Toxicology Data Management System Page: 1 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302306 07/11/97 729 50(3) 37 (693) 510.6 2,4-HEXADIENAL | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302306 07/11/97 732 50(5) 37 (699) 314.6 2,4-HEXADIENAL | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 050516105 03/06/96 729 50(5) 33 (683) 322.1 RIDDELLIINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058812206 06/25/97 727 50(3) 26 (667) 483.6 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805005 10/30/95 729 50(3) 25 (665) 488.4 METHACRYLONITRILE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058812206 06/25/97 728 50(5) 30 (672) 327.2 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805005 10/30/95 731 50(5) 38 (710) 315.4 METHACRYLONITRILE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 4 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302607 08/14/97 733 50( ) 28 (684) 506.2 DECALIN | |BATTELLE NORTHWEST 058800405 09/13/99 729 50( ) 31 (686) 519.5 DIVINYLBENZENE | |BATTELLE NORTHWEST 058812403 01/18/96 733 50( ) 27 (667) 501.0 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 733 49( ) 24 (681) 507.1 NAPHTHALENE | |BATTELLE NORTHWEST 059000407 10/06/97 729 50( ) 27 (675) 540.3 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600105 01/18/99 729 50( ) 29 (701) 534.2 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142707 01/06/97 729 50( ) 20 (668) 518.0 VANADIUM PENTOXIDE | |BATTELLE TOXICOLOGY059700601T 05/25/00 726 50( ) 32 (693) 529.3 METHYL ISOBUTYL KETONE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302607 08/14/97 734 50( ) 32 (700) 345.9 DECALIN | |BATTELLE NORTHWEST 058800405 09/13/99 731 50( ) 33 (679) 355.3 DIVINYLBENZENE | |BATTELLE NORTHWEST 058812403 01/18/96 735 50( ) 34 (682) 337.2 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 734 49( ) 28 (700) 325.2 NAPHTHALENE | |BATTELLE NORTHWEST 059000407 10/06/97 730 50( ) 33 (675) 366.9 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600105 01/18/99 730 50( ) 36 (696) 362.8 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142707 01/06/97 731 50( ) 33 (688) 351.1 VANADIUM PENTOXIDE | |BATTELLE TOXICOLOGY059700601T 05/25/00 727 50( ) 35 (694) 365.6 METHYL ISOBUTYL KETONE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 5 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902905 09/26/94 736 100(5) 57 (692) 498.3 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902905 09/26/94 737 100(5) 59 (692) 338.0 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 6 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058813803 08/16/99 729 50(3) 22 (681) 501.7 BENZOPHENONE | |BATTELLE COLUMBUS 055634803 06/06/96 726 100(3) 52 (681) 492.7 CITRAL | |BATTELLE COLUMBUS 058812003 12/18/95 729 50(3) 24 (659) 496.8 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611103 09/08/97 731 100(3) 60 (689) 492.1 TRANS-CINNAMALDEHYDE | |SOUTHERN RESEARCH 059201205 07/15/98 729 50(3) 35 (704) 446.9 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 059201305 01/20/00 730 50(3) 31 (702) 448.0 4-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520308 02/08/96 729 60(3) 39 (698) 447.3 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520507 11/28/95 729 50(3) 31 (697) 443.8 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058813803 08/16/99 729 50(5) 32 (688) 348.7 BENZOPHENONE | |BATTELLE COLUMBUS 055634803 06/06/96 732 100(5) 75 (705) 335.2 CITRAL | |BATTELLE COLUMBUS 058812003 12/18/95 730 50(5) 36 (694) 330.5 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 055611103 09/08/97 735 100(5) 70 (706) 344.4 TRANS-CINNAMALDEHYDE | |SOUTHERN RESEARCH 059201205 07/15/98 734 50(5) 40 (707) 320.6 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 059201305 01/20/00 735 50(5) 40 (702) 311.3 4-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520308 02/08/96 730 60(5) 47 (713) 299.3 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520507 11/28/95 729 50(5) 39 (702) 295.2 P-NITROTOLUENE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 7 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 058803105 03/31/97 729 50(3) 23 (662) 519.6 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058800705 08/14/95 729 50(3) 29 (665) 502.2 SODIUM NITRITE | |SOUTHERN RESEARCH 059601003 09/16/98 729 50(3) 36 (687) 514.1 SODIUM DICHLORATE | |SOUTHERN RESEARCH 059601803 12/15/98 729 50(3) 29 (682) 511.6 BROMODICHLOROMETHANE | |SOUTHERN RESEARCH 059601705 03/08/00 729 50(3) 34 (683) 522.9 DIBROMOACETIC ACID | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |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 | |SOUTHERN RESEARCH 059601003 09/16/98 734 50(5) 37 (699) 341.7 SODIUM DICHLORATE | |SOUTHERN RESEARCH 059601705 03/08/00 734 50(5) 35 (693) 350.5 DIBROMOACETIC ACID | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 8 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302007 04/24/00 729 50(1) 20 (670) 484.2 DIISOPROPYLCARBODIIMIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302007 04/24/00 731 50(1) 30 (672) 319.5 DIISOPROPYLCARBODIIMIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 9 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 48/50 (96%) 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 21/50 (42%) 18/50 (36%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 47/50 (94%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 11/50 (22%) 10/50 (20%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/50 (8%) 1/50 (2%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/50 (14%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 11 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 2/50 (4%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/49 (2%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/49 (6%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 12 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 4/49 (8%) 7/50 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 13 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 4/50 (8%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 1/50 (2%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 3/50 (6%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 23/50 (46%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 5/50 (10%) 24/50 (48%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 18 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 1/50 (2%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 10/50 (20%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 12/50 (24%) 19/50 (38%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 20 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 12/50 (24%) 19/50 (38%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 21 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 5/50 (10%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 3/50 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 4/50 (8%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 7/50 (14%) 2/50 (4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 25 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 41/50 (82%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 26 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/50 (8%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 5/50 (10%) 13/50 (26%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 27 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 14/50 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 14/50 (28%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: CORN OIL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 31 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 45/50 (90%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 20/50 (40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 47/50 (94%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 12/50 (24%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 32 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 2/50 (4%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 33 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 7/49 (14%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 10/49 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 36 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 28/50 (56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 30/50 (60%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 42 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 43 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 44 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 1/50 (2%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 45 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 1/50 (2%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 46 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 47 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 48 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 1/48 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 2/49 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/49 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 3/49 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 49 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 50 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 11/50 (22%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 51 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: SODIUM PHOSPHATE Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 53 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 47/50 (94%) 37/50 (74%) 35/50 (70%) | | Overall Incidence Total 96/100 (96%) Mean 96% SD 2.83% Total 72/100 (72%) Mean 72% SD 2.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 29/50 (58%) 29/50 (58%) 12/50 (24%) 26/50 (52%) | | Overall Incidence Total 58/100 (58%) Mean 58% SD 0% Total 38/100 (38%) Mean 38% SD 19.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 42/50 (84%) 45/50 (90%) | | Overall Incidence Total 98/100 (98%) Mean 98% SD 0% Total 87/100 (87%) Mean 87% SD 4.24% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 15/50 (30%) 20/50 (40%) 7/50 (14%) 21/50 (42%) | | Mononuclear, or Undifferentiated | | Overall Incidence Total 35/100 (35%) Mean 35% SD 7.07% Total 28/100 (28%) Mean 28% SD 19.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 54 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/50 (14%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 10/100 (10%) Mean 10% SD 5.66% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 7/50 (14%) 4/50 (8%) 3/50 (6%) 1/50 (2%) | | Complex, Malignant, NOS | | Overall Incidence Total 11/100 (11%) Mean 11% SD 4.24% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 55 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/49 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 5/99 (5.05%) Mean 5.04% SD 1.36% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 56 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 2/50 (4%) 3/50 (6%) 3/50 (6%) 3/49 (6%) | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 6/99 (6.06%) Mean 6.06% SD 0.09% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/99 (1.01%) Mean 1.02% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/99 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 57 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 58 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 59 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 60 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 4/100 (4%) Mean 4% SD 2.