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (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%) 0/49 (0%) 0/50 (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%) 0/49 (0%) 1/46 (2%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.12% SD 0.51% Total 1/893 (0.11%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 238 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (0%) 0/50 (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%) 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/49 (0%) 0/50 (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%) 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (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%) 0/49 (0%) 0/50 (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%) 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 1/893 (0.11%) Mean 0.12% SD 0.49% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 1/50 (2%) 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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/48 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.48% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/48 (0%) 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%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 240 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/48 (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%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 2/902 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/48 (15%) 6/49 (12%) 8/50 (16%) | | 6/50 (12%) 4/50 (8%) 8/50 (16%) | | 2/50 (4%) 8/50 (16%) 6/50 (12%) | | 6/50 (12%) 10/50 (20%) 6/50 (12%) | | 5/50 (10%) 2/50 (4%) 2/46 (4%) | | 9/53 (17%) 2/53 (4%) 4/53 (8%) | | Overall Incidence Total 101/902 (11.2%) Mean 11.19% SD 5.01% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/48 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/46 (2%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 6/902 (0.67%) Mean 0.68% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 7/48 (15%) 6/49 (12%) 9/50 (18%) | | 6/50 (12%) 5/50 (10%) 8/50 (16%) | | 2/50 (4%) 8/50 (16%) 6/50 (12%) | | 6/50 (12%) 11/50 (22%) 6/50 (12%) | | 6/50 (12%) 2/50 (4%) 3/46 (7%) | | 9/53 (17%) 2/53 (4%) 4/53 (8%) | | Overall Incidence Total 106/902 (11.75%) Mean 11.76% SD 5.13% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 241 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/48 (0%) 1/49 (2%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 3/902 (0.33%) Mean 0.34% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/48 (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%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/53 (2%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 3/902 (0.33%) Mean 0.33% SD 0.75% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/48 (0%) 0/49 (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%) 0/46 (0%) | | 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 1/902 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/48 (0%) 1/50 (2%) 1/50 (2%) 2/48 (4%) 0/49 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 12/905 (1.33%) Mean 1.32% SD 1.36% Total 5/902 (0.55%) Mean 0.56% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 243 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/48 (0%) 1/50 (2%) 1/50 (2%) 2/48 (4%) 0/49 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/46 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) | | 1/54 (2%) 0/53 (0%) 1/54 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 12/905 (1.33%) Mean 1.32% SD 1.36% Total 6/902 (0.67%) Mean 0.68% SD 1.22% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | | 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 0/902 (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: 245 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 49/52 (94%) 47/50 (94%) 42/50 (84%) 40/50 (80%) 43/50 (86%) | | 48/50 (96%) 49/50 (98%) 44/50 (88%) 37/50 (74%) 39/50 (78%) 40/50 (80%) | | 49/51 (96%) 47/50 (94%) 47/50 (94%) 45/51 (88%) 40/50 (80%) 41/50 (82%) | | 47/50 (94%) 49/50 (98%) 50/51 (98%) 37/50 (74%) 38/50 (76%) 40/50 (80%) | | 50/50 (100%) 46/50 (92%) 49/50 (98%) 43/50 (86%) 40/50 (80%) 42/50 (84%) | | 50/50 (100%) 47/50 (94%) 47/50 (94%) 40/50 (80%) 40/50 (80%) 43/50 (86%) | | Overall Incidence Total 864/904 (95.58%)Mean 95.57% SD 3.03% Total 730/901 (81.02%) Mean 81.01% SD 4.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 37/50 (74%) 38/52 (73%) 38/50 (76%) 22/50 (44%) 24/50 (48%) 21/50 (42%) | | 32/50 (64%) 41/50 (82%) 26/50 (52%) 20/50 (40%) 21/50 (42%) 16/50 (32%) | | 28/51 (55%) 32/50 (64%) 34/50 (68%) 13/51 (25%) 19/50 (38%) 25/50 (50%) | | 27/50 (54%) 36/50 (72%) 32/51 (63%) 17/50 (34%) 27/50 (54%) 21/50 (42%) | | 20/50 (40%) 37/50 (74%) 42/50 (84%) 14/50 (28%) 30/50 (60%) 30/50 (60%) | | 35/50 (70%) 39/50 (78%) 35/50 (70%) 21/50 (42%) 21/50 (42%) 30/50 (60%) | | Overall Incidence Total 609/904 (67.37%)Mean 67.37% SD 11.37% Total 392/901 (43.51%) Mean 43.53% SD 10.38% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 51/52 (98%) 50/50 (100%) 47/50 (94%) 45/50 (90%) 49/50 (98%) | | 50/50 (100%) 50/50 (100%) 45/50 (90%) 45/50 (90%) 47/50 (94%) 46/50 (92%) | | 50/51 (98%) 48/50 (96%) 49/50 (98%) 47/51 (92%) 47/50 (94%) 48/50 (96%) | | 49/50 (98%) 50/50 (100%) 51/51 (100%) 45/50 (90%) 46/50 (92%) 45/50 (90%) | | 50/50 (100%) 50/50 (100%) 50/50 (100%) 48/50 (96%) 49/50 (98%) 48/50 (96%) | | 50/50 (100%) 48/50 (96%) 49/50 (98%) 46/50 (92%) 44/50 (88%) 49/50 (98%) | | Overall Incidence Total 889/904 (98.34%)Mean 98.34% SD 2.5% Total 841/901 (93.34%) Mean 93.34% SD 3.14% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 1/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.76% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.67% SD 1.19% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 246 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 1/52 (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%) 0/50 (0%) | | 0/51 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/904 (1%) Mean 1% SD 1.41% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 1/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 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%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.76% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 30/50 (60%) 32/52 (62%) 27/50 (54%) 18/50 (36%) 19/50 (38%) 14/50 (28%) | | Mononuclear, or Undifferentiated 25/50 (50%) 35/50 (70%) 22/50 (44%) 15/50 (30%) 13/50 (26%) 8/50 (16%) | | 20/51 (39%) 29/50 (58%) 27/50 (54%) 8/51 (16%) 13/50 (26%) 15/50 (30%) | | 18/50 (36%) 32/50 (64%) 27/51 (53%) 11/50 (22%) 14/50 (28%) 15/50 (30%) | | 16/50 (32%) 31/50 (62%) 37/50 (74%) 9/50 (18%) 21/50 (42%) 16/50 (32%) | | 26/50 (52%) 29/50 (58%) 31/50 (62%) 14/50 (28%) 17/50 (34%) 21/50 (42%) | | Overall Incidence Total 494/904 (54.65%)Mean 54.65% SD 11.24% Total 261/901 (28.97%) Mean 28.98% SD 7.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 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%) 0/50 (0%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.22% SD 0.65% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 247 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 2/52 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/51 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 20/904 (2.21%) Mean 2.21% SD 1.51% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 2/52 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/51 (2%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 19/904 (2.1%) Mean 2.1% SD 1.59% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.76% Total 4/901 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 248 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.76% Total 4/901 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 1/52 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/51 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | 2/48 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 9/900 (1%) Mean 1% SD 1.26% Total 13/900 (1.44%) Mean 1.44% SD 1.79% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/52 (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%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (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%) 0/50 (0%) 0/50 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/900 (0%) Mean 0% SD 0% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/47 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (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%) 0/49 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/896 (0.11%) Mean 0.11% SD 0.47% Total 0/896 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 14/50 (28%) 14/52 (27%) 14/50 (28%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 14/50 (28%) 23/50 (46%) 9/50 (18%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 5/50 (10%) 17/49 (35%) 14/47 (30%) 1/51 (2%) 3/50 (6%) 3/50 (6%) | | 15/49 (31%) 16/49 (33%) 6/51 (12%) 1/49 (2%) 2/50 (4%) 1/50 (2%) | | 17/50 (34%) 9/50 (18%) 7/50 (14%) 1/50 (2%) 1/49 (2%) 2/48 (4%) | | 7/49 (14%) 10/50 (20%) 17/50 (34%) 1/50 (2%) 2/49 (4%) 3/50 (6%) | | Overall Incidence Total 228/896 (25.45%)Mean 25.48% SD 9.69% Total 26/896 (2.9%) Mean 2.91% SD 1.85% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 249 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/47 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/49 (2%) 0/51 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 4/896 (0.45%) Mean 0.45% SD 0.86% Total 4/896 (0.45%) Mean 0.45% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 1/49 (2%) 0/47 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 1/49 (2%) 3/51 (6%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 4/50 (8%) 1/50 (2%) 0/49 (0%) 0/48 (0%) | | 6/49 (12%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 28/896 (3.13%) Mean 3.12% SD 3.05% Total 4/896 (0.45%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 14/50 (28%) 14/52 (27%) 14/50 (28%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | | Complex, Malignant, NOS 16/50 (32%) 23/50 (46%) 10/50 (20%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | 7/50 (14%) 18/49 (37%) 14/47 (30%) 1/51 (2%) 3/50 (6%) 3/50 (6%) | | 17/49 (35%) 16/49 (33%) 9/51 (18%) 1/49 (2%) 3/50 (6%) 2/50 (4%) | | 19/50 (38%) 10/50 (20%) 10/50 (20%) 2/50 (4%) 1/49 (2%) 3/48 (6%) | | 12/49 (24%) 11/50 (22%) 18/50 (36%) 1/50 (2%) 2/49 (4%) 3/50 (6%) | | Overall Incidence Total 252/896 (28.13%)Mean 28.16% SD 8.38% Total 34/896 (3.79%) Mean 3.8% SD 1.94% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/50 (0%) 1/52 (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%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/900 (0.11%) Mean 0.11% SD 0.45% Total 0/898 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 250 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.65% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 1/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.45% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 