Toxicology Data Management System Page: 1 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 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 058812206 06/25/97 727 50(3) 26 (667) 483.6 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805005 10/30/95 729 50(3) 25 (665) 488.4 METHACRYLONITRILE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058812206 06/25/97 728 50(5) 30 (672) 327.2 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805005 10/30/95 731 50(5) 38 (710) 315.4 METHACRYLONITRILE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 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 058813803 08/16/99 729 50(3) 22 (681) 501.7 BENZOPHENONE | |BATTELLE COLUMBUS 055634803 06/06/96 726 100(3) 52 (681) 492.7 CITRAL | |BATTELLE COLUMBUS 058812003 12/18/95 729 50(3) 24 (659) 496.8 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611103 09/08/97 731 100(3) 60 (689) 492.1 TRANS-CINNAMALDEHYDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058813803 08/16/99 729 50(5) 32 (688) 348.7 BENZOPHENONE | |BATTELLE COLUMBUS 055634803 06/06/96 732 100(5) 75 (705) 335.2 CITRAL | |BATTELLE COLUMBUS 058812003 12/18/95 730 50(5) 36 (694) 330.5 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611103 09/08/97 735 100(5) 70 (706) 344.4 TRANS-CINNAMALDEHYDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 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 058803105 03/31/97 729 50(3) 23 (662) 519.6 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800705 08/14/95 729 50(3) 29 (665) 502.2 SODIUM NITRITE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058803105 03/31/97 729 50(5) 30 (683) 350.8 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800705 08/14/95 730 50(5) 33 (695) 350.1 SODIUM NITRITE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 4 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 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 059302607 08/14/97 733 50( ) 28 (684) 506.2 DECALIN | |BATTELLE NORTHWEST 058800405 09/13/99 729 50( ) 31 (686) 519.5 DIVINYLBENZENE | |BATTELLE NORTHWEST 058812403 01/18/96 733 50( ) 27 (667) 501.0 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 733 49( ) 24 (681) 507.1 NAPHTHALENE | |BATTELLE NORTHWEST 059000407 10/06/97 729 50( ) 27 (675) 540.3 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600105 01/18/99 729 50( ) 29 (701) 534.2 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142707 01/06/97 729 50( ) 20 (668) 518.0 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302607 08/14/97 734 50( ) 32 (700) 345.9 DECALIN | |BATTELLE NORTHWEST 058800405 09/13/99 731 50( ) 33 (679) 355.3 DIVINYLBENZENE | |BATTELLE NORTHWEST 058812403 01/18/96 735 50( ) 34 (682) 337.2 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 734 49( ) 28 (700) 325.2 NAPHTHALENE | |BATTELLE NORTHWEST 059000407 10/06/97 730 50( ) 33 (675) 366.9 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600105 01/18/99 730 50( ) 36 (696) 362.8 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142707 01/06/97 731 50( ) 33 (688) 351.1 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 5 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 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 TOXICOLOGY059700601T 05/25/00 726 50( ) 32 (693) 529.3 METHYL ISOBUTYL KETONE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE TOXICOLOGY059700601T 05/25/00 727 50( ) 35 (694) 365.6 METHYL ISOBUTYL KETONE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 6 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 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 | |________________________________________________________________________________________________________________________________| | | |IITRI 058902905 09/26/94 736 100(5) 57 (692) 498.3 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902905 09/26/94 737 100(5) 59 (692) 338.0 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 7 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 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 | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302306 07/11/97 729 50(3) 37 (693) 510.6 2,4-HEXADIENAL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302306 07/11/97 732 50(5) 37 (699) 314.6 2,4-HEXADIENAL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 8 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 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 | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050516105 03/06/96 729 50(5) 33 (683) 322.1 RIDDELLIINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 9 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 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 | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059201205 07/15/98 729 50(3) 35 (704) 446.9 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 059201305 01/20/00 730 50(3) 31 (702) 448.0 4-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520308 02/08/96 729 60(3) 39 (698) 447.3 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520507 11/28/95 729 50(3) 31 (697) 443.8 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059201205 07/15/98 734 50(5) 40 (707) 320.6 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 059201305 01/20/00 735 50(5) 40 (702) 311.3 4-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520308 02/08/96 730 60(5) 47 (713) 299.3 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520507 11/28/95 729 50(5) 39 (702) 295.2 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 10 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 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 | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059601003 09/16/98 729 50(3) 36 (687) 514.1 SODIUM DICHLORATE | |SOUTHERN RESEARCH 059601803 12/15/98 729 50(3) 29 (682) 511.6 BROMODICHLOROMETHANE | |SOUTHERN RESEARCH 059601705 03/08/00 729 50(3) 34 (683) 522.9 DIBROMOACETIC ACID | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059601003 09/16/98 734 50(5) 37 (699) 341.7 SODIUM DICHLORATE | |SOUTHERN RESEARCH 059601705 03/08/00 734 50(5) 35 (693) 350.5 DIBROMOACETIC ACID | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 11 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 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 | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302007 04/24/00 729 50(1) 20 (670) 484.2 DIISOPROPYLCARBODIIMIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302007 04/24/00 731 50(1) 30 (672) 319.5 DIISOPROPYLCARBODIIMIDE | |________________________________________________________________________________________________________________________________| This page intentionally left blank Toxicology Data Management System Page: 13 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 47/50 (94%) 37/50 (74%) 35/50 (70%) | | Overall Incidence Total 96/100 (96%) Mean 96% SD 2.83% Total 72/100 (72%) Mean 72% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 29/50 (58%) 29/50 (58%) 12/50 (24%) 26/50 (52%) | | Overall Incidence Total 58/100 (58%) Mean 58% SD 0% Total 38/100 (38%) Mean 38% SD 19.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 42/50 (84%) 45/50 (90%) | | Overall Incidence Total 98/100 (98%) Mean 98% SD 0% Total 87/100 (87%) Mean 87% SD 4.24% | __________________________________________________________________________________________________________________________________ |#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%) 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: | | Hemangiosarcoma or Hemangioma 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: | | 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: Lymphocytic, Monocytic, 15/50 (30%) 20/50 (40%) 7/50 (14%) 21/50 (42%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 35/100 (35%) Mean 35% SD 7.07% Total 28/100 (28%) Mean 28% SD 19.8% | __________________________________________________________________________________________________________________________________ |#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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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%) 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: | | Osteosarcoma or Osteoma 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*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 7/50 (14%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 10/100 (10%) Mean 10% SD 5.66% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |*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 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 4/50 (8%) 3/50 (6%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 11/100 (11%) Mean 11% SD 4.24% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | 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: | | Chordoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 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 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 0/50 (0%) 0/50 (0%) 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: | | 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%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/49 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 5/99 (5.05%) Mean 5.04% SD 1.36% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 2/50 (4%) 3/50 (6%) 3/50 (6%) 3/49 (6%) | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 6/99 (6.06%) Mean 6.06% SD 0.09% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 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: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | 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% | __________________________________________________________________________________________________________________________________ |#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 0/50 (0%) 0/50 (0%) 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% | __________________________________________________________________________________________________________________________________ |*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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | 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 | | 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 | | 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 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% 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 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 | | 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 | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | 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 | | 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: 18 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 0/50 (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% | __________________________________________________________________________________________________________________________________ |*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%) 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% | __________________________________________________________________________________________________________________________________ |*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%) 0/50 (0%) 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 0/50 (0%) 0/50 (0%) 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%) 0/50 (0%) 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 | | 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% | __________________________________________________________________________________________________________________________________ |*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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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 | | 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: | | Hepatocellular 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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 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 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% 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: 20 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*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: | | 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% | __________________________________________________________________________________________________________________________________ |*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, Mesenteric: | | 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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | 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: | | Adenoma 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 2/50 (4%) 15/50 (30%) 21/50 (42%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 36/100 (36%) Mean 36% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 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: 21 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 4/50 (8%) 2/50 (4%) 15/50 (30%) 21/50 (42%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 36/100 (36%) Mean 36% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 2/50 (4%) 16/50 (32%) 23/50 (46%) | | or Adenoma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 39/100 (39%) Mean 39% SD 9.9% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 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% | __________________________________________________________________________________________________________________________________ |*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: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | 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): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | 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% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 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 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 1/50 (2%) | | Malignant, NOS | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 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: 23 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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: | | Thecoma Malignant 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%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*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%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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% | __________________________________________________________________________________________________________________________________ |*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 0/46 (0%) 0/46 (0%) 1/46 (2%) 1/48 (2%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 2/94 (2.13%) Mean 2.13% SD 0.06% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | 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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 19/50 (38%) 17/50 (34%) 21/50 (42%) 12/50 (24%) | | Adenoma | | Overall Incidence Total 36/100 (36%) Mean 36% SD 2.83% Total 33/100 (33%) Mean 33% SD 12.73% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 20/50 (40%) 17/50 (34%) 21/50 (42%) 13/50 (26%) | | Carcinoma or Adenoma | | Overall Incidence Total 37/100 (37%) Mean 37% SD 4.24% Total 34/100 (34%) Mean 34% SD 11.31% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | 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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | 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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or 