Toxicology Data Management System Page: 1 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302306 07/11/97 729 50(3) 37 (693) 510.6 2,4-HEXADIENAL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302306 07/11/97 732 50(5) 37 (699) 314.6 2,4-HEXADIENAL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050516105 03/06/96 729 50(5) 33 (683) 322.1 RIDDELLIINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058812206 06/25/97 727 50(3) 26 (667) 483.6 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805005 10/30/95 729 50(3) 25 (665) 488.4 METHACRYLONITRILE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058812206 06/25/97 728 50(5) 30 (672) 327.2 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805005 10/30/95 731 50(5) 38 (710) 315.4 METHACRYLONITRILE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 4 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302607 08/14/97 733 50( ) 28 (684) 506.2 DECALIN | |BATTELLE NORTHWEST 058812403 01/18/96 733 50( ) 27 (667) 501.0 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 733 49( ) 24 (681) 507.1 NAPHTHALENE | |BATTELLE NORTHWEST 059000407 10/06/97 729 50( ) 27 (675) 540.3 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600105 01/18/99 729 50( ) 29 (701) 534.2 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142707 01/06/97 729 50( ) 20 (668) 518.0 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302607 08/14/97 734 50( ) 32 (700) 345.9 DECALIN | |BATTELLE NORTHWEST 058812403 01/18/96 735 50( ) 34 (682) 337.2 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 734 49( ) 28 (700) 325.2 NAPHTHALENE | |BATTELLE NORTHWEST 059000407 10/06/97 730 50( ) 33 (675) 366.9 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600105 01/18/99 730 50( ) 36 (696) 362.8 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142707 01/06/97 731 50( ) 33 (688) 351.1 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 5 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902905 09/26/94 736 100(5) 57 (692) 498.3 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902905 09/26/94 737 100(5) 59 (692) 338.0 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 6 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 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 055634803 06/06/96 726 50(3) 30 (687) 492.7 CITRAL | |BATTELLE COLUMBUS 058812003 12/18/95 729 50(3) 24 (659) 496.8 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611103 09/08/97 731 50(3) 29 (699) 492.1 TRANS-CINNAMALDEHYDE | |SOUTHERN RESEARCH 059201205 07/15/98 729 50(3) 35 (704) 446.9 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520308 02/08/96 729 60(3) 39 (698) 447.3 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520507 11/28/95 729 50(3) 31 (697) 443.8 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 055634803 06/06/96 732 50(5) 35 (703) 335.2 CITRAL | |BATTELLE COLUMBUS 058812003 12/18/95 730 50(5) 36 (694) 330.5 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611103 09/08/97 735 50(5) 34 (702) 344.4 TRANS-CINNAMALDEHYDE | |SOUTHERN RESEARCH 059201205 07/15/98 734 50(5) 40 (707) 320.6 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520308 02/08/96 730 60(5) 47 (713) 299.3 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520507 11/28/95 729 50(5) 39 (702) 295.2 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 7 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 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 | |________________________________________________________________________________________________________________________________| This page intentionally left blank Toxicology Data Management System Page: 9 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 48/50 (96%) 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 21/50 (42%) 18/50 (36%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 47/50 (94%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 11/50 (22%) 10/50 (20%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/50 (8%) 1/50 (2%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/50 (14%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 11 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 2/50 (4%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/49 (2%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/49 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 4/49 (8%) 7/50 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 12 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 13 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 1/50 (2%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 3/50 (6%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 23/50 (46%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 5/50 (10%) 24/50 (48%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 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: 17 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 12/50 (24%) 19/50 (38%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 12/50 (24%) 19/50 (38%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 18 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 5/50 (10%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 20 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 3/50 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 21 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 4/50 (8%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 7/50 (14%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 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: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 41/50 (82%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/50 (8%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 5/50 (10%) 13/50 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 25 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 14/50 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 14/50 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 27 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 20/50 (40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 47/50 (94%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 12/50 (24%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 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: 29 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 7/49 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 10/49 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 30 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 31 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 32 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 33 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 30/50 (60%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 36 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 1/50 (2%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 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: 42 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 43 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 45 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 47/50 (94%) 37/50 (74%) 35/50 (70%) | | Overall Incidence Total 96/100 (96%) Mean 96% SD 2.83% Total 72/100 (72%) Mean 72% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 29/50 (58%) 29/50 (58%) 12/50 (24%) 26/50 (52%) | | Overall Incidence Total 58/100 (58%) Mean 58% SD 0% Total 38/100 (38%) Mean 38% SD 19.