251 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.76% Total 4/901 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.76% Total 4/901 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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 1/904 (0.11%) Mean 0.11% SD 0.46% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 252 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 2/52 (4%) 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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.32% SD 1% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.47% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 253 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.64% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 254 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (0%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (0%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 1/50 (2%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/904 (0.33%) Mean 0.33% SD 0.77% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma NOS 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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 0/904 (0%) Mean 0% SD 0% Total 1/900 (0.11%) Mean 0.11% SD 0.48% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 255 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 1/50 (2%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/904 (1%) Mean 0.99% SD 1.21% Total 5/900 (0.56%) Mean 0.56% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/50 (2%) 3/52 (6%) 7/48 (15%) 4/49 (8%) 5/49 (10%) 7/49 (14%) | | 4/50 (8%) 2/50 (4%) 1/50 (2%) 4/50 (8%) 4/49 (8%) 3/42 (7%) | | 4/50 (8%) 2/50 (4%) 3/48 (6%) 1/51 (2%) 1/45 (2%) 5/50 (10%) | | 2/50 (4%) 3/50 (6%) 3/51 (6%) 2/47 (4%) 5/47 (11%) 4/48 (8%) | | 2/50 (4%) 4/50 (8%) 5/49 (10%) 0/50 (0%) 3/50 (6%) 11/49 (22%) | | 4/50 (8%) 3/50 (6%) 5/50 (10%) 3/45 (7%) 4/50 (8%) 10/50 (20%) | | Overall Incidence Total 58/898 (6.46%) Mean 6.48% SD 3.14% Total 76/870 (8.74%) Mean 8.69% SD 5.71% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 2/50 (4%) 2/52 (4%) 1/48 (2%) 1/49 (2%) 0/49 (0%) 1/49 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/49 (2%) 1/42 (2%) | | 0/50 (0%) 0/50 (0%) 2/48 (4%) 1/51 (2%) 0/45 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 2/51 (4%) 0/47 (0%) 1/47 (2%) 1/48 (2%) | | 0/50 (0%) 1/50 (2%) 5/49 (10%) 1/50 (2%) 4/50 (8%) 6/49 (12%) | | 7/50 (14%) 1/50 (2%) 0/50 (0%) 4/45 (9%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 25/898 (2.78%) Mean 2.79% SD 3.79% Total 26/870 (2.99%) Mean 2.99% SD 3.35% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 256 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 3/50 (6%) 5/52 (10%) 8/48 (17%) 5/49 (10%) 5/49 (10%) 8/49 (16%) | | 5/50 (10%) 3/50 (6%) 1/50 (2%) 6/50 (12%) 5/49 (10%) 4/42 (10%) | | 4/50 (8%) 2/50 (4%) 5/48 (10%) 2/51 (4%) 1/45 (2%) 6/50 (12%) | | 2/50 (4%) 3/50 (6%) 5/51 (10%) 2/47 (4%) 6/47 (13%) 5/48 (10%) | | 2/50 (4%) 5/50 (10%) 10/49 (20%) 1/50 (2%) 7/50 (14%) 17/49 (35%) | | 11/50 (22%) 4/50 (8%) 5/50 (10%) 7/45 (16%) 4/50 (8%) 10/50 (20%) | | Overall Incidence Total 83/898 (9.24%) Mean 9.27% SD 5.51% Total 101/870 (11.61%) Mean 11.57% SD 7.54% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 0/50 (0%) 0/52 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/42 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/898 (0.22%) Mean 0.22% SD 0.94% Total 0/870 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/52 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/42 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/51 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/47 (0%) 0/47 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/45 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/898 (0.11%) Mean 0.11% SD 0.46% Total 0/870 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 257 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 258 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 0/50 (0%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.94% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.46% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 259 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/49 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.22% SD 0.65% Total 1/899 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (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%) 0/50 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.46% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 260 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 261 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 262 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Leiomyosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 263 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/52 (0%) 2/50 (4%) 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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 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%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.67% SD 1.37% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 264 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/50 (0%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.46% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/52 (0%) 2/50 (4%) 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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 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%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.67% SD 1.37% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/52 (0%) 2/50 (4%) 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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 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%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.67% SD 1.37% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 265 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.65% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.46% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 266 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/50 (4%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | | 2/51 (4%) 1/49 (2%) 2/47 (4%) 0/51 (0%) 0/50 (0%) 2/49 (4%) | | 4/50 (8%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 5/50 (10%) 4/50 (8%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | | 1/49 (2%) 2/49 (4%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/49 (4%) | | Overall Incidence Total 33/898 (3.67%) Mean 3.68% SD 2.85% Total 17/899 (1.89%) Mean 1.9% SD 2.12% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/52 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/47 (0%) 0/51 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | | Overall Incidence Total 6/898 (0.67%) Mean 0.67% SD 1.19% Total 7/899 (0.78%) Mean 0.79% SD 1.58% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/50 (4%) 0/52 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | | 2/51 (4%) 1/49 (2%) 2/47 (4%) 0/51 (0%) 0/50 (0%) 3/49 (6%) | | 4/50 (8%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 2/50 (4%) 5/50 (10%) 5/50 (10%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | | 1/49 (2%) 3/49 (6%) 4/50 (8%) 2/50 (4%) 1/50 (2%) 5/49 (10%) | | Overall Incidence Total 39/898 (4.34%) Mean 4.35% SD 3.16% Total 24/899 (2.67%) Mean 2.68% SD 2.79% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.47% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 267 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.47% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/902 (0.78%) Mean 0.77% SD 1.21% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/902 (0.78%) Mean 0.77% SD 1.21% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 268 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 1/49 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/902 (0.11%) Mean 0.11% SD 0.48% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 269 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/902 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/902 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/902 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/50 (2%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 5/50 (10%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 21/902 (2.33%) Mean 2.34% SD 3.16% Total 4/901 (0.44%) Mean 0.44% SD 1.1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 270 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/52 (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%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/49 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/902 (0.78%) Mean 0.78% SD 1.58% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/52 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 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%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/49 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/902 (0.78%) Mean 0.78% SD 1.58% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) 0/52 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma 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%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 5/50 (10%) 3/50 (6%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 4/49 (8%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 26/902 (2.88%) Mean 2.9% SD 3.46% Total 4/901 (0.44%) Mean 0.44% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/50 (2%) 0/52 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 5/50 (10%) 3/50 (6%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 4/49 (8%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 26/902 (2.88%) Mean 2.9% SD 3.46% Total 4/901 (0.44%) Mean 0.44% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/49 (0%) 0/52 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | | 0/51 (0%) 1/50 (2%) 2/49 (4%) 1/51 (2%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 7/50 (14%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 22/902 (2.44%) Mean 2.45% SD 3.26% Total 13/900 (1.44%) Mean 1.44% SD 1.79% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 271 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/49 (2%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 1/49 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 7/902 (0.78%) Mean 0.77% SD 1.19% Total 4/900 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 1/49 (2%) 2/52 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 1/50 (2%) 2/50 (4%) 3/50 (6%) 0/49 (0%) 1/50 (2%) | | 1/51 (2%) 1/50 (2%) 3/49 (6%) 1/51 (2%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 1/51 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 8/50 (16%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 29/902 (3.22%) Mean 3.22% SD 3.64% Total 17/900 (1.89%) Mean 1.89% SD 1.88% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/49 (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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/902 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrosarcoma 0/49 (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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/902 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 1/49 (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%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/902 (0.11%) Mean 0.11% SD 0.48% Total 1/900 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 272 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/49 (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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/902 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 273 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 3/51 (6%) 0/50 (0%) 1/50 (2%) | | 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%) 2/50 (4%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.22% SD 0.65% Total 21/901 (2.33%) Mean 2.33% SD 2.39% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 3/50 (6%) 3/50 (6%) 4/50 (8%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.22% SD 0.94% Total 31/901 (3.44%) Mean 3.44% SD 2.64% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 4/50 (8%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 3/51 (6%) 1/50 (2%) 3/50 (6%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 3/50 (6%) 3/50 (6%) 4/50 (8%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) 6/50 (12%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) 4/50 (8%) | | Overall Incidence Total 4/904 (0.44%) Mean 0.44% SD 1.1% Total 51/901 (5.66%) Mean 5.66% SD 3.01% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 3/50 (6%) 1/52 (2%) 4/50 (8%) 29/50 (58%) 19/50 (38%) 25/50 (50%) | | 5/50 (10%) 3/50 (6%) 0/50 (0%) 25/50 (50%) 22/50 (44%) 19/50 (38%) | | 0/51 (0%) 1/50 (2%) 0/50 (0%) 15/51 (29%) 15/50 (30%) 13/50 (26%) | | 2/50 (4%) 1/50 (2%) 0/51 (0%) 19/50 (38%) 27/50 (54%) 25/50 (50%) | | 4/50 (8%) 2/50 (4%) 3/50 (6%) 12/50 (24%) 28/50 (56%) 21/50 (42%) | | 3/50 (6%) 2/50 (4%) 6/50 (12%) 17/50 (34%) 22/50 (44%) 30/50 (60%) | | Overall Incidence Total 40/904 (4.42%) Mean 4.44% SD 3.6% Total 383/901 (42.51%) Mean 42.52% SD 11.14% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 274 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 1/52 (2%) 4/50 (8%) 31/50 (62%) 19/50 (38%) 26/50 (52%) | | 5/50 (10%) 3/50 (6%) 0/50 (0%) 25/50 (50%) 24/50 (48%) 22/50 (44%) | | 0/51 (0%) 1/50 (2%) 1/50 (2%) 18/51 (35%) 15/50 (30%) 13/50 (26%) | | 2/50 (4%) 1/50 (2%) 0/51 (0%) 19/50 (38%) 27/50 (54%) 25/50 (50%) | | 4/50 (8%) 2/50 (4%) 3/50 (6%) 12/50 (24%) 28/50 (56%) 22/50 (44%) | | 3/50 (6%) 2/50 (4%) 7/50 (14%) 17/50 (34%) 23/50 (46%) 32/50 (64%) | | Overall Incidence Total 42/904 (4.65%) Mean 4.66% SD 3.76% Total 398/901 (44.17%) Mean 44.18% SD 11.61% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 3/50 (6%) 1/52 (2%) 4/50 (8%) 32/50 (64%) 19/50 (38%) 27/50 (54%) | | or Adenoma 5/50 (10%) 5/50 (10%) 0/50 (0%) 25/50 (50%) 25/50 (50%) 22/50 (44%) | | 0/51 (0%) 1/50 (2%) 1/50 (2%) 18/51 (35%) 16/50 (32%) 14/50 (28%) | | 2/50 (4%) 1/50 (2%) 0/51 (0%) 22/50 (44%) 30/50 (60%) 27/50 (54%) | | 4/50 (8%) 2/50 (4%) 3/50 (6%) 12/50 (24%) 29/50 (58%) 25/50 (50%) | | 3/50 (6%) 2/50 (4%) 7/50 (14%) 18/50 (36%) 25/50 (50%) 32/50 (64%) | | Overall Incidence Total 44/904 (4.87%) Mean 4.88% SD 3.96% Total 418/901 (46.39%) Mean 46.41% SD 12.05% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 276 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.46% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/899 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/899 (0.11%) Mean 0.11% SD 0.46% | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/904 (0.44%) Mean 0.44% SD 0.86% Total 1/899 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 2/52 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/904 (1%) Mean 0.99% SD 1.4% Total 12/901 (1.33%) Mean 1.33% SD 1.68% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 1/50 (2%) | | 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.47% Total 5/901 (0.55%) Mean 0.55% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 2/52 (4%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 10/904 (1.11%) Mean 1.1% SD 1.39% Total 17/901 (1.89%) Mean 1.89% SD 1.88% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 279 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.22% SD 0.65% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.46% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/901 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/51 (2%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 10/901 (1.11%) Mean 1.11% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 281 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/52 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/48 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/49 (10%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 17/899 (1.89%) Mean 1.9% SD 2.82% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/48 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/899 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/52 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/48 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/49 (10%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 17/899 (1.89%) Mean 1.9% SD 2.82% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/48 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/49 (0%) 0/48 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/899 (0%) Mean 0% SD 0% Total 0/899 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 2/47 (4%) 1/51 (2%) 0/39 (0%) 0/48 (0%) 0/46 (0%) 0/42 (0%) | | 1/47 (2%) 0/45 (0%) 1/46 (2%) 1/46 (2%) 0/38 (0%) 0/46 (0%) | | 0/44 (0%) 0/48 (0%) 1/47 (2%) 0/46 (0%) 0/47 (0%) 0/46 (0%) | | 0/43 (0%) 0/38 (0%) 0/50 (0%) 0/45 (0%) 1/45 (2%) 0/47 (0%) | | 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) | | 0/47 (0%) 0/48 (0%) 0/41 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 6/827 (0.73%) Mean 0.7% SD 1.26% Total 2/828 (0.24%) Mean 0.24% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.65% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 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%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.65% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/904 (0.22%) Mean 0.22% SD 0.63% Total 3/901 (0.33%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 14/50 (28%) 13/52 (25%) 17/49 (35%) 27/49 (55%) 23/50 (46%) 31/50 (62%) | | Adenoma 18/50 (36%) 17/49 (35%) 8/50 (16%) 22/50 (44%) 16/49 (33%) 21/50 (42%) | | 8/51 (16%) 11/48 (23%) 23/50 (46%) 30/51 (59%) 26/50 (52%) 26/50 (52%) | | 15/50 (30%) 9/50 (18%) 7/50 (14%) 28/50 (56%) 16/46 (35%) 16/49 (33%) | | 8/49 (16%) 10/50 (20%) 20/50 (40%) 36/50 (72%) 20/49 (41%) 24/50 (48%) | | 14/50 (28%) 19/49 (39%) 13/50 (26%) 28/50 (56%) 18/50 (36%) 35/50 (70%) | | Overall Incidence Total 244/897 (27.2%) Mean 27.23% SD 9.58% Total 443/893 (49.61%) Mean 49.49% SD 11.98% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 284 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 1/48 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/46 (2%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 4/897 (0.45%) Mean 0.45% SD 1.1% Total 11/893 (1.23%) Mean 1.24% SD 1.57% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 14/50 (28%) 13/52 (25%) 17/49 (35%) 27/49 (55%) 23/50 (46%) 31/50 (62%) | | Carcinoma or Adenoma 18/50 (36%) 17/49 (35%) 8/50 (16%) 22/50 (44%) 16/49 (33%) 21/50 (42%) | | 8/51 (16%) 12/48 (25%) 23/50 (46%) 30/51 (59%) 26/50 (52%) 28/50 (56%) | | 17/50 (34%) 9/50 (18%) 7/50 (14%) 30/50 (60%) 17/46 (37%) 16/49 (33%) | | 8/49 (16%) 10/50 (20%) 20/50 (40%) 37/50 (74%) 22/49 (45%) 24/50 (48%) | | 15/50 (30%) 19/49 (39%) 13/50 (26%) 29/50 (58%) 19/50 (38%) 36/50 (72%) | | Overall Incidence Total 248/897 (27.65%)Mean 27.68% SD 9.67% Total 454/893 (50.84%) Mean 50.73% SD 12.28% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Craniopharyngioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/48 (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%) 0/46 (0%) 0/49 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/897 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Ganglioneuroma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/48 (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%) 0/46 (0%) 0/49 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/897 (0%) Mean 0% SD 0% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/52 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/48 (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%) 0/46 (0%) 0/49 (0%) | | 0/49 (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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/897 (0.22%) Mean 0.22% SD 0.65% Total 3/893 (0.34%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 285 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 1/50 (2%) 0/52 (0%) 0/49 (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%) 0/50 (0%) | | 0/51 (0%) 0/48 (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%) 0/46 (0%) 0/49 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/897 (0.11%) Mean 0.11% SD 0.47% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/50 (2%) 0/52 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 0/48 (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%) 0/46 (0%) 0/49 (0%) | | 0/49 (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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/897 (0.33%) Mean 0.33% SD 0.77% Total 3/893 (0.34%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/50 (0%) 0/52 (0%) 0/49 (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%) 0/50 (0%) | | 0/51 (0%) 0/48 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/49 (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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/897 (0.11%) Mean 0.11% SD 0.47% Total 0/893 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/49 (0%) 0/52 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/899 (0.22%) Mean 0.22% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/49 (0%) 0/52 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (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%) | | Overall Incidence Total 0/899 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) 0/52 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/51 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/899 (0.22%) Mean 0.22% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/52 (0%) 0/50 (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%) 0/49 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/49 (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 0/901 (0%) Mean 0% SD 0% Total 0/897 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/52 (0%) 0/50 (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%) 0/49 