Toxicology Data Management System Page: 1 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058813804 09/14/99 730 50(1) 44 (717) 46.0 BENZOPHENONE | |BATTELLE COLUMBUS 055634804 06/19/96 727 100(1) 91 (707) 49.6 CITRAL | |BATTELLE COLUMBUS 058812004 01/04/96 733 50(1) 40 (705) 46.9 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611104 09/24/97 728 100(1) 91 (705) 46.5 TRANS-CINNAMALDEHYDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058813804 09/14/99 729 50(5) 40 (706) 46.2 BENZOPHENONE | |BATTELLE COLUMBUS 055634804 06/19/96 733 99(5) 81 (695) 48.0 CITRAL | |BATTELLE COLUMBUS 058812004 01/04/96 734 50(5) 42 (717) 46.5 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611104 09/24/97 733 100(5) 84 (711) 46.0 TRANS-CINNAMALDEHYDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302606 08/28/97 733 50( ) 40 (701) 54.1 DECALIN | |BATTELLE NORTHWEST 058812404 01/25/96 733 50( ) 37 (711) 51.6 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 059000406 09/29/97 729 50( ) 35 (703) 54.3 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600106 12/21/98 729 50( ) 34 (690) 53.0 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142708 01/13/97 729 50( ) 39 (710) 55.4 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302606 08/28/97 735 49( ) 37 (708) 61.5 DECALIN | |BATTELLE NORTHWEST 058812404 01/25/96 735 50( ) 42 (713) 54.8 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 059000406 09/29/97 731 50( ) 39 (718) 59.8 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600106 12/21/98 731 50( ) 36 (702) 54.6 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142708 01/13/97 731 50( ) 38 (692) 58.7 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059201206 07/29/98 729 50(1) 43 (706) 46.8 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520309 02/20/96 729 60(1) 52 (712) 48.0 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520508 11/14/95 729 50(1) 46 (722) 47.4 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059201206 07/29/98 732 50(5) 46 (720) 38.8 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520309 02/20/96 731 60(5) 52 (708) 46.6 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520508 11/14/95 732 50(5) 46 (727) 41.4 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| This page intentionally left blank Toxicology Data Management System Page: 5 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 27/50 (54%) 40/100(40%) 16/50 (32%) 15/50 (30%) 28/99 (28%) 15/50 (30%) | | 37/100(37%) 32/100(32%) | | Overall Incidence Total 120/300 (40%) Mean 40.75% SD 9.43% Total 90/299 (30.1%) Mean 30.07% SD 1.52% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 17/50 (34%) 32/100(32%) 21/50 (42%) 16/50 (32%) 24/99 (24%) 12/50 (24%) | | 28/100(28%) 46/100(46%) | | Overall Incidence Total 98/300 (32.67%) Mean 34% SD 5.89% Total 98/299 (32.78%) Mean 31.56% SD 10.32% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 38/50 (76%) 55/100(55%) 32/50 (64%) 25/50 (50%) 45/99 (45%) 23/50 (46%) | | 57/100(57%) 62/100(62%) | | Overall Incidence Total 182/300 (60.67%)Mean 63% SD 9.49% Total 155/299 (51.84%) Mean 50.86% SD 7.7% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 3/100(3%) 4/100(4%) | | Overall Incidence Total 5/300 (1.67%) Mean 1.25% SD 1.5% Total 5/299 (1.67%) Mean 1.25% SD 1.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/50 (6%) 3/100(3%) 3/50 (6%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 2/100(2%) 1/100(1%) | | Overall Incidence Total 11/300 (3.67%) Mean 4.25% SD 2.06% Total 2/299 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 3/50 (6%) 5/100(5%) 3/50 (6%) 1/50 (2%) 1/99 (1%) 0/50 (0%) | | 5/100(5%) 5/100(5%) | | Overall Incidence Total 16/300 (5.33%) Mean 5.5% SD 0.58% Total 7/299 (2.34%) Mean 2% SD 2.16% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 2/100(2%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 2/299 (0.67%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 4/100(4%) 3/50 (6%) 8/50 (16%) 7/99 (7%) 6/50 (12%) | | Lymphocytic, Mixed, NOS, or 8/100(8%) 23/100(23%) | | Undifferentiated Cell Type | | Overall Incidence Total 17/300 (5.67%) Mean 5.5% SD 1.91% Total 44/299 (14.72%) Mean 14.52% SD 6.73% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | NOS 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 6 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/299 (1%) Mean 1.25% SD 0.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 3/299 (1%) Mean 1.25% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 2/100(2%) 0/49 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 2/99 (2%) 0/100(0%) | | Overall Incidence Total 4/298 (1.34%) Mean 1.01% SD 1.16% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/99 (0%) 0/100(0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/99 (0%) 0/100(0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/99 (0%) 0/49 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/99 (0%) 0/99 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 1/298 (0.34%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/99 (0%) 0/49 (0%) 0/50 (0%) 1/99 (1%) 1/50 (2%) | | 0/99 (0%) 1/99 (1%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 3/298 (1.01%) Mean 1.01% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/99 (0%) 0/49 (0%) 1/50 (2%) 1/99 (1%) 1/50 (2%) | | Complex, Malignant, NOS 0/99 (0%) 1/99 (1%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 4/298 (1.34%) Mean 1.51% SD 0.57% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/49 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) 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: 7 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.75% SD 0.96% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 8 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | Astrocytoma 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.5% SD 0.58% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.5% SD 0.58% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 9 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 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% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/45 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 0/99 (0%) 0/49 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/45 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 0/99 (0%) 0/49 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 6/50 (12%) 4/100(4%) 5/50 (10%) 1/50 (2%) 3/99 (3%) 3/50 (6%) | | 8/100(8%) 2/100(2%) | | Overall Incidence Total 23/300 (7.67%) Mean 8.5% SD 3.42% Total 9/299 (3.01%) Mean 3.26% SD 1.89% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 2/299 (0.67%) Mean 0.5% SD 0.58% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 7/50 (14%) 4/100(4%) 5/50 (10%) 1/50 (2%) 4/99 (4%) 3/50 (6%) | | 8/100(8%) 3/100(3%) | | Overall Incidence Total 24/300 (8%) Mean 9% SD 4.16% Total 11/299 (3.68%) Mean 3.76% SD 1.71% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 2/100(2%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 0.75% SD 0.96% Total 1/299 (0.33%) 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: 11 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 3/100(3%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 1/100(1%) | | Overall Incidence Total 4/300 (1.33%) Mean 1% SD 1.41% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 3/100(3%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 1/100(1%) | | Overall Incidence Total 4/300 (1.33%) Mean 1% SD 1.41% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 3/100(3%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 1/100(1%) | | Overall Incidence Total 4/300 (1.33%) Mean 1% SD 1.41% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 2/100(2%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 0/100(0%) | | Overall Incidence Total 3/300 (1%) Mean 0.75% SD 0.96% Total 1/299 (0.33%) 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: 12 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 2/100(2%) 2/50 (4%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 4/300 (1.33%) Mean 1.5% SD 1.91% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 13 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 11/50 (22%) 20/100(20%) 6/50 (12%) 5/50 (10%) 8/99 (8%) 4/50 (8%) | | 14/100(14%) 7/99 (7%) | | Overall Incidence Total 51/300 (17%) Mean 17% SD 4.76% Total 24/298 (8.05%) Mean 8.29% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 8/50 (16%) 13/100(13%) 9/50 (18%) 0/50 (0%) 4/99 (4%) 3/50 (6%) | | 13/100(13%) 3/99 (3%) | | Overall Incidence Total 43/300 (14.33%) Mean 15% SD 2.45% Total 10/298 (3.36%) Mean 3.27% SD 2.5% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 8/50 (16%) 13/100(13%) 9/50 (18%) 0/50 (0%) 4/99 (4%) 3/50 (6%) | | Hepatoblastoma 13/100(13%) 3/99 (3%) | | Overall Incidence Total 43/300 (14.33%) Mean 15% SD 2.45% Total 10/298 (3.36%) Mean 3.27% SD 2.5% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 18/50 (36%) 28/100(28%) 15/50 (30%) 5/50 (10%) 12/99 (12%) 6/50 (12%) | | Hepatocellular Adenoma 26/100(26%) 9/99 (9%) | | Overall Incidence Total 87/300 (29%) Mean 30% SD 4.32% Total 32/298 (10.74%) Mean 10.8% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 18/50 (36%) 28/100(28%) 15/50 (30%) 5/50 (10%) 12/99 (12%) 6/50 (12%) | | Hepatocellular Adenoma, or 26/100(26%) 9/99 (9%) | | Hepatoblastoma | | Overall Incidence Total 87/300 (29%) Mean 30% SD 4.32% Total 32/298 (10.74%) Mean 10.8% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/99 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 14/50 (28%) 12/100(12%) 6/50 (12%) 0/50 (0%) 5/99 (5%) 0/50 (0%) | | 9/100(9%) 3/100(3%) | | Overall Incidence Total 41/300 (13.67%) Mean 15.25% SD 8.62% Total 8/299 (2.68%) Mean 2.01% SD 2.47% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 9/100(9%) 7/50 (14%) 1/50 (2%) 6/99 (6%) 0/50 (0%) | | 7/100(7%) 2/100(2%) | | Overall Incidence Total 25/300 (8.33%) Mean 8.5% SD 4.2% Total 9/299 (3.01%) Mean 2.52% SD 2.54% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 16/50 (32%) 20/100(20%) 13/50 (26%) 1/50 (2%) 11/99 (11%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 14/100(14%) 5/100(5%) | | Overall Incidence Total 63/300 (21%) Mean 23% SD 7.75% Total 17/299 (5.69%) Mean 4.53% SD 4.85% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 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% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/96 (0%) 0/99 (0%) | | Overall Incidence Total 0/296 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/96 (0%) 0/99 (0%) | | Overall Incidence Total 0/296 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/96 (0%) 0/99 (0%) | | Overall Incidence Total 0/296 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 