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% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | 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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | 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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | 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% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 25 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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%) 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 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: 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 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 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Basosquamous Tumor Benign | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 26 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |#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: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 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 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 27 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% 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 1/50 (2%) 3/50 (6%) 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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: | | Myxoma 0/50 (0%) 0/50 (0%) 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: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | 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 or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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% | __________________________________________________________________________________________________________________________________ |#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: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 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: | | 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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 44/50 (88%) 40/50 (80%) | | Overall Incidence Total 84/100 (84%) Mean 84% SD 5.66% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 30 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 8/50 (16%) 9/50 (18%) 11/50 (22%) 3/50 (6%) | | Overall Incidence Total 17/100 (17%) Mean 17% SD 1.41% Total 14/100 (14%) Mean 14% SD 11.31% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 10/50 (20%) 10/50 (20%) 11/50 (22%) 5/50 (10%) | | Overall Incidence Total 20/100 (20%) Mean 20% SD 0% Total 16/100 (16%) Mean 16% SD 8.49% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 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% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/100 (2%) Mean 2% 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: | | 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: 31 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | 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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | 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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | 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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | 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: 32 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 0% | __________________________________________________________________________________________________________________________________ |#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 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 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: | | Sarcoma 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: 33 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 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% | __________________________________________________________________________________________________________________________________ *: 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: 35 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 97/100(97%) 42/50 (84%) 42/50 (84%) 78/100(78%) 37/50 (74%) | | 99/100(99%) 78/100(78%) | | Overall Incidence Total 287/300 (95.67%)Mean 94.5% SD 7.05% Total 235/300 (78.33%) Mean 78.5% SD 4.12% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 33/50 (66%) 76/100(76%) 34/50 (68%) 20/50 (40%) 30/100(30%) 16/50 (32%) | | 57/100(57%) 39/100(39%) | | Overall Incidence Total 200/300 (66.67%)Mean 66.75% SD 7.8% Total 105/300 (35%) Mean 35.25% SD 4.99% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 99/100(99%) 49/50 (98%) 46/50 (92%) 92/100(92%) 43/50 (86%) | | 100/100(100%) 92/100(92%) | | Overall Incidence Total 298/300 (99.33%)Mean 99.25% SD 0.96% Total 273/300 (91%) Mean 90.5% SD 3% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.75% SD 0.96% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 27/50 (54%) 68/100(68%) 27/50 (54%) 19/50 (38%) 24/100(24%) 8/50 (16%) | | Mononuclear, or Undifferentiated 40/100(40%) 21/100(21%) | | Overall Incidence Total 162/300 (54%) Mean 54% SD 11.43% Total 72/300 (24%) Mean 24.75% SD 9.43% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/100(0%) 1/100(1%) | | Undifferentiated Cell Type | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/300 (0.67%) Mean 0.5% SD 0.58% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 36 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 4/100(4%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | NOS 5/100(5%) 0/100(0%) | | Overall Incidence Total 13/300 (4.33%) Mean 4.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 4/100(4%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 5/100(5%) 0/100(0%) | | Overall Incidence Total 13/300 (4.33%) Mean 4.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 2/100(2%) 2/50 (4%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 1% Total 5/300 (1.67%) Mean 1.75% SD 1.71% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 8/50 (16%) 10/100(10%) 4/50 (8%) 0/50 (0%) 3/99 (3%) 2/50 (4%) | | 5/100(5%) 1/100(1%) | | Overall Incidence Total 27/300 (9%) Mean 9.75% SD 4.65% Total 6/299 (2.01%) Mean 2.01% SD 1.83% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 2/100(2%) | | Overall Incidence Total 2/300 (0.67%) Mean 1% SD 2% Total 2/299 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 8/50 (16%) 11/100(11%) 6/50 (12%) 0/50 (0%) 3/99 (3%) 2/50 (4%) | | Complex, Malignant, NOS 5/100(5%) 4/100(4%) | | Overall Incidence Total 30/300 (10%) Mean 11% SD 4.55% Total 9/299 (3.01%) Mean 2.76% SD 1.89% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/300 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | Astrocytoma 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 2/300 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 7/100(7%) 3/50 (6%) 3/50 (6%) 15/98 (15%) 1/47 (2%) | | 7/100(7%) 4/99 (4%) | | Overall Incidence Total 17/300 (5.67%) Mean 5% SD 3.37% Total 23/294 (7.82%) Mean 6.87% SD 5.84% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 1/100(1%) 0/50 (0%) 1/50 (2%) 1/98 (1%) 0/47 (0%) | | 4/100(4%) 9/99 (9%) | | Overall Incidence Total 6/300 (2%) Mean 1.75% SD 1.71% Total 11/294 (3.74%) Mean 3.03% SD 4.12% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 1/50 (2%) 8/100(8%) 3/50 (6%) 4/50 (8%) 16/98 (16%) 1/47 (2%) | | 11/100(11%) 13/99 (13%) | | Overall Incidence Total 23/300 (7.67%) Mean 6.75% SD 3.77% Total 34/294 (11.56%) Mean 9.9% SD 6.21% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/294 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/294 (0.34%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 1/100(1%) 0/50 (0%) | | 2/100(2%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 1.15% Total 2/300 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% 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: 41 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 3/99 (3%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 2/100(2%) 0/100(0%) | | Overall Incidence Total 6/299 (2.01%) Mean 1.76% SD 1.27% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/99 (0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 2/100(2%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.5% SD 1% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 3/99 (3%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 2/100(2%) 2/100(2%) | | Overall Incidence Total 7/299 (2.34%) Mean 2.26% SD 0.52% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 42 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% 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: 43 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 2/100(2%) 0/100(0%) | | Overall Incidence Total 4/300 (1.33%) Mean 1.5% SD 1.91% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 1% SD 2% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Hepatoblastoma 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 1% SD 2% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 2/50 (4%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Hepatocellular Adenoma 2/100(2%) 0/100(0%) | | Overall Incidence Total 6/300 (2%) Mean 2.5% SD 1.91% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 2/50 (4%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Hepatocellular Adenoma, or 2/100(2%) 0/100(0%) | | Hepatoblastoma | | Overall Incidence Total 6/300 (2%) Mean 2.5% SD 1.91% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 4/50 (8%) 3/100(3%) 2/50 (4%) 4/50 (8%) 2/100(2%) 0/50 (0%) | | 4/100(4%) 6/100(6%) | | Overall Incidence Total 13/300 (4.33%) Mean 4.75% SD 2.22% Total 12/300 (4%) Mean 4% SD 3.65% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 1/100(1%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 2/300 (0.67%) Mean 0.5% SD 0.58% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 4/50 (8%) 3/100(3%) 2/50 (4%) 4/50 (8%) 3/100(3%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 5/100(5%) 7/100(7%) | | Overall Incidence Total 14/300 (4.67%) Mean 5% SD 2.16% Total 14/300 (4.67%) Mean 4.5% SD 3.7% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% 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: 44 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 2/50 (4%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 4/300 (1.33%) Mean 1.75% SD 1.71% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 1% Total 2/300 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 3/100(3%) 0/50 (0%) 2/50 (4%) 0/100(0%) 2/50 (4%) | | 0/100(0%) 2/100(2%) | | Overall Incidence Total 3/300 (1%) Mean 0.75% SD 1.5% Total 6/300 (2%) Mean 2.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 8/100(8%) 3/50 (6%) 27/50 (54%) 53/100(53%) 15/50 (30%) | | 3/100(3%) 55/100(55%) | | Overall Incidence Total 16/300 (5.33%) Mean 5.25% SD 2.22% Total 150/300 (50%) Mean 48% SD 12.03% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 45 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 9/100(9%) 3/50 (6%) 28/50 (56%) 53/100(53%) 16/50 (32%) | | 3/100(3%) 55/100(55%) | | Overall Incidence Total 17/300 (5.67%) Mean 5.5% SD 2.65% Total 152/300 (50.67%) Mean 49% SD 11.4% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 11/100(11%) 3/50 (6%) 28/50 (56%) 53/100(53%) 16/50 (32%) | | or Adenoma 3/100(3%) 56/100(56%) | | Overall Incidence Total 19/300 (6.33%) Mean 6% SD 3.56% Total 153/300 (51%) Mean 49.25% SD 11.59% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 46 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 0.58% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 2/100(2%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 2/100(2%) 0/100(0%) | | Overall Incidence Total 5/300 (1.67%) Mean 1.5% SD 1% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 0.58% 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: 47 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/100(0%) 0/50 (0%) | | Malignant, NOS 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 48 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 0.75% SD 0.96% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 0.75% SD 0.96% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.75% SD 0.96% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/93 (0%) 0/46 (0%) 0/47 (0%) 2/86 (2%) 0/45 (0%) | | 0/92 (0%) 0/90 (0%) | | Overall Incidence Total 0/280 (0%) Mean 0% SD 0% Total 2/268 (0.75%) Mean 0.58% SD 1.16% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 10/50 (20%) 17/100(17%) 11/50 (22%) 17/50 (34%) 29/100(29%) 23/50 (46%) | | Adenoma 21/100(21%) 35/100(35%) | | Overall Incidence Total 59/300 (19.67%) Mean 20% SD 2.16% Total 104/300 (34.67%) Mean 36% SD 7.16% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 10/50 (20%) 17/100(17%) 11/50 (22%) 17/50 (34%) 29/100(29%) 23/50 (46%) | | Carcinoma or Adenoma 21/100(21%) 35/100(35%) | | Overall Incidence Total 59/300 (19.67%) Mean 20% SD 2.16% Total 104/300 (34.67%) Mean 36% SD 7.16% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 49 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 2/300 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 4/100(4%) | | Overall Incidence Total 4/300 (1.33%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 4/100(4%) | | Overall Incidence Total 4/300 (1.33%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/49 (2%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 3/299 (1%) Mean 1.51% SD 1.92% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 50 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% 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: 51 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Basosquamous Tumor Benign 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 2/100(2%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Tumor Benign, or 2/100(2%) 0/100(0%) | | Trichoepithelioma | | Overall Incidence Total 6/300 (2%) Mean 2% SD 1.63% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 1/100(1%) 0/100(0%) | | NOS) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 2/100(2%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 3/100(3%) 0/100(0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 7/300 (2.33%) Mean 2.25% SD 1.71% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 11/50 (22%) 11/100(11%) 6/50 (12%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 8/100(8%) 0/100(0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 36/300 (12%) Mean 13.25% SD 6.08% Total 4/300 (1.33%) Mean 1.75% SD 2.87% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% 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: 52 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 10/50 (20%) 8/100(8%) 3/50 (6%) 3/50 (6%) 0/100(0%) 0/50 (0%) | | 5/100(5%) 0/100(0%) | | Overall Incidence Total 26/300 (8.67%) Mean 9.75% SD 6.95% Total 3/300 (1%) Mean 1.5% SD 3% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 2/100(2%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 3/300 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 1/100(1%) 0/100(0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1.25% SD 0.96% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1.25% SD 0.96% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 53 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/50 (22%) 9/100(9%) 4/50 (8%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | Papilloma, Squamous Cell 5/100(5%) 0/100(0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 29/300 (9.67%) Mean 11% SD 7.53% Total 4/300 (1.33%) Mean 1.75% SD 2.87% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/50 (22%) 9/100(9%) 4/50 (8%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 5/100(5%) 0/100(0%) | | Overall Incidence Total 29/300 (9.67%) Mean 11% SD 7.53% Total 4/300 (1.33%) Mean 1.75% SD 2.87% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 5/50 (10%) 2/100(2%) 2/50 (4%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | 7/100(7%) 1/100(1%) | | Overall Incidence Total 16/300 (5.33%) Mean 5.75% SD 3.5% Total 5/300 (1.67%) Mean 2% SD 2.