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/49 (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 0/901 (0%) Mean 0% SD 0% Total 0/897 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/52 (0%) 0/50 (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%) 0/49 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/49 (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 0/901 (0%) Mean 0% SD 0% Total 0/897 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/52 (0%) 0/50 (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%) 0/49 (0%) | | 0/51 (0%) 0/50 (0%) 0/49 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/49 (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 1/901 (0.11%) Mean 0.11% SD 0.48% Total 0/897 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 287 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 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 3/904 (0.33%) Mean 0.33% SD 0.77% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 289 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 2/50 (4%) 0/50 (0%) 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 4/904 (0.44%) Mean 0.44% SD 1.1% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Papilloma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/904 (1%) Mean 1% SD 1.41% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Basosquamous Tumor Benign 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/904 (1.33%) Mean 1.33% SD 1.53% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Tumor Benign, or 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 2/50 (4%) 0/50 (0%) | | 2/50 (4%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 13/904 (1.44%) Mean 1.44% SD 1.65% Total 4/901 (0.44%) Mean 0.44% SD 1.1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 290 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/904 (0.44%) Mean 0.44% SD 0.85% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | NOS) 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 6/904 (0.66%) Mean 0.66% SD 1.18% Total 3/901 (0.33%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | (benign, malignant or NOS), or 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 2/50 (4%) 0/50 (0%) | | Trichoepithelioma 2/50 (4%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 19/904 (2.1%) Mean 2.1% SD 1.74% Total 7/901 (0.78%) Mean 0.78% SD 1.4% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 4/50 (8%) 3/52 (6%) 5/50 (10%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 3/50 (6%) 3/50 (6%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, 4/51 (8%) 2/50 (4%) 5/50 (10%) 1/51 (2%) 2/50 (4%) 1/50 (2%) | | Papilloma, Sq Papilloma, 4/50 (8%) 2/50 (4%) 4/51 (8%) 0/50 (0%) 1/50 (2%) 4/50 (8%) | | Keratoacanthoma, 5/50 (10%) 4/50 (8%) 12/50 (24%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Trichoepithelioma 6/50 (12%) 3/50 (6%) 5/50 (10%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 78/904 (8.63%) Mean 8.64% SD 4.4% Total 17/901 (1.89%) Mean 1.89% SD 2% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 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 3/904 (0.33%) Mean 0.33% SD 0.76% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 291 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/50 (0%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.94% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 1/52 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/51 (4%) 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 3/51 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 2/50 (4%) 7/50 (14%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 3/50 (6%) 3/50 (6%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 40/904 (4.42%) Mean 4.43% SD 3.6% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.47% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 292 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 1/52 (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%) | | 1/51 (2%) 0/50 (0%) 1/50 (2%) 1/51 (2%) 0/50 (0%) 0/50 (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%) 0/50 (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 3/904 (0.33%) Mean 0.33% SD 0.75% Total 1/901 (0.11%) Mean 0.11% SD 0.46% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 293 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Tumor (malignant or NOS), or 1/51 (2%) 0/50 (0%) 1/50 (2%) 1/51 (2%) 0/50 (0%) 0/50 (0%) | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/904 (1%) Mean 0.99% SD 1.39% Total 4/901 (0.44%) Mean 0.44% SD 0.85% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 2/50 (4%) 0/52 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 1/50 (2%) 4/50 (8%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 19/904 (2.1%) Mean 2.11% SD 2.32% Total 8/901 (0.89%) Mean 0.89% SD 1.57% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 2/50 (4%) 0/52 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 1/50 (2%) 4/50 (8%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 19/904 (2.1%) Mean 2.11% SD 2.32% Total 8/901 (0.89%) Mean 0.89% SD 1.57% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 2/52 (4%) 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 2/50 (4%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Keratoacanthoma 3/51 (6%) 2/50 (4%) 5/50 (10%) 1/51 (2%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 4/51 (8%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | 5/50 (10%) 3/50 (6%) 10/50 (20%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 4/50 (8%) 3/50 (6%) 4/50 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 62/904 (6.86%) Mean 6.87% SD 4.13% Total 10/901 (1.11%) Mean 1.11% SD 1.57% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 1/52 (2%) 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 2/50 (4%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/51 (4%) 2/50 (4%) 4/50 (8%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 4/51 (8%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | 5/50 (10%) 3/50 (6%) 10/50 (20%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 4/50 (8%) 3/50 (6%) 4/50 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 59/904 (6.53%) Mean 6.54% SD 4.22% Total 9/901 (1%) Mean 1% SD 1.57% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 294 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 5/50 (10%) 0/52 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | 1/51 (2%) 1/50 (2%) 3/50 (6%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 4/50 (8%) 5/50 (10%) 2/51 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | 4/50 (8%) 5/50 (10%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 4/50 (8%) 3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 50/904 (5.53%) Mean 5.55% SD 3.12% Total 13/901 (1.44%) Mean 1.44% SD 1.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 5/50 (10%) 1/52 (2%) 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous 5/50 (10%) 3/50 (6%) 1/50 (2%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | | Histiocytoma 3/51 (6%) 2/50 (4%) 5/50 (10%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 4/50 (8%) 5/50 (10%) 2/51 (4%) 0/50 (0%) 3/50 (6%) 2/50 (4%) | | 5/50 (10%) 5/50 (10%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 6/50 (12%) 3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 64/904 (7.08%) Mean 7.1% SD 3.32% Total 20/901 (2.22%) Mean 2.22% SD 2.16% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/52 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 1/51 (2%) 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (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 9/904 (1%) Mean 0.99% SD 1.41% Total 4/901 (0.44%) Mean 0.44% SD 0.86% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/52 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | Histiocytoma 2/51 (4%) 1/50 (2%) 2/50 (4%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 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%) | | Overall Incidence Total 15/904 (1.66%) Mean 1.66% SD 2.19% Total 7/901 (0.78%) Mean 0.78% SD 1.22% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 295 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/904 (0.22%) Mean 0.22% SD 0.64% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/50 (0%) 2/52 (4%) 0/50 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (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 3/904 (0.33%) Mean 0.32% SD 1% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 2/52 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/904 (1.22%) Mean 1.21% SD 1.82% Total 0/901 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 2/52 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (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) 1/51 (2%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/904 (1.22%) Mean 1.21% SD 1.82% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/52 (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%) 1/50 (2%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/904 (0.44%) Mean 0.44% SD 0.86% Total 3/901 (0.33%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/52 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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%) | | Overall Incidence Total 8/904 (0.88%) Mean 0.89% SD 1.71% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 297 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/50 (0%) 1/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.45% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/50 (0%) 0/52 (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%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/903 (0.11%) Mean 0.11% SD 0.47% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 3/903 (0.33%) Mean 0.33% SD 1.41% Total 0/900 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 1/52 (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%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/903 (0.11%) Mean 0.11% SD 0.45% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/903 (0.33%) Mean 0.33% SD 1.03% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Leiomyosarcoma 0/50 (0%) 0/52 (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%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 2/903 (0.22%) Mean 0.22% SD 0.94% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/903 (0%) Mean 0% SD 0% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (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 1/903 (0.11%) Mean 0.11% SD 0.46% Total 0/900 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 299 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.46% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 1/50 (2%) | | 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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/904 (0.11%) Mean 0.11% SD 0.46% Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 300 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 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%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 