1/299 (0.33%) Mean 0.25% SD 0.51% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/49 (2%) 3/99 (3%) 2/50 (4%) | | 2/100(2%) | | Overall Incidence Total 8/298 (2.68%) Mean 2.77% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/49 (0%) 1/99 (1%) 1/50 (2%) | | 1/100(1%) | | Overall Incidence Total 3/298 (1.01%) Mean 1% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/49 (0%) 1/99 (1%) 1/50 (2%) | | Malignant, NOS 1/100(1%) | | Overall Incidence Total 3/298 (1.01%) Mean 1% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/49 (0%) 1/99 (1%) 0/50 (0%) | | 2/100(2%) | | Overall Incidence Total 3/298 (1.01%) Mean 0.75% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) | | Overall Incidence Total 1/298 (0.34%) 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: 18 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 1/49 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 1/298 (0.34%) Mean 0.51% SD 1.02% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 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% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/98 (0%) 0/49 (0%) 2/50 (4%) 8/97 (8%) 3/48 (6%) | | Adenoma 0/98 (0%) 11/97 (11%) | | Overall Incidence Total 0/293 (0%) Mean 0% SD 0% Total 24/292 (8.22%) Mean 7.46% SD 3.12% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/98 (0%) 0/49 (0%) 0/50 (0%) 0/97 (0%) 0/48 (0%) | | Carcinoma 0/98 (0%) 0/97 (0%) | | Overall Incidence Total 0/293 (0%) Mean 0% SD 0% Total 0/292 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/98 (0%) 0/49 (0%) 2/50 (4%) 8/97 (8%) 3/48 (6%) | | Carcinoma or Adenoma 0/98 (0%) 11/97 (11%) | | Overall Incidence Total 0/293 (0%) Mean 0% SD 0% Total 24/292 (8.22%) Mean 7.46% SD 3.12% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/98 (0%) 0/49 (0%) 0/50 (0%) 2/97 (2%) 1/48 (2%) | | 1/98 (1%) 0/97 (0%) | | Overall Incidence Total 1/293 (0.34%) Mean 0.26% SD 0.51% Total 3/292 (1.03%) Mean 1.04% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/98 (0%) 0/49 (0%) 0/50 (0%) 2/97 (2%) 1/48 (2%) | | 1/98 (1%) 0/97 (0%) | | Overall Incidence Total 1/293 (0.34%) Mean 0.26% SD 0.51% Total 3/292 (1.03%) Mean 1.04% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or 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: 19 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) | | 0/100(0%) 0/98 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) | | 0/100(0%) 0/98 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.51% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 20 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Tumor Benign, or 0/100(0%) 0/100(0%) | | Trichoepithelioma | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/100(0%) 0/100(0%) | | NOS) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/100(0%) 0/100(0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 1/100(1%) 1/100(1%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | 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: 21 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 2/100(2%) 1/100(1%) | | Overall Incidence Total 3/300 (1%) Mean 0.75% SD 0.96% Total 2/299 (0.67%) Mean 0.5% SD 0.58% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/100(0%) 1/100(1%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% 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: 22 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Papilloma 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 1/100(1%) 1/100(1%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) 2/99 (2%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 0/100(0%) 4/100(4%) | | Histiocytoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 8/299 (2.68%) Mean 2.51% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 4/100(4%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 5/299 (1.67%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) 2/99 (2%) 1/50 (2%) | | Myxosarcoma, or Fibrous 0/100(0%) 4/100(4%) | | Histiocytoma | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 8/299 (2.68%) Mean 2.51% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | (malignant or NOS) 0/100(0%) 2/100(2%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 3/299 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/100(0%) 2/100(2%) | | or NOS) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 3/299 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/99 (2%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.51% SD 1.01% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 2/100(2%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 3/299 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/49 (0%) | | 0/100(0%) 0/97 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/49 (0%) | | 1/100(1%) 0/97 (0%) | | Overall Incidence Total 3/300 (1%) Mean 1.25% SD 0.96% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/49 (0%) | | 0/100(0%) 0/97 (0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.25% SD 0.5% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/49 (0%) | | 0/100(0%) 0/97 (0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 0/100(0%) 0/50 (0%) 2/50 (4%) 1/99 (1%) 0/50 (0%) | | Papilloma Squamous 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 4/299 (1.34%) Mean 1.5% SD 1.73% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 