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 6/50 (12%) 8/100(8%) 4/50 (8%) 4/50 (8%) 1/100(1%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 12/100(12%) 1/100(1%) | | Histiocytoma | | Overall Incidence Total 30/300 (10%) Mean 10% SD 2.31% Total 7/300 (2.33%) Mean 3% SD 3.37% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 2/100(2%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) | | 6/100(6%) 0/100(0%) | | Overall Incidence Total 8/300 (2.67%) Mean 2% SD 2.83% Total 2/300 (0.67%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 5/100(5%) 2/50 (4%) 1/50 (2%) 0/100(0%) 1/50 (2%) | | Myxosarcoma, or Fibrous 6/100(6%) 0/100(0%) | | Histiocytoma | | Overall Incidence Total 14/300 (4.67%) Mean 4.25% SD 1.71% Total 2/300 (0.67%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 1/50 (2%) 2/100(2%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 4/300 (1.33%) Mean 1.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 54 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | (malignant or NOS) 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/100(0%) 0/100(0%) | | or NOS) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.75% SD 0.96% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.5% SD 1% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 55 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Papilloma Squamous 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 96/100(96%) 41/50 (82%) | | 91/100(91%) | | Overall Incidence Total 273/300 (91%) Mean 89.75% SD 5.8% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 0/87 (0%) 0/92 (0%) | | Overall Incidence Total 0/278 (0%) Mean 0% SD 0% Total 0/284 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 56 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 1/87 (1%) 0/92 (0%) | | Overall Incidence Total 1/278 (0.36%) Mean 0.29% SD 0.57% Total 0/284 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 0/87 (0%) 1/92 (1%) | | Overall Incidence Total 0/278 (0%) Mean 0% SD 0% Total 1/284 (0.35%) Mean 0.27% SD 0.54% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 1/87 (1%) 1/92 (1%) | | Overall Incidence Total 1/278 (0.36%) Mean 0.29% SD 0.57% Total 1/284 (0.35%) Mean 0.27% SD 0.54% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 10/50 (20%) 12/100(12%) 8/50 (16%) 4/50 (8%) 21/100(21%) 5/50 (10%) | | 12/100(12%) 11/100(11%) | | Overall Incidence Total 42/300 (14%) Mean 15% SD 3.83% Total 41/300 (13.67%) Mean 12.5% SD 5.8% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 4/100(4%) 0/50 (0%) 0/50 (0%) 0/100(0%) 2/50 (4%) | | 3/100(3%) 3/100(3%) | | Overall Incidence Total 8/300 (2.67%) Mean 2.25% SD 1.71% Total 5/300 (1.67%) Mean 1.75% SD 2.06% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 11/50 (22%) 16/100(16%) 8/50 (16%) 4/50 (8%) 21/100(21%) 7/50 (14%) | | 15/100(15%) 14/100(14%) | | Overall Incidence Total 50/300 (16.67%) Mean 17.25% SD 3.2% Total 46/300 (15.33%) Mean 14.25% SD 5.32% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 3/100(3%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 1/100(1%) 1/100(1%) | | Overall Incidence Total 6/300 (2%) Mean 2% SD 1.83% Total 2/300 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 3/100(3%) 0/100(0%) | | Overall Incidence Total 4/300 (1.33%) Mean 1% SD 1.41% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 4/100(4%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) | | 4/100(4%) 1/100(1%) | | Overall Incidence Total 10/300 (3.33%) Mean 3% SD 2% Total 3/300 (1%) Mean 1% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 57 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma Squamous 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 58 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 6/50 (12%) 19/100(19%) 10/50 (20%) | | 14/100(14%) | | Overall Incidence Total 49/300 (16.33%) Mean 16.25% SD 3.86% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 59 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 6/50 (12%) 19/100(19%) 11/50 (22%) | | 14/100(14%) | | Overall Incidence Total 50/300 (16.67%) Mean 16.75% SD 4.57% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.75% SD 0.96% Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 2/300 (0.67%) Mean 0.75% SD 0.96% Total 1/300 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ *: 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: 61 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 47/50 (94%) 44/50 (88%) 42/50 (84%) | | Overall Incidence Total 94/100 (94%) Mean 94% SD 0% Total 86/100 (86%) Mean 86% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 35/50 (70%) 30/50 (60%) 25/50 (50%) 23/50 (46%) | | Overall Incidence Total 65/100 (65%) Mean 65% SD 7.07% Total 48/100 (48%) Mean 48% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 50/50 (100%) 45/50 (90%) | | Overall Incidence Total 98/100 (98%) Mean 98% SD 0% Total 95/100 (95%) Mean 95% SD 7.07% | __________________________________________________________________________________________________________________________________ |#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%) 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 or 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: | | 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: Lymphocytic, Monocytic, 16/50 (32%) 17/50 (34%) 10/50 (20%) 15/50 (30%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 33/100 (33%) Mean 33% SD 1.41% Total 25/100 (25%) Mean 25% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 9/100 (9%) Mean 9% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/100 (9%) Mean 9% SD 4.24% 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: 62 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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%) 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: | | Osteosarcoma or Osteoma 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% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/47 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 4/47 (9%) 6/50 (12%) 0/49 (0%) 4/50 (8%) | | Overall Incidence Total 10/97 (10.31%) Mean 10.26% SD 2.47% Total 4/99 (4.04%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 5/47 (11%) 1/50 (2%) 2/49 (4%) 0/50 (0%) | | Overall Incidence Total 6/97 (6.19%) Mean 6.32% SD 6.11% Total 2/99 (2.02%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 9/47 (19%) 7/50 (14%) 2/49 (4%) 4/50 (8%) | | Complex, Malignant, NOS | | Overall Incidence Total 16/97 (16.49%) Mean 16.57% SD 3.64% Total 6/99 (6.06%) Mean 6.04% SD 2.77% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | 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: | | 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: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 63 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 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 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 0/50 (0%) 0/50 (0%) 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: | | 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, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 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% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 3/50 (6%) 0/50 (0%) 6/48 (13%) 8/46 (17%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 14/94 (14.89%) Mean 14.95% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/50 (6%) 5/50 (10%) 5/48 (10%) 2/46 (4%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 7/94 (7.45%) Mean 7.38% SD 4.29% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 6/50 (12%) 5/50 (10%) 10/48 (21%) 10/46 (22%) | | Overall Incidence Total 11/100 (11%) Mean 11% SD 1.41% Total 20/94 (21.28%) Mean 21.29% SD 0.64% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 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: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | 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% | __________________________________________________________________________________________________________________________________ |#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 0/50 (0%) 0/50 (0%) 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% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% 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: 65 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | 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 | | 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 | | 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 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 | | 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 | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | 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 | | 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: 66 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/44 (5%) 4/50 (8%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 6/94 (6.38%) Mean 6.27% SD 2.44% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/44 (0%) 1/50 (2%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1% SD 1.41% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/44 (5%) 5/50 (10%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 7/94 (7.45%) Mean 7.27% SD 3.86% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (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: 67 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (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: | | Hepatocellular 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular 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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | 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 Adenoma 2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 0/50 (0%) 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: 68 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 4/100 (4%) Mean 4% 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: | | 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% | __________________________________________________________________________________________________________________________________ |*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, Mesenteric: | | 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, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | 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: | | Adenoma 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 5/100 (5%) Mean 5% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 6/100 (6%) Mean 6% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 1/50 (2%) 3/50 (6%) 36/50 (72%) 21/50 (42%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 57/100 (57%) Mean 57% SD 21.21% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 69 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 1/50 (2%) 3/50 (6%) 36/50 (72%) 23/50 (46%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 59/100 (59%) Mean 59% SD 18.38% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 1/50 (2%) 3/50 (6%) 37/50 (74%) 23/50 (46%) | | or Adenoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 60/100 (60%) Mean 60% SD 19.8% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | 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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 70 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 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% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | 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% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 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 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%) | | Malignant, NOS | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 71 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 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 0/44 (0%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 1/44 (2%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1.14% SD 1.61% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/44 (2%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1.14% SD 1.61% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/44 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 2/44 (5%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 2/94 (2.13%) Mean 2.27% SD 3.21% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 1/45 (2%) 0/45 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 1/90 (1.11%) Mean 1.11% SD 1.57% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | 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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/47 (32%) 13/50 (26%) 20/48 (42%) 24/50 (48%) | | Adenoma | | Overall Incidence Total 28/97 (28.87%) Mean 28.96% SD 4.18% Total 44/98 (44.9%) Mean 44.83% SD 4.48% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 72 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/47 (32%) 13/50 (26%) 21/48 (44%) 24/50 (48%) | | Carcinoma or Adenoma | | Overall Incidence Total 28/97 (28.87%) Mean 28.96% SD 4.18% Total 45/98 (45.92%) Mean 45.88% SD 3.01% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 73 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | 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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 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: 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 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 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 74 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#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: | | Hemangiopericytoma 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: | | 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 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 75 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | 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: | | Squamous Cell Papilloma or 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 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: | | Fibroma 6/50 (12%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 8.49% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 76 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 9/50 (18%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 10/100 (10%) Mean 10% SD 11.31% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 4/100 (4%) Mean 4% 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: | | Myxoma 0/50 (0%) 0/50 (0%) 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: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | 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 or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 77 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/43 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/93 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/43 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/93 (0%) Mean 0% SD 0% Total 0/98 (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: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 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% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | 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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 47/50 (94%) | | Overall Incidence Total 92/100 (92%) Mean 92% SD 2.83% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 78 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/39 