Toxicology Data Management System Page: 1 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 055634803 06/06/96 726 100(3) 52 (681) 492.7 CITRAL | |BATTELLE COLUMBUS 058803105 03/31/97 729 50(3) 23 (662) 519.6 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058812206 06/25/97 727 50(3) 26 (667) 483.6 ELMIRON | |BATTELLE COLUMBUS 058805005 10/30/95 729 50(3) 25 (665) 488.4 METHACRYLONITRILE | |BATTELLE COLUMBUS 058812003 12/18/95 729 50(3) 24 (659) 496.8 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 058800705 08/14/95 729 50(3) 29 (665) 502.2 SODIUM NITRITE | |BATTELLE COLUMBUS 055611103 09/08/97 731 100(3) 60 (689) 492.1 TRANS-CINNAMALDEHYDE | |BATTELLE NORTHWEST 059302607 08/14/97 733 50( ) 28 (684) 506.2 DECALIN | |BATTELLE NORTHWEST 058812403 01/18/96 733 50( ) 27 (667) 501.0 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 733 49( ) 24 (681) 507.1 NAPHTHALENE | |BATTELLE NORTHWEST 056142707 01/06/97 729 50( ) 20 (668) 518.0 VANADIUM PENTOXIDE | |IITRI 058902905 09/26/94 736 100(5) 57 (692) 498.3 MAGNETIC FIELDS (EMF) | |SOUTHERN RESEARCH 059302306 07/11/97 729 50(3) 37 (693) 510.6 2,4-HEXADIENAL (2,4-HX) | |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 | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 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 | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 055634803 06/06/96 732 100(5) 75 (705) 335.2 CITRAL | |BATTELLE COLUMBUS 058803105 03/31/97 729 50(5) 30 (683) 350.8 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058812206 06/25/97 728 50(5) 30 (672) 327.2 ELMIRON | |BATTELLE COLUMBUS 058805005 10/30/95 731 50(5) 38 (710) 315.4 METHACRYLONITRILE | |BATTELLE COLUMBUS 058812003 12/18/95 730 50(5) 36 (694) 330.5 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 058800705 08/14/95 730 50(5) 33 (695) 350.1 SODIUM NITRITE | |BATTELLE COLUMBUS 055611103 09/08/97 735 100(5) 70 (706) 344.4 TRANS-CINNAMALDEHYDE | |BATTELLE NORTHWEST 059302607 08/14/97 734 50( ) 32 (700) 345.9 DECALIN | |BATTELLE NORTHWEST 058812403 01/18/96 735 50( ) 34 (682) 337.2 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 050511002 03/28/96 734 49( ) 28 (700) 325.2 NAPHTHALENE | |BATTELLE NORTHWEST 056142707 01/06/97 731 50( ) 33 (688) 351.1 VANADIUM PENTOXIDE | |IITRI 058902905 09/26/94 737 100(5) 59 (692) 338.0 MAGNETIC FIELDS (EMF) | |SOUTHERN RESEARCH 059302306 07/11/97 732 50(5) 37 (699) 314.6 2,4-HEXADIENAL (2,4-HX) | |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 | |SOUTHERN RESEARCH 050516105 03/06/96 729 50(5) 33 (683) 322.1 RIDDELLIINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 97/100(97%) 47/50 (94%) 49/50 (98%) 78/100(78%) 44/50 (88%) 37/50 (74%) | | 47/50 (94%) 42/50 (84%) 47/50 (94%) 35/50 (70%) 37/50 (74%) 42/50 (84%) | | 99/100(99%) 47/50 (94%) 47/50 (94%) 78/100(78%) 46/50 (92%) 44/50 (88%) | | 46/49 (94%) 48/50 (96%) 99/100(99%) 38/49 (78%) 41/50 (82%) 92/100(92%) | | 48/50 (96%) 60/60 (100%) 49/50 (98%) 45/50 (90%) 47/60 (78%) 33/50 (66%) | | 45/50 (90%) | | Overall Incidence Total 872/909 (95.93%)Mean 95.39% SD 3.84% Total 782/959 (81.54%) Mean 81.37% SD 8.13% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 76/100(76%) 35/50 (70%) 29/50 (58%) 30/100(30%) 25/50 (50%) 12/50 (24%) | | 29/50 (58%) 34/50 (68%) 30/50 (60%) 26/50 (52%) 16/50 (32%) 23/50 (46%) | | 57/100(57%) 27/50 (54%) 26/50 (52%) 39/100(39%) 25/50 (50%) 25/50 (50%) | | 34/49 (69%) 28/50 (56%) 66/100(66%) 26/49 (53%) 28/50 (56%) 40/100(40%) | | 21/50 (42%) 37/60 (62%) 33/50 (66%) 18/50 (36%) 24/60 (40%) 22/50 (44%) | | 20/50 (40%) | | Overall Incidence Total 562/909 (61.83%)Mean 60.94% SD 8.56% Total 399/959 (41.61%) Mean 42.63% SD 9.13% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 99/100(99%) 49/50 (98%) 49/50 (98%) 92/100(92%) 50/50 (100%) 42/50 (84%) | | 49/50 (98%) 49/50 (98%) 49/50 (98%) 45/50 (90%) 43/50 (86%) 45/50 (90%) | | 100/100(100%) 49/50 (98%) 49/50 (98%) 92/100(92%) 49/50 (98%) 49/50 (98%) | | 48/49 (98%) 50/50 (100%) 100/100(100%) 44/49 (90%) 47/50 (94%) 98/100(98%) | | 50/50 (100%) 60/60 (100%) 50/50 (100%) 47/50 (94%) 54/60 (90%) 43/50 (86%) | | 47/50 (94%) | | Overall Incidence Total 900/909 (99.01%)Mean 98.86% SD 0.99% Total 887/959 (92.49%) Mean 92.24% SD 4.73% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 1/49 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.33% SD 1.05% Total 4/959 (0.42%) Mean 0.38% SD 0.81% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 1/49 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.38% SD 0.79% Total 3/959 (0.31%) Mean 0.38% SD 0.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 4 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 2/49 (4%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 6/909 (0.66%) Mean 0.71% SD 1.2% Total 7/959 (0.73%) Mean 0.76% SD 1.25% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 1/50 (2%) 0/100(0%) | | 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.24% SD 0.65% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 68/100(68%) 16/50 (32%) 15/50 (30%) 24/100(24%) 10/50 (20%) 7/50 (14%) | | Mononuclear, or Undifferentiated 20/50 (40%) 27/50 (54%) 17/50 (34%) 21/50 (42%) 8/50 (16%) 15/50 (30%) | | 40/100(40%) 19/50 (38%) 16/50 (32%) 21/100(21%) 11/50 (22%) 14/50 (28%) | | 26/49 (53%) 22/50 (44%) 50/100(50%) 16/49 (33%) 21/50 (42%) 20/100(20%) | | 11/50 (22%) 30/60 (50%) 24/50 (48%) 10/50 (20%) 21/60 (35%) 13/50 (26%) | | 12/50 (24%) | | Overall Incidence Total 401/909 (44.11%)Mean 42.34% SD 11.77% Total 244/959 (25.44%) Mean 26.04% SD 8.4% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Undifferentiated Cell Type 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.4% SD 1.12% Total 2/959 (0.21%) Mean 0.13% SD 0.34% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.41% SD 1.14% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 5 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/100(4%) 6/50 (12%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | NOS 0/50 (0%) 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/100(5%) 1/50 (2%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 1/50 (2%) 