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%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 46/50 (92%) 46/52 (88%) 45/50 (90%) | | 42/50 (84%) 41/50 (82%) 42/50 (84%) | | 48/51 (94%) 46/50 (92%) 37/50 (74%) | | 45/50 (90%) 47/50 (94%) 49/51 (96%) | | 47/50 (94%) 44/50 (88%) 39/49 (80%) | | 48/50 (96%) 44/50 (88%) 46/50 (92%) | | Overall Incidence Total 802/903 (88.82%)Mean 88.79% SD 6.03% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) 0/44 (0%) | | 0/51 (0%) 0/41 (0%) 0/41 (0%) 0/48 (0%) 0/48 (0%) 0/41 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/44 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/45 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/850 (0%) Mean 0% SD 0% Total 0/856 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 301 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) 1/44 (2%) | | 0/51 (0%) 0/41 (0%) 0/41 (0%) 0/48 (0%) 0/48 (0%) 0/41 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/44 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/45 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/850 (0%) Mean 0% SD 0% Total 1/856 (0.12%) Mean 0.13% SD 0.54% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 2/46 (4%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) 0/44 (0%) | | 0/51 (0%) 0/41 (0%) 0/41 (0%) 0/48 (0%) 0/48 (0%) 0/41 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 1/44 (2%) 0/49 (0%) | | 1/48 (2%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/45 (0%) 1/48 (2%) 0/50 (0%) 1/47 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 2/850 (0.24%) Mean 0.23% SD 0.67% Total 4/856 (0.47%) Mean 0.49% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) 0/50 (0%) | | 0/49 (0%) 1/49 (2%) 0/42 (0%) 0/48 (0%) 1/49 (2%) 0/44 (0%) | | 0/51 (0%) 0/41 (0%) 0/41 (0%) 0/48 (0%) 0/48 (0%) 0/41 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/44 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/45 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/850 (0.12%) Mean 0.11% SD 0.48% Total 1/856 (0.12%) Mean 0.11% SD 0.48% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) 0/44 (0%) | | 0/51 (0%) 0/41 (0%) 0/41 (0%) 0/48 (0%) 0/48 (0%) 0/41 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/44 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/45 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/850 (0%) Mean 0% SD 0% Total 0/856 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) 2/46 (4%) 0/50 (0%) | | 0/49 (0%) 1/49 (2%) 0/42 (0%) 0/48 (0%) 1/49 (2%) 0/44 (0%) | | 0/51 (0%) 0/41 (0%) 0/41 (0%) 0/48 (0%) 0/48 (0%) 0/41 (0%) | | 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) 1/44 (2%) 0/49 (0%) | | 1/48 (2%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/45 (0%) 1/48 (2%) 0/50 (0%) 1/47 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 3/850 (0.35%) Mean 0.34% SD 0.79% Total 5/856 (0.58%) Mean 0.6% SD 1.24% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 302 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/50 (0%) 0/52 (0%) 0/50 (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%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/49 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 0/898 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 5/50 (10%) 6/52 (12%) 10/50 (20%) 3/49 (6%) 8/50 (16%) 6/50 (12%) | | 5/50 (10%) 7/50 (14%) 10/50 (20%) 3/50 (6%) 5/49 (10%) 5/50 (10%) | | 12/51 (24%) 4/50 (8%) 2/50 (4%) 9/51 (18%) 3/50 (6%) 6/50 (12%) | | 7/50 (14%) 3/50 (6%) 7/51 (14%) 3/50 (6%) 4/50 (8%) 6/50 (12%) | | 8/50 (16%) 5/50 (10%) 6/50 (12%) 4/50 (8%) 4/49 (8%) 2/50 (4%) | | 1/49 (2%) 4/49 (8%) 9/50 (18%) 5/50 (10%) 9/50 (18%) 7/50 (14%) | | Overall Incidence Total 111/902 (12.31%)Mean 12.28% SD 5.76% Total 92/898 (10.24%) Mean 10.23% SD 4.17% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/52 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 1/50 (2%) 2/50 (4%) 0/51 (0%) 1/50 (2%) 2/50 (4%) | | 1/50 (2%) 2/50 (4%) 1/51 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | 1/49 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 10/902 (1.11%) Mean 1.11% SD 1.41% Total 17/898 (1.89%) Mean 1.89% SD 1.6% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 5/50 (10%) 6/52 (12%) 10/50 (20%) 3/49 (6%) 9/50 (18%) 7/50 (14%) | | 5/50 (10%) 8/50 (16%) 10/50 (20%) 5/50 (10%) 5/49 (10%) 5/50 (10%) | | 12/51 (24%) 5/50 (10%) 4/50 (8%) 9/51 (18%) 4/50 (8%) 8/50 (16%) | | 8/50 (16%) 5/50 (10%) 8/51 (16%) 4/50 (8%) 6/50 (12%) 8/50 (16%) | | 9/50 (18%) 5/50 (10%) 6/50 (12%) 4/50 (8%) 5/49 (10%) 2/50 (4%) | | 2/49 (4%) 4/49 (8%) 9/50 (18%) 7/50 (14%) 10/50 (20%) 8/50 (16%) | | Overall Incidence Total 121/902 (13.41%)Mean 13.39% SD 5.19% Total 109/898 (12.14%) Mean 12.12% SD 4.53% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/52 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 0/51 (0%) 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/49 (0%) 0/50 (0%) | | 1/49 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/902 (0.78%) Mean 0.78% SD 1% Total 3/898 (0.33%) Mean 0.33% SD 0.77% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 303 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 0/52 (0%) 3/50 (6%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 3/50 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 1/49 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/902 (1.22%) Mean 1.22% SD 1.96% Total 5/898 (0.56%) Mean 0.56% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/52 (2%) 4/50 (8%) 0/49 (0%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | | 0/51 (0%) 1/50 (2%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 2/49 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 18/902 (2%) Mean 2% SD 2.28% Total 8/898 (0.89%) Mean 0.89% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 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%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 304 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/904 (0%) Mean 0% SD 0% Total 2/901 (0.22%) Mean 0.22% SD 0.94% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 306 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/50 (2%) 1/52 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 5/904 (0.55%) Mean 0.55% SD 0.91% Total 9/901 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 1/50 (2%) 1/52 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/904 (0.55%) Mean 0.55% SD 0.91% Total 7/901 (0.78%) Mean 0.78% SD 1.22% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Malignant 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 307 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/52 (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%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 2/901 (0.22%) Mean 0.22% SD 0.64% | __________________________________________________________________________________________________________________________________ |#Urethra: | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 0/904 (0%) Mean 0% SD 0% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/51 (0%) 0/43 (0%) 0/49 (0%) 0/51 (0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/49 (0%) | | Overall Incidence Total 1/891 (0.11%) Mean 0.11% SD 0.48% Total 0/891 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) | | 1/48 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/51 (0%) 0/43 (0%) 0/49 (0%) 0/51 (0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 3/891 (0.34%) Mean 0.34% SD 0.77% Total 2/891 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 308 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/51 (0%) 0/43 (0%) 0/49 (0%) 0/51 (0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/49 (0%) | | Overall Incidence Total 0/891 (0%) Mean 0% SD 0% Total 0/891 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/49 (0%) 0/52 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/51 (0%) 0/43 (0%) 0/49 (0%) 0/51 (0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/48 (0%) 0/50 (0%) 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/891 (0.11%) Mean 0.11% SD 0.47% Total 0/891 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 1/52 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) | | 1/48 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/51 (0%) 0/43 (0%) 0/49 (0%) 0/51 (0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/51 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/891 (0.22%) Mean 0.22% SD 0.65% Total 2/891 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/901 (0.33%) Mean 0.33% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 4/901 (0.44%) Mean 0.44% SD 0.85% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 309 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 310 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 2/50 (4%) 13/50 (26%) 2/50 (4%) | | 6/50 (12%) 8/50 (16%) 4/50 (8%) | | 6/51 (12%) 5/50 (10%) 9/50 (18%) | | 1/50 (2%) 1/50 (2%) 5/50 (10%) | | 13/50 (26%) 6/50 (12%) 12/50 (24%) | | 9/50 (18%) 5/50 (10%) 4/50 (8%) | | Overall Incidence Total 111/901 (12.32%) Mean 12.32% SD 7.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 2/50 (4%) 0/50 (0%) | | 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 4/901 (0.44%) Mean 0.44% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 2/50 (4%) 13/50 (26%) 3/50 (6%) | | 6/50 (12%) 8/50 (16%) 4/50 (8%) | | 6/51 (12%) 7/50 (14%) 9/50 (18%) | | 1/50 (2%) 1/50 (2%) 5/50 (10%) | | 13/50 (26%) 6/50 (12%) 12/50 (24%) | | 9/50 (18%) 5/50 (10%) 5/50 (10%) | | Overall Incidence Total 115/901 (12.76%) Mean 12.76% SD 7.46% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 311 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/901 (0.22%) Mean 0.22% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 312 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.11% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (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%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/50 (2%) 1/52 (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%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | 1/50 (2%) 0/50 (0%) 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/904 (1%) Mean 0.99% SD 1.22% Total 5/901 (0.55%) Mean 0.56% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 313 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/50 (2%) 1/52 (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%) 0/50 (0%) | | 1/51 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 2/50 (4%) | | 1/50 (2%) 0/50 (0%) 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 10/904 (1.11%) Mean 1.1% SD 1.4% Total 5/901 (0.55%) Mean 0.56% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell Papilloma 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | | 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%) 0/50 (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 1/904 (0.11%) Mean 0.11% SD 0.47% Total 0/901 (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: 315 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 74/80 (93%) 46/50 (92%) 47/51 (92%) 63/80 (79%) 43/50 (86%) 45/50 (90%) | | 47/50 (94%) 48/50 (96%) 47/50 (94%) 43/50 (86%) 43/50 (86%) 39/50 (78%) | | Overall Incidence Total 309/331 (93.35%)Mean 93.44% SD 1.54% Total 276/330 (83.64%) Mean 84.13% SD 4.72% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 58/80 (73%) 39/50 (78%) 31/51 (61%) 38/80 (48%) 27/50 (54%) 16/50 (32%) | | 38/50 (76%) 40/50 (80%) 34/50 (68%) 32/50 (64%) 26/50 (52%) 21/50 (42%) | | Overall Incidence Total 240/331 (72.51%)Mean 72.55% SD 7.16% Total 160/330 (48.48%) Mean 48.58% SD 10.94% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 76/80 (95%) 50/50 (100%) 50/51 (98%) 73/80 (91%) 48/50 (96%) 48/50 (96%) | | 49/50 (98%) 48/50 (96%) 49/50 (98%) 48/50 (96%) 48/50 (96%) 45/50 (90%) | | Overall Incidence Total 322/331 (97.28%)Mean 97.51% SD 1.76% Total 310/330 (93.94%) Mean 94.21% SD 2.