Toxicology Data Management System Page: 1 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058803105 03/31/97 729 50(3) 23 (662) 519.6 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800705 08/14/95 729 50(3) 29 (665) 502.2 SODIUM NITRITE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058803105 03/31/97 729 50(5) 30 (683) 350.8 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800705 08/14/95 730 50(5) 33 (695) 350.1 SODIUM NITRITE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059601003 09/16/98 729 50(3) 36 (687) 514.1 SODIUM DICHLORATE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059601003 09/16/98 734 50(5) 37 (699) 341.7 SODIUM DICHLORATE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 47/50 (94%) 44/50 (88%) 42/50 (84%) | | Overall Incidence Total 94/100 (94%) Mean 94% SD 0% Total 86/100 (86%) Mean 86% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 35/50 (70%) 30/50 (60%) 25/50 (50%) 23/50 (46%) | | Overall Incidence Total 65/100 (65%) Mean 65% SD 7.07% Total 48/100 (48%) Mean 48% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 50/50 (100%) 45/50 (90%) | | Overall Incidence Total 98/100 (98%) Mean 98% SD 0% Total 95/100 (95%) Mean 95% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 16/50 (32%) 17/50 (34%) 10/50 (20%) 15/50 (30%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 33/100 (33%) Mean 33% SD 1.41% Total 25/100 (25%) Mean 25% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 9/100 (9%) Mean 9% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/100 (9%) Mean 9% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/47 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ *: 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: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 4/47 (9%) 6/50 (12%) 0/49 (0%) 4/50 (8%) | | Overall Incidence Total 10/97 (10.31%) Mean 10.26% SD 2.47% Total 4/99 (4.04%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 5/47 (11%) 1/50 (2%) 2/49 (4%) 0/50 (0%) | | Overall Incidence Total 6/97 (6.19%) Mean 6.32% SD 6.11% Total 2/99 (2.02%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 9/47 (19%) 7/50 (14%) 2/49 (4%) 4/50 (8%) | | Complex, Malignant, NOS | | Overall Incidence Total 16/97 (16.49%) Mean 16.57% SD 3.64% Total 6/99 (6.06%) Mean 6.04% SD 2.77% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 3/50 (6%) 0/50 (0%) 6/48 (13%) 8/46 (17%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 14/94 (14.89%) Mean 14.95% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/50 (6%) 5/50 (10%) 5/48 (10%) 2/46 (4%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 7/94 (7.45%) Mean 7.38% SD 4.29% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 6/50 (12%) 5/50 (10%) 10/48 (21%) 10/46 (22%) | | Overall Incidence Total 11/100 (11%) Mean 11% SD 1.41% Total 20/94 (21.28%) Mean 21.29% SD 0.64% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: 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: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/44 (5%) 4/50 (8%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 6/94 (6.38%) Mean 6.27% SD 2.44% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/44 (0%) 1/50 (2%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1% SD 1.41% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/44 (5%) 5/50 (10%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 7/94 (7.45%) Mean 7.27% SD 3.86% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ *: 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: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 5/100 (5%) Mean 5% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 6/100 (6%) Mean 6% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 1/50 (2%) 3/50 (6%) 36/50 (72%) 21/50 (42%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 57/100 (57%) Mean 57% SD 21.21% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 1/50 (2%) 3/50 (6%) 36/50 (72%) 23/50 (46%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 59/100 (59%) Mean 59% SD 18.38% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 1/50 (2%) 3/50 (6%) 37/50 (74%) 23/50 (46%) | | or Adenoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 60/100 (60%) Mean 60% SD 19.8% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) | | Malignant, NOS | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 7 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/44 (0%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 1/44 (2%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1.14% SD 1.61% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/44 (2%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1.14% SD 1.61% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 2/44 (5%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 2/94 (2.13%) Mean 2.27% SD 3.21% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 1/45 (2%) 0/45 (0%) 0/49 (0%) 0/46 (0%) | | Overall Incidence Total 1/90 (1.11%) Mean 1.11% SD 1.57% Total 0/95 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/47 (32%) 13/50 (26%) 20/48 (42%) 24/50 (48%) | | Adenoma | | Overall Incidence Total 28/97 (28.87%) Mean 28.96% SD 4.18% Total 44/98 (44.9%) Mean 44.83% SD 4.48% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/47 (32%) 13/50 (26%) 21/48 (44%) 24/50 (48%) | | Carcinoma or Adenoma | | Overall Incidence Total 28/97 (28.87%) Mean 28.96% SD 4.18% Total 45/98 (45.92%) Mean 45.88% SD 3.01% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: 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: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: 