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/39 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/39 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/39 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/42 (10%) 12/50 (24%) 6/45 (13%) 7/50 (14%) | | Overall Incidence Total 16/92 (17.39%) Mean 16.76% SD 10.24% Total 13/95 (13.68%) Mean 13.67% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/42 (5%) 2/50 (4%) 1/45 (2%) 2/50 (4%) | | Overall Incidence Total 4/92 (4.35%) Mean 4.38% SD 0.54% Total 3/95 (3.16%) Mean 3.11% SD 1.26% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 6/42 (14%) 14/50 (28%) 7/45 (16%) 9/50 (18%) | | Overall Incidence Total 20/92 (21.74%) Mean 21.14% SD 9.7% Total 16/95 (16.84%) Mean 16.78% SD 1.73% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/42 (2%) 1/50 (2%) 0/45 (0%) 1/50 (2%) | | Overall Incidence Total 2/92 (2.17%) Mean 2.19% SD 0.27% Total 1/95 (1.05%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/42 (0%) 1/50 (2%) 1/45 (2%) 1/50 (2%) | | Overall Incidence Total 1/92 (1.09%) Mean 1% SD 1.41% Total 2/95 (2.11%) Mean 2.11% SD 0.16% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/42 (2%) 2/50 (4%) 1/45 (2%) 2/50 (4%) | | Overall Incidence Total 3/92 (3.26%) Mean 3.19% SD 1.14% Total 3/95 (3.16%) Mean 3.11% SD 1.26% | __________________________________________________________________________________________________________________________________ |#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: | | 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: 79 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | 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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/46 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/46 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.02% SD 1.44% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/46 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/46 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.02% SD 1.44% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 1/46 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.09% SD 1.54% 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: 80 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 8/50 (16%) 7/50 (14%) | | Overall Incidence Total 15/100 (15%) Mean 15% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 9/50 (18%) 7/50 (14%) | | Overall Incidence Total 16/100 (16%) Mean 16% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 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: | | Sarcoma 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: 81 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (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: 83 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 49/50 (98%) 47/50 (94%) 46/50 (92%) 43/50 (86%) 44/50 (88%) | | 46/49 (94%) 50/50 (100%) 50/50 (100%) 38/49 (78%) 41/50 (82%) 37/50 (74%) | | 48/50 (96%) 41/50 (82%) | | Overall Incidence Total 337/349 (96.56%)Mean 96.55% SD 2.78% Total 290/349 (83.09%) Mean 83.08% SD 6.16% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 27/50 (54%) 29/50 (58%) 26/50 (52%) 25/50 (50%) 17/50 (34%) 25/50 (50%) | | 34/49 (69%) 35/50 (70%) 33/50 (66%) 26/49 (53%) 33/50 (66%) 30/50 (60%) | | 28/50 (56%) 28/50 (56%) | | Overall Incidence Total 212/349 (60.74%)Mean 60.77% SD 7.53% Total 184/349 (52.72%) Mean 52.72% SD 10.05% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 50/50 (100%) 49/50 (98%) 49/50 (98%) 46/50 (92%) 49/50 (98%) | | 48/49 (98%) 50/50 (100%) 50/50 (100%) 44/49 (90%) 49/50 (98%) 44/50 (88%) | | 50/50 (100%) 47/50 (94%) | | Overall Incidence Total 346/349 (99.14%)Mean 99.14% SD 1.08% Total 328/349 (93.98%) Mean 93.97% SD 4.2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 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 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.77% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 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 1/349 (0.29%) Mean 0.29% SD 0.76% Total 2/349 (0.57%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 3/349 (0.86%) Mean 0.87% SD 1.6% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 3/349 (0.86%) Mean 0.86% SD 1.57% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 19/50 (38%) 22/50 (44%) 16/50 (32%) 11/50 (22%) 10/50 (20%) 14/50 (28%) | | Mononuclear, or Undifferentiated 26/49 (53%) 33/50 (66%) 25/50 (50%) 16/49 (33%) 24/50 (48%) 26/50 (52%) | | 22/50 (44%) 21/50 (42%) | | Overall Incidence Total 163/349 (46.7%) Mean 46.72% SD 11.03% Total 122/349 (34.96%) Mean 34.95% SD 12.62% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 84 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.58% SD 1.54% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS 2/49 (4%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 10/349 (2.87%) Mean 2.87% SD 1.58% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 8/349 (2.29%) Mean 2.29% SD 1.8% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/349 (2.58%) Mean 2.58% SD 1.9% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/349 (2.58%) Mean 2.58% SD 1.9% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 2/49 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/49 (4%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.58% SD 1.54% Total 4/346 (1.16%) Mean 1.17% SD 1.61% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 85 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 2/346 (0.58%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 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%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/49 (14%) 12/50 (24%) 10/50 (20%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | 4/49 (8%) 12/50 (24%) 5/50 (10%) 3/48 (6%) 2/49 (4%) 2/50 (4%) | | 4/50 (8%) 2/49 (4%) | | Overall Incidence Total 54/348 (15.52%) Mean 15.49% SD 7.15% Total 14/346 (4.05%) Mean 4.06% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 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%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 1/50 (2%) | | 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 8/348 (2.3%) Mean 2.3% SD 1.4% Total 1/346 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 8/49 (16%) 13/50 (26%) 10/50 (20%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Complex, Malignant, NOS 5/49 (10%) 14/50 (28%) 6/50 (12%) 3/48 (6%) 2/49 (4%) 3/50 (6%) | | 5/50 (10%) 2/49 (4%) | | Overall Incidence Total 61/348 (17.53%) Mean 17.5% SD 7.41% Total 15/346 (4.34%) Mean 4.34% SD 1.43% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 86 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/349 (2.58%) Mean 2.58% SD 1.9% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 9/349 (2.58%) Mean 2.58% SD 1.9% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/348 (0.29%) Mean 0.29% SD 0.76% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 87 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/49 (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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 1/347 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/348 (0.29%) Mean 0.29% SD 0.76% Total 1/347 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/48 (0%) 1/50 (2%) 8/48 (17%) 0/50 (0%) 5/49 (10%) | | 3/48 (6%) 1/50 (2%) 0/50 (0%) 4/49 (8%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 5/346 (1.45%) Mean 1.46% SD 2.31% Total 20/345 (5.8%) Mean 5.86% SD 6.16% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/48 (0%) 2/50 (4%) 1/48 (2%) 0/50 (0%) 0/49 (0%) | | 3/48 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/346 (1.73%) Mean 1.75% SD 2.5% Total 4/345 (1.16%) Mean 1.16% SD 1.59% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/48 (0%) 3/50 (6%) 9/48 (19%) 0/50 (0%) 5/49 (10%) | | 6/48 (13%) 2/50 (4%) 0/50 (0%) 4/49 (8%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 11/346 (3.18%) Mean 3.21% SD 4.76% Total 24/345 (6.96%) Mean 7.02% SD 6.24% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/346 (0%) Mean 0% SD 0% Total 0/345 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 88 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/346 (0%) Mean 0% SD 0% Total 0/345 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/346 (0%) Mean 0% SD 0% Total 0/345 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/346 (0%) Mean 0% SD 0% Total 0/345 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 89 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 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%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/348 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 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%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/348 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 90 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 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%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 91 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 5/50 (10%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 2/49 (4%) 4/50 (8%) 3/50 (6%) 1/49 (2%) 0/49 (0%) 1/49 (2%) | | 1/50 (2%) 1/49 (2%) | | Overall Incidence Total 19/349 (5.44%) Mean 5.44% SD 2.99% Total 6/346 (1.73%) Mean 1.73% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 4/50 (8%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 4/49 (8%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/49 (2%) 0/49 (0%) | | 1/50 (2%) 1/49 (2%) | | Overall Incidence Total 13/349 (3.72%) Mean 3.74% SD 3.18% Total 4/346 (1.16%) Mean 1.16% SD 1.09% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 7/50 (14%) 6/50 (12%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | 6/49 (12%) 4/50 (8%) 4/50 (8%) 2/49 (4%) 1/49 (2%) 1/49 (2%) | | 2/50 (4%) 2/49 (4%) | | Overall Incidence Total 32/349 (9.17%) Mean 9.18% SD 3.66% Total 10/346 (2.89%) Mean 2.89% SD 1.09% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.86% SD 1.08% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.86% SD 1.08% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.86% SD 1.07% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 92 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 1/346 (0.29%) Mean 0.3% SD 0.79% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/349 (1.15%) Mean 1.14% SD 1.07% Total 1/346 (0.29%) Mean 0.3% SD 0.79% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 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%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 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%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/346 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 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%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 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%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 93 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 4/349 (1.15%) Mean 1.15% SD 2.27% Total 2/347 (0.58%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.77% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.77% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma 2/49 (4%) 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/349 (1.43%) Mean 1.44% SD 2.52% Total 2/347 (0.58%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 2/49 (4%) 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | | Hepatoblastoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/349 (1.43%) Mean 1.44% SD 2.52% Total 2/347 (0.58%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 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%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 4/50 (8%) 0/49 (0%) | | Overall Incidence Total 14/349 (4.01%) Mean 4.01% SD 4.47% Total 2/347 (0.58%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 5/349 (1.43%) Mean 1.43% SD 0.98% Total 2/347 (0.58%) Mean 0.57% SD 0.98% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 94 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 1/50 (2%) 7/50 (14%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Alveolar/Bronchiolar Adenoma 2/49 (4%) 1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 4/50 (8%) 0/49 (0%) | | Overall Incidence Total 19/349 (5.44%) Mean 5.44% SD 4.27% Total 4/347 (1.15%) Mean 1.15% SD 1.58% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 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%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 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%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 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%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 95 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 5/50 (10%) 3/50 (6%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/49 (6%) 5/50 (10%) 4/50 (8%) | | 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.86% SD 1.08% Total 22/349 (6.3%) Mean 6.3% SD 3.54% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 5/50 (10%) 3/50 (6%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/49 (6%) 5/50 (10%) 4/50 (8%) | | 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 4/349 (1.15%) Mean 1.15% SD 1.58% Total 23/349 (6.59%) Mean 6.59% SD 3.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 1/50 (2%) 2/50 (4%) 25/50 (50%) 20/50 (40%) 20/50 (40%) | | 0/49 (0%) 2/50 (4%) 3/50 (6%) 17/49 (35%) 25/50 (50%) 19/50 (38%) | | 2/50 (4%) 16/50 (32%) | | Overall Incidence Total 12/349 (3.44%) Mean 3.43% SD 1.9% Total 142/349 (40.69%) Mean 40.67% SD 6.99% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 1/50 (2%) 2/50 (4%) 25/50 (50%) 20/50 (40%) 20/50 (40%) | | 0/49 (0%) 2/50 (4%) 3/50 (6%) 17/49 (35%) 25/50 (50%) 19/50 (38%) | | 2/50 (4%) 17/50 (34%) | | Overall Incidence Total 13/349 (3.72%) Mean 3.71% SD 2.14% Total 143/349 (40.97%) Mean 40.96% SD 6.6% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 1/50 (2%) 2/50 (4%) 29/50 (58%) 22/50 (44%) 20/50 (40%) | | or Adenoma 1/49 (2%) 2/50 (4%) 3/50 (6%) 18/49 (37%) 27/50 (54%) 23/50 (46%) | | 2/50 (4%) 19/50 (38%) | | Overall Incidence Total 15/349 (4.3%) Mean 4.29% SD 2.13% Total 158/349 (45.27%) Mean 45.25% SD 8.1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 96 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.77% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 97 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/49 (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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/347 (0.29%) Mean 0.29% SD 0.76% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/49 (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%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 1/347 (0.29%) Mean 0.29% SD 0.76% Total 1/347 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/347 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 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%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/347 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 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 2/349 (0.57%) Mean 0.57% SD 0.98% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 2/349 (0.57%) Mean 0.57% SD 1.51% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 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 2/349 (0.57%) Mean 0.57% SD 0.98% Total 3/349 (0.86%) Mean 0.86% SD 2.27% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 98 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.58% SD 1.54% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Malignant, NOS 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.87% SD 1.6% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.86% SD 