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Granulocytic 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 54/80 (68%) 35/50 (70%) 25/51 (49%) 26/80 (33%) 15/50 (30%) 8/50 (16%) | | Mononuclear, or Undifferentiated 30/50 (60%) 32/50 (64%) 29/50 (58%) 22/50 (44%) 19/50 (38%) 12/50 (24%) | | Overall Incidence Total 205/331 (61.93%)Mean 61.42% SD 7.55% Total 102/330 (30.91%) Mean 30.75% SD 9.95% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 1/50 (2%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Undifferentiated Cell Type | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 316 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 1/80 (1%) 1/50 (2%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 3/331 (0.91%) Mean 0.88% SD 1% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/80 (1%) 1/50 (2%) 1/51 (2%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | NOS 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/331 (2.42%) Mean 2.54% SD 2.14% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/331 (1.51%) Mean 1.66% SD 2.34% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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 3/331 (0.91%) Mean 0.99% SD 1.09% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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 3/331 (0.91%) Mean 0.99% SD 1.09% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/80 (1%) 1/49 (2%) 0/51 (0%) 1/80 (1%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 3/330 (0.91%) Mean 0.88% SD 1.01% Total 3/329 (0.91%) Mean 0.88% SD 1% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% Total 1/329 (0.3%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/79 (0%) 0/49 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 24/79 (30%) 11/49 (22%) 23/51 (45%) 6/80 (8%) 2/50 (4%) 7/50 (14%) | | 9/50 (18%) 13/50 (26%) 17/50 (34%) 3/50 (6%) 2/49 (4%) 3/50 (6%) | | Overall Incidence Total 97/329 (29.48%) Mean 29.32% SD 9.57% Total 23/329 (6.99%) Mean 6.93% SD 3.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 317 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 1/79 (1%) 0/49 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 1/329 (0.3%) Mean 0.21% SD 0.52% Total 1/329 (0.3%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/79 (3%) 2/49 (4%) 2/51 (4%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 11/329 (3.34%) Mean 3.42% SD 2.69% Total 1/329 (0.3%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 25/79 (32%) 13/49 (27%) 25/51 (49%) 6/80 (8%) 2/50 (4%) 7/50 (14%) | | Complex, Malignant, NOS 12/50 (24%) 14/50 (28%) 17/50 (34%) 3/50 (6%) 4/49 (8%) 3/50 (6%) | | Overall Incidence Total 106/329 (32.22%)Mean 32.2% SD 8.98% Total 25/329 (7.6%) Mean 7.61% SD 3.45% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Fibrosarcoma 0/79 (0%) 0/45 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 0/322 (0%) Mean 0% SD 0% Total 0/327 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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 2/331 (0.6%) Mean 0.66% SD 1.02% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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 2/331 (0.6%) Mean 0.66% SD 1.02% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 1/80 (1%) 1/50 (2%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 4/328 (1.22%) Mean 1.21% SD 1.6% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (0%) 1/50 (2%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.8% Total 1/328 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant, Mixed 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Hemangioma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/80 (0%) 0/50 (0%) 1/51 (2%) 1/80 (1%) 2/50 (4%) 0/48 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.8% Total 5/328 (1.52%) Mean 1.54% SD 1.96% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 7/80 (9%) 1/49 (2%) 3/50 (6%) 10/78 (13%) 0/50 (0%) 5/48 (10%) | | 2/50 (4%) 1/50 (2%) 3/50 (6%) 4/49 (8%) 1/49 (2%) 2/47 (4%) | | Overall Incidence Total 17/329 (5.17%) Mean 4.8% SD 2.63% Total 22/321 (6.85%) Mean 6.28% SD 5% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/80 (1%) 1/49 (2%) 1/50 (2%) 1/78 (1%) 3/50 (6%) 1/48 (2%) | | 1/50 (2%) 1/50 (2%) 5/50 (10%) 3/49 (6%) 4/49 (8%) 0/47 (0%) | | Overall Incidence Total 10/329 (3.04%) Mean 3.22% SD 3.34% Total 12/321 (3.74%) Mean 3.94% SD 3.25% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 8/80 (10%) 2/49 (4%) 4/50 (8%) 11/78 (14%) 3/50 (6%) 6/48 (13%) | | 3/50 (6%) 2/50 (4%) 8/50 (16%) 7/49 (14%) 5/49 (10%) 2/47 (4%) | | Overall Incidence Total 27/329 (8.21%) Mean 8.01% SD 4.55% Total 34/321 (10.59%) Mean 10.22% SD 4.25% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Carcinoma 0/80 (0%) 0/49 (0%) 0/50 (0%) 0/78 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% Total 0/321 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/80 (0%) 0/49 (0%) 0/50 (0%) 0/78 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% Total 0/321 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 1/80 (1%) 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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Ear: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 2/80 (3%) 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 0/331 (0%) Mean 0% SD 0% Total 2/330 (0.61%) Mean 0.42% SD 1.02% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 321 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Ear: | | Neurofibrosarcoma 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 1/331 (0.3%) Mean 0.21% SD 0.51% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Schwannoma NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Carcinoma 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 1/331 (0.3%) Mean 0.21% SD 0.51% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Esophagus: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 1/331 (0.3%) Mean 0.33% SD 0.82% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 322 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Fibroma 0/80 (0%) 1/50 (2%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 2/331 (0.6%) Mean 0.54% SD 0.87% Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 1/80 (1%) 0/50 (0%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 2/331 (0.6%) Mean 0.54% SD 0.86% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 1/80 (1%) 0/50 (0%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 2/331 (0.6%) Mean 0.54% SD 0.86% Total 1/330 (0.3%) 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: 323 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 324 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 2/331 (0.6%) Mean 0.66% SD 1.02% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 1/80 (1%) 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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Mast Cell Tumor Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 2/331 (0.6%) Mean 0.66% SD 1.02% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 2/331 (0.6%) Mean 0.66% SD 1.02% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 1/80 (1%) 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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Mast Cell Tumor Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/79 (3%) 3/45 (7%) 5/51 (10%) 3/80 (4%) 0/49 (0%) 0/50 (0%) | | 15/50 (30%) 2/49 (4%) 4/50 (8%) 1/50 (2%) 1/46 (2%) 1/49 (2%) | | Overall Incidence Total 31/324 (9.57%) Mean 10.18% SD 10.06% Total 6/324 (1.85%) Mean 1.66% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 1/79 (1%) 2/45 (4%) 2/51 (4%) 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) 0/49 (0%) | | Overall Incidence Total 7/324 (2.16%) Mean 2.27% SD 2.09% Total 1/324 (0.31%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/79 (4%) 5/45 (11%) 7/51 (14%) 3/80 (4%) 0/49 (0%) 0/50 (0%) | | 17/50 (34%) 2/49 (4%) 4/50 (8%) 2/50 (4%) 1/46 (2%) 1/49 (2%) | | Overall Incidence Total 38/324 (11.73%) Mean 12.45% SD 11.25% Total 7/324 (2.16%) Mean 1.99% SD 1.74% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 326 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 1/324 (0.31%) Mean 0.36% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 2/327 (0.61%) Mean 0.67% SD 1.03% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 2/327 (0.61%) Mean 0.67% SD 1.03% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Nephroblastoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Oncocytoma Benign 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 1/327 (0.31%) Mean 0.33% SD 0.82% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/79 (0%) 0/47 (0%) 0/51 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/327 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/330 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangioma 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/330 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Fibrosarcoma 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (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 0/330 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/80 (1%) 0/49 (0%) 2/51 (4%) 2/80 (3%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 6/330 (1.82%) Mean 1.86% SD 1.28% Total 5/330 (1.52%) Mean 1.42% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/330 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/80 (1%) 0/49 (0%) 2/51 (4%) 2/80 (3%) 0/50 (0%) 1/50 (2%) | | Hepatocellular Adenoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 6/330 (1.82%) Mean 1.86% SD 1.28% Total 5/330 (1.52%) Mean 1.42% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/80 (1%) 0/49 (0%) 2/51 (4%) 2/80 (3%) 0/50 (0%) 1/50 (2%) | | Hepatocellular Adenoma, or 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Hepatoblastoma | | Overall Incidence Total 6/330 (1.82%) Mean 1.86% SD 1.28% Total 5/330 (1.52%) Mean 1.42% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 2/80 (3%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/331 (0.91%) Mean 0.99% SD 1.09% Total 5/330 (1.52%) Mean 1.42% SD 