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: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 6/50 (12%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 8.49% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 9/50 (18%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 10/100 (10%) Mean 10% SD 11.31% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: 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: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 47/50 (94%) | | Overall Incidence Total 92/100 (92%) Mean 92% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/39 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/39 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/42 (10%) 12/50 (24%) 6/45 (13%) 7/50 (14%) | | Overall Incidence Total 16/92 (17.39%) Mean 16.76% SD 10.24% Total 13/95 (13.68%) Mean 13.67% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/42 (5%) 2/50 (4%) 1/45 (2%) 2/50 (4%) | | Overall Incidence Total 4/92 (4.35%) Mean 4.38% SD 0.54% Total 3/95 (3.16%) Mean 3.11% SD 1.26% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 6/42 (14%) 14/50 (28%) 7/45 (16%) 9/50 (18%) | | Overall Incidence Total 20/92 (21.74%) Mean 21.14% SD 9.7% Total 16/95 (16.84%) Mean 16.78% SD 1.73% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 11 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/42 (2%) 1/50 (2%) 0/45 (0%) 1/50 (2%) | | Overall Incidence Total 2/92 (2.17%) Mean 2.19% SD 0.27% Total 1/95 (1.05%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/42 (0%) 1/50 (2%) 1/45 (2%) 1/50 (2%) | | Overall Incidence Total 1/92 (1.09%) Mean 1% SD 1.41% Total 2/95 (2.11%) Mean 2.11% SD 0.16% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/42 (2%) 2/50 (4%) 1/45 (2%) 2/50 (4%) | | Overall Incidence Total 3/92 (3.26%) Mean 3.19% SD 1.14% Total 3/95 (3.16%) Mean 3.11% SD 1.26% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/46 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.02% SD 1.44% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/46 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.02% SD 1.44% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 1/46 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.09% SD 1.54% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 8/50 (16%) 7/50 (14%) | | Overall Incidence Total 15/100 (15%) Mean 15% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 12 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 9/50 (18%) 7/50 (14%) | | Overall Incidence Total 16/100 (16%) Mean 16% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 13 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 48/50 (96%) 46/50 (92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 27/50 (54%) 21/50 (42%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 13/50 (26%) 11/50 (22%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 6/49 (12%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 3/49 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 9/49 (18%) 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/48 (2%) 11/49 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/48 (6%) 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 4/48 (8%) 14/49 (29%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 2/50 (4%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 5/50 (10%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/47 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/47 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/47 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 3/50 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 4/50 (8%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 33/50 (66%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 35/50 (70%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 37/50 (74%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/50 (2%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/49 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/49 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 16/48 (33%) 23/49 (47%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 1/49 (2%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 16/48 (33%) 24/49 (49%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 18 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 2/50 (4%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 3/50 (6%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 5/50 (10%) 3/50 (6%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 4/50 (8%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/50 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 9/50 (18%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 10/50 (20%) 4/50 (8%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 20 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 9/47 (19%) 12/47 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/47 (4%) 1/47 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 11/47 (23%) 13/47 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 21 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/47 (2%) 0/47 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/47 (0%) 1/47 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/47 (2%) 1/47 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/48 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 9/50 (18%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 11/09/04 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 9-NOV-2004 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 10/50 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________