4/100(4%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 4/50 (8%) 2/60 (3%) 5/50 (10%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 43/909 (4.73%) Mean 4.83% SD 3.11% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/100(4%) 6/50 (12%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/100(5%) 1/50 (2%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 4/100(4%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 4/50 (8%) 2/60 (3%) 5/50 (10%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 41/909 (4.51%) Mean 4.56% SD 3.35% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 8/909 (0.88%) Mean 1.05% SD 1.66% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 8/909 (0.88%) Mean 1.05% SD 1.66% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 2/100(2%) 0/47 (0%) 0/50 (0%) 2/100(2%) 1/49 (2%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/49 (2%) | | 2/49 (4%) 0/50 (0%) 0/99 (0%) 1/49 (2%) 0/49 (0%) 6/100(6%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 2/60 (3%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 6/905 (0.66%) Mean 0.67% SD 1.25% Total 21/956 (2.2%) Mean 2.03% SD 1.52% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 6 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/100(0%) 0/47 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/99 (0%) 0/49 (0%) 0/49 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/905 (0%) Mean 0% SD 0% Total 2/956 (0.21%) Mean 0.19% SD 0.55% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Ganglioneuroma 0/100(0%) 1/47 (2%) 0/50 (0%) 0/99 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/48 (0%) 0/49 (0%) 0/96 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/903 (0.22%) Mean 0.21% SD 0.59% Total 0/950 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 10/100(10%) 4/47 (9%) 7/50 (14%) 3/99 (3%) 0/49 (0%) 2/50 (4%) | | 3/50 (6%) 4/50 (8%) 6/50 (12%) 1/50 (2%) 2/50 (4%) 4/50 (8%) | | 5/100(5%) 7/49 (14%) 10/50 (20%) 1/100(1%) 1/50 (2%) 2/50 (4%) | | 4/49 (8%) 4/50 (8%) 24/98 (24%) 3/48 (6%) 2/49 (4%) 7/96 (7%) | | 7/50 (14%) 2/60 (3%) 3/50 (6%) 1/50 (2%) 2/60 (3%) 2/49 (4%) | | 1/50 (2%) | | Overall Incidence Total 100/903 (11.07%)Mean 10.79% SD 5.79% Total 34/950 (3.58%) Mean 3.57% SD 2.18% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 1/100(1%) 0/47 (0%) 0/50 (0%) 0/99 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/48 (0%) 0/49 (0%) 0/96 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.07% SD 0.26% Total 1/950 (0.11%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/100(0%) 5/47 (11%) 1/50 (2%) 0/99 (0%) 2/49 (4%) 1/50 (2%) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 2/49 (4%) 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 2/98 (2%) 0/48 (0%) 0/49 (0%) 0/96 (0%) | | 0/50 (0%) 2/60 (3%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/49 (0%) | | 1/50 (2%) | | Overall Incidence Total 18/903 (1.99%) Mean 2.28% SD 2.72% Total 7/950 (0.74%) Mean 0.76% SD 1.25% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 7 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 11/100(11%) 9/47 (19%) 7/50 (14%) 3/99 (3%) 2/49 (4%) 3/50 (6%) | | Complex, Malignant, NOS 4/50 (8%) 6/50 (12%) 7/50 (14%) 1/50 (2%) 2/50 (4%) 4/50 (8%) | | 5/100(5%) 8/49 (16%) 10/50 (20%) 4/100(4%) 1/50 (2%) 2/50 (4%) | | 5/49 (10%) 5/50 (10%) 26/98 (27%) 3/48 (6%) 2/49 (4%) 7/96 (7%) | | 7/50 (14%) 4/60 (7%) 3/50 (6%) 2/50 (4%) 2/60 (3%) 2/49 (4%) | | 2/50 (4%) | | Overall Incidence Total 117/903 (12.96%)Mean 12.86% SD 5.88% Total 42/950 (4.42%) Mean 4.38% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chordoma 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 8/909 (0.88%) Mean 1.05% SD 1.66% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 8/909 (0.88%) Mean 1.05% SD 1.66% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 2/50 (4%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 6/959 (0.63%) Mean 0.63% SD 1.15% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 8 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Brain: | | Granular Cell Tumor Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 9 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 2/100(2%) 0/49 (0%) 0/50 (0%) 2/100(2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 2/50 (4%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.27% SD 0.7% Total 9/959 (0.94%) Mean 0.94% SD 1.24% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 7/100(7%) 3/50 (6%) 1/50 (2%) 15/98 (15%) 6/48 (13%) 3/50 (6%) | | 2/50 (4%) 3/50 (6%) 0/50 (0%) 2/49 (4%) 1/47 (2%) 8/46 (17%) | | 7/100(7%) 0/50 (0%) 1/50 (2%) 4/99 (4%) 8/48 (17%) 5/49 (10%) | | 3/48 (6%) 0/50 (0%) 13/100(13%) 4/49 (8%) 2/50 (4%) 11/90 (12%) | | 1/49 (2%) 2/60 (3%) 2/50 (4%) 5/50 (10%) 12/59 (20%) 7/50 (14%) | | 7/49 (14%) | | Overall Incidence Total 45/907 (4.96%) Mean 4.17% SD 3.5% Total 100/931 (10.74%) Mean 10.71% SD 5.54% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/100(1%) 3/50 (6%) 1/50 (2%) 1/98 (1%) 5/48 (10%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 5/50 (10%) 1/49 (2%) 0/47 (0%) 2/46 (4%) | | 4/100(4%) 0/50 (0%) 2/50 (4%) 9/99 (9%) 1/48 (2%) 0/49 (0%) | | 3/48 (6%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/90 (0%) | | 3/49 (6%) 2/60 (3%) 2/50 (4%) 2/50 (4%) 2/59 (3%) 2/50 (4%) | | 3/49 (6%) | | Overall Incidence Total 27/907 (2.98%) Mean 3.25% SD 2.96% Total 28/931 (3.01%) Mean 2.91% SD 3.32% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 8/100(8%) 6/50 (12%) 2/50 (4%) 16/98 (16%) 10/48 (21%) 3/50 (6%) | | 3/50 (6%) 3/50 (6%) 5/50 (10%) 3/49 (6%) 1/47 (2%) 10/46 (22%) | | 11/100(11%) 0/50 (0%) 3/50 (6%) 13/99 (13%) 9/48 (19%) 5/49 (10%) | | 6/48 (13%) 0/50 (0%) 13/100(13%) 4/49 (8%) 2/50 (4%) 11/90 (12%) | | 4/49 (8%) 4/60 (7%) 4/50 (8%) 7/50 (14%) 14/59 (24%) 8/50 (16%) | | 10/49 (20%) | | Overall Incidence Total 72/907 (7.94%) Mean 7.42% SD 4.03% Total 126/931 (13.53%) Mean 13.36% SD 6.77% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/47 (0%) 0/46 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/48 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/90 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | 0/49 (0%) | | Overall Incidence Total 