1.08% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 99 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.58% SD 0.99% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.58% SD 0.99% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/46 (0%) 1/44 (2%) 0/49 (0%) 0/49 (0%) 0/40 (0%) | | 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/42 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/45 (0%) | | Overall Incidence Total 1/332 (0.3%) Mean 0.32% SD 0.86% Total 0/323 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 100 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) 36/50 (72%) 36/49 (73%) 34/50 (68%) 37/50 (74%) 30/50 (60%) | | Adenoma 31/49 (63%) 35/50 (70%) 38/50 (76%) 23/49 (47%) 30/49 (61%) 27/49 (55%) | | 35/50 (70%) 31/49 (63%) | | Overall Incidence Total 238/348 (68.39%)Mean 68.39% SD 7.48% Total 212/346 (61.27%) Mean 61.22% SD 8.72% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/348 (0.57%) Mean 0.58% SD 0.99% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) 36/50 (72%) 37/49 (76%) 34/50 (68%) 37/50 (74%) 30/50 (60%) | | Carcinoma or Adenoma 31/49 (63%) 35/50 (70%) 39/50 (78%) 23/49 (47%) 30/49 (61%) 27/49 (55%) | | 35/50 (70%) 31/49 (63%) | | Overall Incidence Total 240/348 (68.97%)Mean 68.97% SD 8.09% Total 212/346 (61.27%) Mean 61.22% SD 8.72% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/346 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 101 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 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%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/348 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 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%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/348 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 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%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/348 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 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%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/348 (0%) Mean 0% SD 0% Total 0/348 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 102 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/349 (1.72%) Mean 1.72% SD 2.14% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/349 (1.72%) Mean 1.72% SD 2.14% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 103 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 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 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.57% SD 0.98% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | NOS) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 2/349 (0.57%) Mean 0.57% SD 0.98% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 3/50 (6%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 4/49 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | | B), Basal Cell Adenoma, Adenoma, 5/50 (10%) 0/50 (0%) | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 19/349 (5.44%) Mean 5.45% SD 2.79% Total 4/349 (1.15%) Mean 1.15% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 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 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.77% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 4/49 (8%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 12/349 (3.44%) Mean 3.45% SD 3.45% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 8/349 (2.29%) Mean 2.29% SD 1.38% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 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%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 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%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 105 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Cell Carcinoma, Basosquamous 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 2/349 (0.57%) Mean 0.57% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/349 (1.43%) Mean 1.43% SD 0.98% Total 1/349 (0.29%) Mean 0.29% SD 0.77% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/349 (1.43%) Mean 1.43% SD 0.98% Total 1/349 (0.29%) Mean 0.29% SD 0.77% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell 4/49 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma or Keratoacanthoma 5/50 (10%) 0/50 (0%) | | Overall Incidence Total 17/349 (4.87%) Mean 4.88% SD 3.05% Total 3/349 (0.86%) Mean 0.86% SD 1.08% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 4/49 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | | 5/50 (10%) 0/50 (0%) | | Overall Incidence Total 17/349 (4.87%) Mean 4.88% SD 3.05% Total 2/349 (0.57%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 2/50 (4%) 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | 5/49 (10%) 2/50 (4%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 19/349 (5.44%) Mean 5.46% SD 3.26% Total 5/349 (1.43%) Mean 1.43% SD 2.23% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 4/50 (8%) 6/50 (12%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous 7/49 (14%) 3/50 (6%) 3/50 (6%) 1/49 (2%) 3/50 (6%) 0/50 (0%) | | Histiocytoma 6/50 (12%) 1/50 (2%) | | Overall Incidence Total 31/349 (8.88%) Mean 8.9% SD 3.87% Total 10/349 (2.87%) Mean 2.86% SD 2.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 106 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 8/349 (2.29%) Mean 2.3% SD 1.4% Total 2/349 (0.57%) Mean 0.57% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous 2/49 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 2/50 (4%) 0/50 (0%) | | Histiocytoma 4/50 (8%) 0/50 (0%) | | Overall Incidence Total 12/349 (3.44%) Mean 3.44% SD 2.23% Total 5/349 (1.43%) Mean 1.43% SD 1.9% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 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%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 3/349 (0.86%) Mean 0.86% SD 1.57% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 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%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 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 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | or NOS) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 107 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 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%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 2/349 (0.57%) Mean 0.58% SD 0.99% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 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%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 0/347 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 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%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% Total 1/347 (0.29%) Mean 0.29% SD 0.77% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 40/50 (80%) 38/50 (76%) 40/50 (80%) | | 38/49 (78%) 41/50 (82%) 41/50 (82%) | | 36/50 (72%) | | Overall Incidence Total 274/349 (78.51%)Mean 78.51% SD 3.61% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 109 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/337 (0%) Mean 0% SD 0% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 1/49 (2%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/337 (0.3%) Mean 0.29% SD 0.77% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 1/49 (2%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/337 (0.3%) Mean 0.29% SD 0.77% Total 0/325 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 7/50 (14%) 2/50 (4%) 5/49 (10%) 5/50 (10%) 0/50 (0%) 6/47 (13%) | | 9/46 (20%) 3/50 (6%) 7/50 (14%) 4/47 (9%) 8/49 (16%) 3/49 (6%) | | 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 34/345 (9.86%) Mean 9.97% SD 6.32% Total 28/342 (8.19%) Mean 8.25% SD 5.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 3/50 (6%) 1/50 (2%) 3/47 (6%) | | 1/46 (2%) 1/50 (2%) 2/50 (4%) 3/47 (6%) 2/49 (4%) 1/49 (2%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 6/345 (1.74%) Mean 1.74% SD 1.39% Total 14/342 (4.09%) Mean 4.13% SD 2.12% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 7/50 (14%) 3/50 (6%) 6/49 (12%) 8/50 (16%) 1/50 (2%) 8/47 (17%) | | 10/46 (22%) 4/50 (8%) 9/50 (18%) 7/47 (15%) 9/49 (18%) 4/49 (8%) | | 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 40/345 (11.59%) Mean 11.71% SD 6.91% Total 40/342 (11.7%) Mean 11.78% SD 6.33% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/345 (0.29%) Mean 0.29% SD 0.76% Total 0/342 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 110 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/47 (2%) | | 0/46 (0%) 1/50 (2%) 1/50 (2%) 1/47 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/345 (0.58%) Mean 0.57% SD 0.98% Total 4/342 (1.17%) Mean 1.18% SD 1.6% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/47 (2%) | | 0/46 (0%) 1/50 (2%) 1/50 (2%) 1/47 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/345 (0.87%) Mean 0.86% SD 1.07% Total 4/342 (1.17%) Mean 1.18% SD 1.6% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 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 0/349 (0%) Mean 0% SD 0% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 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 1/349 (0.29%) Mean 0.29% SD 0.76% Total 2/349 (0.57%) Mean 0.57% SD 1.51% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 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 1/349 (0.29%) Mean 0.29% SD 0.76% Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/347 (0%) Mean 0% SD 0% Total 1/345 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/48 (2%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 1/49 (2%) | | 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 1/347 (0.29%) Mean 0.3% SD 0.79% Total 3/345 (0.87%) Mean 0.87% SD 1.09% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/347 (0%) Mean 0% SD 0% Total 1/345 (0.29%) Mean 0.29% SD 0.77% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/48 (2%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/347 (0.29%) Mean 0.3% SD 0.79% Total 2/345 (0.58%) Mean 0.59% SD 1.01% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 112 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/347 (0%) Mean 0% SD 0% Total 0/345 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/50 (14%) 9/50 (18%) 10/50 (20%) | | 15/49 (31%) 5/50 (10%) 10/50 (20%) | | 6/50 (12%) | | Overall Incidence Total 62/349 (17.77%) Mean 17.8% SD 6.87% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 7/50 (14%) 9/50 (18%) 10/50 (20%) | | 15/49 (31%) 5/50 (10%) 11/50 (22%) | | 6/50 (12%) | | Overall Incidence Total 63/349 (18.05%) Mean 18.09% SD 7.01% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/349 (0.57%) Mean 0.57% SD 0.98% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 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 0/349 (0%) Mean 0% SD 0% Total 0/349 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 7/349 (2.01%) Mean 2.01% SD 1.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 114 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/349 (0.29%) Mean 0.29% SD 0.76% Total 7/349 (2.01%) Mean 2.01% SD 1.65% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 115 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 50/50 (100%) 44/50 (88%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 31/50 (62%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 46/50 (92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 25/50 (50%) 14/50 (28%) | | 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 | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 116 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 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 8/50 (16%) 3/50 (6%) | | 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, 8/50 (16%) 3/50 (6%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 117 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 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, Glioma, or 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 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: 118 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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: 119 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 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 | | 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 Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 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 | | 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: 120 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 4/50 (8%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 7/50 (14%) 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 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 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: 121 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 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: | | Hepatocellular Adenoma 1/50 (2%) 0/50 (0%) | | 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 | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/50 (2%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar 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: 122 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 0/50 (0%) 1/50 (2%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 123 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 26/50 (52%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 124 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 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 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca 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: 125 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/46 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 35/50 (70%) 24/49 (49%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 126 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/49 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 35/50 (70%) 24/49 (49%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 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 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 127 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 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 | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 128 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 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: 129 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 4/50 (8%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 130 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 5/50 (10%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma 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: 131 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 42/50 (84%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 132 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 1/50 (2%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 3/50 (6%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 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 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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: 133 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 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: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | 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: 134 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 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 | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 13/50 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 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: 135 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE TOXICOLOGY NORTHWEST Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 137 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 99/100(99%) 92/100(92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 66/100(66%) 40/100(40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 100/100(100%) 98/100(98%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 50/100(50%) 20/100(20%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/100(0%) 0/100(0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/100(4%) 0/100(0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/100(4%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 138 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/99 (0%) 6/100(6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/99 (0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/98 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 24/98 (24%) 7/96 (7%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/98 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/98 (2%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 26/98 (27%) 7/96 (7%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 139 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 1/100(1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 2/100(2%) 2/100(2%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 13/100(13%) 11/90 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 140 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 13/100(13%) 11/90 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 141 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 2/100(2%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 142 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/99 (3%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 1/99 (1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 4/99 (4%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 143 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 0/100(0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/100(1%) 0/100(0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/100(1%) 0/100(0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 3/100(3%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 144 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/100(3%) 4/100(4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/100(0%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/100(0%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 6/100(6%) 56/100(56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 145 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 6/100(6%) 56/100(56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 6/100(6%) 58/100(58%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 146 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/100(0%) 0/100(0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/100(0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 147 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 3/98 (3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 3/98 (3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/85 (0%) 1/88 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/98 (35%) 61/99 (62%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 148 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/98 (0%) 3/99 (3%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/98 (35%) 64/99 (65%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 149 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 3/100(3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 3/100(3%) 0/100(0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 3/100(3%) 0/100(0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 150 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/100(0%) 0/100(0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 3/100(3%) 0/100(0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 14/100(14%) 1/100(1%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 10/100(10%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 151 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) 0/100(0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/100(1%) 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/100(11%) 1/100(1%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/100(11%) 1/100(1%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 12/100(12%) 4/100(4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 152 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 13/100(13%) 6/100(6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/100(1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/100(1%) 2/100(2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/100(0%) 0/100(0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/100(0%) 0/100(0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 153 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/100(1%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 93/100(93%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 154 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/97 (0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 2/97 (2%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/97 (0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 2/97 (2%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 15/99 (15%) 15/100(15%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/99 (1%) 5/100(5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 16/99 (16%) 19/100(19%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/99 (1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/99 (1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 155 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/100(0%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/99 (1%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/99 (1%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 156 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 13/100(13%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 13/100(13%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 157 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 159 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 48/50 (96%) 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 21/50 (42%) 18/50 (36%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 47/50 (94%) | | 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 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 11/50 (22%) 10/50 (20%) | | 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, 4/50 (8%) 1/50 (2%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/50 (8%) 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: 160 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/50 (14%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 161 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 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, Glioma, or 0/50 (0%) 2/50 (4%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/49 (2%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/49 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 162 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 4/49 (8%) 7/50 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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: 163 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 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 | | 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 Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 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 | | 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: 164 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 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: 165 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 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: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) | | 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 | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar 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: 166 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 1/50 (2%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 3/50 (6%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 167 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 23/50 (46%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 5/50 (10%) 24/50 (48%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 1/50 (2%) | | 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, 1/50 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca 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: 169 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 12/50 (24%) 19/50 (38%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 170 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 12/50 (24%) 19/50 (38%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 2/49 (4%) | | 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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 171 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 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 | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | 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 1/50 (2%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 172 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 5/50 (10%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 3/50 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 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: 173 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 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 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 4/50 (8%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 174 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 7/50 (14%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma 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: 175 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 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 | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 41/50 (82%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 176 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/50 (8%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 5/50 (10%) 13/50 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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: 177 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 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: | | Odontogenic Tumor 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*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: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | 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: 178 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 14/50 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 14/50 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 179 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | 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 This page intentionally left blank Toxicology Data Management System Page: 181 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 20/50 (40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 47/50 (94%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 12/50 (24%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: 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: 182 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 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: 183 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 7/49 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 184 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 10/49 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 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: 185 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 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: 186 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 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: 187 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 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: 188 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 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: 189 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 30/50 (60%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 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: 190 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca 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: 191 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 192 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 193 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 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: 194 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma 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: 195 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 1/50 (2%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 196 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 197 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 198 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 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: 199 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 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: 200 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 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: 201 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 203 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 50/50 (100%) 60/60 (100%) 43/50 (86%) 48/50 (96%) 47/60 (78%) | | 49/50 (98%) 33/50 (66%) | | Overall Incidence Total 208/210 (99.05%)Mean 99% SD 1.15% Total 171/210 (81.43%) Mean 81.58% SD 12.