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 2/50 (4%) 15/50 (30%) 21/50 (42%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 0% Total 36/100 (36%) Mean 36% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 61 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 4/50 (8%) 2/50 (4%) 15/50 (30%) 21/50 (42%) | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 36/100 (36%) Mean 36% SD 8.49% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 2/50 (4%) 16/50 (32%) 23/50 (46%) | | or Adenoma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 39/100 (39%) Mean 39% SD 9.9% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 62 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 1/50 (2%) | | Malignant, NOS | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 63 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/46 (0%) 0/46 (0%) 1/46 (2%) 1/48 (2%) | | Overall Incidence Total 0/92 (0%) Mean 0% SD 0% Total 2/94 (2.13%) Mean 2.13% SD 0.06% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 19/50 (38%) 17/50 (34%) 21/50 (42%) 12/50 (24%) | | Adenoma | | Overall Incidence Total 36/100 (36%) Mean 36% SD 2.83% Total 33/100 (33%) Mean 33% SD 12.73% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 20/50 (40%) 17/50 (34%) 21/50 (42%) 13/50 (26%) | | Carcinoma or Adenoma | | Overall Incidence Total 37/100 (37%) Mean 37% SD 4.24% Total 34/100 (34%) Mean 34% SD 11.31% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 65 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Basosquamous Tumor Benign | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 66 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 2.83% Total 3/100 (3%) Mean 3% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 67 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 5/100 (5%) Mean 5% SD 1.41% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/100 (4%) Mean 4% SD 2.83% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 68 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 6/100 (6%) Mean 6% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 69 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 44/50 (88%) 40/50 (80%) | | Overall Incidence Total 84/100 (84%) Mean 84% SD 5.66% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 70 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/45 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/94 (0%) Mean 0% SD 0% Total 0/93 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 8/50 (16%) 9/50 (18%) 11/50 (22%) 3/50 (6%) | | Overall Incidence Total 17/100 (17%) Mean 17% SD 1.41% Total 14/100 (14%) Mean 14% SD 11.31% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/100 (2%) Mean 2% SD 2.83% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 10/50 (20%) 10/50 (20%) 11/50 (22%) 5/50 (10%) | | Overall Incidence Total 20/100 (20%) Mean 20% SD 0% Total 16/100 (16%) Mean 16% SD 8.49% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 2/100 (2%) Mean 2% SD 2.83% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 3/100 (3%) Mean 3% SD 1.41% Total 2/100 (2%) Mean 2% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 71 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 72 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 7/50 (14%) 7/50 (14%) | | Overall Incidence Total 14/100 (14%) Mean 14% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 73 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: GAVAGE Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 0/100 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/100 (0%) Mean 0% SD 0% Total 1/100 (1%) Mean 1% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 75 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 49/50 (98%) 47/50 (94%) 46/50 (92%) 43/50 (86%) 44/50 (88%) | | 46/49 (94%) 50/50 (100%) 50/50 (100%) 38/49 (78%) 41/50 (82%) 37/50 (74%) | | 48/50 (96%) 50/50 (100%) 41/50 (82%) 44/50 (88%) | | Overall Incidence Total 387/399 (96.99%)Mean 96.98% SD 2.85% Total 334/399 (83.71%) Mean 83.69% SD 5.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 27/50 (54%) 29/50 (58%) 26/50 (52%) 25/50 (50%) 17/50 (34%) 25/50 (50%) | | 34/49 (69%) 35/50 (70%) 33/50 (66%) 26/49 (53%) 33/50 (66%) 30/50 (60%) | | 28/50 (56%) 31/50 (62%) 28/50 (56%) 22/50 (44%) | | Overall Incidence Total 243/399 (60.9%) Mean 60.92% SD 6.98% Total 206/399 (51.63%) Mean 51.63% SD 9.8% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 50/50 (100%) 49/50 (98%) 49/50 (98%) 46/50 (92%) 49/50 (98%) | | 48/49 (98%) 50/50 (100%) 50/50 (100%) 44/49 (90%) 49/50 (98%) 44/50 (88%) | | 50/50 (100%) 50/50 (100%) 47/50 (94%) 46/50 (92%) | | Overall Incidence Total 396/399 (99.25%)Mean 99.24% SD 1.04% Total 374/399 (93.73%) Mean 93.72% SD 3.95% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/399 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 2/399 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% Total 3/399 (0.75%) Mean 0.76% SD 1.51% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 5/399 (1.25%) Mean 1.25% SD 1.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 19/50 (38%) 22/50 (44%) 16/50 (32%) 11/50 (22%) 10/50 (20%) 14/50 (28%) | | Mononuclear, or Undifferentiated 26/49 (53%) 33/50 (66%) 25/50 (50%) 16/49 (33%) 24/50 (48%) 26/50 (52%) | | 22/50 (44%) 25/50 (50%) 21/50 (42%) 14/50 (28%) | | Overall Incidence Total 188/399 (47.12%)Mean 47.13% SD 10.28% Total 136/399 (34.09%) Mean 34.08% SD 11.94% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 76 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.51% SD 1.44% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS 2/49 (4%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 11/399 (2.76%) Mean 2.76% SD 1.5% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/399 (2.26%) Mean 2.25% SD 1.67% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/399 (2.26%) Mean 2.26% SD 1.98% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/399 (2.26%) Mean 2.26% SD 1.98% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 2/49 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/49 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.51% SD 1.44% Total 4/396 (1.01%) Mean 1.02% SD 1.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 77 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 2/396 (0.51%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 7/49 (14%) 12/50 (24%) 10/50 (20%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | 4/49 (8%) 12/50 (24%) 5/50 (10%) 3/48 (6%) 2/49 (4%) 2/50 (4%) | | 4/50 (8%) 8/50 (16%) 2/49 (4%) 3/50 (6%) | | Overall Incidence Total 62/398 (15.58%) Mean 15.56% SD 6.62% Total 17/396 (4.29%) Mean 4.3% SD 1.33% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/48 (0%) 0/49 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 8/398 (2.01%) Mean 2.02% SD 1.53% Total 1/396 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 8/49 (16%) 13/50 (26%) 10/50 (20%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Complex, Malignant, NOS 5/49 (10%) 14/50 (28%) 6/50 (12%) 3/48 (6%) 2/49 (4%) 3/50 (6%) | | 5/50 (10%) 8/50 (16%) 2/49 (4%) 3/50 (6%) | | Overall Incidence Total 69/398 (17.34%) Mean 17.32% SD 6.89% Total 18/396 (4.55%) Mean 4.55% SD 1.45% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (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: 78 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/399 (2.26%) Mean 2.26% SD 1.98% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/399 (2.26%) Mean 2.26% SD 1.98% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/398 (0.25%) Mean 0.25% SD 0.71% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 79 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 1/397 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Astrocytoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/398 (0.25%) Mean 0.25% SD 0.71% Total 1/397 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/48 (0%) 1/50 (2%) 8/48 (17%) 0/50 (0%) 5/49 (10%) | | 3/48 (6%) 1/50 (2%) 0/50 (0%) 4/49 (8%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 5/396 (1.26%) Mean 1.28% SD 2.2% Total 20/395 (5.06%) Mean 5.13% SD 6.07% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/48 (0%) 2/50 (4%) 1/48 (2%) 0/50 (0%) 0/49 (0%) | | 3/48 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/49 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 7/396 (1.77%) Mean 1.78% SD 2.32% Total 5/395 (1.27%) Mean 1.27% SD 1.5% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/48 (0%) 3/50 (6%) 9/48 (19%) 0/50 (0%) 5/49 (10%) | | 6/48 (13%) 2/50 (4%) 0/50 (0%) 4/49 (8%) 3/50 (6%) 1/49 (2%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 12/396 (3.03%) Mean 3.06% SD 4.43% Total 25/395 (6.33%) Mean 6.39% SD 6.04% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 80 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/396 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 81 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (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: 82 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/50 (6%) 5/50 (10%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | | 2/49 (4%) 4/50 (8%) 3/50 (6%) 1/49 (2%) 0/49 (0%) 1/49 (2%) | | 1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 22/399 (5.51%) Mean 5.51% SD 2.77% Total 6/396 (1.52%) Mean 1.52% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 4/50 (8%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 4/49 (8%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/49 (2%) 0/49 (0%) | | 1/50 (2%) 4/50 (8%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 17/399 (4.26%) Mean 4.27% SD 3.31% Total 4/396 (1.01%) Mean 1.02% SD 1.09% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 7/50 (14%) 6/50 (12%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | 6/49 (12%) 4/50 (8%) 4/50 (8%) 2/49 (4%) 1/49 (2%) 1/49 (2%) | | 2/50 (4%) 7/50 (14%) 2/49 (4%) 0/50 (0%) | | Overall Incidence Total 39/399 (9.77%) Mean 9.78% SD 3.79% Total 10/396 (2.53%) Mean 2.53% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.76% SD 1.04% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.76% SD 1.04% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.75% SD 1.04% Total 0/396 (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: 84 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/396 (0.25%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/399 (1%) Mean 1% SD 1.07% Total 1/396 (0.25%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/396 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/396 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (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: 85 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/399 (1.25%) Mean 1.26% SD 2.12% Total 2/397 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.26% SD 0.72% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.26% SD 0.72% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma 2/49 (4%) 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 6/399 (1.5%) Mean 1.51% SD 2.34% Total 2/397 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 2/49 (4%) 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | | Hepatoblastoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 6/399 (1.5%) Mean 1.51% SD 2.34% Total 2/397 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 4/50 (8%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 14/399 (3.51%) Mean 3.51% SD 4.38% Total 3/397 (0.76%) Mean 0.76% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 5/399 (1.25%) Mean 1.25% SD 1.04% Total 2/397 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 86 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 2/50 (4%) 1/50 (2%) 7/50 (14%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Alveolar/Bronchiolar Adenoma 2/49 (4%) 1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 4/50 (8%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 19/399 (4.76%) Mean 4.76% SD 4.4% Total 5/397 (1.26%) Mean 1.26% SD 1.49% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 87 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 5/50 (10%) 3/50 (6%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/49 (6%) 5/50 (10%) 4/50 (8%) | | 0/50 (0%) 2/50 (4%) 2/50 (4%) 5/50 (10%) | | Overall Incidence Total 5/399 (1.25%) Mean 