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 42/50 (84%) 45/50 (90%) | | Overall Incidence Total 98/100 (98%) Mean 98% SD 0% Total 87/100 (87%) Mean 87% SD 4.24% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 15/50 (30%) 20/50 (40%) 7/50 (14%) 21/50 (42%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 35/100 (35%) Mean 35% SD 7.07% Total 28/100 (28%) Mean 28% SD 19.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 46 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/50 (14%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 10/100 (10%) Mean 10% SD 5.66% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 4/50 (8%) 3/50 (6%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 11/100 (11%) Mean 11% SD 4.24% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 47 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/49 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 5/99 (5.05%) Mean 5.04% SD 1.36% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 2/50 (4%) 3/50 (6%) 3/50 (6%) 3/49 (6%) | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 6/99 (6.06%) Mean 6.06% SD 0.09% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 48 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 49 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 50 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 51 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 2/50 (4%) 15/50 (30%) 21/50 (42%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 36/100 (36%) Mean 36% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 4/50 (8%) 2/50 (4%) 15/50 (30%) 21/50 (42%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 36/100 (36%) Mean 36% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 2/50 (4%) 16/50 (32%) 23/50 (46%) | | or Adenoma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 39/100 (39%) Mean 39% SD 9.9% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 52 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 1/50 (2%) | | Malignant, NOS | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 53 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/46 (0%) 0/46 (0%) 1/46 (2%) 1/48 (2%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 2/94 (2.13%) Mean 2.13% SD 0.06% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 19/50 (38%) 17/50 (34%) 21/50 (42%) 12/50 (24%) | | Adenoma | | Overall Incidence Total 36/100 (36%) Mean 36% SD 2.83% Total 33/100 (33%) Mean 33% SD 12.73% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 20/50 (40%) 17/50 (34%) 21/50 (42%) 13/50 (26%) | | Carcinoma or Adenoma | | Overall Incidence Total 37/100 (37%) Mean 37% SD 4.24% Total 34/100 (34%) Mean 34% SD 11.31% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 54 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 55 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Basosquamous Tumor Benign | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 56 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 57 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 58 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 44/50 (88%) 40/50 (80%) | | Overall Incidence Total 84/100 (84%) Mean 84% SD 5.66% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 59 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 8/50 (16%) 9/50 (18%) 11/50 (22%) 3/50 (6%) | | Overall Incidence Total 17/100 (17%) Mean 17% SD 1.41% Total 14/100 (14%) Mean 14% SD 11.31% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 10/50 (20%) 10/50 (20%) 11/50 (22%) 5/50 (10%) | | Overall Incidence Total 20/100 (20%) Mean 20% SD 0% Total 16/100 (16%) Mean 16% SD 8.49% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 60 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 61 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 63 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 47/50 (94%) 46/49 (94%) 46/50 (92%) 44/50 (88%) 38/49 (78%) | | 50/50 (100%) 50/50 (100%) 48/50 (96%) 41/50 (82%) 37/50 (74%) 41/50 (82%) | | Overall Incidence Total 288/299 (96.32%)Mean 96.31% SD 2.96% Total 247/299 (82.61%) Mean 82.59% SD 6.6% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 27/50 (54%) 26/50 (52%) 34/49 (69%) 25/50 (50%) 25/50 (50%) 26/49 (53%) | | 35/50 (70%) 33/50 (66%) 28/50 (56%) 33/50 (66%) 30/50 (60%) 28/50 (56%) | | Overall Incidence Total 183/299 (61.2%) Mean 61.23% SD 8.14% Total 167/299 (55.85%) Mean 55.84% SD 6.27% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 48/49 (98%) 49/50 (98%) 49/50 (98%) 44/49 (90%) | | 50/50 (100%) 50/50 (100%) 50/50 (100%) 49/50 (98%) 44/50 (88%) 47/50 (94%) | | Overall Incidence Total 296/299 (99%) Mean 98.99% SD 1.1% Total 282/299 (94.31%) Mean 94.3% SD 4.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 2/299 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 3/299 (1%) Mean 1.01% SD 1.7% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 19/50 (38%) 16/50 (32%) 26/49 (53%) 11/50 (22%) 14/50 (28%) 16/49 (33%) | | Mononuclear, or Undifferentiated 33/50 (66%) 25/50 (50%) 22/50 (44%) 24/50 (48%) 26/50 (52%) 21/50 (42%) | | Overall Incidence Total 141/299 (47.16%)Mean 47.18% SD 12.01% Total 112/299 (37.46%) Mean 37.44% SD 11.79% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.68% SD 1.67% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/50 (2%) 2/50 (4%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | NOS 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.68% SD 1.65% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/299 (2.01%) Mean 2% SD 1.79% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.67% SD 2.06% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.67% SD 2.06% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/49 (2%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.68% SD 1.67% Total 4/296 (1.35%) Mean 1.36% SD 1.67% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/296 (0.68%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/49 (14%) 10/50 (20%) 4/49 (8%) 1/50 (2%) 2/50 (4%) 3/48 (6%) | | 12/50 (24%) 5/50 (10%) 4/50 (8%) 2/49 (4%) 2/50 (4%) 2/49 (4%) | | Overall Incidence Total 42/298 (14.09%) Mean 14.07% SD 6.67% Total 12/296 (4.05%) Mean 4.07% SD 1.35% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 65 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/49 (4%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 7/298 (2.35%) Mean 2.35% SD 1.52% Total 1/296 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 8/49 (16%) 10/50 (20%) 5/49 (10%) 1/50 (2%) 2/50 (4%) 3/48 (6%) | | Complex, Malignant, NOS 14/50 (28%) 6/50 (12%) 5/50 (10%) 2/49 (4%) 3/50 (6%) 2/49 (4%) | | Overall Incidence Total 48/298 (16.11%) Mean 16.09% SD 7.01% Total 13/296 (4.39%) Mean 4.4% SD 1.56% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.67% SD 2.06% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.67% SD 2.06% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 66 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/297 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Astrocytoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/297 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 1/50 (2%) 3/48 (6%) 8/48 (17%) 5/49 (10%) 4/49 (8%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 5/298 (1.68%) Mean 1.71% SD 2.43% Total 20/295 (6.78%) Mean 6.84% SD 6.13% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 2/50 (4%) 3/48 (6%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 6/298 (2.01%) Mean 2.04% SD 2.61% Total 4/295 (1.36%) Mean 1.35% SD 1.64% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 3/50 (6%) 6/48 (13%) 9/48 (19%) 5/49 (10%) 4/49 (8%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/49 (2%) 2/50 (4%) | | Overall Incidence Total 11/298 (3.69%) Mean 3.75% SD 4.98% Total 24/295 (8.14%) Mean 8.19% SD 5.93% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 67 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 68 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 1/50 (2%) 2/49 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | | 4/50 (8%) 3/50 (6%) 1/50 (2%) 0/49 (0%) 1/49 (2%) 1/49 (2%) | | Overall Incidence Total 14/299 (4.68%) Mean 4.68% SD 2.42% Total 5/296 (1.69%) Mean 1.69% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 4/50 (8%) 2/50 (4%) 4/49 (8%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 0/49 (0%) 1/49 (2%) | | Overall Incidence Total 12/299 (4.01%) Mean 4.03% SD 3.39% Total 4/296 (1.35%) Mean 1.35% SD 1.05% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 7/50 (14%) 3/50 (6%) 6/49 (12%) 2/50 (4%) 1/50 (2%) 2/49 (4%) | | 4/50 (8%) 4/50 (8%) 2/50 (4%) 1/49 (2%) 1/49 (2%) 2/49 (4%) | | Overall Incidence Total 26/299 (8.7%) Mean 8.71% SD 3.77% Total 9/296 (3.04%) Mean 3.04% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 3/299 (1%) Mean 1% SD 1.1% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/296 (0.34%) Mean 0.35% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.33% SD 1.03% Total 1/296 (0.34%) Mean 0.35% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/296 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 69 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.34% SD 2.42% Total 2/297 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.34% SD 0.83% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.34% SD 0.83% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Hepatocellular Adenoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 5/299 (1.67%) Mean 1.68% SD 2.67% Total 2/297 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Hepatocellular Adenoma, or 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) 1/50 (2%) | | Hepatoblastoma | | Overall Incidence Total 5/299 (1.67%) Mean 1.68% SD 2.67% Total 2/297 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 6/50 (12%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 1/50 (2%) 4/50 (8%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 14/299 (4.68%) Mean 4.68% SD 4.5% Total 2/297 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 70 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.33% SD 1.03% Total 2/297 (0.67%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 7/50 (14%) 2/49 (4%) 2/50 (4%) 1/50 (2%) 1/49 (2%) | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 2/50 (4%) 4/50 (8%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 18/299 (6.02%) Mean 6.01% SD 4.37% Total 4/297 (1.35%) Mean 1.34% SD 1.64% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 1/49 (2%) 5/50 (10%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 5/50 (10%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 19/299 (6.35%) Mean 6.35% SD 3.88% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 0/50 (0%) 1/49 (2%) 5/50 (10%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 5/50 (10%) 4/50 (8%) 3/50 (6%) | | Overall Incidence Total 3/299 (1%) Mean 1.01% SD 1.68% Total 20/299 (6.69%) Mean 6.69% SD 3.72% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 71 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 2/50 (4%) 0/49 (0%) 25/50 (50%) 20/50 (40%) 17/49 (35%) | | 2/50 (4%) 3/50 (6%) 2/50 (4%) 25/50 (50%) 19/50 (38%) 16/50 (32%) | | Overall Incidence Total 11/299 (3.68%) Mean 3.67% SD 1.97% Total 122/299 (40.8%) Mean 40.78% SD 7.65% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 2/50 (4%) 0/49 (0%) 25/50 (50%) 20/50 (40%) 17/49 (35%) | | 2/50 (4%) 3/50 (6%) 2/50 (4%) 25/50 (50%) 19/50 (38%) 17/50 (34%) | | Overall Incidence Total 12/299 (4.01%) Mean 4% SD 2.19% Total 123/299 (41.14%) Mean 41.12% SD 7.22% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 2/50 (4%) 1/49 (2%) 29/50 (58%) 20/50 (40%) 18/49 (37%) | | or Adenoma 2/50 (4%) 3/50 (6%) 2/50 (4%) 27/50 (54%) 23/50 (46%) 19/50 (38%) | | Overall Incidence Total 14/299 (4.68%) Mean 4.67% SD 2.06% Total 136/299 (45.48%) Mean 45.46% SD 8.86% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.34% SD 0.83% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/297 (0.34%) Mean 0.33% SD 0.82% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/49 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 1/297 (0.34%) Mean 0.33% SD 0.82% Total 1/297 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 72 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 1/50 (2%) 0/49 (0%) 3/50 (6%) 0/50 (0%) 0/49 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 3/299 (1%) Mean 1% SD 2.45% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 2/49 (4%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.68% SD 1.67% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 1/50 (2%) 2/49 (4%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/299 (1%) Mean 1.01% SD 1.7% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/299 (1%) Mean 1.01% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 73 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.04% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/297 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 1/44 (2%) 0/45 (0%) 0/49 (0%) 0/40 (0%) 0/42 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/45 (0%) | | Overall Incidence Total 1/286 (0.35%) Mean 0.38% SD 0.93% Total 0/274 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) 36/49 (73%) 31/49 (63%) 34/50 (68%) 30/50 (60%) 23/49 (47%) | | Adenoma 35/50 (70%) 38/50 (76%) 35/50 (70%) 30/49 (61%) 27/49 (55%) 31/49 (63%) | | Overall Incidence Total 202/298 (67.79%)Mean 67.79% SD 8% Total 175/296 (59.12%) Mean 59.09% SD 7.29% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 74 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 2/298 (0.67%) Mean 0.67% SD 1.04% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) 37/49 (76%) 31/49 (63%) 34/50 (68%) 30/50 (60%) 23/49 (47%) | | Carcinoma or Adenoma 35/50 (70%) 39/50 (78%) 35/50 (70%) 30/49 (61%) 27/49 (55%) 31/49 (63%) | | Overall Incidence Total 204/298 (68.46%)Mean 68.46% SD 8.74% Total 175/296 (59.12%) Mean 59.09% SD 7.29% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/296 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/298 (0%) Mean 0% SD 0% Total 0/298 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 75 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/299 (2.01%) Mean 2.01% SD 2.19% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/299 (2.01%) Mean 2.01% SD 2.19% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 76 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 3/50 (6%) 2/50 (4%) 4/49 (8%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | | Carcinoma, Basosq. Tumor (M or 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 17/299 (5.69%) Mean 5.69% SD 2.97% Total 4/299 (1.34%) Mean 1.34% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 2/50 (4%) 4/49 (8%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 12/299 (4.01%) Mean 4.03% SD 3.39% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/299 (2.34%) Mean 2.34% SD 1.5% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 77 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.33% SD 1.03% Total 1/299 (0.33%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Papilloma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/299 (1.34%) Mean 1.33% SD 