Toxicology Data Management System Page: 1 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-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 058803106 03/19/97 729 50(1) 40 (703) 53.9 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800706 08/02/95 727 50(1) 39 (708) 51.4 SODIUM NITRITE | |SOUTHERN RESEARCH 059601004 09/30/98 729 50(1) 38 (694) 54.1 SODIUM DICHLORATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058803106 03/19/97 728 50(5) 37 (699) 61.4 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800706 08/02/95 728 50(5) 40 (702) 58.8 SODIUM NITRITE | |SOUTHERN RESEARCH 059601004 09/30/98 735 50(5) 36 (691) 66.5 SODIUM DICHLORATE | |________________________________________________________________________________________________________________________________| This page intentionally left blank Toxicology Data Management System Page: 3 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 27/50 (54%) 28/50 (56%) 34/50 (68%) 22/50 (44%) 13/50 (26%) 38/50 (76%) | | Overall Incidence Total 89/150 (59.33%) Mean 59.33% SD 7.57% Total 73/150 (48.67%) Mean 48.67% SD 25.32% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 19/50 (38%) 27/50 (54%) 29/50 (58%) 18/50 (36%) 12/50 (24%) 33/50 (66%) | | Overall Incidence Total 75/150 (50%) Mean 50% SD 10.58% Total 63/150 (42%) Mean 42% SD 21.63% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 39/50 (78%) 40/50 (80%) 45/50 (90%) 32/50 (64%) 21/50 (42%) 47/50 (94%) | | Overall Incidence Total 124/150 (82.67%)Mean 82.67% SD 6.43% Total 100/150 (66.67%) Mean 66.67% SD 26.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 2.31% Total 4/150 (2.67%) Mean 2.67% SD 2.31% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 7/50 (14%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 8/150 (5.33%) Mean 5.33% SD 7.57% Total 7/150 (4.67%) Mean 4.67% SD 2.31% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 2/50 (4%) 7/50 (14%) 1/50 (2%) 5/50 (10%) 1/50 (2%) 5/50 (10%) | | Overall Incidence Total 10/150 (6.67%) Mean 6.67% SD 6.43% Total 11/150 (7.33%) Mean 7.33% SD 4.62% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 1/50 (2%) 3/50 (6%) 5/50 (10%) 7/50 (14%) 23/50 (46%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 5/150 (3.33%) Mean 3.33% SD 2.31% Total 35/150 (23.33%) Mean 23.33% SD 19.73% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 3.46% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 4 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | Complex, Malignant, NOS | | Overall Incidence Total 0/149 (0%) Mean 0% SD 0% Total 3/150 (2%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/149 (1.34%) Mean 1.33% SD 2.31% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 2/50 (4%) 4/50 (8%) 6/50 (12%) 1/50 (2%) 0/50 (0%) 11/50 (22%) | | Overall Incidence Total 12/150 (8%) Mean 8% SD 4% Total 12/150 (8%) Mean 8% SD 12.17% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 3/50 (6%) 4/50 (8%) 6/50 (12%) 1/50 (2%) 0/50 (0%) 12/50 (24%) | | Overall Incidence Total 13/150 (8.67%) Mean 8.67% SD 3.06% Total 13/150 (8.67%) Mean 8.67% SD 13.32% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 2% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/50 (2%) 5/50 (10%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/150 (5.33%) Mean 5.33% SD 4.16% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 5 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 5/50 (10%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/150 (5.33%) Mean 5.33% SD 4.16% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 5/50 (10%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/150 (6%) Mean 6% SD 4% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/150 (2.67%) Mean 2.67% SD 2.31% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 0/50 (0%) 3/50 (6%) 1/48 (2%) 2/50 (4%) 0/50 (0%) 0/46 (0%) | | Overall Incidence Total 4/148 (2.7%) Mean 2.69% SD 3.05% Total 2/146 (1.37%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 0/50 (0%) 3/50 (6%) 1/48 (2%) 2/50 (4%) 0/50 (0%) 0/46 (0%) | | Overall Incidence Total 4/148 (2.7%) Mean 2.69% SD 3.05% Total 2/146 (1.37%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/149 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/148 (0.68%) Mean 0.69% SD 1.2% Total 0/149 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/48 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | | Overall Incidence Total 1/148 (0.68%) Mean 0.67% SD 1.15% Total 3/149 (2.01%) Mean 2.03% SD 2.04% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 0/50 (0%) 2/50 (4%) 1/48 (2%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 3/148 (2.03%) Mean 2.03% SD 2% Total 3/149 (2.01%) Mean 2.01% SD 2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 5/50 (10%) 6/48 (13%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 11/148 (7.43%) Mean 7.5% SD 6.61% Total 1/149 (0.67%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 6 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 17/50 (34%) 19/50 (38%) 30/48 (63%) 11/50 (22%) 9/50 (18%) 30/49 (61%) | | Overall Incidence Total 66/148 (44.59%) Mean 44.83% SD 15.43% Total 50/149 (33.56%) Mean 33.74% SD 23.88% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 14/50 (28%) 9/50 (18%) 20/48 (42%) 7/50 (14%) 2/50 (4%) 3/49 (6%) | | Overall Incidence Total 43/148 (29.05%) Mean 29.22% SD 11.88% Total 12/149 (8.05%) Mean 8.04% SD 5.