0/907 (0%) Mean 0% SD 0% Total 1/931 (0.11%) Mean 0.13% SD 0.51% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Sarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/98 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/48 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/90 (0%) | | 0/49 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | 0/49 (0%) | | Overall Incidence Total 1/907 (0.11%) Mean 0.13% SD 0.52% Total 0/931 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/46 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/48 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/90 (0%) | | 0/49 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | 0/49 (0%) | | Overall Incidence Total 1/907 (0.11%) Mean 0.13% SD 0.52% Total 0/931 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Melanoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (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: 11 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/100(0%) 2/50 (4%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.4% SD 1.12% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 2/100(2%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 5/909 (0.55%) Mean 0.4% SD 0.83% Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Carcinoma or Adenoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/100(0%) 0/50 (0%) 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.38% SD 0.79% Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 12 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Leiomyoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 13 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Leiomyoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/99 (3%) 2/44 (5%) 1/50 (2%) 0/100(0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/100(2%) 3/50 (6%) 1/50 (2%) 0/100(0%) 1/50 (2%) 1/50 (2%) | | 2/49 (4%) 1/50 (2%) 3/99 (3%) 1/49 (2%) 1/49 (2%) 1/100(1%) | | 4/50 (8%) 2/60 (3%) 3/50 (6%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | 2/50 (4%) | | Overall Incidence Total 31/901 (3.44%) Mean 3.6% SD 2.51% Total 9/955 (0.94%) Mean 1.05% SD 1.23% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/99 (0%) 0/44 (0%) 0/50 (0%) 0/100(0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 4/50 (8%) 2/50 (4%) 2/100(2%) 1/50 (2%) 0/50 (0%) | | 4/49 (8%) 1/50 (2%) 1/99 (1%) 1/49 (2%) 1/49 (2%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 16/901 (1.78%) Mean 2.08% SD 2.81% Total 6/955 (0.63%) Mean 0.57% SD 0.9% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/99 (3%) 2/44 (5%) 1/50 (2%) 0/100(0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 5/50 (10%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/100(2%) 7/50 (14%) 3/50 (6%) 2/100(2%) 2/50 (4%) 1/50 (2%) | | 6/49 (12%) 2/50 (4%) 4/99 (4%) 2/49 (4%) 2/49 (4%) 2/100(2%) | | 4/50 (8%) 2/60 (3%) 5/50 (10%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | 2/50 (4%) | | Overall Incidence Total 47/901 (5.22%) Mean 5.68% SD 4.2% Total 15/955 (1.57%) Mean 1.61% SD 1.68% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/47 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/906 (0.22%) Mean 0.27% SD 0.71% Total 0/957 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/47 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/906 (0.22%) Mean 0.27% SD 0.71% Total 0/957 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/100(0%) 1/47 (2%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/100(0%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/906 (0.33%) Mean 0.41% SD 0.85% Total 1/957 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/100(0%) 0/47 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 1/48 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/906 (0%) Mean 0% SD 0% Total 3/957 (0.31%) Mean 0.32% SD 0.72% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/100(0%) 1/47 (2%) 0/50 (0%) 2/100(2%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/100(0%) 1/48 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/906 (0.33%) Mean 0.41% SD 0.85% Total 4/957 (0.42%) Mean 0.38% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/100(0%) 0/47 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/906 (0.11%) Mean 0.07% SD 0.26% Total 0/957 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Lipoma 0/100(0%) 0/47 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/906 (0%) Mean 0% SD 0% Total 1/957 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Sarcoma 0/100(0%) 0/47 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/906 (0.11%) Mean 0.07% SD 0.26% Total 0/957 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Stromal Nephroma 0/100(0%) 1/47 (2%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/906 (0.11%) Mean 0.14% SD 0.55% Total 0/957 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Cholangiocarcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 1/100(1%) 0/49 (0%) 1/50 (2%) 0/100(0%) | | 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 7/909 (0.77%) Mean 0.69% SD 1.11% Total 4/959 (0.42%) Mean 0.48% SD 0.86% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 5/909 (0.55%) Mean 0.65% SD 1.21% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Hepatoblastoma 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 5/909 (0.55%) Mean 0.65% SD 1.21% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Hepatocellular Adenoma 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 1/100(1%) 0/49 (0%) 1/50 (2%) 0/100(0%) | | 0/50 (0%) 3/60 (5%) 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 12/909 (1.32%) Mean 1.34% SD 1.77% Total 5/959 (0.52%) Mean 0.6% SD 0.