1.26% SD 1.49% Total 27/399 (6.77%) Mean 6.77% SD 3.53% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 2/50 (4%) 1/50 (2%) 0/50 (0%) 5/50 (10%) 3/50 (6%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/49 (6%) 5/50 (10%) 4/50 (8%) | | 0/50 (0%) 2/50 (4%) 3/50 (6%) 5/50 (10%) | | Overall Incidence Total 6/399 (1.5%) Mean 1.51% SD 1.77% Total 28/399 (7.02%) Mean 7.02% SD 3.38% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 1/50 (2%) 2/50 (4%) 25/50 (50%) 20/50 (40%) 20/50 (40%) | | 0/49 (0%) 2/50 (4%) 3/50 (6%) 17/49 (35%) 25/50 (50%) 19/50 (38%) | | 2/50 (4%) 2/50 (4%) 16/50 (32%) 22/50 (44%) | | Overall Incidence Total 14/399 (3.51%) Mean 3.5% SD 1.77% Total 164/399 (41.1%) Mean 41.09% SD 6.58% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 3/50 (6%) 1/50 (2%) 2/50 (4%) 25/50 (50%) 20/50 (40%) 20/50 (40%) | | 0/49 (0%) 2/50 (4%) 3/50 (6%) 17/49 (35%) 25/50 (50%) 19/50 (38%) | | 2/50 (4%) 2/50 (4%) 17/50 (34%) 22/50 (44%) | | Overall Incidence Total 15/399 (3.76%) Mean 3.75% SD 1.98% Total 165/399 (41.35%) Mean 41.34% SD 6.21% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 4/50 (8%) 1/50 (2%) 2/50 (4%) 29/50 (58%) 22/50 (44%) 20/50 (40%) | | or Adenoma 1/49 (2%) 2/50 (4%) 3/50 (6%) 18/49 (37%) 27/50 (54%) 23/50 (46%) | | 2/50 (4%) 4/50 (8%) 19/50 (38%) 26/50 (52%) | | Overall Incidence Total 19/399 (4.76%) Mean 4.76% SD 2.37% Total 184/399 (46.12%) Mean 46.09% SD 7.87% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 88 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.26% SD 0.72% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 89 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.25% SD 0.71% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/397 (0.25%) Mean 0.25% SD 0.71% Total 1/397 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 2/399 (0.5%) Mean 0.5% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.75% SD 1.04% Total 3/399 (0.75%) Mean 0.75% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 90 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.51% SD 1.44% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Malignant, NOS 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.76% SD 1.51% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.76% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 91 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.51% SD 0.94% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.51% SD 0.94% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/46 (0%) 1/44 (2%) 0/49 (0%) 0/49 (0%) 0/40 (0%) | | 0/45 (0%) 0/49 (0%) 0/50 (0%) 0/42 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/49 (0%) 0/45 (0%) 0/46 (0%) | | Overall Incidence Total 1/381 (0.26%) Mean 0.28% SD 0.8% Total 0/369 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 92 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) 36/50 (72%) 36/49 (73%) 34/50 (68%) 37/50 (74%) 30/50 (60%) | | Adenoma 31/49 (63%) 35/50 (70%) 38/50 (76%) 23/49 (47%) 30/49 (61%) 27/49 (55%) | | 35/50 (70%) 35/50 (70%) 31/49 (63%) 24/49 (49%) | | Overall Incidence Total 273/398 (68.59%)Mean 68.59% SD 6.94% Total 236/395 (59.75%) Mean 59.69% SD 9.16% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 2/398 (0.5%) Mean 0.51% SD 0.94% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 27/50 (54%) 36/50 (72%) 37/49 (76%) 34/50 (68%) 37/50 (74%) 30/50 (60%) | | Carcinoma or Adenoma 31/49 (63%) 35/50 (70%) 39/50 (78%) 23/49 (47%) 30/49 (61%) 27/49 (55%) | | 35/50 (70%) 35/50 (70%) 31/49 (63%) 24/49 (49%) | | Overall Incidence Total 275/398 (69.1%) Mean 69.1% SD 7.49% Total 236/395 (59.75%) Mean 59.69% SD 9.16% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 93 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/398 (0%) Mean 0% SD 0% Total 0/398 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (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: 94 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/399 (1.75%) Mean 1.76% SD 1.98% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 7/399 (1.75%) Mean 1.76% SD 1.98% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 95 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 3/50 (6%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 4/49 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | | B), Basal Cell Adenoma, Adenoma, 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 19/399 (4.76%) Mean 4.77% SD 3.22% Total 4/399 (1%) Mean 1.01% SD 1.07% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 96 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 4/49 (8%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/399 (3.01%) Mean 3.02% SD 3.42% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/399 (2.01%) Mean 2.01% SD 1.51% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 97 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Cell Carcinoma, Basosquamous 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 2/399 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/399 (1.25%) Mean 1.25% SD 1.04% Total 1/399 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/399 (1.25%) Mean 1.25% SD 1.04% Total 1/399 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Papilloma, Squamous Cell 4/49 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma or Keratoacanthoma 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 17/399 (4.26%) Mean 4.27% SD 3.31% Total 3/399 (0.75%) Mean 0.76% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 4/49 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | | 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 17/399 (4.26%) Mean 4.27% SD 3.31% Total 2/399 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 2/50 (4%) 5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | 5/49 (10%) 2/50 (4%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 4/50 (8%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 23/399 (5.76%) Mean 5.78% SD 3.15% Total 5/399 (1.25%) Mean 1.25% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 4/50 (8%) 6/50 (12%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous 7/49 (14%) 3/50 (6%) 3/50 (6%) 1/49 (2%) 3/50 (6%) 0/50 (0%) | | Histiocytoma 6/50 (12%) 5/50 (10%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 36/399 (9.02%) Mean 9.04% SD 3.6% Total 10/399 (2.51%) Mean 2.51% SD 2.56% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 98 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 9/399 (2.26%) Mean 2.26% SD 1.3% Total 2/399 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous 2/49 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) 2/50 (4%) 0/50 (0%) | | Histiocytoma 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 13/399 (3.26%) Mean 3.26% SD 2.13% Total 5/399 (1.25%) Mean 1.26% SD 1.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.75% SD 1.49% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 99 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 2/399 (0.5%) Mean 0.51% SD 0.94% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/397 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/397 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 100 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 40/50 (80%) 38/50 (76%) 40/50 (80%) | | 38/49 (78%) 41/50 (82%) 41/50 (82%) | | 36/50 (72%) 42/50 (84%) | | Overall Incidence Total 316/399 (79.2%) Mean 79.19% SD 3.87% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (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: 101 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/386 (0%) Mean 0% SD 0% Total 0/372 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 0/386 (0%) Mean 0% SD 0% Total 0/372 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 1/49 (2%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 1/386 (0.26%) Mean 0.26% SD 0.72% Total 0/372 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) 0/45 (0%) | | 0/47 (0%) 0/47 (0%) 1/49 (2%) 0/46 (0%) 0/45 (0%) 0/47 (0%) | | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | | Overall Incidence Total 1/386 (0.26%) Mean 0.26% SD 0.72% Total 0/372 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 7/50 (14%) 2/50 (4%) 5/49 (10%) 5/50 (10%) 0/50 (0%) 6/47 (13%) | | 9/46 (20%) 3/50 (6%) 7/50 (14%) 4/47 (9%) 8/49 (16%) 3/49 (6%) | | 1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 35/395 (8.86%) Mean 8.97% SD 6.49% Total 31/392 (7.91%) Mean 7.97% SD 5.12% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 1/50 (2%) 1/49 (2%) 3/50 (6%) 1/50 (2%) 3/47 (6%) | | 1/46 (2%) 1/50 (2%) 2/50 (4%) 3/47 (6%) 2/49 (4%) 1/49 (2%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 8/395 (2.03%) Mean 2.03% SD 1.51% Total 15/392 (3.83%) Mean 3.86% SD 2.11% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 7/50 (14%) 3/50 (6%) 6/49 (12%) 8/50 (16%) 1/50 (2%) 8/47 (17%) | | 10/46 (22%) 4/50 (8%) 9/50 (18%) 7/47 (15%) 9/49 (18%) 4/49 (8%) | | 1/50 (2%) 3/50 (6%) 3/50 (6%) 4/50 (8%) | | Overall Incidence Total 43/395 (10.89%) Mean 11% SD 6.71% Total 44/392 (11.22%) Mean 11.31% SD 6.01% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | | 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/395 (0.25%) Mean 0.25% SD 0.71% Total 1/392 (0.26%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 102 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/47 (2%) | | 0/46 (0%) 1/50 (2%) 1/50 (2%) 1/47 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 3/395 (0.76%) Mean 0.75% SD 1.04% Total 4/392 (1.02%) Mean 1.03% SD 1.54% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/47 (2%) | | 0/46 (0%) 1/50 (2%) 1/50 (2%) 1/47 (2%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 4/395 (1.01%) Mean 1% SD 1.07% Total 5/392 (1.28%) Mean 1.28% SD 1.51% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 103 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 2/399 (0.5%) Mean 0.5% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 1/395 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/48 (2%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 1/49 (2%) | | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/397 (0.5%) Mean 0.51% SD 0.95% Total 3/395 (0.76%) Mean 0.77% SD 1.06% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 1/395 (0.25%) Mean 0.26% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/48 (2%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 1/49 (2%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/397 (0.5%) Mean 0.51% SD 0.95% Total 2/395 (0.51%) Mean 0.52% SD 0.95% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 104 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/397 (0%) Mean 0% SD 0% Total 0/395 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 7/50 (14%) 9/50 (18%) 10/50 (20%) | | 15/49 (31%) 5/50 (10%) 10/50 (20%) | | 6/50 (12%) 12/50 (24%) | | Overall Incidence Total 74/399 (18.55%) Mean 18.58% SD 6.72% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 7/50 (14%) 9/50 (18%) 10/50 (20%) | | 15/49 (31%) 5/50 (10%) 11/50 (22%) | | 6/50 (12%) 13/50 (26%) | | Overall Incidence Total 76/399 (19.05%) Mean 19.08% SD 7.07% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/399 (0.25%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/399 (0.75%) Mean 0.75% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/399 (0%) Mean 0% SD 0% Total 0/399 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% Total 7/399 (1.75%) Mean 1.76% SD 1.68% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 106 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: INHALATION Date of Species: RATS Vehicle: AIR Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) 2/50 (4%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/399 (0.5%) Mean 0.5% SD 0.93% Total 7/399 (1.75%) Mean 1.76% SD 1.68% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 107 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 99/100(99%) 92/100(92%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 