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 22/50 (44%) 22/50 (44%) 37/60 (62%) 19/50 (38%) 19/50 (38%) 24/60 (40%) | | 33/50 (66%) 22/50 (44%) | | Overall Incidence Total 114/210 (54.29%)Mean 53.92% SD 11.59% Total 84/210 (40%) Mean 40% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 50/50 (100%) 60/60 (100%) 45/50 (90%) 48/50 (96%) 54/60 (90%) | | 50/50 (100%) 43/50 (86%) | | Overall Incidence Total 210/210 (100%) Mean 100% SD 0% Total 190/210 (90.48%) Mean 90.5% SD 4.12% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 0.92% SD 1.07% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.92% SD 1.64% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 2/50 (4%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.42% SD 0.83% Total 2/210 (0.95%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 15/50 (30%) 15/50 (30%) 30/60 (50%) 6/50 (12%) 9/50 (18%) 21/60 (35%) | | Mononuclear, or Undifferentiated 24/50 (48%) 13/50 (26%) | | Overall Incidence Total 84/210 (40%) Mean 39.5% SD 11% Total 49/210 (23.33%) Mean 22.75% SD 9.98% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Lymphocytic, Mixed, NOS, or 2/50 (4%) 0/50 (0%) | | Undifferentiated Cell Type | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 204 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | NOS 5/50 (10%) 0/50 (0%) | | Overall Incidence Total 9/210 (4.29%) Mean 4.33% SD 4.16% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 5/50 (10%) 0/50 (0%) | | Overall Incidence Total 9/210 (4.29%) Mean 4.33% SD 4.16% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.42% SD 0.83% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/210 (1.43%) Mean 1.42% SD 1.89% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 1/50 (2%) 0/60 (0%) 5/50 (10%) 1/49 (2%) 2/60 (3%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 8/209 (3.83%) Mean 3.84% SD 4.33% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/206 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 8/50 (16%) 8/50 (16%) 2/60 (3%) 0/49 (0%) 2/48 (4%) 2/60 (3%) | | 3/50 (6%) 2/49 (4%) | | Overall Incidence Total 21/210 (10%) Mean 10.33% SD 6.63% Total 6/206 (2.91%) Mean 2.9% SD 1.97% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 2/50 (4%) 0/60 (0%) 0/49 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 0/206 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/50 (0%) 2/60 (3%) 0/49 (0%) 1/48 (2%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 0.83% SD 1.67% Total 1/206 (0.49%) Mean 0.52% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 8/50 (16%) 10/50 (20%) 4/60 (7%) 0/49 (0%) 3/48 (6%) 2/60 (3%) | | Complex, Malignant, NOS 3/50 (6%) 2/49 (4%) | | Overall Incidence Total 25/210 (11.9%) Mean 12.17% SD 6.94% Total 7/206 (3.4%) Mean 3.42% SD 2.59% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.42% SD 0.83% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/210 (1.43%) Mean 1.42% SD 1.89% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Astrocytoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 2/50 (4%) 2/60 (3%) 5/50 (10%) 8/50 (16%) 12/59 (20%) | | 2/50 (4%) 7/50 (14%) | | Overall Incidence Total 6/210 (2.86%) Mean 2.83% SD 1.91% Total 32/209 (15.31%) Mean 15.08% SD 4.3% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 2/60 (3%) 3/50 (6%) 2/50 (4%) 2/59 (3%) | | 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.83% SD 2.13% Total 9/209 (4.31%) Mean 4.35% SD 1.14% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 2/50 (4%) 4/60 (7%) 8/50 (16%) 10/50 (20%) 14/59 (24%) | | 4/50 (8%) 8/50 (16%) | | Overall Incidence Total 10/210 (4.76%) Mean 4.67% SD 3.53% Total 40/209 (19.14%) Mean 18.93% SD 3.71% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/209 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/209 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.42% SD 0.83% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 209 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 3/50 (6%) 2/60 (3%) 0/50 (0%) 0/49 (0%) 1/60 (2%) | | 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 8/210 (3.81%) Mean 3.83% SD 2.85% Total 1/209 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/49 (0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 2/209 (0.96%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 3/50 (6%) 2/60 (3%) 2/50 (4%) 0/49 (0%) 1/60 (2%) | | 5/50 (10%) 0/50 (0%) | | Overall Incidence Total 10/210 (4.76%) Mean 4.83% SD 4.23% Total 3/209 (1.44%) Mean 1.42% SD 1.89% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) 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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 1/48 (2%) 0/60 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 1/208 (0.48%) Mean 0.52% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/49 (0%) 1/48 (2%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/207 (0.48%) Mean 0.52% SD 1.04% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/49 (0%) 0/48 (0%) 0/60 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/207 (0%) Mean 0% SD 0% Total 0/208 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 211 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 0.83% SD 1.67% Total 2/210 (0.95%) Mean 0.92% SD 1.07% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 0.92% SD 1.07% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Hepatoblastoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 0.92% SD 1.07% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 3/60 (5%) 1/50 (2%) 0/50 (0%) 1/60 (2%) | | Hepatocellular Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.75% SD 2.36% Total 2/210 (0.95%) Mean 0.92% SD 1.07% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 3/60 (5%) 1/50 (2%) 0/50 (0%) 1/60 (2%) | | Hepatocellular Adenoma, or 1/50 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 4/210 (1.9%) Mean 1.75% SD 2.36% Total 2/210 (0.95%) Mean 0.92% SD 1.07% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.92% SD 1.64% Total 1/210 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/210 (1.43%) Mean 1.42% SD 1.89% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 4/50 (8%) 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 7/210 (3.33%) Mean 3.33% SD 3.4% Total 1/210 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 212 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 4/50 (8%) 2/50 (4%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 7/210 (3.33%) Mean 3.5% SD 3.42% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 4/50 (8%) 2/50 (4%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 7/210 (3.33%) Mean 3.5% SD 3.42% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 0/50 (0%) 3/50 (6%) 0/60 (0%) 26/50 (52%) 24/50 (48%) 23/60 (38%) | | 0/50 (0%) 14/50 (28%) | | Overall Incidence Total 3/210 (1.43%) Mean 1.5% SD 3% Total 87/210 (41.43%) Mean 41.58% SD 10.72% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 213 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 3/50 (6%) 0/60 (0%) 26/50 (52%) 24/50 (48%) 23/60 (38%) | | 0/50 (0%) 14/50 (28%) | | Overall Incidence Total 3/210 (1.43%) Mean 1.5% SD 3% Total 87/210 (41.43%) Mean 41.58% SD 10.72% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 3/50 (6%) 0/60 (0%) 28/50 (56%) 25/50 (50%) 23/60 (38%) | | or Adenoma 0/50 (0%) 14/50 (28%) | | Overall Incidence Total 3/210 (1.43%) Mean 1.5% SD 3% Total 90/210 (42.86%) Mean 43.08% SD 12.45% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 214 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 1/50 (2%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/209 (0.48%) Mean 0.5% SD 1% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 2/210 (0.95%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 215 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Malignant, NOS 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 216 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/49 (2%) 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/209 (1.44%) Mean 1.43% SD 0.97% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/209 (0.48%) Mean 0.5% SD 1% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/49 (2%) 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/209 (1.91%) Mean 1.93% SD 0.17% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/47 (0%) 1/48 (2%) 0/58 (0%) 0/49 (0%) 0/50 (0%) 0/57 (0%) | | 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 1/201 (0.5%) Mean 0.52% SD 1.04% Total 0/202 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 9/50 (18%) 16/49 (33%) 11/59 (19%) 23/50 (46%) 29/48 (60%) 19/59 (32%) | | Adenoma 15/48 (31%) 15/50 (30%) | | Overall Incidence Total 51/206 (24.76%) Mean 25.14% SD 7.89% Total 86/207 (41.55%) Mean 42.16% SD 14.08% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/49 (0%) 0/59 (0%) 2/50 (4%) 0/48 (0%) 0/59 (0%) | | Carcinoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/206 (0.49%) Mean 0.52% SD 1.04% Total 2/207 (0.97%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 9/50 (18%) 16/49 (33%) 11/59 (19%) 25/50 (50%) 29/48 (60%) 19/59 (32%) | | Carcinoma or Adenoma 16/48 (33%) 15/50 (30%) | | Overall Incidence Total 52/206 (25.24%) Mean 25.66% SD 8.48% Total 88/207 (42.51%) Mean 43.16% SD 14.58% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 217 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/50 (2%) 0/49 (0%) 0/59 (0%) 0/50 (0%) 0/48 (0%) 1/59 (2%) | | 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/206 (0.49%) Mean 0.5% SD 1% Total 1/207 (0.48%) Mean 0.42% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/49 (0%) 0/59 (0%) 0/50 (0%) 0/48 (0%) 0/59 (0%) | | 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/206 (0%) Mean 0% SD 0% Total 0/207 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/50 (2%) 0/49 (0%) 0/59 (0%) 0/50 (0%) 0/48 (0%) 1/59 (2%) | | 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 1/206 (0.49%) Mean 0.5% SD 1% Total 1/207 (0.48%) Mean 0.42% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/50 (0%) 2/60 (3%) | | 2/50 (4%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.83% SD 2.13% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 2/60 (3%) | | 2/50 (4%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.83% SD 2.13% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 218 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 1/50 (2%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.83% SD 1.37% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 219 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 1/50 (2%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor Benign 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/210 (1.9%) Mean 1.83% SD 1.37% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 1/50 (2%) 2/60 (3%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | Tumor Benign, or 1/50 (2%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 5/210 (2.38%) Mean 2.33% SD 0.67% Total 2/210 (0.95%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 1/50 (2%) 2/60 (3%) 2/50 (4%) 1/50 (2%) 0/60 (0%) | | Adenoma, Basosquamous Tumor 1/50 (2%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 5/210 (2.38%) Mean 2.33% SD 0.67% Total 3/210 (1.43%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 2/50 (4%) 3/50 (6%) 7/60 (12%) 2/50 (4%) 2/50 (4%) 0/60 (0%) | | Carcinoma, Basosq. Tumor (M or 4/50 (8%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 16/210 (7.62%) Mean 7.42% SD 3.27% Total 4/210 (1.9%) Mean 2% SD 2.31% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 2/210 (0.95%) Mean 1% SD 2% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.42% SD 0.83% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 220 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 1/50 (2%) 5/60 (8%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 9/210 (4.29%) Mean 4.08% SD 2.99% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 221 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 5/60 (8%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Papilloma, Squamous Cell 3/50 (6%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 11/210 (5.24%) Mean 5.08% SD 2.71% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 1/50 (2%) 5/60 (8%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Papilloma, or Keratoacanthoma 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 10/210 (4.76%) Mean 4.58% SD 3.13% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 2/50 (4%) 8/50 (16%) 5/60 (8%) 1/50 (2%) 1/50 (2%) 3/60 (5%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 16/210 (7.62%) Mean 7.58% SD 6.2% Total 5/210 (2.38%) Mean 2.25% SD 2.06% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 2/50 (4%) 8/50 (16%) 5/60 (8%) 1/50 (2%) 1/50 (2%) 3/60 (5%) | | Myxoma, Myxosarcoma, or Fibrous 2/50 (4%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 17/210 (8.1%) Mean 8.08% SD 5.66% Total 7/210 (3.33%) Mean 3.25% SD 1.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Myxosarcoma, or Fibrous 1/50 (2%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 2/210 (0.95%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 222 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 223 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 48/50 (96%) 46/50 (92%) 55/60 (92%) | | 49/50 (98%) | | Overall Incidence Total 198/210 (94.29%)Mean 94.42% SD 3.1% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) 0/48 (0%) 0/56 (0%) 0/48 (0%) 0/47 (0%) 0/57 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/201 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 224 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 0/48 (0%) 0/56 (0%) 0/48 (0%) 0/47 (0%) 0/57 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/201 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/48 (0%) 0/48 (0%) 0/56 (0%) 0/48 (0%) 0/47 (0%) 0/57 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/201 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 0/48 (0%) 0/56 (0%) 0/48 (0%) 0/47 (0%) 0/57 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/201 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 9/48 (19%) 11/47 (23%) 10/59 (17%) 9/49 (18%) 10/47 (21%) 9/60 (15%) | | 11/50 (22%) 6/50 (12%) | | Overall Incidence Total 41/204 (20.1%) Mean 20.28% SD 2.95% Total 34/206 (16.5%) Mean 16.66% SD 4.03% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/48 (2%) 0/47 (0%) 0/59 (0%) 0/49 (0%) 1/47 (2%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/204 (0.49%) Mean 0.52% SD 1.04% Total 2/206 (0.97%) Mean 0.95% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 10/48 (21%) 11/47 (23%) 10/59 (17%) 9/49 (18%) 11/47 (23%) 10/60 (17%) | | 11/50 (22%) 6/50 (12%) | | Overall Incidence Total 42/204 (20.59%) Mean 20.8% SD 2.77% Total 36/206 (17.48%) Mean 17.61% SD 4.71% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/48 (2%) 0/47 (0%) 0/59 (0%) 0/49 (0%) 2/47 (4%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/204 (0.49%) Mean 0.52% SD 1.04% Total 2/206 (0.97%) Mean 1.06% SD 2.13% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/48 (0%) 0/47 (0%) 1/59 (2%) 1/49 (2%) 0/47 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/204 (0.49%) Mean 0.42% SD 0.85% Total 2/206 (0.97%) Mean 1.01% SD 1.17% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/48 (2%) 0/47 (0%) 1/59 (2%) 1/49 (2%) 2/47 (4%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/204 (0.98%) Mean 0.94% SD 1.1% Total 4/206 (1.94%) Mean 2.07% SD 1.74% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 225 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 226 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/49 (0%) 1/60 (2%) 1/50 (2%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/209 (0.48%) Mean 0.42% SD 0.83% Total 1/209 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/49 (0%) 1/60 (2%) 1/50 (2%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/209 (0.48%) Mean 0.42% SD 0.83% Total 1/209 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/209 (0%) Mean 0% SD 0% Total 0/209 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 8/50 (16%) 16/50 (32%) 11/60 (18%) | | 6/50 (12%) | | Overall Incidence Total 41/210 (19.52%) Mean 19.58% SD 8.68% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 227 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 8/50 (16%) 17/50 (34%) 11/60 (18%) | | 6/50 (12%) | | Overall Incidence Total 42/210 (20%) Mean 20.08% SD 9.64% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) | | Overall Incidence Total 1/210 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/210 (0%) Mean 0% SD 0% Total 1/210 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 3/50 (6%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 5/210 (2.38%) Mean 2.5% SD 3% Total 1/210 (0.48%) Mean 0.42% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 3/50 (6%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 2/60 (3%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 5/210 (2.38%) Mean 2.5% SD 3% Total 2/210 (0.95%) Mean 0.83% SD 1.67% | __________________________________________________________________________________________________________________________________ *: 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: 229 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 48/50 (96%) 49/50 (98%) 47/50 (94%) 46/50 (92%) 42/50 (84%) | | Overall Incidence Total 144/150 (96%) Mean 96% SD 2% Total 88/100 (88%) Mean 88% SD 5.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 27/50 (54%) 28/50 (56%) 29/50 (58%) 21/50 (42%) 16/50 (32%) | | Overall Incidence Total 84/150 (56%) Mean 56% SD 2% Total 37/100 (37%) Mean 37% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 50/50 (100%) 50/50 (100%) 49/50 (98%) 45/50 (90%) | | Overall Incidence Total 149/150 (99.33%)Mean 99.33% SD 1.15% Total 94/100 (94%) Mean 94% SD 5.