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Hepatocellular Adenoma, or 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 1/100(1%) 0/49 (0%) 1/50 (2%) 0/100(0%) | | 0/50 (0%) 3/60 (5%) 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 12/909 (1.32%) Mean 1.34% SD 1.77% Total 5/959 (0.52%) Mean 0.6% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/49 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/958 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 3/100(3%) 2/50 (4%) 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | 4/100(4%) 1/50 (2%) 6/50 (12%) 6/100(6%) 1/50 (2%) 0/50 (0%) | | 2/49 (4%) 4/50 (8%) 3/100(3%) 1/49 (2%) 0/49 (0%) 3/100(3%) | | 1/50 (2%) 1/60 (2%) 1/50 (2%) 3/50 (6%) 1/60 (2%) 0/50 (0%) | | 2/50 (4%) | | Overall Incidence Total 32/909 (3.52%) Mean 3.58% SD 3.03% Total 22/958 (2.3%) Mean 2.04% SD 2.32% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/100(0%) 1/50 (2%) 2/50 (4%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 1/50 (2%) 1/50 (2%) 1/100(1%) 1/50 (2%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 1/100(1%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 7/909 (0.77%) Mean 0.84% SD 1.23% Total 6/958 (0.63%) Mean 0.56% SD 0.81% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/100(3%) 3/50 (6%) 2/50 (4%) 3/100(3%) 1/50 (2%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | 5/100(5%) 2/50 (4%) 7/50 (14%) 7/100(7%) 2/50 (4%) 1/50 (2%) | | 2/49 (4%) 4/50 (8%) 3/100(3%) 1/49 (2%) 0/49 (0%) 4/100(4%) | | 1/50 (2%) 2/60 (3%) 1/50 (2%) 3/50 (6%) 1/60 (2%) 0/50 (0%) | | 2/50 (4%) | | Overall Incidence Total 39/909 (4.29%) Mean 4.43% SD 3.22% Total 28/958 (2.92%) Mean 2.61% SD 2.37% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 18 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Carcinoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/958 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Squamous Cell Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/958 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(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%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 1/50 (2%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 2/50 (4%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.33% SD 0.72% Total 10/959 (1.04%) Mean 1.13% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 4/50 (8%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 5/50 (10%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 3/49 (6%) 2/50 (4%) 2/100(2%) | | 2/50 (4%) 0/60 (0%) 0/50 (0%) 2/50 (4%) 0/60 (0%) 1/50 (2%) | | 2/50 (4%) | | Overall Incidence Total 6/909 (0.66%) Mean 0.67% SD 1.24% Total 28/959 (2.92%) Mean 3.32% SD 2.95% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 3/100(3%) 0/50 (0%) 1/50 (2%) 0/100(0%) 4/50 (8%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | | 0/100(0%) 2/50 (4%) 0/50 (0%) 2/100(2%) 5/50 (10%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 3/49 (6%) 3/50 (6%) 3/100(3%) | | 2/50 (4%) 0/60 (0%) 0/50 (0%) 3/50 (6%) 0/60 (0%) 1/50 (2%) | | 3/50 (6%) | | Overall Incidence Total 9/909 (0.99%) Mean 1% SD 1.56% Total 35/959 (3.65%) Mean 4.07% SD 2.98% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 8/100(8%) 1/50 (2%) 2/50 (4%) 53/100(53%) 36/50 (72%) 15/50 (30%) | | 2/50 (4%) 3/50 (6%) 3/50 (6%) 21/50 (42%) 15/50 (30%) 21/50 (42%) | | 3/100(3%) 2/50 (4%) 2/50 (4%) 55/100(55%) 25/50 (50%) 20/50 (40%) | | 0/49 (0%) 2/50 (4%) 6/100(6%) 17/49 (35%) 16/50 (32%) 56/100(56%) | | 3/50 (6%) 0/60 (0%) 0/50 (0%) 22/50 (44%) 23/60 (38%) 14/50 (28%) | | 28/50 (56%) | | Overall Incidence Total 37/909 (4.07%) Mean 3.8% SD 2.46% Total 437/959 (45.57%) Mean 43.94% SD 12.23% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (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: 20 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 9/100(9%) 1/50 (2%) 4/50 (8%) 53/100(53%) 36/50 (72%) 15/50 (30%) | | 2/50 (4%) 3/50 (6%) 3/50 (6%) 21/50 (42%) 16/50 (32%) 23/50 (46%) | | 3/100(3%) 3/50 (6%) 2/50 (4%) 55/100(55%) 25/50 (50%) 20/50 (40%) | | 0/49 (0%) 2/50 (4%) 6/100(6%) 17/49 (35%) 17/50 (34%) 56/100(56%) | | 3/50 (6%) 0/60 (0%) 0/50 (0%) 23/50 (46%) 23/60 (38%) 14/50 (28%) | | 28/50 (56%) | | Overall Incidence Total 41/909 (4.51%) Mean 4.27% SD 2.84% Total 442/959 (46.09%) Mean 44.56% SD 11.97% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 11/100(11%) 1/50 (2%) 4/50 (8%) 53/100(53%) 37/50 (74%) 16/50 (32%) | | or Adenoma 2/50 (4%) 3/50 (6%) 3/50 (6%) 23/50 (46%) 16/50 (32%) 23/50 (46%) | | 3/100(3%) 4/50 (8%) 2/50 (4%) 56/100(56%) 29/50 (58%) 20/50 (40%) | | 1/49 (2%) 2/50 (4%) 6/100(6%) 18/49 (37%) 19/50 (38%) 58/100(58%) | | 5/50 (10%) 0/60 (0%) 0/50 (0%) 24/50 (48%) 23/60 (38%) 14/50 (28%) | | 30/50 (60%) | | Overall Incidence Total 47/909 (5.17%) Mean 4.94% SD 3.35% Total 459/959 (47.86%) Mean 46.5% SD 12.59% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Hemangioma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Lipoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (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: 21 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Liposarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.27% SD 0.71% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/100(0%) 0/46 (0%) 0/50 (0%) 1/100(1%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/903 (0%) Mean 0% SD 0% Total 1/957 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/100(0%) 0/46 (0%) 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/49 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/100(0%) 0/49 (0%) 1/50 (2%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/903 (0.11%) Mean 0.13% SD 0.52% Total 1/957 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 4/909 (0.44%) Mean 0.4% SD 0.74% Total 4/959 (0.42%) Mean 0.44% SD 0.