66/100(66%) 40/100(40%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 100/100(100%) 98/100(98%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 50/100(50%) 20/100(20%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/100(0%) 0/100(0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/100(4%) 0/100(0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/100(4%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 108 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/99 (0%) 6/100(6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/99 (0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/98 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 24/98 (24%) 7/96 (7%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/98 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/98 (2%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 26/98 (27%) 7/96 (7%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 109 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 1/100(1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 2/100(2%) 2/100(2%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 13/100(13%) 11/90 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 110 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 13/100(13%) 11/90 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/100(0%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 111 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 2/100(2%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 112 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/99 (3%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 1/99 (1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 4/99 (4%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 113 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 0/100(0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 1/100(1%) 0/100(0%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 1/100(1%) 0/100(0%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 3/100(3%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 114 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/100(3%) 4/100(4%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/100(0%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/100(0%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 6/100(6%) 56/100(56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 115 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 6/100(6%) 56/100(56%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 6/100(6%) 58/100(58%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 116 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/100(0%) 0/100(0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/100(0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 117 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 3/98 (3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 3/98 (3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/98 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/85 (0%) 1/88 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/98 (35%) 61/99 (62%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 118 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/98 (0%) 3/99 (3%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/98 (35%) 64/99 (65%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/98 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 119 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 3/100(3%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 3/100(3%) 0/100(0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 3/100(3%) 0/100(0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 120 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/100(0%) 0/100(0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 3/100(3%) 0/100(0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 14/100(14%) 1/100(1%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 10/100(10%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 121 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) 0/100(0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/100(1%) 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/100(11%) 1/100(1%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/100(11%) 1/100(1%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 12/100(12%) 4/100(4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 122 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 13/100(13%) 6/100(6%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 1/100(1%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/100(1%) 2/100(2%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/100(0%) 0/100(0%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/100(0%) 0/100(0%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 123 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/100(1%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 93/100(93%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 124 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/97 (0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 2/97 (2%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/97 (0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 2/97 (2%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 15/99 (15%) 15/100(15%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/99 (1%) 5/100(5%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 16/99 (16%) 19/100(19%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/99 (1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/99 (0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/99 (1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 125 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/100(0%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 1/99 (1%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 1/99 (1%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 126 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 13/100(13%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 13/100(13%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 127 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: MAGNETIC FIELDS Date of Species: RATS Vehicle: MAGNETIC FIELDS Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 129 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 49/50 (98%) 97/100(97%) 42/50 (84%) 42/50 (84%) 78/100(78%) 37/50 (74%) | | 99/100(99%) 49/50 (98%) 50/50 (100%) 78/100(78%) 43/50 (86%) 48/50 (96%) | | 60/60 (100%) 49/50 (98%) 47/60 (78%) 33/50 (66%) | | Overall Incidence Total 495/510 (97.06%)Mean 96.75% SD 5.26% Total 406/510 (79.61%) Mean 80.04% SD 8.87% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 33/50 (66%) 76/100(76%) 34/50 (68%) 20/50 (40%) 30/100(30%) 16/50 (32%) | | 57/100(57%) 22/50 (44%) 22/50 (44%) 39/100(39%) 19/50 (38%) 19/50 (38%) | | 37/60 (62%) 33/50 (66%) 24/60 (40%) 22/50 (44%) | | Overall Incidence Total 314/510 (61.57%)Mean 60.33% SD 11.43% Total 189/510 (37.06%) Mean 37.63% SD 4.53% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 99/100(99%) 49/50 (98%) 46/50 (92%) 92/100(92%) 43/50 (86%) | | 100/100(100%) 50/50 (100%) 50/50 (100%) 92/100(92%) 45/50 (90%) 48/50 (96%) | | 60/60 (100%) 50/50 (100%) 54/60 (90%) 43/50 (86%) | | Overall Incidence Total 508/510 (99.61%)Mean 99.63% SD 0.74% Total 463/510 (90.78%) Mean 90.5% SD 3.34% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 2/50 (4%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.63% SD 1.41% Total 3/510 (0.59%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.71% SD 0.98% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 2/50 (4%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 6/510 (1.18%) Mean 1.33% SD 1.39% Total 3/510 (0.59%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 2/50 (4%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.21% SD 0.59% Total 2/510 (0.39%) Mean 0.5% SD 1.41% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 27/50 (54%) 68/100(68%) 27/50 (54%) 19/50 (38%) 24/100(24%) 8/50 (16%) | | Mononuclear, or Undifferentiated 40/100(40%) 15/50 (30%) 15/50 (30%) 21/100(21%) 6/50 (12%) 9/50 (18%) | | 30/60 (50%) 24/50 (48%) 21/60 (35%) 13/50 (26%) | | Overall Incidence Total 246/510 (48.24%)Mean 46.75% SD 12.96% Total 121/510 (23.73%) Mean 23.75% SD 9.05% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 130 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type 0/60 (0%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.5% SD 1.41% Total 2/510 (0.39%) Mean 0.25% SD 0.46% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 2/50 (4%) 4/100(4%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | NOS 5/100(5%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/60 (3%) 5/50 (10%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 22/510 (4.31%) Mean 4.29% SD 2.75% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 2/50 (4%) 4/100(4%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 5/100(5%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/60 (3%) 5/50 (10%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 22/510 (4.31%) Mean 4.29% SD 2.75% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.5% SD 1.41% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.46% SD 0.85% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 2/50 (4%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.96% SD 1.48% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 2/100(2%) 2/50 (4%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 1/100(1%) 5/50 (10%) 1/49 (2%) | | 0/60 (0%) 0/50 (0%) 2/60 (3%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.93% Total 13/509 (2.55%) Mean 2.8% SD 3.24% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 131 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/505 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 8/50 (16%) 10/100(10%) 4/50 (8%) 0/50 (0%) 3/99 (3%) 2/50 (4%) | | 5/100(5%) 8/50 (16%) 8/50 (16%) 1/100(1%) 0/49 (0%) 2/48 (4%) | | 2/60 (3%) 3/50 (6%) 2/60 (3%) 2/49 (4%) | | Overall Incidence Total 48/510 (9.41%) Mean 10.04% SD 5.31% Total 12/505 (2.38%) Mean 2.45% SD 1.82% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 2/50 (4%) 1/100(1%) 0/49 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.63% SD 1.41% Total 1/505 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/49 (0%) 1/48 (2%) | | 2/60 (3%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.92% SD 1.71% Total 3/505 (0.59%) Mean 0.51% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 8/50 (16%) 11/100(11%) 6/50 (12%) 0/50 (0%) 3/99 (3%) 2/50 (4%) | | Complex, Malignant, NOS 5/100(5%) 8/50 (16%) 10/50 (20%) 4/100(4%) 0/49 (0%) 3/48 (6%) | | 4/60 (7%) 3/50 (6%) 2/60 (3%) 2/49 (4%) | | Overall Incidence Total 55/510 (10.78%) Mean 11.58% SD 5.46% Total 16/505 (3.17%) Mean 3.09% SD 2.13% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.5% SD 1.41% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.21% SD 0.59% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 2/50 (4%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.71% SD 1.45% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 3/510 (0.59%) Mean 0.63% SD 0.92% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 133 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | Astrocytoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 3/510 (0.59%) Mean 0.63% SD 0.92% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 7/100(7%) 3/50 (6%) 3/50 (6%) 15/98 (15%) 1/47 (2%) | | 7/100(7%) 0/50 (0%) 2/50 (4%) 4/99 (4%) 5/50 (10%) 8/50 (16%) | | 2/60 (3%) 2/50 (4%) 12/59 (20%) 7/50 (14%) | | Overall Incidence Total 23/510 (4.51%) Mean 3.92% SD 2.79% Total 55/503 (10.93%) Mean 10.98% SD 6.47% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 1/100(1%) 0/50 (0%) 1/50 (2%) 1/98 (1%) 0/47 (0%) | | 4/100(4%) 0/50 (0%) 0/50 (0%) 9/99 (9%) 3/50 (6%) 2/50 (4%) | | 2/60 (3%) 2/50 (4%) 2/59 (3%) 2/50 (4%) | | Overall Incidence Total 10/510 (1.96%) Mean 1.79% SD 1.79% Total 20/503 (3.98%) Mean 3.69% SD 2.89% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 1/50 (2%) 8/100(8%) 3/50 (6%) 4/50 (8%) 16/98 (16%) 1/47 (2%) | | 11/100(11%) 0/50 (0%) 2/50 (4%) 13/99 (13%) 8/50 (16%) 10/50 (20%) | | 4/60 (7%) 4/50 (8%) 14/59 (24%) 8/50 (16%) | | Overall Incidence Total 33/510 (6.47%) Mean 5.71% SD 3.56% Total 74/503 (14.71%) Mean 14.41% SD 6.77% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/503 (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: 134 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/503 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/503 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/98 (0%) 0/47 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 2/503 (0.4%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 1/100(1%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.93% Total 3/510 (0.59%) Mean 0.63% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (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: 136 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.21% SD 0.59% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (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: 137 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/50 (2%) 3/99 (3%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 3/50 (6%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 2/60 (3%) 3/50 (6%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 14/509 (2.75%) Mean 2.8% SD 2.32% Total 1/509 (0.2%) Mean 0.21% SD 0.59% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/99 (0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 2/50 (4%) 0/49 (0%) | | 0/60 (0%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/509 (0.59%) Mean 0.75% SD 1.49% Total 4/509 (0.79%) Mean 0.75% SD 1.49% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/50 (2%) 3/99 (3%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 3/50 (6%) 2/100(2%) 2/50 (4%) 0/49 (0%) | | 2/60 (3%) 5/50 (10%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 17/509 (3.34%) Mean 3.55% SD 3.11% Total 5/509 (0.98%) Mean 0.96% SD 1.48% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Carcinoma 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Carcinoma or Adenoma 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Papilloma 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 1/48 (2%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 1/508 (0.2%) Mean 0.26% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/507 (0.2%) Mean 0.25% SD 0.71% Total 1/508 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 138 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 1/508 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/507 (0.2%) Mean 0.25% SD 0.71% Total 2/508 (0.39%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 1/48 (2%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/507 (0.2%) Mean 0.26% SD 0.74% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/48 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/507 (0%) Mean 0% SD 0% Total 0/508 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.38% SD 0.74% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 139 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 2/60 (3%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 6/510 (1.18%) Mean 1.17% SD 1.7% Total 2/510 (0.39%) Mean 0.46% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.96% SD 1.48% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Hepatoblastoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.96% SD 1.48% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 2/50 (4%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Hepatocellular Adenoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 3/60 (5%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 10/510 (1.96%) Mean 2.13% SD 2.03% Total 2/510 (0.39%) Mean 0.46% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 2/50 (4%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Hepatocellular Adenoma, or 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Hepatoblastoma 3/60 (5%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 10/510 (1.96%) Mean 2.13% SD 2.03% Total 2/510 (0.39%) Mean 0.46% SD 0.85% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 4/50 (8%) 3/100(3%) 2/50 (4%) 4/50 (8%) 2/100(2%) 0/50 (0%) | | 4/100(4%) 2/50 (4%) 0/50 (0%) 6/100(6%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 17/510 (3.33%) Mean 3.33% SD 2.36% Total 13/510 (2.55%) Mean 2.21% SD 3.11% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 1/100(1%) 2/50 (4%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.83% SD 1.43% Total 2/510 (0.39%) Mean 0.25% SD 0.46% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 140 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 4/50 (8%) 3/100(3%) 2/50 (4%) 4/50 (8%) 3/100(3%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 5/100(5%) 4/50 (8%) 0/50 (0%) 7/100(7%) 0/50 (0%) 0/50 (0%) | | 2/60 (3%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 21/510 (4.12%) Mean 4.17% SD 2.78% Total 15/510 (2.94%) Mean 2.46% SD 3.3% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (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: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 2/50 (4%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 4/510 (0.78%) Mean 0.88% SD 1.46% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 4/50 (8%) 2/50 (4%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.25% SD 0.71% Total 9/510 (1.76%) Mean 2.13% SD 2.75% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 3/100(3%) 0/50 (0%) 2/50 (4%) 0/100(0%) 2/50 (4%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 4/50 (8%) 2/50 (4%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.38% SD 1.06% Total 13/510 (2.55%) Mean 3% SD 2.62% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 2/50 (4%) 8/100(8%) 3/50 (6%) 27/50 (54%) 53/100(53%) 15/50 (30%) | | 3/100(3%) 0/50 (0%) 3/50 (6%) 55/100(55%) 26/50 (52%) 24/50 (48%) | | 0/60 (0%) 0/50 (0%) 23/60 (38%) 14/50 (28%) | | Overall Incidence Total 19/510 (3.73%) Mean 3.38% SD 3.16% Total 237/510 (46.47%) Mean 44.79% SD 11.09% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 2/50 (4%) 9/100(9%) 3/50 (6%) 28/50 (56%) 53/100(53%) 16/50 (32%) | | 3/100(3%) 0/50 (0%) 3/50 (6%) 55/100(55%) 26/50 (52%) 24/50 (48%) | | 0/60 (0%) 0/50 (0%) 23/60 (38%) 14/50 (28%) | | Overall Incidence Total 20/510 (3.92%) Mean 3.5% SD 3.38% Total 239/510 (46.86%) Mean 45.29% SD 10.99% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 2/50 (4%) 11/100(11%) 3/50 (6%) 28/50 (56%) 53/100(53%) 16/50 (32%) | | or Adenoma 3/100(3%) 0/50 (0%) 3/50 (6%) 56/100(56%) 28/50 (56%) 25/50 (50%) | | 0/60 (0%) 0/50 (0%) 23/60 (38%) 14/50 (28%) | | Overall Incidence Total 22/510 (4.31%) Mean 3.75% SD 3.88% Total 243/510 (47.65%) Mean 46.17% SD 11.61% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 142 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (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: 143 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/509 (0.2%) Mean 0.25% SD 0.71% Total 1/509 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.76% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.25% SD 0.46% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 1/50 (2%) 2/100(2%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 2/50 (4%) | | Overall Incidence Total 5/510 (0.98%) Mean 0.75% SD 1.04% Total 3/510 (0.59%) Mean 0.63% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.25% SD 0.46% Total 0/510 (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: 144 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/100(0%) 0/50 (0%) | | Malignant, NOS 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (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: 145 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 1/49 (2%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 6/509 (1.18%) Mean 1.09% SD 0.96% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/509 (0.2%) Mean 0.25% SD 0.71% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 1/49 (2%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 1/60 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 7/509 (1.38%) Mean 1.34% SD 0.9% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/509 (0.2%) Mean 0.13% SD 0.35% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/509 (0.39%) Mean 0.38% SD 0.74% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/93 (0%) 0/46 (0%) 0/47 (0%) 2/86 (2%) 0/45 (0%) | | 0/92 (0%) 0/47 (0%) 1/48 (2%) 0/90 (0%) 0/49 (0%) 0/50 (0%) | | 0/58 (0%) 0/48 (0%) 0/57 (0%) 0/46 (0%) | | Overall Incidence Total 1/481 (0.21%) Mean 0.26% SD 0.74% Total 2/470 (0.43%) Mean 0.29% SD 0.82% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 146 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 10/50 (20%) 17/100(17%) 11/50 (22%) 17/50 (34%) 29/100(29%) 23/50 (46%) | | Adenoma 21/100(21%) 9/50 (18%) 16/49 (33%) 35/100(35%) 23/50 (46%) 29/48 (60%) | | 11/59 (19%) 15/48 (31%) 19/59 (32%) 15/50 (30%) | | Overall Incidence Total 110/506 (21.74%)Mean 22.57% SD 6.02% Total 190/507 (37.48%) Mean 39.08% SD 10.86% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Carcinoma 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 2/50 (4%) 0/48 (0%) | | 0/59 (0%) 1/48 (2%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 1/506 (0.2%) Mean 0.26% SD 0.74% Total 2/507 (0.39%) Mean 0.5% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 10/50 (20%) 17/100(17%) 11/50 (22%) 17/50 (34%) 29/100(29%) 23/50 (46%) | | Carcinoma or Adenoma 21/100(21%) 9/50 (18%) 16/49 (33%) 35/100(35%) 25/50 (50%) 29/48 (60%) | | 11/59 (19%) 16/48 (33%) 19/59 (32%) 15/50 (30%) | | Overall Incidence Total 111/506 (21.94%)Mean 22.83% SD 6.48% Total 192/507 (37.87%) Mean 39.58% SD 11.3% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/59 (0%) 0/48 (0%) 1/59 (2%) 0/50 (0%) | | Overall Incidence Total 2/506 (0.4%) Mean 0.38% SD 0.74% Total 3/507 (0.59%) Mean 0.46% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/59 (0%) 0/48 (0%) 0/59 (0%) 0/50 (0%) | | Overall Incidence Total 0/506 (0%) Mean 0% SD 0% Total 0/507 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/48 (0%) | | 0/59 (0%) 0/48 (0%) 1/59 (2%) 0/50 (0%) | | Overall Incidence Total 2/506 (0.4%) Mean 0.38% SD 0.74% Total 3/507 (0.59%) Mean 0.46% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 4/100(4%) 0/50 (0%) 0/50 (0%) | | 2/60 (3%) 2/50 (4%) | | Overall Incidence Total 8/510 (1.57%) Mean 1.42% SD 1.97% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 147 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 4/100(4%) 0/50 (0%) 0/50 (0%) | | 2/60 (3%) 2/50 (4%) | | Overall Incidence Total 8/510 (1.57%) Mean 1.42% SD 1.97% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 1/49 (2%) 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/509 (0.79%) Mean 1.01% SD 1.52% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (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: 148 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 2/510 (0.39%) Mean 0.33% SD 0.64% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 2/60 (3%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 7/510 (1.37%) Mean 1.42% SD 1.14% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 149 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Basosquamous Tumor Benign 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 2/60 (3%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 7/510 (1.37%) Mean 1.42% SD 1.14% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 2/100(2%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Tumor Benign, or 2/100(2%) 1/50 (2%) 1/50 (2%) 0/100(0%) 1/50 (2%) 1/50 (2%) | | Trichoepithelioma 2/60 (3%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 11/510 (2.16%) Mean 2.17% SD 1.17% Total 2/510 (0.39%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | NOS) 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 2/100(2%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 3/100(3%) 1/50 (2%) 1/50 (2%) 0/100(0%) 2/50 (4%) 1/50 (2%) | | (benign, malignant or NOS), or 2/60 (3%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 12/510 (2.35%) Mean 2.29% SD 1.2% Total 3/510 (0.59%) Mean 0.75% SD 1.49% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 11/50 (22%) 11/100(11%) 6/50 (12%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 8/100(8%) 2/50 (4%) 3/50 (6%) 0/100(0%) 2/50 (4%) 2/50 (4%) | | B), Basal Cell Adenoma, Adenoma, 7/60 (12%) 4/50 (8%) 0/60 (0%) 0/50 (0%) | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 52/510 (10.2%) Mean 10.33% SD 5.49% Total 8/510 (1.57%) Mean 1.88% SD 2.42% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.5% SD 1.41% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (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: 150 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.46% SD 0.85% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 10/50 (20%) 8/100(8%) 3/50 (6%) 3/50 (6%) 0/100(0%) 0/50 (0%) | | 5/100(5%) 1/50 (2%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 5/60 (8%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 35/510 (6.86%) Mean 6.92% SD 5.8% Total 3/510 (0.59%) Mean 0.75% SD 2.12% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 2/100(2%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 4/510 (0.78%) Mean 0.75% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (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: 151 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 2/510 (0.39%) Mean 0.38% SD 0.74% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.88% SD 0.99% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.88% SD 0.99% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/50 (22%) 9/100(9%) 4/50 (8%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | Papilloma, Squamous Cell 5/100(5%) 1/50 (2%) 2/50 (4%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Carcinoma or Keratoacanthoma 5/60 (8%) 3/50 (6%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 40/510 (7.84%) Mean 8.04% SD 6.12% Total 5/510 (0.98%) Mean 1.13% SD 2.1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 11/50 (22%) 9/100(9%) 4/50 (8%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 5/100(5%) 1/50 (2%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 5/60 (8%) 3/50 (6%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 39/510 (7.65%) Mean 7.79% SD 6.34% Total 5/510 (0.98%) Mean 1.13% SD 2.1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 4/510 (0.78%) Mean 0.75% SD 0.89% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 5/50 (10%) 2/100(2%) 2/50 (4%) 3/50 (6%) 1/100(1%) 0/50 (0%) | | 7/100(7%) 2/50 (4%) 8/50 (16%) 1/100(1%) 1/50 (2%) 1/50 (2%) | | 5/60 (8%) 1/50 (2%) 3/60 (5%) 0/50 (0%) | | Overall Incidence Total 32/510 (6.27%) Mean 6.67% SD 4.76% Total 10/510 (1.96%) Mean 2.13% SD 2.23% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 6/50 (12%) 8/100(8%) 4/50 (8%) 4/50 (8%) 1/100(1%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 12/100(12%) 2/50 (4%) 8/50 (16%) 1/100(1%) 1/50 (2%) 1/50 (2%) | | Histiocytoma 5/60 (8%) 2/50 (4%) 3/60 (5%) 2/50 (4%) | | Overall Incidence Total 47/510 (9.22%) Mean 9.04% SD 4.13% Total 14/510 (2.75%) Mean 3.13% SD 2.42% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 152 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 2/100(2%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) | | 6/100(6%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 8/510 (1.57%) Mean 1% SD 2.14% Total 3/510 (0.59%) Mean 0.75% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 1/50 (2%) 5/100(5%) 2/50 (4%) 1/50 (2%) 0/100(0%) 1/50 (2%) | | Myxosarcoma, or Fibrous 6/100(6%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Histiocytoma 0/60 (0%) 1/50 (2%) 0/60 (0%) 2/50 (4%) | | Overall Incidence Total 15/510 (2.94%) Mean 2.38% SD 2.39% Total 4/510 (0.78%) Mean 1% SD 1.51% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 1/50 (2%) 2/100(2%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 5/510 (0.98%) Mean 1% SD 1.07% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | (malignant or NOS) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.93% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | or NOS) 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.93% Total 0/510 (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: 153 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.38% SD 0.74% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.93% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (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: 154 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Papilloma Squamous 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 96/100(96%) 41/50 (82%) | | 91/100(91%) 48/50 (96%) 46/50 (92%) | | 55/60 (92%) 49/50 (98%) | | Overall Incidence Total 471/510 (92.35%)Mean 92.08% SD 4.97% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (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: 155 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 0/87 (0%) 0/48 (0%) 0/48 (0%) 0/92 (0%) 0/48 (0%) 0/47 (0%) | | 0/56 (0%) 0/49 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/479 (0%) Mean 0% SD 0% Total 0/484 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 1/87 (1%) 0/48 (0%) 0/48 (0%) 0/92 (0%) 0/48 (0%) 0/47 (0%) | | 0/56 (0%) 0/49 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 1/479 (0.21%) Mean 0.14% SD 0.41% Total 0/484 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 0/87 (0%) 0/48 (0%) 0/48 (0%) 1/92 (1%) 0/48 (0%) 0/47 (0%) | | 0/56 (0%) 0/49 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 0/479 (0%) Mean 0% SD 0% Total 1/484 (0.21%) Mean 0.14% SD 0.38% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/48 (0%) 0/97 (0%) 0/46 (0%) 0/50 (0%) 0/96 (0%) 0/46 (0%) | | 1/87 (1%) 0/48 (0%) 0/48 (0%) 1/92 (1%) 0/48 (0%) 0/47 (0%) | | 0/56 (0%) 0/49 (0%) 0/57 (0%) 0/48 (0%) | | Overall Incidence Total 1/479 (0.21%) Mean 0.14% SD 0.41% Total 1/484 (0.21%) Mean 0.14% SD 0.38% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 10/50 (20%) 12/100(12%) 8/50 (16%) 4/50 (8%) 21/100(21%) 5/50 (10%) | | 12/100(12%) 9/48 (19%) 11/47 (23%) 11/100(11%) 9/49 (18%) 10/47 (21%) | | 10/59 (17%) 11/50 (22%) 9/60 (15%) 6/50 (12%) | | Overall Incidence Total 83/504 (16.47%) Mean 17.64% SD 4.24% Total 75/506 (14.82%) Mean 14.58% SD 5.13% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 1/50 (2%) 4/100(4%) 0/50 (0%) 0/50 (0%) 0/100(0%) 2/50 (4%) | | 3/100(3%) 1/48 (2%) 0/47 (0%) 3/100(3%) 0/49 (0%) 1/47 (2%) | | 0/59 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 9/504 (1.79%) Mean 1.39% SD 1.6% Total 7/506 (1.38%) Mean 1.35% SD 1.59% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 11/50 (22%) 16/100(16%) 8/50 (16%) 4/50 (8%) 21/100(21%) 7/50 (14%) | | 15/100(15%) 10/48 (21%) 11/47 (23%) 14/100(14%) 9/49 (18%) 11/47 (23%) | | 10/59 (17%) 11/50 (22%) 10/60 (17%) 6/50 (12%) | | Overall Incidence Total 92/504 (18.25%) Mean 19.02% SD 3.36% Total 82/506 (16.21%) Mean 15.93% SD 4.98% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 2/50 (4%) 3/100(3%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 1/100(1%) 1/48 (2%) 0/47 (0%) 1/100(1%) 0/49 (0%) 2/47 (4%) | | 0/59 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 7/504 (1.39%) Mean 1.26% SD 1.59% Total 4/506 (0.79%) Mean 0.91% SD 1.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 156 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 3/100(3%) 0/48 (0%) 0/47 (0%) 0/100(0%) 1/49 (2%) 0/47 (0%) | | 1/59 (2%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 5/504 (0.99%) Mean 0.71% SD 1.12% Total 3/506 (0.59%) Mean 0.63% SD 0.92% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 2/50 (4%) 4/100(4%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) | | 4/100(4%) 1/48 (2%) 0/47 (0%) 1/100(1%) 1/49 (2%) 2/47 (4%) | | 1/59 (2%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 12/504 (2.38%) Mean 1.97% SD 1.86% Total 7/506 (1.38%) Mean 1.54% SD 1.38% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 157 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma Squamous 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.76% Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 3/510 (0.59%) Mean 0.5% SD 0.76% Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 1/50 (2%) 0/49 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/509 (0.2%) Mean 0.21% SD 0.59% Total 2/509 (0.39%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 1/50 (2%) 0/49 (0%) | | 1/60 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/509 (0.2%) Mean 0.21% SD 0.59% Total 2/509 (0.39%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 158 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/60 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/509 (0%) Mean 0% SD 0% Total 0/509 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.13% SD 0.35% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.38% SD 0.74% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 6/50 (12%) 19/100(19%) 10/50 (20%) | | 14/100(14%) 8/50 (16%) 16/50 (32%) | | 11/60 (18%) 6/50 (12%) | | Overall Incidence Total 90/510 (17.65%) Mean 17.92% SD 6.47% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 159 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/100(0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 2/510 (0.39%) Mean 0.5% SD 0.93% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 6/50 (12%) 19/100(19%) 11/50 (22%) | | 14/100(14%) 8/50 (16%) 17/50 (34%) | | 11/60 (18%) 6/50 (12%) | | Overall Incidence Total 92/510 (18.04%) Mean 18.42% SD 7.21% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 1/50 (2%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.25% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 1/510 (0.2%) Mean 0.21% SD 0.59% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 0/510 (0%) Mean 0% SD 0% Total 2/510 (0.39%) Mean 0.33% SD 0.64% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 3/50 (6%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 2/50 (4%) 1/60 (2%) 0/50 (0%) | | Overall Incidence Total 7/510 (1.37%) Mean 1.63% SD 2.26% Total 1/510 (0.2%) Mean 0.21% SD 0.59% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 160 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: FEED Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/60 (0%) 2/50 (4%) 2/60 (3%) 0/50 (0%) | | Overall Incidence Total 7/510 (1.37%) Mean 1.63% SD 2.26% Total 3/510 (0.59%) Mean 0.54% SD 1.18% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 161 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 47/50 (94%) 48/50 (96%) 44/50 (88%) 42/50 (84%) 46/50 (92%) | | 49/50 (98%) 47/50 (94%) 42/50 (84%) | | Overall Incidence Total 238/250 (95.2%) Mean 95.2% SD 1.79% Total 174/200 (87%) Mean 87% SD 3.83% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 35/50 (70%) 30/50 (60%) 27/50 (54%) 25/50 (50%) 23/50 (46%) 21/50 (42%) | | 28/50 (56%) 29/50 (58%) 16/50 (32%) | | Overall Incidence Total 149/250 (59.6%) Mean 59.6% SD 6.23% Total 85/200 (42.5%) Mean 42.5% SD 7.72% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 49/50 (98%) 49/50 (98%) 49/50 (98%) 50/50 (100%) 45/50 (90%) 49/50 (98%) | | 50/50 (100%) 50/50 (100%) 45/50 (90%) | | Overall Incidence Total 247/250 (98.8%) Mean 98.8% SD 1.1% Total 189/200 (94.5%) Mean 94.5% SD 5.26% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 16/50 (32%) 17/50 (34%) 13/50 (26%) 10/50 (20%) 15/50 (30%) 11/50 (22%) | | Mononuclear, or Undifferentiated 16/50 (32%) 17/50 (34%) 11/50 (22%) | | Overall Incidence Total 79/250 (31.6%) Mean 31.6% SD 