1.11% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 328 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 0/80 (0%) 0/50 (0%) 1/51 (2%) 2/80 (3%) 1/50 (2%) 1/50 (2%) | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/331 (0.91%) Mean 0.99% SD 1.09% Total 5/330 (1.52%) Mean 1.42% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Plasma Cell Tumor Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoacanthoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.8% Total 6/330 (1.82%) Mean 2% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 6/50 (12%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 11/330 (3.33%) Mean 3.67% SD 4.27% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (0%) 2/50 (4%) 3/50 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 8/50 (16%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.8% Total 17/330 (5.15%) Mean 5.67% SD 5.57% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 6/80 (8%) 2/50 (4%) 2/51 (4%) 22/80 (28%) 15/50 (30%) 16/50 (32%) | | 1/50 (2%) 7/50 (14%) 4/50 (8%) 12/50 (24%) 29/50 (58%) 27/50 (54%) | | Overall Incidence Total 22/331 (6.65%) Mean 6.57% SD 4.3% Total 121/330 (36.67%) Mean 37.58% SD 14.57% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 6/80 (8%) 2/50 (4%) 3/51 (6%) 22/80 (28%) 16/50 (32%) 17/50 (34%) | | 1/50 (2%) 7/50 (14%) 4/50 (8%) 14/50 (28%) 29/50 (58%) 27/50 (54%) | | Overall Incidence Total 23/331 (6.95%) Mean 6.9% SD 4.13% Total 125/330 (37.88%) Mean 38.92% SD 13.51% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 6/80 (8%) 2/50 (4%) 3/51 (6%) 22/80 (28%) 17/50 (34%) 19/50 (38%) | | or Adenoma 1/50 (2%) 7/50 (14%) 4/50 (8%) 17/50 (34%) 30/50 (60%) 27/50 (54%) | | Overall Incidence Total 23/331 (6.95%) Mean 6.9% SD 4.13% Total 132/330 (40%) Mean 41.25% SD 12.8% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Lipoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) 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: 330 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) 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: 331 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Osteosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/80 (0%) 1/50 (2%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 4/331 (1.21%) Mean 1.33% SD 1.03% Total 3/330 (0.91%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 1/80 (1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 3/330 (0.91%) Mean 0.88% SD 1.61% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/80 (0%) 1/50 (2%) 0/51 (0%) 1/80 (1%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous, or Papilloma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 4/331 (1.21%) Mean 1.33% SD 1.03% Total 6/330 (1.82%) Mean 1.88% SD 1.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 332 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 1/80 (1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 3/330 (0.91%) Mean 0.88% SD 1.61% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 2/331 (0.6%) Mean 0.67% SD 1.03% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Adenoma 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Arrhenoblastoma Benign 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/329 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 1/80 (1%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/329 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/80 (1%) 0/49 (0%) 0/50 (0%) | | Malignant, NOS 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/329 (0.61%) Mean 0.54% SD 0.87% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Benign 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/329 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/329 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/79 (0%) 3/45 (7%) 4/51 (8%) 1/80 (1%) 1/49 (2%) 0/50 (0%) | | 3/50 (6%) 1/48 (2%) 2/50 (4%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 13/323 (4.02%) Mean 4.43% SD 2.98% Total 2/325 (0.62%) Mean 0.55% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/79 (0%) 1/45 (2%) 0/51 (0%) 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 1/323 (0.31%) Mean 0.37% SD 0.91% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/79 (0%) 4/45 (9%) 4/51 (8%) 1/80 (1%) 1/49 (2%) 0/50 (0%) | | 3/50 (6%) 1/48 (2%) 2/50 (4%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 14/323 (4.33%) Mean 4.8% SD 3.42% Total 2/325 (0.62%) Mean 0.55% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibrous Histiocytoma 0/79 (0%) 0/45 (0%) 0/51 (0%) 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/323 (0%) Mean 0% SD 0% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/79 (0%) 0/45 (0%) 0/51 (0%) 0/80 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/323 (0%) Mean 0% SD 0% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 4/77 (5%) 0/48 (0%) 0/50 (0%) 0/79 (0%) 0/43 (0%) 0/49 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) | | Overall Incidence Total 4/323 (1.24%) Mean 0.87% SD 2.12% Total 0/316 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Paraganglioma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Schwannoma: Benign, Malignant, NOS 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Pharynx: | | Squamous Cell Papilloma 0/80 (0%) 1/50 (2%) 0/51 (0%) 0/80 (0%) 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 1/331 (0.3%) Mean 0.33% SD 0.82% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/80 (19%) 21/48 (44%) 20/50 (40%) 32/80 (40%) 29/48 (60%) 33/50 (66%) | | Adenoma 33/49 (67%) 15/48 (31%) 16/50 (32%) 30/50 (60%) 29/49 (59%) 18/49 (37%) | | Overall Incidence Total 120/325 (36.92%)Mean 38.85% SD 16.41% Total 171/326 (52.45%) Mean 53.72% SD 12.18% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/80 (0%) 1/48 (2%) 0/50 (0%) 0/80 (0%) 4/48 (8%) 0/50 (0%) | | Carcinoma 1/49 (2%) 0/48 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 2/325 (0.62%) Mean 0.69% SD 1.06% Total 6/326 (1.84%) Mean 2.06% SD 3.23% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/80 (19%) 22/48 (46%) 20/50 (40%) 32/80 (40%) 33/48 (69%) 33/50 (66%) | | Carcinoma or Adenoma 33/49 (67%) 15/48 (31%) 16/50 (32%) 31/50 (62%) 30/49 (61%) 18/49 (37%) | | Overall Incidence Total 121/325 (37.23%)Mean 39.2% SD 16.55% Total 177/326 (54.29%) Mean 55.78% SD 13.8% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/80 (0%) 0/48 (0%) 0/50 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | Craniopharyngioma 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/325 (0%) Mean 0% SD 0% Total 0/326 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/80 (0%) 0/48 (0%) 0/50 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | Ganglioneuroma 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/325 (0%) Mean 0% SD 0% Total 0/326 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/80 (0%) 0/48 (0%) 0/50 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/325 (0.31%) Mean 0.33% SD 0.82% Total 1/326 (0.31%) 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: 335 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/80 (0%) 0/48 (0%) 0/50 (0%) 1/80 (1%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/325 (0%) Mean 0% SD 0% Total 1/326 (0.31%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/80 (0%) 0/48 (0%) 0/50 (0%) 1/80 (1%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/325 (0.31%) Mean 0.33% SD 0.82% Total 2/326 (0.61%) Mean 0.54% SD 0.87% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Nervosa | | Adenoma 0/80 (0%) 0/48 (0%) 0/50 (0%) 0/80 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/325 (0%) Mean 0% SD 0% Total 0/326 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/79 (0%) 0/48 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/328 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma 0/79 (0%) 0/48 (0%) 0/51 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/79 (0%) 0/48 (0%) 0/51 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/328 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/49 (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 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/49 (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 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/49 (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 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/49 (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 0/331 (0%) Mean 0% SD 0% Total 0/328 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 336 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrous Histiocytoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 1/331 (0.3%) Mean 0.21% SD 0.51% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (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%) 0/50 (0%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.21% SD 0.51% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/80 (1%) 1/50 (2%) 0/51 (0%) 1/80 (1%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 2/331 (0.6%) Mean 0.54% SD 0.87% Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/80 (0%) 1/50 (2%) 0/51 (0%) 0/80 (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 2/331 (0.6%) Mean 0.67% SD 1.03% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/80 (0%) 1/50 (2%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 2/331 (0.6%) Mean 0.67% SD 1.03% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/80 (1%) 2/50 (4%) 0/51 (0%) 1/80 (1%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 4/331 (1.21%) Mean 1.21% SD 1.6% Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 11/80 (14%) 3/50 (6%) 5/51 (10%) 1/80 (1%) 2/50 (4%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 3/50 (6%) 3/50 (6%) 8/50 (16%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 33/331 (9.97%) Mean 9.59% SD 4.41% Total 5/330 (1.52%) Mean 1.54% SD 1.