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.13% SD 0.35% Total 5/959 (0.52%) Mean 0.63% SD 1.2% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 2/100(2%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 2/100(2%) 0/50 (0%) 1/50 (2%) 0/100(0%) 3/50 (6%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 2/50 (4%) | | 0/50 (0%) | | Overall Incidence Total 6/909 (0.66%) Mean 0.53% SD 0.92% Total 9/959 (0.94%) Mean 1.06% SD 1.77% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.13% SD 0.35% Total 2/959 (0.21%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.27% SD 0.7% Total 2/959 (0.21%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.06% SD 0.25% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/49 (4%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/959 (0.31%) Mean 0.38% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/100(0%) 0/50 (0%) 0/50 (0%) | | Malignant, NOS 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) | | 2/49 (4%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 4/959 (0.42%) Mean 0.51% SD 1.17% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/959 (0.21%) Mean 0.25% SD 0.69% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Sarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 3/100(3%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/959 (0.31%) Mean 0.19% SD 0.75% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 2/100(2%) 0/44 (0%) 0/50 (0%) 0/100(0%) 1/47 (2%) 1/50 (2%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 3/98 (3%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 10/50 (20%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 21/901 (2.33%) Mean 2.38% SD 5.04% Total 4/956 (0.42%) Mean 0.51% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma 0/100(0%) 1/44 (2%) 0/50 (0%) 0/100(0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/901 (0.22%) Mean 0.28% SD 0.75% Total 0/956 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 25 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 2/100(2%) 1/44 (2%) 0/50 (0%) 0/100(0%) 1/47 (2%) 1/50 (2%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 3/98 (3%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 10/50 (20%) 1/60 (2%) 1/50 (2%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 23/901 (2.55%) Mean 2.67% SD 4.95% Total 4/956 (0.42%) Mean 0.51% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 1/100(1%) 0/44 (0%) 0/50 (0%) 0/100(0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.07% SD 0.26% Total 0/956 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Mixed Tumor Benign 0/100(0%) 2/44 (5%) 0/50 (0%) 0/100(0%) 0/47 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/901 (0.33%) Mean 0.37% SD 1.18% Total 0/956 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/93 (0%) 1/45 (2%) 0/46 (0%) 2/86 (2%) 0/49 (0%) 1/46 (2%) | | 0/46 (0%) 0/46 (0%) 0/45 (0%) 1/48 (2%) 0/45 (0%) 0/46 (0%) | | 0/92 (0%) 0/49 (0%) 1/44 (2%) 0/90 (0%) 0/49 (0%) 0/40 (0%) | | 0/45 (0%) 0/49 (0%) 0/85 (0%) 0/42 (0%) 0/45 (0%) 1/88 (1%) | | 0/50 (0%) 0/58 (0%) 0/48 (0%) 0/49 (0%) 0/57 (0%) 0/46 (0%) | | 0/48 (0%) | | Overall Incidence Total 2/841 (0.24%) Mean 0.3% SD 0.79% Total 5/874 (0.57%) Mean 0.48% SD 0.9% | __________________________________________________________________________________________________________________________________ |#Peripheral Nerve: | | Sarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (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: 26 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 17/100(17%) 15/47 (32%) 19/50 (38%) 29/100(29%) 20/48 (42%) 21/50 (42%) | | Adenoma 17/50 (34%) 11/50 (22%) 13/50 (26%) 12/50 (24%) 23/50 (46%) 24/50 (48%) | | 21/100(21%) 27/50 (54%) 36/49 (73%) 35/100(35%) 34/50 (68%) 30/50 (60%) | | 31/49 (63%) 35/50 (70%) 34/98 (35%) 23/49 (47%) 31/49 (63%) 61/99 (62%) | | 12/50 (24%) 11/59 (19%) 15/48 (31%) 19/50 (38%) 19/59 (32%) 15/50 (30%) | | 27/50 (54%) | | Overall Incidence Total 314/900 (34.89%)Mean 37.28% SD 18.86% Total 423/954 (44.34%) Mean 44.98% SD 13.45% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/100(0%) 0/47 (0%) 1/50 (2%) 0/100(0%) 1/48 (2%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/49 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/49 (0%) 3/99 (3%) | | 0/50 (0%) 0/59 (0%) 1/48 (2%) 0/50 (0%) 0/59 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/900 (0.33%) Mean 0.41% SD 0.85% Total 5/954 (0.52%) Mean 0.44% SD 0.98% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 17/100(17%) 15/47 (32%) 20/50 (40%) 29/100(29%) 21/48 (44%) 21/50 (42%) | | Carcinoma or Adenoma 17/50 (34%) 11/50 (22%) 13/50 (26%) 13/50 (26%) 23/50 (46%) 24/50 (48%) | | 21/100(21%) 27/50 (54%) 37/49 (76%) 35/100(35%) 34/50 (68%) 30/50 (60%) | | 31/49 (63%) 35/50 (70%) 34/98 (35%) 23/49 (47%) 31/49 (63%) 64/99 (65%) | | 12/50 (24%) 11/59 (19%) 16/48 (33%) 19/50 (38%) 19/59 (32%) 15/50 (30%) | | 27/50 (54%) | | Overall Incidence Total 317/900 (35.22%)Mean 37.69% SD 19.11% Total 428/954 (44.86%) Mean 45.43% SD 13.49% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/100(1%) 0/47 (0%) 1/50 (2%) 2/100(2%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/49 (0%) 0/99 (0%) | | 0/50 (0%) 0/59 (0%) 0/48 (0%) 1/50 (2%) 1/59 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/900 (0.22%) Mean 0.2% SD 0.56% Total 4/954 (0.42%) Mean 0.36% SD 0.77% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/100(1%) 0/47 (0%) 1/50 (2%) 2/100(2%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/49 (0%) 0/99 (0%) | | 0/50 (0%) 0/59 (0%) 0/48 (0%) 1/50 (2%) 1/59 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/900 (0.22%) Mean 0.2% SD 0.56% Total 4/954 (0.42%) Mean 0.36% SD 0.77% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 27 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/100(0%) 1/48 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 4/100(4%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 2/49 (4%) 2/60 (3%) 2/50 (4%) | | | | Overall Incidence Total 13/906 (1.43%) Mean 1.43% SD 1.72% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/100(0%) 1/48 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 4/100(4%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 2/49 (4%) 2/60 (3%) 2/50 (4%) | | | | Overall Incidence Total 13/906 (1.43%) Mean 1.43% SD 1.72% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/99 (0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/906 (0%) Mean 0% SD 0% Total 1/957 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/99 (0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/906 (0%) Mean 0% SD 0% Total 1/957 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/100(0%) 0/49 (0%) 1/50 (2%) 0/100(0%) 0/49 (0%) 0/50 (0%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/99 (0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 7/906 (0.77%) Mean 0.93% SD 1.49% Total 0/957 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Lipoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 