3.29% Total 47/200 (23.5%) Mean 23.5% SD 4.43% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 162 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS 3/50 (6%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 15/250 (6%) Mean 6% SD 4.24% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 6/50 (12%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 15/250 (6%) Mean 6% SD 4.24% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 2.61% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 2.61% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 1/49 (2%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 3/198 (1.52%) Mean 1.52% SD 1.01% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 1/47 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/245 (0.41%) Mean 0.43% SD 0.95% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 4/47 (9%) 6/50 (12%) 6/49 (12%) 0/49 (0%) 4/50 (8%) 2/50 (4%) | | 8/50 (16%) 7/49 (14%) 1/49 (2%) | | Overall Incidence Total 31/245 (12.65%) Mean 12.61% SD 2.81% Total 7/198 (3.54%) Mean 3.51% SD 3.41% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/47 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 2/245 (0.82%) Mean 0.8% SD 1.79% Total 0/198 (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: 163 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 5/47 (11%) 1/50 (2%) 3/49 (6%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 10/245 (4.08%) Mean 4.15% SD 4.26% Total 2/198 (1.01%) Mean 1.02% SD 2.04% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 9/47 (19%) 7/50 (14%) 9/49 (18%) 2/49 (4%) 4/50 (8%) 2/50 (4%) | | Complex, Malignant, NOS 11/50 (22%) 7/49 (14%) 1/49 (2%) | | Overall Incidence Total 43/245 (17.55%) Mean 17.56% SD 3.4% Total 9/198 (4.55%) Mean 4.53% SD 2.5% | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/199 (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%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/199 (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: 164 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/199 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/199 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Astrocytoma 2/50 (4%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 3/50 (6%) 0/50 (0%) 1/48 (2%) 6/48 (13%) 8/46 (17%) 11/49 (22%) | | 2/50 (4%) 3/50 (6%) 8/50 (16%) | | Overall Incidence Total 9/248 (3.63%) Mean 3.62% SD 2.6% Total 33/193 (17.1%) Mean 17.09% SD 4.13% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 3/50 (6%) 5/50 (10%) 3/48 (6%) 5/48 (10%) 2/46 (4%) 3/49 (6%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 12/248 (4.84%) Mean 4.85% SD 3.92% Total 11/193 (5.7%) Mean 5.72% SD 3.56% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 6/50 (12%) 5/50 (10%) 4/48 (8%) 10/48 (21%) 10/46 (22%) 14/49 (29%) | | 3/50 (6%) 3/50 (6%) 9/50 (18%) | | Overall Incidence Total 21/248 (8.47%) Mean 8.47% SD 2.6% Total 43/193 (22.28%) Mean 22.29% SD 4.48% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/193 (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: 165 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/248 (0.4%) Mean 0.4% SD 0.89% Total 0/193 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/193 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/248 (0.4%) Mean 0.4% SD 0.89% Total 0/193 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 166 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 167 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/44 (5%) 4/50 (8%) 3/50 (6%) 0/47 (0%) 0/50 (0%) 2/50 (4%) | | 3/49 (6%) 5/48 (10%) 0/47 (0%) | | Overall Incidence Total 17/241 (7.05%) Mean 7.02% SD 2.26% Total 2/194 (1.03%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/44 (0%) 1/50 (2%) 2/50 (4%) 0/47 (0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 3/241 (1.24%) Mean 1.2% SD 1.79% Total 1/194 (0.52%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/44 (5%) 5/50 (10%) 5/50 (10%) 0/47 (0%) 0/50 (0%) 3/50 (6%) | | 3/49 (6%) 5/48 (10%) 0/47 (0%) | | Overall Incidence Total 20/241 (8.3%) Mean 8.22% SD 2.7% Total 3/194 (1.55%) Mean 1.5% SD 3% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (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: 168 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/47 (2%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 2/242 (0.83%) Mean 0.83% SD 1.14% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/47 (2%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 2/242 (0.83%) Mean 0.83% SD 1.14% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/47 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 1/47 (2%) 0/50 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/242 (0.41%) Mean 0.43% SD 0.95% Total 0/199 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 169 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 2/200 (1%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 2/200 (1%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Hepatocellular Adenoma, or 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Hepatoblastoma | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 2/200 (1%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 7/250 (2.8%) Mean 2.8% SD 1.79% Total 5/200 (2.5%) Mean 2.5% SD 2.52% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/250 (2%) Mean 2% SD 2.45% Total 3/200 (1.5%) Mean 1.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/50 (6%) 2/50 (4%) 4/50 (8%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 12/250 (4.8%) Mean 4.8% SD 2.28% Total 8/200 (4%) Mean 4% SD 1.63% | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 170 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 5/200 (2.5%) Mean 2.5% SD 3% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) 1/50 (2%) 3/50 (6%) | | 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 11/200 (5.5%) Mean 5.5% SD 2.52% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) 6/50 (12%) | | 1/50 (2%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 15/200 (7.5%) Mean 7.5% SD 3.42% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 1/50 (2%) 3/50 (6%) 2/50 (4%) 36/50 (72%) 21/50 (42%) 33/50 (66%) | | 1/50 (2%) 4/50 (8%) 32/50 (64%) | | Overall Incidence Total 11/250 (4.4%) Mean 4.4% SD 2.61% Total 122/200 (61%) Mean 61% SD 13.11% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 171 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 1/50 (2%) 3/50 (6%) 2/50 (4%) 36/50 (72%) 23/50 (46%) 35/50 (70%) | | 2/50 (4%) 4/50 (8%) 32/50 (64%) | | Overall Incidence Total 12/250 (4.8%) Mean 4.8% SD 2.28% Total 126/200 (63%) Mean 63% SD 11.83% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 1/50 (2%) 3/50 (6%) 2/50 (4%) 37/50 (74%) 23/50 (46%) 37/50 (74%) | | or Adenoma 2/50 (4%) 5/50 (10%) 32/50 (64%) | | Overall Incidence Total 13/250 (5.2%) Mean 5.2% SD 3.03% Total 129/200 (64.5%) Mean 64.5% SD 13.2% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 172 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/244 (0.41%) Mean 0.4% SD 0.89% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 0/46 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 0/198 (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%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/200 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 2/200 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 173 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Malignant, NOS 0/50 (0%) | | Overall Incidence Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 174 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 0/44 (0%) 0/50 (0%) 0/49 (0%) 1/47 (2%) 0/50 (0%) 2/50 (4%) | | 3/49 (6%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 3/240 (1.25%) Mean 1.22% SD 2.74% Total 3/194 (1.55%) Mean 1.53% SD 1.93% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 1/44 (2%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 1/240 (0.42%) Mean 0.45% SD 1.02% Total 0/194 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 1/44 (2%) 0/50 (0%) 0/49 (0%) 1/47 (2%) 0/50 (0%) 2/50 (4%) | | 3/49 (6%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 4/240 (1.67%) Mean 1.68% SD 2.67% Total 3/194 (1.55%) Mean 1.53% SD 1.93% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/44 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/194 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 2/44 (5%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) 0/47 (0%) | | Overall Incidence Total 2/240 (0.83%) Mean 0.91% SD 2.03% Total 0/194 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 1/45 (2%) 0/45 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) 0/47 (0%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/237 (0.42%) Mean 0.44% SD 0.99% Total 0/192 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/47 (32%) 13/50 (26%) 16/48 (33%) 20/48 (42%) 24/50 (48%) 23/49 (47%) | | Adenoma 22/49 (45%) 23/50 (46%) 26/50 (52%) | | Overall Incidence Total 89/244 (36.48%) Mean 36.43% SD 8.69% Total 93/197 (47.21%) Mean 47.15% SD 4.26% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/47 (0%) 0/50 (0%) 0/48 (0%) 1/48 (2%) 0/50 (0%) 1/49 (2%) | | Carcinoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 2/197 (1.02%) Mean 1.03% SD 1.19% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 15/47 (32%) 13/50 (26%) 16/48 (33%) 21/48 (44%) 24/50 (48%) 24/49 (49%) | | Carcinoma or Adenoma 22/49 (45%) 23/50 (46%) 26/50 (52%) | | Overall Incidence Total 89/244 (36.48%) Mean 36.43% SD 8.69% Total 95/197 (48.22%) Mean 48.18% SD 3.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 175 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 2/197 (1.02%) Mean 1.01% SD 1.17% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 0/197 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 2/197 (1.02%) Mean 1.01% SD 1.17% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 1/48 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/248 (0.4%) Mean 0.42% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/48 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/248 (0.4%) Mean 0.42% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/248 (0%) Mean 0% SD 0% Total 0/198 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 176 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 177 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Tumor Benign, or 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.1% Total 3/200 (1.5%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.1% Total 2/200 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Basosquamous Tumor (malignant or 1/50 (2%) 1/50 (2%) 0/50 (0%) | | NOS) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.1% Total 2/200 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | Adenoma, Basosquamous Tumor 2/50 (4%) 2/50 (4%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 6/250 (2.4%) Mean 2.4% SD 1.67% Total 5/200 (2.5%) Mean 2.5% SD 3% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 1/50 (2%) 3/50 (6%) 5/50 (10%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | | Carcinoma, Basosq. Tumor (M or 4/50 (8%) 7/50 (14%) 1/50 (2%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 20/250 (8%) Mean 8% SD 4.47% Total 7/200 (3.5%) Mean 3.5% SD 3% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 178 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 2/50 (4%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 13/250 (5.2%) Mean 5.2% SD 2.28% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Cell Carcinoma, Basosquamous 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.1% Total 3/200 (1.5%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.79% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.79% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 179 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma, Squamous Cell 3/50 (6%) 6/50 (12%) 1/50 (2%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 