1/100(1%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 3/299 (1%) Mean 1% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 1/100(1%) 1/50 (2%) | | 1/100(1%) | | Overall Incidence Total 3/300 (1%) Mean 1% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Testes: | | 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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli 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% | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli 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% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/46 (0%) 0/99 (0%) 0/45 (0%) 0/46 (0%) 0/95 (0%) 0/49 (0%) | | 0/87 (0%) 0/93 (0%) | | Overall Incidence Total 0/277 (0%) Mean 0% SD 0% Total 0/283 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/46 (0%) 0/99 (0%) 0/45 (0%) 0/46 (0%) 0/95 (0%) 0/49 (0%) | | 0/87 (0%) 0/93 (0%) | | Overall Incidence Total 0/277 (0%) Mean 0% SD 0% Total 0/283 (0%) 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: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/46 (0%) 0/99 (0%) 0/45 (0%) 0/46 (0%) 0/95 (0%) 0/49 (0%) | | 0/87 (0%) 0/93 (0%) | | Overall Incidence Total 0/277 (0%) Mean 0% SD 0% Total 0/283 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/50 (0%) | | 0/99 (0%) 0/98 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/50 (0%) | | 0/99 (0%) 0/98 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/50 (0%) | | 0/99 (0%) 0/98 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/97 (0%) 2/50 (4%) | | 1/99 (1%) 1/98 (1%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.5% SD 0.57% Total 3/295 (1.02%) Mean 1.26% SD 1.89% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/50 (0%) | | 0/99 (0%) 0/98 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/97 (0%) 2/50 (4%) | | 1/99 (1%) 1/98 (1%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.5% SD 0.57% Total 3/295 (1.02%) Mean 1.26% SD 1.89% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.51% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 26 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | Papilloma Squamous 0/100(0%) 0/100(0%) | | Overall Incidence Total 0/300 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.25% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/100(0%) | | Overall Incidence Total 1/300 (0.33%) Mean 0.5% SD 1% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 27 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.25% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 4/50 (8%) 2/99 (2%) 1/50 (2%) | | 1/100(1%) | | Overall Incidence Total 8/299 (2.68%) Mean 3.26% SD 3.2% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 5/50 (10%) 2/99 (2%) 1/50 (2%) | | 1/100(1%) | | Overall Incidence Total 9/299 (3.01%) Mean 3.76% SD 4.19% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 32/50 (64%) 29/50 (58%) 30/50 (60%) 28/49 (57%) 25/50 (50%) 25/50 (50%) | | 32/50 (64%) 31/50 (62%) 27/50 (54%) 19/50 (38%) | | Overall Incidence Total 154/250 (61.6%) Mean 61.6% SD 2.61% Total 124/249 (49.8%) Mean 49.83% SD 7.26% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 23/50 (46%) 21/50 (42%) 22/50 (44%) 22/49 (45%) 20/50 (40%) 23/50 (46%) | | 23/50 (46%) 27/50 (54%) 19/50 (38%) 17/50 (34%) | | Overall Incidence Total 116/250 (46.4%) Mean 46.4% SD 4.56% Total 101/249 (40.56%) Mean 40.58% SD 4.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 43/50 (86%) 41/50 (82%) 41/50 (82%) 39/49 (80%) 35/50 (70%) 37/50 (74%) | | 42/50 (84%) 42/50 (84%) 39/50 (78%) 32/50 (64%) | | Overall Incidence Total 209/250 (83.6%) Mean 83.6% SD 1.67% Total 182/249 (73.09%) Mean 73.12% SD 6.31% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 3/249 (1.2%) Mean 1.21% SD 1.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 3/50 (6%) 3/50 (6%) 1/49 (2%) 3/50 (6%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 9/250 (3.6%) Mean 3.6% SD 2.19% Total 8/249 (3.21%) Mean 3.21% SD 1.78% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 3/50 (6%) 4/50 (8%) 2/49 (4%) 4/50 (8%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 11/250 (4.4%) Mean 4.4% SD 2.61% Total 11/249 (4.42%) Mean 4.42% SD 2.19% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 7/249 (2.81%) Mean 2.8% SD 2.28% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 1/50 (2%) 3/50 (6%) 11/49 (22%) 8/50 (16%) 13/50 (26%) | | Lymphocytic, Mixed, NOS, or 3/50 (6%) 2/50 (4%) 5/50 (10%) 7/50 (14%) | | Undifferentiated Cell Type | | Overall Incidence Total 12/250 (4.8%) Mean 4.8% SD 1.79% Total 44/249 (17.67%) Mean 17.69% SD 6.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 30 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 2/49 (4%) 2/50 (4%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 4/49 (8%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 10/246 (4.07%) Mean 4.07% SD 2.5% Total 2/248 (0.81%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 1/248 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/50 (0%) 0/47 (0%) 2/48 (4%) 2/49 (4%) 0/47 (0%) | | 0/48 (0%) 0/50 (0%) 1/49 (2%) 2/49 (4%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 7/242 (2.89%) Mean 2.87% SD 1.84% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/47 (0%) | | 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 1/242 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 0/50 (0%) 0/47 (0%) 2/48 (4%) 2/49 (4%) 0/47 (0%) | | Complex, Malignant, NOS 0/48 (0%) 0/50 (0%) 2/49 (4%) 2/49 (4%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 8/242 (3.31%) Mean 3.28% SD 1.84% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/49 (2%) 1/49 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/246 (0.81%) Mean 0.82% SD 1.12% Total 2/247 (0.81%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 31 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 32 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 33 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/42 (0%) 0/43 (0%) 0/38 (0%) 0/41 (0%) 0/46 (0%) 0/40 (0%) | | 0/39 (0%) 0/42 (0%) 0/40 (0%) 0/46 (0%) | | Overall Incidence Total 0/204 (0%) Mean 0% SD 0% Total 0/213 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/42 (0%) 0/43 (0%) 0/38 (0%) 0/41 (0%) 0/46 (0%) 0/40 (0%) | | 0/39 (0%) 0/42 (0%) 0/40 (0%) 0/46 (0%) | | Overall Incidence Total 0/204 (0%) Mean 0% SD 0% Total 0/213 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 6/50 (12%) 1/50 (2%) 6/50 (12%) 3/49 (6%) 3/50 (6%) 3/50 (6%) | | 7/50 (14%) 8/50 (16%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 28/250 (11.2%) Mean 11.2% SD 5.4% Total 15/249 (6.02%) Mean 6.02% SD 1.42% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 2.61% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 9/50 (18%) 1/50 (2%) 7/50 (14%) 4/49 (8%) 3/50 (6%) 3/50 (6%) | | 7/50 (14%) 8/50 (16%) 5/50 (10%) 2/50 (4%) | | Overall Incidence Total 32/250 (12.8%) Mean 12.8% SD 6.26% Total 17/249 (6.83%) Mean 6.83% SD 2.3% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.79% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 1.67% Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 36 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/49 (2%) 3/50 (6%) 2/48 (4%) 1/49 (2%) 0/50 (0%) 1/49 (2%) | | 0/48 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 7/245 (2.86%) Mean 2.84% SD 2.3% Total 3/247 (1.21%) Mean 1.22% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/49 (2%) 3/50 (6%) 2/48 (4%) 1/49 (2%) 0/50 (0%) 1/49 (2%) | | 0/48 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 7/245 (2.86%) Mean 2.84% SD 2.3% Total 3/247 (1.21%) Mean 1.22% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/249 (0.8%) Mean 0.8% SD 1.79% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/250 (2.4%) Mean 2.4% SD 1.67% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 22/50 (44%) 17/50 (34%) 18/50 (36%) 7/49 (14%) 12/50 (24%) 14/49 (29%) | | 23/50 (46%) 15/50 (30%) 9/50 (18%) 6/50 (12%) | | Overall Incidence Total 95/250 (38%) Mean 38% SD 6.78% Total 48/248 (19.35%) Mean 19.37% SD 6.86% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 10/50 (20%) 11/50 (22%) 9/50 (18%) 4/49 (8%) 6/50 (12%) 4/49 (8%) | | 16/50 (32%) 14/50 (28%) 6/50 (12%) 6/50 (12%) | | Overall Incidence Total 60/250 (24%) Mean 24% SD 5.83% Total 26/248 (10.48%) Mean 10.47% SD 2.1% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 11/50 (22%) 9/50 (18%) 4/49 (8%) 6/50 (12%) 4/49 (8%) | | Hepatoblastoma 16/50 (32%) 14/50 (28%) 6/50 (12%) 6/50 (12%) | | Overall Incidence Total 60/250 (24%) Mean 24% SD 5.83% Total 26/248 (10.48%) Mean 10.47% SD 2.1% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 28/50 (56%) 26/50 (52%) 25/50 (50%) 11/49 (22%) 18/50 (36%) 18/49 (37%) | | Hepatocellular Adenoma 34/50 (68%) 26/50 (52%) 13/50 (26%) 12/50 (24%) | | Overall Incidence Total 139/250 (55.6%) Mean 55.6% SD 7.27% Total 72/248 (29.03%) Mean 29.04% SD 6.81% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 28/50 (56%) 26/50 (52%) 25/50 (50%) 11/49 (22%) 18/50 (36%) 18/49 (37%) | | Hepatocellular Adenoma, or 34/50 (68%) 26/50 (52%) 13/50 (26%) 12/50 (24%) | | Hepatoblastoma | | Overall Incidence Total 139/250 (55.6%) Mean 55.6% SD 7.27% Total 72/248 (29.03%) Mean 29.04% SD 6.81% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 8/50 (16%) 13/50 (26%) 13/50 (26%) 1/49 (2%) 3/50 (6%) 2/50 (4%) | | 6/50 (12%) 13/50 (26%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 53/250 (21.2%) Mean 21.2% SD 6.72% Total 9/249 (3.61%) Mean 3.61% SD 1.66% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 8/50 (16%) 6/50 (12%) 6/50 (12%) 6/49 (12%) 1/50 (2%) 1/50 (2%) | | 7/50 (14%) 12/50 (24%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 39/250 (15.6%) Mean 15.6% SD 4.98% Total 8/249 (3.21%) Mean 3.25% SD 5.13% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 15/50 (30%) 18/50 (36%) 17/50 (34%) 7/49 (14%) 4/50 (8%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma 13/50 (26%) 22/50 (44%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 85/250 (34%) Mean 34% SD 6.78% Total 17/249 (6.83%) Mean 6.86% SD 4.72% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangioma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% Total 1/248 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (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%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/49 (2%) 0/47 (0%) 2/50 (4%) | | 1/49 (2%) 1/48 (2%) | | Overall Incidence Total 5/243 (2.06%) Mean 2.03% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/49 (2%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/49 (2%) 0/47 (0%) 0/50 (0%) | | Malignant, NOS 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 1/49 (2%) 0/47 (0%) 0/50 (0%) | | 1/49 (2%) 0/48 (0%) | | Overall Incidence Total 