2/959 (0.21%) Mean 0.17% SD 0.47% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) 1/50 (2%) 1/50 (2%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 4/909 (0.44%) Mean 0.54% SD 0.92% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/100(0%) 1/50 (2%) 1/50 (2%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 5/909 (0.55%) Mean 0.6% SD 0.91% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 3/100(3%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 11/909 (1.21%) Mean 1.09% SD 1.2% Total 2/959 (0.21%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Basosquamous Tumor Benign 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 3/100(3%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 11/909 (1.21%) Mean 1.09% SD 1.2% Total 2/959 (0.21%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 2/100(2%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Tumor Benign, or 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Trichoepithelioma 2/100(2%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 3/100(3%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 15/909 (1.65%) Mean 1.49% SD 1.39% Total 3/959 (0.31%) Mean 0.38% SD 0.81% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.2% SD 0.56% Total 3/959 (0.31%) Mean 0.38% SD 0.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 30 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | NOS) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.2% SD 0.56% Total 3/959 (0.31%) Mean 0.38% SD 0.81% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 2/100(2%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | (benign, malignant or NOS), or 3/100(3%) 1/50 (2%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Trichoepithelioma 0/49 (0%) 0/50 (0%) 3/100(3%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 17/909 (1.87%) Mean 1.69% SD 1.37% Total 6/959 (0.63%) Mean 0.75% SD 1.24% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 11/100(11%) 1/50 (2%) 4/50 (8%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | Carcinoma, Basosq. Tumor (M or 2/50 (4%) 6/50 (12%) 3/50 (6%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | | B), Basal Cell Adenoma, Adenoma, 8/100(8%) 3/50 (6%) 2/50 (4%) 0/100(0%) 1/50 (2%) 1/50 (2%) | | Papilloma, Sq Papilloma, 4/49 (8%) 5/50 (10%) 14/100(14%) 1/49 (2%) 0/50 (0%) 1/100(1%) | | Keratoacanthoma, 5/50 (10%) 7/60 (12%) 4/50 (8%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | Trichoepithelioma 1/50 (2%) | | Overall Incidence Total 79/909 (8.69%) Mean 8.19% SD 3.36% Total 13/959 (1.36%) Mean 1.5% SD 1.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 1/49 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.27% SD 1.03% Total 1/959 (0.1%) Mean 0.13% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiopericytoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 31 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.38% SD 0.79% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 8/100(8%) 1/50 (2%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/100(5%) 1/50 (2%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 4/49 (8%) 4/50 (8%) 10/100(10%) 0/49 (0%) 0/50 (0%) 1/100(1%) | | 3/50 (6%) 5/60 (8%) 2/50 (4%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 53/909 (5.83%) Mean 5.43% SD 2.6% Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/100(0%) 1/50 (2%) 1/50 (2%) 2/100(2%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/49 (2%) 2/50 (4%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 1/50 (2%) | | Overall Incidence Total 11/909 (1.21%) Mean 1.4% SD 1.18% Total 6/959 (0.63%) Mean 0.63% SD 0.96% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.27% SD 0.7% Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 32 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 2/959 (0.21%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Tumor (malignant or NOS), or 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 1/50 (2%) | | Carcinoma 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.33% SD 0.72% Total 5/959 (0.52%) Mean 0.63% SD 1.2% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/100(1%) 0/50 (0%) 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/100(1%) 1/49 (2%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 8/909 (0.88%) Mean 0.93% SD 0.96% Total 3/959 (0.31%) Mean 0.32% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/100(1%) 0/50 (0%) 1/50 (2%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 1/100(1%) 1/49 (2%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 8/909 (0.88%) Mean 0.93% SD 0.96% Total 3/959 (0.31%) Mean 0.32% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 9/100(9%) 1/50 (2%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 2/50 (4%) 4/50 (8%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Carcinoma or Keratoacanthoma 5/100(5%) 2/50 (4%) 2/50 (4%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 4/49 (8%) 5/50 (10%) 11/100(11%) 1/49 (2%) 0/50 (0%) 1/100(1%) | | 4/50 (8%) 5/60 (8%) 3/50 (6%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 62/909 (6.82%) Mean 6.5% SD 2.64% Total 7/959 (0.73%) Mean 0.75% SD 0.93% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 33 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 9/100(9%) 1/50 (2%) 3/50 (6%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 5/100(5%) 2/50 (4%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 4/49 (8%) 5/50 (10%) 11/100(11%) 1/49 (2%) 0/50 (0%) 1/100(1%) | | 4/50 (8%) 5/60 (8%) 3/50 (6%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 61/909 (6.71%) Mean 6.37% SD 2.82% Total 5/959 (0.52%) Mean 0.5% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 4/909 (0.44%) Mean 0.4% SD 0.74% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 2/100(2%) 6/50 (12%) 1/50 (2%) 1/100(1%) 1/50 (2%) 1/50 (2%) | | 3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 7/100(7%) 2/50 (4%) 1/50 (2%) 1/100(1%) 0/50 (0%) 3/50 (6%) | | 5/49 (10%) 2/50 (4%) 12/100(12%) 0/49 (0%) 1/50 (2%) 4/100(4%) | | 4/50 (8%) 5/60 (8%) 1/50 (2%) 2/50 (4%) 3/60 (5%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 53/909 (5.83%) Mean 5.57% SD 3.87% Total 19/959 (1.98%) Mean 