1.03% Total 1/299 (0.33%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 2/50 (4%) 4/49 (8%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | Papilloma, Squamous Cell 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 16/299 (5.35%) Mean 5.36% SD 3.04% Total 3/299 (1%) Mean 1.01% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 2/50 (4%) 4/49 (8%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Papilloma, or Keratoacanthoma 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 16/299 (5.35%) Mean 5.36% SD 3.04% Total 2/299 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 2/50 (4%) 1/50 (2%) 5/49 (10%) 0/50 (0%) 3/50 (6%) 0/49 (0%) | | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 14/299 (4.68%) Mean 4.7% SD 2.81% Total 5/299 (1.67%) Mean 1.67% SD 2.34% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 78 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 4/50 (8%) 2/50 (4%) 7/49 (14%) 2/50 (4%) 3/50 (6%) 1/49 (2%) | | Myxoma, Myxosarcoma, or Fibrous 3/50 (6%) 3/50 (6%) 6/50 (12%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | | Histiocytoma | | Overall Incidence Total 25/299 (8.36%) Mean 8.38% SD 3.97% Total 10/299 (3.34%) Mean 3.34% SD 2.42% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 1/50 (2%) 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/299 (2.68%) Mean 2.68% SD 1.05% Total 2/299 (0.67%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 2/49 (4%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | | Myxosarcoma, or Fibrous 1/50 (2%) 1/50 (2%) 4/50 (8%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Histiocytoma | | Overall Incidence Total 11/299 (3.68%) Mean 3.68% SD 2.34% Total 5/299 (1.67%) Mean 1.67% SD 1.97% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.63% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 2/299 (0.67%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 79 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/297 (0.34%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 40/50 (80%) 40/50 (80%) 38/49 (78%) | | 41/50 (82%) 41/50 (82%) 36/50 (72%) | | Overall Incidence Total 236/299 (78.93%)Mean 78.93% SD 3.77% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 80 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 0/49 (0%) 0/49 (0%) 0/45 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/289 (0%) Mean 0% SD 0% Total 0/280 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 1/49 (2%) 0/49 (0%) 0/45 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 1/289 (0.35%) Mean 0.34% SD 0.83% Total 0/280 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/46 (0%) | | 0/47 (0%) 1/49 (2%) 0/49 (0%) 0/45 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 1/289 (0.35%) Mean 0.34% SD 0.83% Total 0/280 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 7/50 (14%) 5/49 (10%) 9/46 (20%) 5/50 (10%) 6/47 (13%) 4/47 (9%) | | 3/50 (6%) 7/50 (14%) 1/50 (2%) 8/49 (16%) 3/49 (6%) 2/50 (4%) | | Overall Incidence Total 32/295 (10.85%) Mean 10.96% SD 6.29% Total 28/292 (9.59%) Mean 9.62% SD 4.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 1/49 (2%) 1/46 (2%) 3/50 (6%) 3/47 (6%) 3/47 (6%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/49 (4%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 5/295 (1.69%) Mean 1.7% SD 1.52% Total 13/292 (4.45%) Mean 4.48% SD 2.09% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 7/50 (14%) 6/49 (12%) 10/46 (22%) 8/50 (16%) 8/47 (17%) 7/47 (15%) | | 4/50 (8%) 9/50 (18%) 1/50 (2%) 9/49 (18%) 4/49 (8%) 3/50 (6%) | | Overall Incidence Total 37/295 (12.54%) Mean 12.66% SD 7.05% Total 39/292 (13.36%) Mean 13.41% SD 5.08% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/47 (0%) 0/47 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/295 (0%) Mean 0% SD 0% Total 0/292 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/49 (0%) 0/46 (0%) 0/50 (0%) 1/47 (2%) 1/47 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 2/295 (0.68%) Mean 0.67% SD 1.03% Total 4/292 (1.37%) Mean 1.38% SD 1.66% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 0/49 (0%) 0/46 (0%) 0/50 (0%) 1/47 (2%) 1/47 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | | Overall Incidence Total 2/295 (0.68%) Mean 0.67% SD 1.03% Total 4/292 (1.37%) Mean 1.38% SD 1.66% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 81 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 2/299 (0.67%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 1/295 (0.34%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 1/297 (0.34%) Mean 0.35% SD 0.85% Total 3/295 (1.02%) Mean 1.02% SD 1.12% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 82 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 1/295 (0.34%) Mean 0.34% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 1/297 (0.34%) Mean 0.35% SD 0.85% Total 2/295 (0.68%) Mean 0.69% SD 1.06% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/297 (0%) Mean 0% SD 0% Total 0/295 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/50 (14%) 10/50 (20%) 15/49 (31%) | | 5/50 (10%) 10/50 (20%) 6/50 (12%) | | Overall Incidence Total 53/299 (17.73%) Mean 17.77% SD 7.52% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 83 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 7/50 (14%) 10/50 (20%) 15/49 (31%) | | 5/50 (10%) 11/50 (22%) 6/50 (12%) | | Overall Incidence Total 54/299 (18.06%) Mean 18.1% SD 7.68% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/299 (0.67%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/299 (0%) Mean 0% SD 0% Total 0/299 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 6/299 (2.01%) Mean 2.01% SD 1.81% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/299 (0.33%) Mean 0.33% SD 0.82% Total 6/299 (2.01%) Mean 2.01% SD 1.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 85 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 99/100(99%) 92/100(92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 66/100(66%) 40/100(40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 100/100(100%) 98/100(98%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 50/100(50%) 20/100(20%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/100(0%) 0/100(0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/100(4%) 0/100(0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/100(4%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 86 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/99 (0%) 6/100(6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/99 (0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/98 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 24/98 (24%) 7/96 (7%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/98 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/98 (2%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 26/98 (27%) 7/96 (7%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 87 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 1/100(1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 2/100(2%) 2/100(2%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 13/100(13%) 11/90 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 13/100(13%) 11/90 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 88 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 2/100(2%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/99 (3%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 89 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 1/99 (1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 4/99 (4%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 90 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 0/100(0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/100(1%) 0/100(0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/100(1%) 0/100(0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 3/100(3%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/100(3%) 4/100(4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 91 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/100(0%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/100(0%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 6/100(6%) 56/100(56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 6/100(6%) 56/100(56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 6/100(6%) 58/100(58%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 92 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/100(0%) 0/100(0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/100(0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 93 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 3/98 (3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 3/98 (3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/85 (0%) 1/88 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/98 (35%) 61/99 (62%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/98 (0%) 3/99 (3%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/98 (35%) 64/99 (65%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 94 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 95 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 3/100(3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 3/100(3%) 0/100(0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 3/100(3%) 0/100(0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/100(0%) 0/100(0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 3/100(3%) 0/100(0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 14/100(14%) 1/100(1%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 96 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 10/100(10%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) 0/100(0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/100(1%) 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/100(11%) 1/100(1%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 97 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/100(11%) 1/100(1%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 12/100(12%) 4/100(4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 13/100(13%) 6/100(6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/100(1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/100(1%) 2/100(2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/100(0%) 0/100(0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/100(0%) 0/100(0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 98 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/100(1%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 93/100(93%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 99 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 2/97 (2%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/97 (0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 2/97 (2%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 15/99 (15%) 15/100(15%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/99 (1%) 5/100(5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 16/99 (16%) 19/100(19%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/99 (1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/99 (1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 100 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/100(0%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/99 (1%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/99 (1%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 101 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 13/100(13%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 13/100(13%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 103 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 50/50 (100%) 42/50 (84%) 50/50 (100%) 37/50 (74%) 37/50 (74%) 39/50 (78%) | | 49/50 (98%) 60/60 (100%) 49/50 (98%) 43/50 (86%) 47/60 (78%) 33/50 (66%) | | Overall Incidence Total 300/310 (96.77%)Mean 96.67% SD 6.28% Total 236/310 (76.13%) Mean 76.06% SD 6.59% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 35/50 (70%) 34/50 (68%) 30/50 (60%) 15/50 (30%) 16/50 (32%) 21/50 (42%) | | 22/50 (44%) 37/60 (62%) 33/50 (66%) 19/50 (38%) 24/60 (40%) 22/50 (44%) | | Overall Incidence Total 191/310 (61.61%)Mean 61.61% SD 9.41% Total 117/310 (37.74%) Mean 37.67% SD 5.57% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 49/50 (98%) 50/50 (100%) 47/50 (94%) 43/50 (86%) 45/50 (90%) | | 50/50 (100%) 60/60 (100%) 50/50 (100%) 45/50 (90%) 54/60 (90%) 43/50 (86%) | | Overall Incidence Total 309/310 (99.68%)Mean 99.67% SD 0.82% Total 277/310 (89.35%) Mean 89.33% SD 3.01% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.67% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 0.94% SD 1.04% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/60 (2%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 6/310 (1.94%) Mean 1.94% SD 1.27% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 33/50 (66%) 27/50 (54%) 22/50 (44%) 14/50 (28%) 8/50 (16%) 9/50 (18%) | | Mononuclear, or Undifferentiated 15/50 (30%) 30/60 (50%) 24/50 (48%) 6/50 (12%) 21/60 (35%) 13/50 (26%) | | Overall Incidence Total 151/310 (48.71%)Mean 48.67% SD 11.84% Total 71/310 (22.9%) Mean 22.5% SD 8.62% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Undifferentiated Cell Type | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.63% Total 2/310 (0.65%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 104 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS 2/50 (4%) 2/60 (3%) 5/50 (10%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 16/310 (5.16%) Mean 5.22% SD 2.51% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 2/60 (3%) 5/50 (10%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 16/310 (5.16%) Mean 5.22% SD 2.51% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.63% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 0.94% SD 1.64% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 5/50 (10%) 2/60 (3%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 11/310 (3.55%) Mean 3.56% SD 3.44% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/307 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 6/50 (12%) 4/50 (8%) 5/50 (10%) 2/49 (4%) 2/50 (4%) 0/50 (0%) | | 8/50 (16%) 2/60 (3%) 3/50 (6%) 0/49 (0%) 2/60 (3%) 2/49 (4%) | | Overall Incidence Total 28/310 (9.03%) Mean 9.22% SD 4.49% Total 8/307 (2.61%) Mean 2.58% SD 2.02% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/307 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 105 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.22% SD 1.91% Total 1/307 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 6/50 (12%) 5/50 (10%) 2/49 (4%) 2/50 (4%) 1/50 (2%) | | Complex, Malignant, NOS 8/50 (16%) 4/60 (7%) 3/50 (6%) 0/49 (0%) 2/60 (3%) 2/49 (4%) | | Overall Incidence Total 33/310 (10.65%) Mean 10.78% SD 3.99% Total 9/307 (2.93%) Mean 2.92% SD 1.64% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.63% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 0.94% SD 1.64% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 3/310 (0.97%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 106 