2/243 (0.82%) Mean 0.82% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/49 (2%) 0/47 (0%) 2/50 (4%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 3/243 (1.23%) Mean 1.21% SD 1.79% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 1/49 (2%) 0/48 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/243 (0%) 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: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/48 (2%) 0/48 (0%) 0/43 (0%) 13/49 (27%) 10/50 (20%) 9/48 (19%) | | Adenoma 0/49 (0%) 1/50 (2%) 10/47 (21%) 8/49 (16%) | | Overall Incidence Total 2/238 (0.84%) Mean 0.82% SD 1.12% Total 50/243 (20.58%) Mean 20.58% SD 3.8% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/48 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Carcinoma 0/49 (0%) 1/50 (2%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 1/238 (0.42%) Mean 0.4% SD 0.89% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/48 (2%) 0/48 (0%) 0/43 (0%) 13/49 (27%) 10/50 (20%) 9/48 (19%) | | Carcinoma or Adenoma 0/49 (0%) 2/50 (4%) 10/47 (21%) 8/49 (16%) | | Overall Incidence Total 3/238 (1.26%) Mean 1.22% SD 1.8% Total 50/243 (20.58%) Mean 20.58% SD 3.8% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/48 (0%) 0/43 (0%) 1/49 (2%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/48 (0%) 0/43 (0%) 1/49 (2%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/48 (0%) 0/50 (0%) 1/49 (2%) | | 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 1/49 (2%) | | 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 43 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 44 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 45 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 3/249 (1.2%) Mean 1.2% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) 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: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 6/249 (2.41%) Mean 2.42% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 6/249 (2.41%) Mean 2.42% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 47 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 6/249 (2.41%) Mean 2.42% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/49 (0%) 2/50 (4%) 2/48 (4%) 1/49 (2%) 1/50 (2%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) | | Overall Incidence Total 4/246 (1.63%) Mean 1.63% SD 2.24% Total 5/247 (2.02%) Mean 2.02% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 2.19% Total 3/249 (1.2%) Mean 1.2% SD 1.79% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 48 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 2/249 (0.8%) Mean 0.8% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 2/50 (4%) 2/50 (4%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/250 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli Tumor: Benign, 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/44 (0%) 0/35 (0%) 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) | | 0/41 (0%) 0/35 (0%) 0/43 (0%) 0/44 (0%) | | Overall Incidence Total 0/195 (0%) Mean 0% SD 0% Total 0/227 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/44 (0%) 0/35 (0%) 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) | | 0/41 (0%) 0/35 (0%) 0/43 (0%) 0/44 (0%) | | Overall Incidence Total 0/195 (0%) Mean 0% SD 0% Total 0/227 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 49 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/44 (0%) 0/35 (0%) 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) | | 0/41 (0%) 0/35 (0%) 0/43 (0%) 0/44 (0%) | | Overall Incidence Total 0/195 (0%) Mean 0% SD 0% Total 0/227 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/48 (0%) 0/47 (0%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 1/49 (2%) 0/48 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 2/240 (0.83%) Mean 0.82% SD 1.13% Total 3/248 (1.21%) Mean 1.21% SD 1.79% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/48 (0%) 1/47 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/240 (0.42%) Mean 0.43% SD 0.95% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/48 (0%) 1/47 (2%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 1/49 (2%) 0/48 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 3/240 (1.25%) Mean 1.25% SD 1.14% Total 3/248 (1.21%) Mean 1.21% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 50 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 2/246 (0.81%) Mean 0.82% SD 1.12% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 2/246 (0.81%) Mean 0.82% SD 1.12% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 51 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 4/249 (1.61%) Mean 1.6% SD 2.19% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 3/50 (6%) 2/50 (4%) | | Overall Incidence Total 6/249 (2.41%) Mean 2.4% SD 2.61% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 52 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: INHALATION Date of Species: MICE Vehicle: AIR Input File: 19-APR-2004 Strain: B6C3F1 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 53 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 23/50 (46%) 30/60 (50%) 25/50 (50%) 13/50 (26%) 21/60 (35%) 17/50 (34%) | | Overall Incidence Total 78/160 (48.75%) Mean 48.67% SD 2.31% Total 51/160 (31.88%) Mean 31.67% SD 4.93% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 20/50 (40%) 26/60 (43%) 14/50 (28%) 12/50 (24%) 16/60 (27%) 9/50 (18%) | | Overall Incidence Total 60/160 (37.5%) Mean 37.11% SD 8.06% Total 37/160 (23.13%) Mean 22.89% SD 4.44% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 32/50 (64%) 45/60 (75%) 31/50 (62%) 23/50 (46%) 33/60 (55%) 21/50 (42%) | | Overall Incidence Total 108/160 (67.5%) Mean 67% SD 7% Total 77/160 (48.13%) Mean 47.67% SD 6.66% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 3/60 (5%) 1/50 (2%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 4/160 (2.5%) Mean 2.33% SD 2.52% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 2/50 (4%) 4/60 (7%) 1/50 (2%) 2/50 (4%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 7/160 (4.38%) Mean 4.22% SD 2.34% Total 3/160 (1.88%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/50 (4%) 5/60 (8%) 1/50 (2%) 2/50 (4%) 3/60 (5%) 2/50 (4%) | | Overall Incidence Total 8/160 (5%) Mean 4.78% SD 3.24% Total 7/160 (4.38%) Mean 4.33% SD 0.58% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/160 (1.88%) Mean 1.89% SD 0.19% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 3/60 (5%) 3/50 (6%) 6/50 (12%) 8/60 (13%) 3/50 (6%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 8/160 (5%) Mean 5% SD 1% Total 17/160 (10.63%) Mean 10.44% SD 3.91% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 54 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 2/60 (3%) 3/49 (6%) 0/50 (0%) 1/59 (2%) 0/50 (0%) | | Overall Incidence Total 5/159 (3.14%) Mean 3.15% SD 3.07% Total 1/159 (0.63%) Mean 0.56% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Complex, Malignant, NOS | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 55 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 56 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Adenoma 0/46 (0%) 0/54 (0%) 0/49 (0%) 0/49 (0%) 0/54 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/152 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/46 (0%) 0/54 (0%) 0/49 (0%) 0/49 (0%) 0/54 (0%) 0/49 (0%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 0/152 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 9/50 (18%) 4/60 (7%) 3/50 (6%) 3/50 (6%) 4/60 (7%) 2/50 (4%) | | Overall Incidence Total 16/160 (10%) Mean 10.22% SD 6.74% Total 9/160 (5.63%) Mean 5.56% SD 1.39% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 2/160 (1.25%) Mean 1.22% SD 1.07% Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 10/50 (20%) 5/60 (8%) 3/50 (6%) 4/50 (8%) 5/60 (8%) 2/50 (4%) | | Overall Incidence Total 18/160 (11.25%) Mean 11.44% SD 7.5% Total 11/160 (6.88%) Mean 6.78% SD 2.41% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 57 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/160 (1.88%) Mean 1.78% SD 1.68% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 58 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/160 (1.88%) Mean 1.78% SD 1.68% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/160 (1.88%) Mean 1.78% SD 1.68% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 1/50 (2%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 1/158 (0.63%) Mean 0.67% SD 1.15% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 1/158 (0.63%) Mean 0.67% SD 1.15% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/158 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 59 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 3/160 (1.88%) Mean 1.89% SD 0.19% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 7/50 (14%) 18/60 (30%) 14/50 (28%) 3/50 (6%) 7/60 (12%) 6/49 (12%) | | Overall Incidence Total 39/160 (24.38%) Mean 24% SD 8.72% Total 16/159 (10.06%) Mean 9.97% SD 3.45% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 4/50 (8%) 12/60 (20%) 8/50 (16%) 2/50 (4%) 2/60 (3%) 3/49 (6%) | | Overall Incidence Total 24/160 (15%) Mean 14.67% SD 6.11% Total 7/159 (4.4%) Mean 4.49% SD 1.46% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 4/50 (8%) 13/60 (22%) 8/50 (16%) 2/50 (4%) 2/60 (3%) 3/49 (6%) | | Hepatoblastoma | | Overall Incidence Total 25/160 (15.63%) Mean 15.22% SD 6.87% Total 7/159 (4.4%) Mean 4.49% SD 1.46% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 27/60 (45%) 20/50 (40%) 4/50 (8%) 9/60 (15%) 8/49 (16%) | | Hepatocellular Adenoma | | Overall Incidence Total 57/160 (35.63%) Mean 35% SD 13.23% Total 21/159 (13.21%) Mean 13.11% SD 4.47% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 10/50 (20%) 28/60 (47%) 20/50 (40%) 4/50 (8%) 9/60 (15%) 8/49 (16%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 58/160 (36.25%) Mean 35.56% SD 13.88% Total 21/159 (13.21%) Mean 13.11% SD 4.47% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 2/160 (1.25%) Mean 1.33% SD 2.31% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 60 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 11/50 (22%) 9/60 (15%) 6/50 (12%) 4/50 (8%) 2/60 (3%) 5/50 (10%) | | Overall Incidence Total 26/160 (16.25%) Mean 16.33% SD 5.13% Total 11/160 (6.88%) Mean 7.11% SD 3.42% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 6/50 (12%) 5/60 (8%) 2/50 (4%) 0/50 (0%) 3/60 (5%) 1/50 (2%) | | Overall Incidence Total 13/160 (8.13%) Mean 8.11% SD 4% Total 4/160 (2.5%) Mean 2.33% SD 2.52% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 14/60 (23%) 8/50 (16%) 4/50 (8%) 5/60 (8%) 6/50 (12%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 36/160 (22.5%) Mean 22.44% SD 6.05% Total 15/160 (9.38%) Mean 9.44% SD 2.22% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 