1.94% SD 1.91% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 8/100(8%) 9/50 (18%) 3/50 (6%) 1/100(1%) 1/50 (2%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 3/50 (6%) 4/50 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Histiocytoma 12/100(12%) 4/50 (8%) 2/50 (4%) 1/100(1%) 2/50 (4%) 3/50 (6%) | | 7/49 (14%) 6/50 (12%) 13/100(13%) 1/49 (2%) 1/50 (2%) 6/100(6%) | | 7/50 (14%) 5/60 (8%) 2/50 (4%) 2/50 (4%) 3/60 (5%) 2/50 (4%) | | 3/50 (6%) | | Overall Incidence Total 86/909 (9.46%) Mean 9.17% SD 4.53% Total 29/959 (3.02%) Mean 3.07% SD 1.95% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/100(2%) 0/50 (0%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 6/100(6%) 2/50 (4%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 2/49 (4%) 1/50 (2%) 1/100(1%) 0/49 (0%) 0/50 (0%) 1/100(1%) | | 3/50 (6%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 1/50 (2%) | | Overall Incidence Total 21/909 (2.31%) Mean 2.21% SD 2.15% Total 5/959 (0.52%) Mean 0.56% SD 0.89% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 5/100(5%) 3/50 (6%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Myxosarcoma, or Fibrous 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Histiocytoma 6/100(6%) 2/50 (4%) 1/50 (2%) 0/100(0%) 2/50 (4%) 0/50 (0%) | | 2/49 (4%) 4/50 (8%) 1/100(1%) 1/49 (2%) 0/50 (0%) 2/100(2%) | | 3/50 (6%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 2/50 (4%) | | 2/50 (4%) | | Overall Incidence Total 33/909 (3.63%) Mean 3.61% SD 2.39% Total 10/959 (1.04%) Mean 1.13% SD 1.63% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 2/50 (4%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 6/909 (0.66%) Mean 0.67% SD 1.23% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.27% SD 0.7% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.27% SD 0.7% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 1/100(1%) 3/50 (6%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/100(0%) 1/49 (2%) 0/50 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 6/909 (0.66%) Mean 0.73% SD 1.62% Total 4/959 (0.42%) Mean 0.44% SD 0.82% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.27% SD 0.7% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/100(0%) 0/43 (0%) 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 1/49 (2%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/902 (0%) Mean 0% SD 0% Total 1/957 (0.1%) Mean 0.13% SD 0.51% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Leiomyosarcoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (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: 36 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Lipoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.27% SD 0.59% Total 2/959 (0.21%) Mean 0.25% SD 1% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/909 (0.33%) Mean 0.27% SD 0.59% Total 2/959 (0.21%) Mean 0.25% SD 1% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.27% SD 0.7% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 96/100(96%) 45/50 (90%) 44/50 (88%) | | 40/50 (80%) 41/50 (82%) 47/50 (94%) | | 91/100(91%) 40/50 (80%) 40/50 (80%) | | 38/49 (78%) 36/50 (72%) 93/100(93%) | | 41/50 (82%) 55/60 (92%) 49/50 (98%) | | | | Overall Incidence Total 796/909 (87.57%)Mean 86.35% SD 7.74% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/97 (0%) 0/39 (0%) 0/45 (0%) 0/96 (0%) 1/48 (2%) 0/45 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 1/87 (1%) 0/50 (0%) 0/47 (0%) 0/92 (0%) 0/48 (0%) 0/45 (0%) | | 0/47 (0%) 0/49 (0%) 2/97 (2%) 0/46 (0%) 0/49 (0%) 0/95 (0%) | | 0/50 (0%) 0/56 (0%) 0/49 (0%) 0/48 (0%) 0/57 (0%) 0/48 (0%) | | 0/48 (0%) | | Overall Incidence Total 3/858 (0.35%) Mean 0.21% SD 0.59% Total 1/908 (0.11%) Mean 0.13% SD 0.52% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/97 (0%) 0/39 (0%) 0/45 (0%) 0/96 (0%) 0/48 (0%) 0/45 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 0/87 (0%) 0/50 (0%) 0/47 (0%) 1/92 (1%) 0/48 (0%) 0/45 (0%) | | 0/47 (0%) 0/49 (0%) 0/97 (0%) 0/46 (0%) 0/49 (0%) 0/95 (0%) | | 0/50 (0%) 0/56 (0%) 0/49 (0%) 0/48 (0%) 0/57 (0%) 0/48 (0%) | | 1/48 (2%) | | Overall Incidence Total 0/858 (0%) Mean 0% SD 0% Total 2/908 (0.22%) Mean 0.2% SD 0.57% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/97 (0%) 0/39 (0%) 0/45 (0%) 0/96 (0%) 1/48 (2%) 0/45 (0%) | | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) | | 1/87 (1%) 0/50 (0%) 0/47 (0%) 1/92 (1%) 0/48 (0%) 0/45 (0%) | | 0/47 (0%) 0/49 (0%) 2/97 (2%) 0/46 (0%) 0/49 (0%) 0/95 (0%) | | 0/50 (0%) 0/56 (0%) 0/49 (0%) 0/48 (0%) 0/57 (0%) 0/48 (0%) | | 1/48 (2%) | | Overall Incidence Total 3/858 (0.35%) Mean 0.21% SD 0.59% Total 3/908 (0.33%) Mean 0.33% SD 0.74% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 12/100(12%) 4/42 (10%) 8/50 (16%) 21/100(21%) 6/45 (13%) 11/50 (22%) | | 9/50 (18%) 8/50 (16%) 12/50 (24%) 3/50 (6%) 5/50 (10%) 7/50 (14%) | | 12/100(12%) 7/50 (14%) 5/49 (10%) 11/100(11%) 5/50 (10%) 6/47 (13%) | | 9/46 (20%) 1/50 (2%) 15/99 (15%) 4/47 (9%) 2/50 (4%) 15/100(15%) | | 4/50 (8%) 10/59 (17%) 11/50 (22%) 12/50 (24%) 9/60 (15%) 6/50 (12%) | | 2/49 (4%) | | Overall Incidence Total 127/895 (14.19%)Mean 14.36% SD 5.67% Total 125/948 (13.19%) Mean 12.67% SD 5.92% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 4/100(4%) 2/42 (5%) 2/50 (4%) 0/100(0%) 1/45 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | | 3/100(3%) 0/50 (0%) 1/49 (2%) 3/100(3%) 3/50 (6%) 3/47 (6%) | | 1/46 (2%) 0/50 (0%) 1/99 (1%) 3/47 (6%) 1/50 (2%) 5/100(5%) | | 1/50 (2%) 0/59 (0%) 0/50 (0%) 1/50 (2%) 1/60 (2%) 0/50 (0%) | | 1/49 (2%) | | Overall Incidence Total 18/895 (2.01%) Mean 1.93% SD 1.72% Total 28/948 (2.95%) Mean 3.04% SD 2.18% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 16/100(16%) 6/42 (14%) 10/50 (20%) 21/100(21%) 7/45 (16%) 11/50 (22%) | | 10/50 (20%) 8/50 (16%) 14/50 (28%) 5/50 (10%) 7/50 (14%) 9/50 (18%) | | 15/100(15%) 7/50 (14%) 6/49 (12%) 14/100(14%) 8/50 (16%) 8/47 (17%) | | 10/46 (22%) 1/50 (2%) 16/99 (16%) 7/47 (15%) 3/50 (6%) 19/100(19%) | | 5/50 (10%) 10/59 (17%) 11/50 (22%) 13/50 (26%) 10/60 (17%) 6/50 (12%) | | 3/49 (6%) | | Overall Incidence Total 145/895 (16.2%) Mean 16.29% SD 5.97% Total 151/948 (15.93%) Mean 