16/250 (6.4%) Mean 6.4% SD 3.85% Total 2/200 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 1/50 (2%) 2/50 (4%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 3/50 (6%) 5/50 (10%) 1/50 (2%) | | Overall Incidence Total 15/250 (6%) Mean 6% SD 3.16% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 3/200 (1.5%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 6/50 (12%) 0/50 (0%) 9/50 (18%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | | 6/50 (12%) 5/50 (10%) 1/50 (2%) | | Overall Incidence Total 26/250 (10.4%) Mean 10.4% SD 6.54% Total 7/200 (3.5%) Mean 3.5% SD 3% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 9/50 (18%) 1/50 (2%) 10/50 (20%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | | Myxoma, Myxosarcoma, or Fibrous 7/50 (14%) 6/50 (12%) 1/50 (2%) | | Histiocytoma | | Overall Incidence Total 33/250 (13.2%) Mean 13.2% SD 7.01% Total 7/200 (3.5%) Mean 3.5% SD 3% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Histiocytoma | | Overall Incidence Total 7/250 (2.8%) Mean 2.8% SD 1.79% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 180 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | 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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/250 (2%) Mean 2% SD 2.45% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/43 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/48 (0%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 0/239 (0%) Mean 0% SD 0% Total 0/195 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/43 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 1/48 (2%) 0/50 (0%) 0/47 (0%) | | Overall Incidence Total 1/239 (0.42%) Mean 0.42% SD 0.93% Total 0/195 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 181 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 3/200 (1.5%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 3/200 (1.5%) Mean 1.5% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 45/50 (90%) 47/50 (94%) 45/50 (90%) | | 45/50 (90%) 41/50 (82%) | | Overall Incidence Total 223/250 (89.2%) Mean 89.2% SD 4.38% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/39 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 1/234 (0.43%) Mean 0.41% SD 0.91% Total 0/195 (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: 182 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/39 (0%) 0/50 (0%) 0/48 (0%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 1/234 (0.43%) Mean 0.41% SD 0.91% Total 1/195 (0.51%) Mean 0.52% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/39 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/234 (0%) Mean 0% SD 0% Total 0/195 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/39 (0%) 0/50 (0%) 0/48 (0%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 1/234 (0.43%) Mean 0.41% SD 0.91% Total 1/195 (0.51%) Mean 0.52% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 4/42 (10%) 12/50 (24%) 9/47 (19%) 6/45 (13%) 7/50 (14%) 12/47 (26%) | | 8/46 (17%) 6/50 (12%) 6/50 (12%) | | Overall Incidence Total 39/235 (16.6%) Mean 16.41% SD 5.76% Total 31/192 (16.15%) Mean 16.22% SD 6.27% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 2/42 (5%) 2/50 (4%) 2/47 (4%) 1/45 (2%) 2/50 (4%) 1/47 (2%) | | 1/46 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 8/235 (3.4%) Mean 3.44% SD 1.27% Total 4/192 (2.08%) Mean 2.09% SD 1.64% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 6/42 (14%) 14/50 (28%) 11/47 (23%) 7/45 (16%) 9/50 (18%) 13/47 (28%) | | 9/46 (20%) 7/50 (14%) 6/50 (12%) | | Overall Incidence Total 47/235 (20%) Mean 19.85% SD 6.01% Total 35/192 (18.23%) Mean 18.3% SD 6.71% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/42 (2%) 1/50 (2%) 1/47 (2%) 0/45 (0%) 1/50 (2%) 0/47 (0%) | | 0/46 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/235 (1.7%) Mean 1.7% SD 0.96% Total 1/192 (0.52%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/42 (0%) 1/50 (2%) 0/47 (0%) 1/45 (2%) 1/50 (2%) 1/47 (2%) | | 0/46 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/235 (0.43%) Mean 0.4% SD 0.89% Total 3/192 (1.56%) Mean 1.59% SD 1.06% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/42 (2%) 2/50 (4%) 1/47 (2%) 1/45 (2%) 2/50 (4%) 1/47 (2%) | | 0/46 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/235 (2.13%) Mean 2.1% SD 1.42% Total 4/192 (2.08%) Mean 2.09% SD 1.64% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 183 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (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%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/242 (0.41%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 184 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/46 (0%) 1/49 (2%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/242 (0.83%) Mean 0.81% SD 1.11% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/46 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/242 (0%) Mean 0% SD 0% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/46 (0%) 1/49 (2%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/242 (0.41%) Mean 0.41% SD 0.91% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 1/46 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/242 (0.41%) Mean 0.43% SD 0.97% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/200 (1%) Mean 1% SD 2% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 8/50 (16%) 7/50 (14%) 9/50 (18%) | | 4/50 (8%) | | Overall Incidence Total 28/200 (14%) Mean 14% SD 4.32% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 185 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ORAL Date of Species: RATS Vehicle: WATER Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 2/200 (1%) Mean 1% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 9/50 (18%) 7/50 (14%) 10/50 (20%) | | 4/50 (8%) | | Overall Incidence Total 30/200 (15%) Mean 15% SD 5.29% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/200 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/250 (2%) Mean 2% SD 2.45% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 6/250 (2.4%) Mean 2.4% SD 2.19% Total 1/200 (0.5%) Mean 0.5% SD 1% | __________________________________________________________________________________________________________________________________ *: 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: 187 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 47/50 (94%) 44/50 (88%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 34/50 (68%) 22/50 (44%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 50/50 (100%) 48/50 (96%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 13/50 (26%) 9/50 (18%) | | Mononuclear, or Undifferentiated | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 1/50 (2%) 0/50 (0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 188 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 0/50 (0%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 3/50 (6%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 0/50 (0%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 4/50 (8%) 0/49 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 6/50 (12%) 0/49 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Blood Vessel: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 189 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 1/50 (2%) 0/50 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 1/50 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/50 (2%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 190 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 2/50 (4%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Amelanotic Melanoma, Benign 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 191 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 192 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 5/50 (10%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 7/50 (14%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/50 (0%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 193 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/50 (0%) 6/50 (12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 0/50 (0%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/50 (0%) 6/50 (12%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/50 (0%) 6/50 (12%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 194 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 1/50 (2%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 4/50 (8%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 0/50 (0%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 195 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 12/50 (24%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 14/50 (28%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 196 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Squamous Cell Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 3/50 (6%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 197 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/49 (0%) 0/45 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 29/50 (58%) 33/50 (66%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 198 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 5/50 (10%) 3/50 (6%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 34/50 (68%) 36/50 (72%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 2/50 (4%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 3/50 (6%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Sarcoma 1/49 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 199 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 200 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 4/50 (8%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 3/50 (6%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 201 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 4/50 (8%) 1/50 (2%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 5/50 (10%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 202 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 5/50 (10%) 0/50 (0%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibroma or Schwannoma benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 2/50 (4%) 2/50 (4%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 2/50 (4%) 2/50 (4%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Benign 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 203 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 2/50 (4%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 1/50 (2%) 0/50 (0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Lipoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 36/50 (72%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 204 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Sarcoma 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/49 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 5/50 (10%) 3/50 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 5/50 (10%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 10/50 (20%) 5/50 (10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Leiomyoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 205 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Paraganglioma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Liposarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 2/50 (4%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 2/50 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 206 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 1/50 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 10/50 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 10/50 (20%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 207 Version: 02/10/05 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: SKIN APPLICATION Date of Species: RATS Vehicle: ETHANOL Input File: 28-JAN-2005 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________