61 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 62 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 1/59 (2%) 3/48 (6%) | | Overall Incidence Total 4/157 (2.55%) Mean 2.65% SD 3.23% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/59 (0%) 1/48 (2%) | | Overall Incidence Total 1/157 (0.64%) Mean 0.69% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/59 (0%) 1/48 (2%) | | Malignant, NOS | | Overall Incidence Total 1/157 (0.64%) Mean 0.69% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) 0/59 (0%) 1/48 (2%) | | Overall Incidence Total 1/157 (0.64%) Mean 0.69% SD 1.2% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) 0/59 (0%) 0/48 (0%) | | Overall Incidence Total 0/157 (0%) 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: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 2/59 (3%) 0/48 (0%) | | Overall Incidence Total 2/157 (1.27%) Mean 1.13% SD 1.96% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) 0/59 (0%) 0/48 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) 0/59 (0%) 0/48 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/59 (0%) 0/48 (0%) | | Overall Incidence Total 0/157 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 1/53 (2%) 0/46 (0%) 1/50 (2%) 3/58 (5%) 0/45 (0%) | | Adenoma | | Overall Incidence Total 1/148 (0.68%) Mean 0.63% SD 1.09% Total 4/153 (2.61%) Mean 2.39% SD 2.61% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/53 (0%) 0/46 (0%) 0/50 (0%) 0/58 (0%) 0/45 (0%) | | Carcinoma | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/153 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 1/53 (2%) 0/46 (0%) 1/50 (2%) 3/58 (5%) 0/45 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 1/148 (0.68%) Mean 0.63% SD 1.09% Total 4/153 (2.61%) Mean 2.39% SD 2.61% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/49 (0%) 0/53 (0%) 0/46 (0%) 0/50 (0%) 0/58 (0%) 0/45 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/153 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/49 (0%) 0/53 (0%) 0/46 (0%) 0/50 (0%) 0/58 (0%) 0/45 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 0/153 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 65 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 2/160 (1.25%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 66 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 67 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 3/160 (1.88%) Mean 1.89% SD 2.01% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 3/160 (1.88%) Mean 1.89% SD 2.01% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 1/50 (2%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 2/160 (1.25%) Mean 1.22% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 3/160 (1.88%) Mean 1.78% SD 1.68% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 68 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/60 (0%) 1/50 (2%) 2/50 (4%) 1/60 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 3/160 (1.88%) Mean 1.89% SD 2.01% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 1/50 (2%) 2/50 (4%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% Total 3/160 (1.88%) Mean 1.89% SD 2.01% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli Tumor: Benign, 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Malignant, NOS | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 69 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli Cell Tumor Malignant 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/47 (0%) 0/57 (0%) 0/47 (0%) 0/50 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/151 (0%) Mean 0% SD 0% Total 0/155 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/47 (0%) 0/57 (0%) 0/47 (0%) 0/50 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/151 (0%) Mean 0% SD 0% Total 0/155 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/47 (0%) 0/57 (0%) 0/47 (0%) 0/50 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/151 (0%) Mean 0% SD 0% Total 0/155 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/59 (2%) 0/50 (0%) 1/49 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/159 (0.63%) Mean 0.56% SD 0.98% Total 1/159 (0.63%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/159 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 1/59 (2%) 0/50 (0%) 1/49 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/159 (0.63%) Mean 0.56% SD 0.98% Total 1/159 (0.63%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/160 (1.25%) Mean 1.11% SD 1.92% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 70 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) | | Overall Incidence Total 0/159 (0%) Mean 0% SD 0% Total 0/158 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.56% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 71 Version: 04/26/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: MICE Vehicle: FEED Input File: 19-APR-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 2/60 (3%) 3/50 (6%) | | Overall Incidence Total 5/160 (3.13%) Mean 3.11% SD 3.01% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/160 (0.63%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/50 (2%) 2/60 (3%) 3/50 (6%) | | Overall Incidence Total 6/160 (3.75%) Mean 3.78% SD 2.04% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/160 (0%) Mean 0% SD 0% Total 0/160 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________