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Astrocytoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 3/310 (0.97%) Mean 1% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 4/50 (8%) 3/50 (6%) 2/50 (4%) 9/49 (18%) 1/47 (2%) 4/49 (8%) | | 0/50 (0%) 2/60 (3%) 2/50 (4%) 5/50 (10%) 12/59 (20%) 7/50 (14%) | | Overall Incidence Total 13/310 (4.19%) Mean 4.22% SD 2.69% Total 38/304 (12.5%) Mean 12.17% SD 6.78% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/49 (0%) 0/47 (0%) 3/49 (6%) | | 0/50 (0%) 2/60 (3%) 2/50 (4%) 3/50 (6%) 2/59 (3%) 2/50 (4%) | | Overall Incidence Total 8/310 (2.58%) Mean 2.56% SD 2.36% Total 10/304 (3.29%) Mean 3.25% SD 2.74% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 5/50 (10%) 3/50 (6%) 5/50 (10%) 9/49 (18%) 1/47 (2%) 7/49 (14%) | | 0/50 (0%) 4/60 (7%) 4/50 (8%) 8/50 (16%) 14/59 (24%) 8/50 (16%) | | Overall Incidence Total 21/310 (6.77%) Mean 6.78% SD 3.71% Total 47/304 (15.46%) Mean 15.08% SD 7.15% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/304 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/304 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/304 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/304 (0.33%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 107 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 2/310 (0.65%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 108 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/60 (3%) 3/50 (6%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 7/309 (2.27%) Mean 2.23% SD 2.26% Total 1/310 (0.32%) Mean 0.28% SD 0.68% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/309 (0.97%) Mean 1% SD 1.67% Total 4/310 (1.29%) Mean 1.33% SD 2.07% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/49 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 0/50 (0%) 2/60 (3%) 5/50 (10%) 2/50 (4%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 10/309 (3.24%) Mean 3.23% SD 3.48% Total 5/310 (1.61%) Mean 1.61% SD 1.96% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 109 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.03% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/60 (3%) 0/50 (0%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 0.89% SD 1.44% Total 2/310 (0.65%) Mean 0.61% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.28% SD 1.61% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.28% SD 1.61% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma 0/50 (0%) 3/60 (5%) 1/50 (2%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 7/310 (2.26%) Mean 2.17% SD 2.04% Total 2/310 (0.65%) Mean 0.61% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 0/50 (0%) 3/60 (5%) 1/50 (2%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 7/310 (2.26%) Mean 2.17% SD 2.04% Total 2/310 (0.65%) Mean 0.61% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | 2/50 (4%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 10/310 (3.23%) Mean 3.28% SD 1.12% Total 4/310 (1.29%) Mean 1.28% SD 1.61% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 110 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 2/50 (4%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 0.94% SD 1.64% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma 4/50 (8%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 13/310 (4.19%) Mean 4.22% SD 2.01% Total 5/310 (1.61%) Mean 1.61% SD 2.33% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 4/50 (8%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 7/310 (2.26%) Mean 2.33% SD 2.94% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 4/50 (8%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 8/310 (2.58%) Mean 2.67% SD 3.01% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 111 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 3/50 (6%) 3/50 (6%) 2/50 (4%) 26/50 (52%) 15/50 (30%) 25/50 (50%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 26/50 (52%) 23/60 (38%) 14/50 (28%) | | Overall Incidence Total 8/310 (2.58%) Mean 2.67% SD 3.01% Total 129/310 (41.61%) Mean 41.72% SD 11.11% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 4/50 (8%) 3/50 (6%) 2/50 (4%) 26/50 (52%) 16/50 (32%) 25/50 (50%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 26/50 (52%) 23/60 (38%) 14/50 (28%) | | Overall Incidence Total 9/310 (2.9%) Mean 3% SD 3.52% Total 130/310 (41.94%) Mean 42.06% SD 10.71% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 3/50 (6%) 2/50 (4%) 26/50 (52%) 16/50 (32%) 26/50 (52%) | | or Adenoma 0/50 (0%) 0/60 (0%) 0/50 (0%) 28/50 (56%) 23/60 (38%) 14/50 (28%) | | Overall Incidence Total 9/310 (2.9%) Mean 3% SD 3.52% Total 133/310 (42.9%) Mean 43.06% SD 11.82% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 112 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.03% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 2/50 (4%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.03% Total 2/310 (0.65%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 113 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/309 (1.29%) Mean 1.28% SD 1% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/309 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 5/309 (1.62%) Mean 1.62% SD 0.8% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/48 (0%) 0/46 (0%) 0/47 (0%) 2/43 (5%) 0/45 (0%) 0/47 (0%) | | 0/47 (0%) 0/58 (0%) 0/48 (0%) 0/49 (0%) 0/57 (0%) 0/46 (0%) | | Overall Incidence Total 0/294 (0%) Mean 0% SD 0% Total 2/287 (0.7%) Mean 0.78% SD 1.9% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 8/50 (16%) 11/50 (22%) 13/50 (26%) 12/50 (24%) 23/50 (46%) 19/50 (38%) | | Adenoma 9/50 (18%) 11/59 (19%) 15/48 (31%) 23/50 (46%) 19/59 (32%) 15/50 (30%) | | Overall Incidence Total 67/307 (21.82%) Mean 21.98% SD 5.74% Total 111/309 (35.92%) Mean 36.03% SD 8.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 114 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/59 (0%) 1/48 (2%) 2/50 (4%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 1/307 (0.33%) Mean 0.35% SD 0.85% Total 2/309 (0.65%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 8/50 (16%) 11/50 (22%) 13/50 (26%) 12/50 (24%) 23/50 (46%) 19/50 (38%) | | Carcinoma or Adenoma 9/50 (18%) 11/59 (19%) 16/48 (33%) 25/50 (50%) 19/59 (32%) 15/50 (30%) | | Overall Incidence Total 68/307 (22.15%) Mean 22.33% SD 6.44% Total 113/309 (36.57%) Mean 36.7% SD 9.91% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/59 (0%) 0/48 (0%) 0/50 (0%) 1/59 (2%) 0/50 (0%) | | Overall Incidence Total 2/307 (0.65%) Mean 0.67% SD 1.03% Total 2/309 (0.65%) Mean 0.62% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/59 (0%) 0/48 (0%) 0/50 (0%) 1/59 (2%) 0/50 (0%) | | Overall Incidence Total 2/307 (0.65%) Mean 0.67% SD 1.03% Total 2/309 (0.65%) Mean 0.62% SD 0.96% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/60 (3%) 2/50 (4%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.22% SD 1.91% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/60 (3%) 2/50 (4%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.22% SD 1.91% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.67% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 115 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.28% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/60 (3%) 1/50 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.22% SD 1.42% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 2/60 (3%) 1/50 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/310 (1.29%) Mean 1.22% SD 1.42% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 1/50 (2%) 2/60 (3%) 1/50 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 7/310 (2.26%) Mean 2.22% SD 1.38% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 116 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 1/50 (2%) 2/60 (3%) 1/50 (2%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 8/310 (2.58%) Mean 2.56% SD 0.89% Total 2/310 (0.65%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 7/50 (14%) 6/50 (12%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 2/50 (4%) 7/60 (12%) 4/50 (8%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 30/310 (9.68%) Mean 9.61% SD 3.63% Total 2/310 (0.65%) Mean 0.67% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.63% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.61% SD 0.95% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 5/50 (10%) 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 5/60 (8%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 19/310 (6.13%) Mean 6.06% SD 2.88% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 4/310 (1.29%) Mean 1.33% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 117 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.1% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.1% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 6/50 (12%) 4/50 (8%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 1/50 (2%) 5/60 (8%) 3/50 (6%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 22/310 (7.1%) Mean 7.06% SD 3.31% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 6/50 (12%) 4/50 (8%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 1/50 (2%) 5/60 (8%) 3/50 (6%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 22/310 (7.1%) Mean 7.06% SD 3.31% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.1% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 5/60 (8%) 1/50 (2%) 1/50 (2%) 3/60 (5%) 0/50 (0%) | | Overall Incidence Total 12/310 (3.87%) Mean 3.72% SD 2.46% Total 4/310 (1.29%) Mean 1.17% SD 2.04% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 118 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 4/50 (8%) 4/50 (8%) 5/50 (10%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous 2/50 (4%) 5/60 (8%) 2/50 (4%) 1/50 (2%) 3/60 (5%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 22/310 (7.1%) Mean 7.06% SD 2.48% Total 7/310 (2.26%) Mean 2.17% SD 2.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 0/50 (0%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 6/310 (1.94%) Mean 2% SD 3.35% Total 2/310 (0.65%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 2/50 (4%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Myxosarcoma, or Fibrous 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 10/310 (3.23%) Mean 3.33% SD 3.27% Total 3/310 (0.97%) Mean 1% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.1% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 119 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/309 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 49/50 (98%) 41/50 (82%) 45/50 (90%) | | 48/50 (96%) 55/60 (92%) 49/50 (98%) | | Overall Incidence Total 287/310 (92.58%)Mean 92.61% SD 6.16% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 120 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/46 (0%) 0/43 (0%) 0/49 (0%) 0/46 (0%) 0/43 (0%) | | 0/48 (0%) 0/56 (0%) 0/49 (0%) 0/48 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/292 (0%) Mean 0% SD 0% Total 0/291 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/46 (0%) 0/43 (0%) 0/49 (0%) 0/46 (0%) 1/43 (2%) | | 0/48 (0%) 0/56 (0%) 0/49 (0%) 0/48 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/292 (0%) Mean 0% SD 0% Total 1/291 (0.34%) Mean 0.39% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/46 (0%) 0/43 (0%) 0/49 (0%) 0/46 (0%) 1/43 (2%) | | 0/48 (0%) 0/56 (0%) 0/49 (0%) 0/48 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/292 (0%) Mean 0% SD 0% Total 1/291 (0.34%) Mean 0.39% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 7/50 (14%) 8/50 (16%) 4/50 (8%) 8/50 (16%) 5/50 (10%) 5/50 (10%) | | 9/48 (19%) 10/59 (17%) 11/50 (22%) 9/49 (18%) 9/60 (15%) 6/50 (12%) | | Overall Incidence Total 49/307 (15.96%) Mean 15.95% SD 4.74% Total 42/309 (13.59%) Mean 13.56% SD 3.43% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | 1/48 (2%) 0/59 (0%) 0/50 (0%) 0/49 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 4/307 (1.3%) Mean 1.35% SD 1.64% Total 6/309 (1.94%) Mean 1.94% SD 2.53% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 9/50 (18%) 8/50 (16%) 5/50 (10%) 8/50 (16%) 7/50 (14%) 8/50 (16%) | | 10/48 (21%) 10/59 (17%) 11/50 (22%) 9/49 (18%) 10/60 (17%) 6/50 (12%) | | Overall Incidence Total 53/307 (17.26%) Mean 17.3% SD 4.25% Total 48/309 (15.53%) Mean 15.51% SD 2.22% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/48 (2%) 0/59 (0%) 0/50 (0%) 0/49 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 5/307 (1.63%) Mean 1.68% SD 2.34% Total 1/309 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/48 (0%) 1/59 (2%) 0/50 (0%) 1/49 (2%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/307 (0.98%) Mean 0.95% SD 1.05% Total 2/309 (0.65%) Mean 0.67% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 4/50 (8%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 1/48 (2%) 1/59 (2%) 0/50 (0%) 1/49 (2%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 8/307 (2.61%) Mean 2.63% SD 3.02% Total 3/309 (0.97%) Mean 1.01% SD 1.1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 121 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.03% Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/310 (0.65%) Mean 0.67% SD 1.03% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% Total 2/310 (0.65%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 122 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% Total 2/310 (0.65%) Mean 0.67% SD 1.03% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 14/50 (28%) 10/50 (20%) 7/50 (14%) | | 8/50 (16%) 11/60 (18%) 6/50 (12%) | | Overall Incidence Total 56/310 (18.06%) Mean 18.06% SD 5.66% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 123 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 14/50 (28%) 11/50 (22%) 7/50 (14%) | | 8/50 (16%) 11/60 (18%) 6/50 (12%) | | Overall Incidence Total 57/310 (18.39%) Mean 18.39% SD 5.85% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.33% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 1/310 (0.32%) Mean 0.28% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/310 (0%) Mean 0% SD 0% Total 2/310 (0.65%) Mean 0.61% SD 0.95% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.67% Total 1/310 (0.32%) Mean 0.28% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 2/60 (3%) 0/50 (0%) | | Overall Incidence Total 3/310 (0.97%) Mean 1% SD 1.67% Total 3/310 (0.97%) Mean 0.89% SD 1.