15.52% SD 5.36% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 3/100(3%) 1/42 (2%) 0/50 (0%) 0/100(0%) 0/45 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | 1/100(1%) 0/50 (0%) 0/49 (0%) 1/100(1%) 0/50 (0%) 0/47 (0%) | | 0/46 (0%) 0/50 (0%) 1/99 (1%) 0/47 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/59 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/49 (0%) | | Overall Incidence Total 8/895 (0.89%) Mean 0.76% SD 1.07% Total 3/948 (0.32%) Mean 0.31% SD 0.7% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/100(1%) 0/42 (0%) 2/50 (4%) 1/100(1%) 1/45 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 3/100(3%) 0/50 (0%) 0/49 (0%) 0/100(0%) 0/50 (0%) 1/47 (2%) | | 0/46 (0%) 0/50 (0%) 0/99 (0%) 1/47 (2%) 2/50 (4%) 0/100(0%) | | 1/50 (2%) 1/59 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) | | 0/49 (0%) | | Overall Incidence Total 9/895 (1.01%) Mean 0.91% SD 1.32% Total 11/948 (1.16%) Mean 1.34% SD 1.22% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 4/100(4%) 1/42 (2%) 2/50 (4%) 1/100(1%) 1/45 (2%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | 4/100(4%) 0/50 (0%) 0/49 (0%) 1/100(1%) 0/50 (0%) 1/47 (2%) | | 0/46 (0%) 0/50 (0%) 1/99 (1%) 1/47 (2%) 2/50 (4%) 0/100(0%) | | 1/50 (2%) 1/59 (2%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) | | 0/49 (0%) | | Overall Incidence Total 17/895 (1.9%) Mean 1.67% SD 1.68% Total 14/948 (1.48%) Mean 1.65% SD 1.27% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Schwannoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.07% SD 0.26% Total 0/959 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 3/959 (0.31%) Mean 0.38% SD 0.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 2/50 (4%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.13% SD 0.35% Total 5/959 (0.52%) Mean 0.56% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/909 (0.22%) Mean 0.13% SD 0.35% Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontogenic Tumor 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/909 (0%) Mean 0% SD 0% Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/100(0%) 0/46 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/99 (0%) 0/48 (0%) 1/50 (2%) 0/99 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 0/901 (0%) Mean 0% SD 0% Total 1/956 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/100(0%) 0/46 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 1/48 (2%) 0/49 (0%) 1/99 (1%) 1/48 (2%) 1/50 (2%) 0/99 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 4/901 (0.44%) Mean 0.45% SD 0.81% Total 4/956 (0.42%) Mean 0.51% SD 0.9% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/100(0%) 0/46 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 1/48 (2%) 0/49 (0%) 1/99 (1%) 1/48 (2%) 0/50 (0%) 0/99 (0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 4/901 (0.44%) Mean 0.45% SD 0.81% Total 3/956 (0.31%) Mean 0.38% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/100(0%) 1/46 (2%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/99 (0%) 0/48 (0%) 0/50 (0%) 0/99 (0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/901 (0.11%) Mean 0.14% SD 0.56% Total 0/956 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/100(1%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 4/959 (0.42%) Mean 0.5% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 2/959 (0.21%) Mean 0.19% SD 0.54% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 42 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 1/50 (2%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 2/100(2%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 3/959 (0.31%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 19/100(19%) 8/50 (16%) 7/50 (14%) | | 7/50 (14%) 10/50 (20%) 7/50 (14%) | | 14/100(14%) 7/50 (14%) 10/50 (20%) | | 15/49 (31%) 6/50 (12%) 13/100(13%) | | 14/50 (28%) 11/60 (18%) 6/50 (12%) | | 11/50 (22%) | | Overall Incidence Total 165/959 (17.21%) Mean 17.56% SD 5.55% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 2/959 (0.21%) Mean 0.25% SD 0.68% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 43 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 19/100(19%) 9/50 (18%) 7/50 (14%) | | 7/50 (14%) 11/50 (22%) 7/50 (14%) | | 14/100(14%) 7/50 (14%) 10/50 (20%) | | 15/49 (31%) 6/50 (12%) 13/100(13%) | | 14/50 (28%) 11/60 (18%) 6/50 (12%) | | 11/50 (22%) | | Overall Incidence Total 167/959 (17.41%) Mean 17.81% SD 5.61% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 3/100(3%) | | 0/50 (0%) 0/60 (0%) 1/50 (2%) | | 0/50 (0%) | | Overall Incidence Total 4/959 (0.42%) Mean 0.31% SD 0.87% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.1% SD 0.42% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Sarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) | | 0/50 (0%) 0/60 (0%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/959 (0.1%) Mean 0.13% SD 0.5% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 44 Version: 04/01/02 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: ALL ROUTES Date of Species: RATS Vehicle: ALL VEHICLES Input File: 31-JAN-2002 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(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%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/100(0%) 0/49 (0%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 1/909 (0.11%) Mean 0.13% SD 0.52% Total 3/959 (0.31%) Mean 0.29% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/100(1%) 3/50 (6%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 2/49 (4%) 0/50 (0%) 0/100(0%) | | 1/50 (2%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 10/909 (1.1%) Mean 1.2% SD 1.78% Total 4/959 (0.42%) Mean 0.48% SD 1.15% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/100(1%) 3/50 (6%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | 0/49 (0%) 0/50 (0%) 1/100(1%) 2/49 (4%) 0/50 (0%) 0/100(0%) | | 2/50 (4%) 0/60 (0%) 2/50 (4%) 0/50 (0%) 2/60 (3%) 0/50 (0%) | | 0/50 (0%) | | Overall Incidence Total 11/909 (1.21%) Mean 1.33% SD 1.91% Total 7/959 (0.73%) Mean 0.78% SD 1.35% | __________________________________________________________________________________________________________________________________