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 13/50 (26%) 16/50 (32%) 17/50 (34%) 11/50 (22%) 11/50 (22%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 46/150 (30.67%) Mean 30.67% SD 4.16% Total 22/100 (22%) Mean 22% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 6/150 (4%) Mean 4% SD 3.46% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/150 (4%) Mean 4% SD 3.46% 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: 230 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 3.46% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 3.46% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 6/49 (12%) 8/50 (16%) 7/49 (14%) 2/50 (4%) 1/49 (2%) | | Overall Incidence Total 21/148 (14.19%) Mean 14.18% SD 1.88% Total 3/99 (3.03%) Mean 3.02% SD 1.39% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/148 (1.35%) Mean 1.33% SD 2.31% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 3/49 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 4/148 (2.7%) Mean 2.71% SD 3.12% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 9/49 (18%) 11/50 (22%) 7/49 (14%) 2/50 (4%) 1/49 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 27/148 (18.24%) Mean 18.22% SD 3.86% Total 3/99 (3.03%) Mean 3.02% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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: 231 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/48 (2%) 2/50 (4%) 3/50 (6%) 11/49 (22%) 8/50 (16%) | | Overall Incidence Total 6/148 (4.05%) Mean 4.03% SD 1.96% Total 19/99 (19.19%) Mean 19.22% SD 4.56% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/48 (6%) 1/50 (2%) 0/50 (0%) 3/49 (6%) 1/50 (2%) | | Overall Incidence Total 4/148 (2.7%) Mean 2.75% SD 3.19% Total 4/99 (4.04%) Mean 4.06% SD 2.92% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 232 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 4/48 (8%) 3/50 (6%) 3/50 (6%) 14/49 (29%) 9/50 (18%) | | Overall Incidence Total 10/148 (6.76%) Mean 6.78% SD 1.35% Total 23/99 (23.23%) Mean 23.29% SD 7.48% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/148 (0.68%) Mean 0.67% SD 1.15% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (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: 233 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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: 234 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 3/49 (6%) 5/48 (10%) 2/50 (4%) 0/47 (0%) | | Overall Incidence Total 11/147 (7.48%) Mean 7.51% SD 2.52% Total 2/97 (2.06%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 2/50 (4%) 0/49 (0%) 0/48 (0%) 1/50 (2%) 0/47 (0%) | | Overall Incidence Total 2/147 (1.36%) Mean 1.33% SD 2.31% Total 1/97 (1.03%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 5/50 (10%) 3/49 (6%) 5/48 (10%) 3/50 (6%) 0/47 (0%) | | Overall Incidence Total 13/147 (8.84%) Mean 8.85% SD 2.37% Total 3/97 (3.09%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/47 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/47 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/145 (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: 235 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/145 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Hepatocellular Adenoma | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 4/150 (2.67%) Mean 2.67% SD 3.06% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 236 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 4/50 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 7/150 (4.67%) Mean 4.67% SD 3.06% Total 4/100 (4%) Mean 4% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 6/100 (6%) Mean 6% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 6/50 (12%) 3/50 (6%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 9/100 (9%) Mean 9% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 1/50 (2%) 4/50 (8%) 33/50 (66%) 32/50 (64%) | | Overall Incidence Total 7/150 (4.67%) Mean 4.67% SD 3.06% Total 65/100 (65%) Mean 65% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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: 237 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 2/50 (4%) 4/50 (8%) 35/50 (70%) 32/50 (64%) | | Overall Incidence Total 8/150 (5.33%) Mean 5.33% SD 2.31% Total 67/100 (67%) Mean 67% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 2/50 (4%) 5/50 (10%) 37/50 (74%) 32/50 (64%) | | or Adenoma | | Overall Incidence Total 9/150 (6%) Mean 6% SD 3.46% Total 69/100 (69%) Mean 69% SD 7.07% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (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: 238 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/49 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/148 (0.68%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% 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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*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 Malignant 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: 239 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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: | | Thecoma Malignant 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 0/49 (0%) 3/49 (6%) 0/48 (0%) 2/50 (4%) 0/47 (0%) | | Overall Incidence Total 3/146 (2.05%) Mean 2.04% SD 3.53% Total 2/97 (2.06%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 3/49 (6%) 0/48 (0%) 2/50 (4%) 0/47 (0%) | | Overall Incidence Total 3/146 (2.05%) Mean 2.04% SD 3.53% Total 2/97 (2.06%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 16/48 (33%) 22/49 (45%) 23/50 (46%) 23/49 (47%) 26/50 (52%) | | Adenoma | | Overall Incidence Total 61/147 (41.5%) Mean 41.41% SD 7.02% Total 49/99 (49.49%) Mean 49.47% SD 3.58% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 240 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 16/48 (33%) 22/49 (45%) 23/50 (46%) 24/49 (49%) 26/50 (52%) | | Carcinoma or Adenoma | | Overall Incidence Total 61/147 (41.5%) Mean 41.41% SD 7.02% Total 50/99 (50.51%) Mean 50.49% SD 2.14% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (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: 241 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 3/150 (2%) Mean 2% SD 0% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 242 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 5/150 (3.33%) Mean 3.33% SD 1.15% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 5/50 (10%) 4/50 (8%) 7/50 (14%) 3/50 (6%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 16/150 (10.67%) Mean 10.67% SD 3.06% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 4/50 (8%) 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 10/150 (6.67%) Mean 6.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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: 243 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 2.31% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 2.31% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 3/50 (6%) 6/50 (12%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 13/150 (8.67%) Mean 8.67% SD 3.06% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 3/50 (6%) 5/50 (10%) 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 12/150 (8%) Mean 8% SD 2% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 9/50 (18%) 6/50 (12%) 5/50 (10%) 4/50 (8%) 1/50 (2%) | | Overall Incidence Total 20/150 (13.33%) Mean 13.33% SD 4.16% Total 5/100 (5%) Mean 5% SD 4.24% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 244 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 10/50 (20%) 7/50 (14%) 6/50 (12%) 4/50 (8%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 23/150 (15.33%) Mean 15.33% SD 4.16% Total 5/100 (5%) Mean 5% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 3/150 (2%) Mean 2% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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: 245 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/146 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/48 (0%) 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 1/146 (0.68%) Mean 0.69% SD 1.2% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 45/50 (90%) 41/50 (82%) | | Overall Incidence Total 131/150 (87.33%)Mean 87.33% SD 4.62% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 246 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) 0/48 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 0/48 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 0/48 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 9/47 (19%) 8/46 (17%) 6/50 (12%) 12/47 (26%) 6/50 (12%) | | Overall Incidence Total 23/143 (16.08%) Mean 16.18% SD 3.73% Total 18/97 (18.56%) Mean 18.77% SD 9.57% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/47 (4%) 1/46 (2%) 1/50 (2%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 4/143 (2.8%) Mean 2.81% SD 1.25% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 11/47 (23%) 9/46 (20%) 7/50 (14%) 13/47 (28%) 6/50 (12%) | | Overall Incidence Total 27/143 (18.88%) Mean 18.99% SD 4.73% Total 19/97 (19.59%) Mean 19.83% SD 11.07% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/47 (2%) 0/46 (0%) 1/50 (2%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 2/143 (1.4%) Mean 1.38% SD 1.19% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/47 (0%) 0/46 (0%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 0/143 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/47 (2%) 0/46 (0%) 1/50 (2%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 2/143 (1.4%) Mean 1.38% SD 1.19% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (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: 247 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (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%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/48 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/147 (0.68%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/48 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/147 (0.68%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/147 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/147 (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: 248 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 9/50 (18%) 4/50 (8%) | | Overall Incidence Total 13/100 (13%) Mean 13% SD 7.07% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 10/50 (20%) 4/50 (8%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 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: | | Sarcoma 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: 249 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: 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: 251 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 44/50 (88%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 34/50 (68%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 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: Lymphocytic, Monocytic, 13/50 (26%) 9/50 (18%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 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 | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 252 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 3/50 (6%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 4/50 (8%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 6/50 (12%) 0/49 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 253 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 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, Glioma, or 1/50 (2%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/50 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 254 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 2/50 (4%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma 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: 255 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 1/50 (2%) 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 1/50 (2%) 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 Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 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 | | 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: 256 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 5/50 (10%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 7/50 (14%) 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 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 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: 257 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 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: | | Hepatocellular Adenoma 0/50 (0%) 6/50 (12%) | | 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 | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 6/50 (12%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 6/50 (12%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar 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: 258 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 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%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 0/50 (0%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 259 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 14/50 (28%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 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: 260 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 3/50 (6%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca 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: 261 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 29/50 (58%) 33/50 (66%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 262 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 5/50 (10%) 3/50 (6%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/50 (68%) 36/50 (72%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 263 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 264 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 4/50 (8%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 3/50 (6%) 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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 265 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 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 | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 266 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 5/50 (10%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 2/50 (4%) 2/50 (4%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 2/50 (4%) 2/50 (4%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma 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: 267 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 2/50 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 36/50 (72%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 268 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 5/50 (10%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 5/50 (10%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 10/50 (20%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | 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: 269 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 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%) 2/50 (4%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*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: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | 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: 270 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 10/50 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 10/50 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 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: 271 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________