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 14/50 (28%) 12/50 (24%) 23/48 (48%) 7/50 (14%) 2/50 (4%) 4/49 (8%) | | Hepatoblastoma | | Overall Incidence Total 49/148 (33.11%) Mean 33.31% SD 12.81% Total 13/149 (8.72%) Mean 8.72% SD 5.02% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 29/50 (58%) 24/50 (48%) 41/48 (85%) 17/50 (34%) 10/50 (20%) 31/49 (63%) | | Hepatocellular Adenoma | | Overall Incidence Total 94/148 (63.51%) Mean 63.81% SD 19.37% Total 58/149 (38.93%) Mean 39.09% SD 22.08% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 29/50 (58%) 26/50 (52%) 41/48 (85%) 17/50 (34%) 10/50 (20%) 31/49 (63%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 96/148 (64.86%) Mean 65.14% SD 17.82% Total 58/149 (38.93%) Mean 39.09% SD 22.08% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 1/149 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 3/50 (6%) 10/50 (20%) 6/50 (12%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 19/150 (12.67%) Mean 12.67% SD 7.02% Total 6/150 (4%) Mean 4% SD 2% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 4/50 (8%) 4/50 (8%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 11/150 (7.33%) Mean 7.33% SD 1.15% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 6/50 (12%) 13/50 (26%) 10/50 (20%) 3/50 (6%) 1/50 (2%) 4/50 (8%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 29/150 (19.33%) Mean 19.33% SD 7.02% Total 8/150 (5.33%) Mean 5.33% SD 3.06% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 7 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | or Adenoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/47 (0%) 1/45 (2%) | | Overall Incidence Total 1/142 (0.7%) Mean 0.74% SD 1.28% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) 0/47 (0%) 1/45 (2%) | | Overall Incidence Total 2/142 (1.41%) Mean 1.41% SD 1.22% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) 0/47 (0%) 1/45 (2%) | | Malignant, NOS | | Overall Incidence Total 2/142 (1.41%) Mean 1.41% SD 1.22% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 8 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/47 (0%) 3/45 (7%) | | Overall Incidence Total 3/142 (2.11%) Mean 2.22% SD 3.85% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/49 (0%) 0/47 (0%) 1/49 (2%) 1/48 (2%) 3/46 (7%) | | Adenoma | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 5/143 (3.5%) Mean 3.55% SD 2.57% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/49 (0%) 0/47 (0%) 1/49 (2%) 1/48 (2%) 3/46 (7%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/145 (0%) Mean 0% SD 0% Total 5/143 (3.5%) Mean 3.55% SD 2.57% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/49 (2%) 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/143 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/49 (2%) 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 1/145 (0.69%) Mean 0.68% SD 1.18% Total 0/143 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 2/150 (1.33%) Mean 1.33% SD 2.31% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 4/150 (2.67%) Mean 2.67% SD 3.06% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 4/150 (2.67%) Mean 2.67% SD 3.06% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | (malignant or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 3/150 (2%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 9 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-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%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 3/150 (2%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 4/150 (2.67%) Mean 2.67% SD 3.06% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 3/150 (2%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 3/50 (6%) 0/48 (0%) 1/50 (2%) 0/49 (0%) 2/49 (4%) | | Overall Incidence Total 3/148 (2.03%) Mean 2% SD 3.46% Total 3/148 (2.03%) Mean 2.03% SD 2.04% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 0/150 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 2/150 (1.33%) Mean 1.33% SD 1.15% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% Total 3/150 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/150 (2%) Mean 2% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/46 (0%) 0/37 (0%) 0/43 (0%) 1/49 (2%) 0/46 (0%) 0/48 (0%) | | Overall Incidence Total 0/126 (0%) Mean 0% SD 0% Total 1/143 (0.7%) Mean 0.68% SD 1.18% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/46 (0%) 0/37 (0%) 0/43 (0%) 0/49 (0%) 1/46 (2%) 0/48 (0%) | | Overall Incidence Total 0/126 (0%) Mean 0% SD 0% Total 1/143 (0.7%) Mean 0.72% SD 1.26% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/46 (0%) 0/37 (0%) 0/43 (0%) 0/49 (0%) 1/46 (2%) 0/48 (0%) | | Overall Incidence Total 0/126 (0%) Mean 0% SD 0% Total 1/143 (0.7%) Mean 0.72% SD 1.26% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 1/48 (2%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 1/146 (0.68%) Mean 0.69% SD 1.2% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: MICE Vehicle: WATER Input File: 9-NOV-2004 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) 1/48 (2%) | | Overall Incidence Total 0/148 (0%) Mean 0% SD 0% Total 1/146 (0.68%) Mean 0.69% SD 1.2% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/150 (0%) Mean 0% SD 0% Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/150 (0.67%) Mean 0.67% SD 1.15% | __________________________________________________________________________________________________________________________________