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 125 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 47/50 (94%) 44/50 (88%) 42/50 (84%) | | Overall Incidence Total 94/100 (94%) Mean 94% SD 0% Total 86/100 (86%) Mean 86% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 35/50 (70%) 30/50 (60%) 25/50 (50%) 23/50 (46%) | | Overall Incidence Total 65/100 (65%) Mean 65% SD 7.07% Total 48/100 (48%) Mean 48% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 50/50 (100%) 45/50 (90%) | | Overall Incidence Total 98/100 (98%) Mean 98% SD 0% Total 95/100 (95%) Mean 95% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 16/50 (32%) 17/50 (34%) 10/50 (20%) 15/50 (30%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 33/100 (33%) Mean 33% SD 1.41% Total 25/100 (25%) Mean 25% SD 7.07% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 9/100 (9%) Mean 9% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/100 (9%) Mean 9% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 126 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/47 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 2/99 (2.02%) Mean 2.02% SD 0.03% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 4/47 (9%) 6/50 (12%) 0/49 (0%) 4/50 (8%) | | Overall Incidence Total 10/97 (10.31%) Mean 10.26% SD 2.47% Total 4/99 (4.04%) Mean 4% SD 5.66% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 5/47 (11%) 1/50 (2%) 2/49 (4%) 0/50 (0%) | | Overall Incidence Total 6/97 (6.19%) Mean 6.32% SD 6.11% Total 2/99 (2.02%) Mean 2.04% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 9/47 (19%) 7/50 (14%) 2/49 (4%) 4/50 (8%) | | Complex, Malignant, NOS | | Overall Incidence Total 16/97 (16.49%) Mean 16.57% SD 3.64% Total 6/99 (6.06%) Mean 6.04% SD 2.77% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 127 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 3/50 (6%) 0/50 (0%) 6/48 (13%) 8/46 (17%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 14/94 (14.89%) Mean 14.95% SD 3.46% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/50 (6%) 5/50 (10%) 5/48 (10%) 2/46 (4%) | | Overall Incidence Total 8/100 (8%) Mean 8% SD 2.83% Total 7/94 (7.45%) Mean 7.38% SD 4.29% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 6/50 (12%) 5/50 (10%) 10/48 (21%) 10/46 (22%) | | Overall Incidence Total 11/100 (11%) Mean 11% SD 1.41% Total 20/94 (21.28%) Mean 21.29% SD 0.64% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 128 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/94 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*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 | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 129 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/44 (0%) 1/50 (2%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1% SD 1.41% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/44 (5%) 5/50 (10%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 7/94 (7.45%) Mean 7.27% SD 3.86% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/97 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/97 (1.03%) Mean 1.06% SD 1.5% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 130 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 131 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 5/100 (5%) Mean 5% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 6/100 (6%) Mean 6% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 1/50 (2%) 3/50 (6%) 36/50 (72%) 21/50 (42%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 57/100 (57%) Mean 57% SD 21.21% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 1/50 (2%) 3/50 (6%) 36/50 (72%) 23/50 (46%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 59/100 (59%) Mean 59% SD 18.38% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 1/50 (2%) 3/50 (6%) 37/50 (74%) 23/50 (46%) | | or Adenoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 60/100 (60%) Mean 60% SD 19.8% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 132 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/96 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) | | Malignant, NOS | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 133 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 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% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/44 (0%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 1/44 (2%) 0/50 (0%) 0/47 (0%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1.14% SD 1.61% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/44 (2%) 0/50 (0%) 1/47 (2%) 0/50 (0%) | | Overall Incidence Total 1/94 (1.06%) Mean 1.14% SD 1.61% Total 1/97 (1.03%) Mean 1.06% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 134 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*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% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) | | Overall Incidence Total 1/98 (1.02%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/99 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 135 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 3/100 (3%) Mean 3% SD 4.24% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 136 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 137 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 138 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 4.24% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/43 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | | Overall Incidence Total 0/93 (0%) Mean 0% SD 0% Total 0/98 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 47/50 (94%) | | Overall Incidence Total 92/100 (92%) Mean 92% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 139 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/39 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/39 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 0/97 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/39 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 0/89 (0%) Mean 0% SD 0% Total 1/97 (1.03%) Mean 1.04% SD 1.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/42 (10%) 12/50 (24%) 6/45 (13%) 7/50 (14%) | | Overall Incidence Total 16/92 (17.39%) Mean 16.76% SD 10.24% Total 13/95 (13.68%) Mean 13.67% SD 0.47% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/42 (5%) 2/50 (4%) 1/45 (2%) 2/50 (4%) | | Overall Incidence Total 4/92 (4.35%) Mean 4.38% SD 0.54% Total 3/95 (3.16%) Mean 3.11% SD 1.26% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 6/42 (14%) 14/50 (28%) 7/45 (16%) 9/50 (18%) | | Overall Incidence Total 20/92 (21.74%) Mean 21.14% SD 9.7% Total 16/95 (16.84%) Mean 16.78% SD 1.73% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/42 (2%) 1/50 (2%) 0/45 (0%) 1/50 (2%) | | Overall Incidence Total 2/92 (2.17%) Mean 2.19% SD 0.27% Total 1/95 (1.05%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/42 (0%) 1/50 (2%) 1/45 (2%) 1/50 (2%) | | Overall Incidence Total 1/92 (1.09%) Mean 1% SD 1.41% Total 2/95 (2.11%) Mean 2.11% SD 0.16% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/42 (2%) 2/50 (4%) 1/45 (2%) 2/50 (4%) | | Overall Incidence Total 3/92 (3.26%) Mean 3.19% SD 1.14% Total 3/95 (3.16%) Mean 3.11% SD 1.26% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 140 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/46 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/46 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.02% SD 1.44% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/46 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/95 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/46 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.02% SD 1.44% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 1/46 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/95 (1.05%) Mean 1.09% SD 1.54% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 141 Version: 03/03/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 3-MAR-2003 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 8/50 (16%) 7/50 (14%) | | Overall Incidence Total 15/100 (15%) Mean 15% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 9/50 (18%) 7/50 (14%) | | Overall Incidence Total 16/100 (16%) Mean 16% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________