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 338 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basosquamous Tumor Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 9/80 (11%) 1/50 (2%) 3/51 (6%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 6/50 (12%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 21/331 (6.34%) Mean 5.86% SD 4.89% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/80 (1%) 1/50 (2%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 4/331 (1.21%) Mean 1.2% SD 0.97% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 1/51 (2%) 0/80 (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%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.8% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/80 (0%) 1/50 (2%) 1/51 (2%) 0/80 (0%) 1/50 (2%) 1/50 (2%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 3/331 (0.91%) Mean 0.99% SD 1.09% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/80 (1%) 0/50 (0%) 1/51 (2%) 0/80 (0%) 1/50 (2%) 0/50 (0%) | | 3/50 (6%) 0/50 (0%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/331 (2.72%) Mean 2.87% SD 3.35% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/80 (1%) 0/50 (0%) 1/51 (2%) 0/80 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma 3/50 (6%) 0/50 (0%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/331 (2.72%) Mean 2.87% SD 3.35% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 10/80 (13%) 1/50 (2%) 5/51 (10%) 0/80 (0%) 2/50 (4%) 1/50 (2%) | | Papilloma, Squamous Cell 3/50 (6%) 2/50 (4%) 8/50 (16%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 29/331 (8.76%) Mean 8.38% SD 5.34% Total 4/330 (1.21%) Mean 1.33% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 10/80 (13%) 1/50 (2%) 4/51 (8%) 0/80 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 3/50 (6%) 2/50 (4%) 8/50 (16%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 28/331 (8.46%) Mean 8.06% SD 5.3% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/80 (0%) 1/50 (2%) 0/51 (0%) 1/80 (1%) 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 1/331 (0.3%) Mean 0.33% SD 0.82% Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 4/50 (8%) 2/50 (4%) | | 1/50 (2%) 3/50 (6%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 8/331 (2.42%) Mean 2.67% SD 3.5% Total 7/330 (2.12%) Mean 2.33% SD 3.2% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/80 (1%) 1/50 (2%) 1/51 (2%) 0/80 (0%) 6/50 (12%) 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous 3/50 (6%) 4/50 (8%) 4/50 (8%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | | Histiocytoma | | Overall Incidence Total 14/331 (4.23%) Mean 4.54% SD 3.16% Total 13/330 (3.94%) Mean 4.33% SD 4.46% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 340 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/80 (1%) 1/50 (2%) 1/51 (2%) 0/80 (0%) 1/50 (2%) 1/50 (2%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/331 (1.51%) Mean 1.54% SD 1.5% Total 4/330 (1.21%) Mean 1.33% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/80 (1%) 1/50 (2%) 1/51 (2%) 0/80 (0%) 2/50 (4%) 1/50 (2%) | | Myxosarcoma, or Fibrous 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Histiocytoma | | Overall Incidence Total 6/331 (1.81%) Mean 1.87% SD 1.3% Total 6/330 (1.82%) Mean 2% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 0/50 (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) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 2/330 (0.61%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Astrocytoma Malignant 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 1/331 (0.3%) Mean 0.21% SD 0.51% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Chordoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Spinal Cord: | | Glioma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibroma 0/79 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/328 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Fibrosarcoma 1/79 (1%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 1/328 (0.3%) Mean 0.21% SD 0.52% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/79 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/328 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/79 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/328 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Leiomyosarcoma 0/79 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/328 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Osteosarcoma 0/79 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/328 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Sarcoma 0/79 (0%) 1/49 (2%) 0/51 (0%) 0/80 (0%) 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 1/328 (0.3%) Mean 0.34% SD 0.83% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Basal Cell Adenoma 1/80 (1%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 1/331 (0.3%) Mean 0.21% SD 0.51% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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%) | | Overall Incidence Total 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoid Tumor Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 343 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 70/80 (88%) 39/49 (80%) 33/51 (65%) | | 34/50 (68%) 46/50 (92%) 42/49 (86%) | | Overall Incidence Total 264/329 (80.24%)Mean 79.59% SD 11.04% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/69 (0%) 0/44 (0%) 0/46 (0%) 0/70 (0%) 0/44 (0%) 0/49 (0%) | | 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% Total 0/309 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Schwannoma Malignant 0/69 (0%) 0/44 (0%) 0/46 (0%) 0/70 (0%) 0/44 (0%) 0/49 (0%) | | 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% Total 0/309 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/69 (0%) 0/44 (0%) 0/46 (0%) 1/70 (1%) 0/44 (0%) 0/49 (0%) | | 1/45 (2%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.37% SD 0.91% Total 1/309 (0.32%) Mean 0.24% SD 0.58% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/69 (0%) 0/44 (0%) 0/46 (0%) 0/70 (0%) 0/44 (0%) 0/49 (0%) | | 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% Total 0/309 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma NOS 0/69 (0%) 0/44 (0%) 0/46 (0%) 0/70 (0%) 0/44 (0%) 0/49 (0%) | | 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/303 (0%) Mean 0% SD 0% Total 0/309 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/69 (0%) 0/44 (0%) 0/46 (0%) 1/70 (1%) 0/44 (0%) 0/49 (0%) | | 1/45 (2%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/303 (0.33%) Mean 0.37% SD 0.91% Total 1/309 (0.32%) Mean 0.24% SD 0.58% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/80 (0%) 0/49 (0%) 0/51 (0%) 0/80 (0%) 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 0/330 (0%) Mean 0% SD 0% Total 0/329 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 14/80 (18%) 5/49 (10%) 6/51 (12%) 13/80 (16%) 5/49 (10%) 4/50 (8%) | | 4/50 (8%) 5/50 (10%) 2/50 (4%) 7/50 (14%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 36/330 (10.91%) Mean 10.24% SD 4.45% Total 34/329 (10.33%) Mean 9.74% SD 4.71% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/80 (1%) 0/49 (0%) 1/51 (2%) 1/80 (1%) 1/49 (2%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/330 (0.91%) Mean 0.87% SD 0.99% Total 4/329 (1.22%) Mean 1.22% SD 0.99% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 344 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 15/80 (19%) 5/49 (10%) 7/51 (14%) 14/80 (18%) 5/49 (10%) 5/50 (10%) | | 5/50 (10%) 5/50 (10%) 2/50 (4%) 8/50 (16%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 39/330 (11.82%) Mean 11.11% SD 4.88% Total 37/329 (11.25%) Mean 10.62% SD 5.33% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/80 (0%) 1/49 (2%) 0/51 (0%) 0/80 (0%) 1/49 (2%) 3/50 (6%) | | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/330 (1.21%) Mean 1.34% SD 1.64% Total 5/329 (1.52%) Mean 1.67% SD 2.34% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/80 (1%) 0/49 (0%) 0/51 (0%) 2/80 (3%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/330 (0.91%) Mean 0.88% SD 1.61% Total 3/329 (0.91%) Mean 0.75% SD 1.17% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/80 (1%) 1/49 (2%) 0/51 (0%) 2/80 (3%) 1/49 (2%) 3/50 (6%) | | 4/50 (8%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/330 (2.12%) Mean 2.22% SD 2.98% Total 8/329 (2.43%) Mean 2.42% SD 2.33% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Chemodectoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibroma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Hemangiosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Osteosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 345 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Yolk Sac Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 3/330 (0.91%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/331 (0.3%) Mean 0.33% SD 0.82% Total 3/330 (0.91%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Benign 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Adamantinoma Malignant 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Fibrosarcoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Urethra: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/79 (0%) 0/42 (0%) 0/51 (0%) 0/80 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/320 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/79 (0%) 0/42 (0%) 0/51 (0%) 0/80 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/320 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyoma 0/79 (0%) 1/42 (2%) 0/51 (0%) 0/80 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/320 (0.31%) Mean 0.4% SD 0.97% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/79 (0%) 0/42 (0%) 0/51 (0%) 0/80 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/320 (0%) Mean 0% SD 0% Total 0/324 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/79 (0%) 0/42 (0%) 0/51 (0%) 0/80 (0%) 0/45 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/320 (0%) Mean 0% SD 0% Total 0/324 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibroma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Fibrosarcoma 1/80 (1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Granular Cell Tumor Malignant 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 12/80 (15%) 13/50 (26%) 10/50 (20%) | | 11/50 (22%) 7/50 (14%) 4/50 (8%) | | Overall Incidence Total 57/330 (17.27%) Mean 17.5% SD 6.44% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 348 Version: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 12/80 (15%) 13/50 (26%) 10/50 (20%) | | 11/50 (22%) 7/50 (14%) 5/50 (10%) | | Overall Incidence Total 58/330 (17.58%) Mean 17.83% SD 5.88% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma NOS 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Squamous Cell Carcinoma 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Fibrosarcoma 1/80 (1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 1/80 (1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.21% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Polyp 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/80 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Schwannoma Malignant 0/80 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/330 (0%) 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: 11/12/97 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 15-OCT-1997 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (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 0/331 (0%) Mean 0% SD 0% Total 1/330 (0.3%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 3/80 (4%) 0/50 (0%) 1/51 (2%) 1/80 (1%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/331 (1.81%) Mean 1.62% SD 1.43% Total 4/330 (1.21%) Mean 1.21% SD 1.6% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 3/80 (4%) 0/50 (0%) 1/51 (2%) 1/80 (1%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/331 (1.81%) Mean 1.62% SD 1.43% Total 5/330 (1.52%) Mean 1.54% SD 1.5% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Squamous Cell Papilloma 0/80 (0%) 0/50 (0%) 0/51 (0%) 0/80 (0%) 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 0/331 (0%) Mean 0% SD 0% Total 0/330 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________