Toxicology Data Management System Page: 1 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 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 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 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 | |I. I. T. RESEARCH I058902905 09/26/94 736 100(5) 57 (692) 498.3 MAGNETIC FIELDS (EMF) | |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 | |SOUTHERN RESEARCH 050516105 03/06/96 497 50(3) 49 (496) 519.7 RIDDELLIINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 055634803 06/06/96 732 100(5) 75 (705) 335.2 CITRAL | |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 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 | |I. I. T. RESEARCH I058902905 09/26/94 737 100(5) 59 (692) 338.0 MAGNETIC FIELDS (EMF) | |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 | |________________________________________________________________________________________________________________________________| This page intentionally left blank Toxicology Data Management System Page: 3 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 97/100(97%) 47/50 (94%) 42/50 (84%) 78/100(78%) 35/50 (70%) 37/50 (74%) | | 47/50 (94%) 47/50 (94%) 46/49 (94%) 42/50 (84%) 44/50 (88%) 38/49 (78%) | | 48/50 (96%) 99/100(99%) 60/60 (100%) 41/50 (82%) 92/100(92%) 47/60 (78%) | | 49/50 (98%) 47/50 (94%) 33/50 (66%) 45/50 (90%) | | Overall Incidence Total 629/659 (95.45%)Mean 94.9% SD 4.26% Total 532/659 (80.73%) Mean 79.99% SD 8.2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 76/100(76%) 29/50 (58%) 34/50 (68%) 30/100(30%) 26/50 (52%) 15/50 (30%) | | 30/50 (60%) 26/50 (52%) 34/49 (69%) 23/50 (46%) 25/50 (50%) 26/49 (53%) | | 28/50 (56%) 66/100(66%) 37/60 (62%) 28/50 (56%) 40/100(40%) 24/60 (40%) | | 33/50 (66%) 9/50 (18%) 22/50 (44%) 20/50 (40%) | | Overall Incidence Total 402/659 (61%) Mean 59.19% SD 15.24% Total 279/659 (42.34%) Mean 43.73% SD 8.77% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 99/100(99%) 49/50 (98%) 49/50 (98%) 92/100(92%) 45/50 (90%) 42/50 (84%) | | 49/50 (98%) 49/50 (98%) 48/49 (98%) 45/50 (90%) 49/50 (98%) 44/49 (90%) | | 50/50 (100%) 10/100(10%) 60/60 (100%) 47/50 (94%) 98/100(98%) 54/60 (90%) | | 50/50 (100%) 47/50 (94%) 43/50 (86%) 47/50 (94%) | | Overall Incidence Total 560/659 (84.98%)Mean 90.27% SD 26.67% Total 606/659 (91.96%) Mean 91.44% SD 4.4% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.45% SD 1.21% Total 4/659 (0.61%) Mean 0.55% SD 0.94% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.52% SD 0.89% Total 3/659 (0.46%) Mean 0.55% SD 0.94% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/100(1%) 0/50 (0%) 1/50 (2%) 2/100(2%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 0.97% SD 1.32% Total 7/659 (1.06%) Mean 1.1% SD 1.39% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 1/50 (2%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.15% SD 0.5% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 4 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Leukemia: Lymphocytic, Monocytic, 68/100(68%) 20/50 (40%) 27/50 (54%) 24/100(24%) 21/50 (42%) 8/50 (16%) | | Mononuclear, or Undifferentiated 17/50 (34%) 16/50 (32%) 26/49 (53%) 15/50 (30%) 14/50 (28%) 16/49 (33%) | | 22/50 (44%) 50/100(50%) 30/60 (50%) 21/50 (42%) 20/100(20%) 21/60 (35%) | | 24/50 (48%) 2/50 (4%) 13/50 (26%) 12/50 (24%) | | Overall Incidence Total 302/659 (45.83%)Mean 43.37% SD 16.44% Total 185/659 (28.07%) Mean 29.06% SD 8.36% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Lymphocytic, Mixed, NOS, or 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Undifferentiated Cell Type 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.36% SD 1.21% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: 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%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.37% SD 1.23% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 4/100(4%) 0/50 (0%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | NOS 3/50 (6%) 2/50 (4%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 4/100(4%) 2/60 (3%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 5/50 (10%) 4/50 (8%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 29/659 (4.4%) Mean 4.49% SD 2.72% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 4/100(4%) 0/50 (0%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 4/100(4%) 2/60 (3%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 5/50 (10%) 4/50 (8%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 27/659 (4.1%) Mean 4.12% SD 3.04% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.43% SD 1.8% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.43% SD 1.8% Total 0/659 (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: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 2/100(2%) 1/50 (2%) 0/50 (0%) 2/100(2%) 1/50 (2%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) 1/49 (2%) 1/49 (2%) | | 0/50 (0%) 0/99 (0%) 0/60 (0%) 0/49 (0%) 6/100(6%) 2/60 (3%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/657 (0.76%) Mean 0.73% SD 1.37% Total 17/657 (2.59%) Mean 2.31% SD 1.69% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | 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%) 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) | | 0/50 (0%) 0/99 (0%) 0/60 (0%) 0/49 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/657 (0%) Mean 0% SD 0% Total 2/657 (0.3%) Mean 0.28% SD 0.66% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 10/100(10%) 3/50 (6%) 4/50 (8%) 3/99 (3%) 1/50 (2%) 2/50 (4%) | | 6/50 (12%) 10/50 (20%) 4/49 (8%) 4/50 (8%) 2/50 (4%) 3/48 (6%) | | 4/50 (8%) 24/98 (24%) 2/60 (3%) 2/49 (4%) 7/96 (7%) 2/60 (3%) | | 3/50 (6%) 2/49 (4%) 2/49 (4%) 1/50 (2%) | | Overall Incidence Total 72/656 (10.98%) Mean 10.01% SD 6.61% Total 29/651 (4.45%) Mean 4.37% SD 1.99% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Complex 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/98 (0%) 0/60 (0%) 0/49 (0%) 0/96 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 1/656 (0.15%) Mean 0.09% SD 0.3% Total 0/651 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/100(0%) 1/50 (2%) 2/50 (4%) 0/99 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 1/50 (2%) 2/98 (2%) 2/60 (3%) 0/49 (0%) 0/96 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 10/656 (1.52%) Mean 1.58% SD 1.41% Total 1/651 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 11/100(11%) 4/50 (8%) 6/50 (12%) 3/99 (3%) 1/50 (2%) 2/50 (4%) | | Complex, Malignant, NOS 7/50 (14%) 10/50 (20%) 5/49 (10%) 4/50 (8%) 2/50 (4%) 3/48 (6%) | | 5/50 (10%) 26/98 (27%) 4/60 (7%) 2/49 (4%) 7/96 (7%) 2/60 (3%) | | 3/50 (6%) 2/49 (4%) 2/49 (4%) 2/50 (4%) | | Overall Incidence Total 83/656 (12.65%) Mean 11.68% SD 6.55% Total 30/651 (4.61%) Mean 4.55% SD 1.84% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.43% SD 1.8% Total 0/659 (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: 6 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.43% SD 1.8% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Astrocytoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 3/659 (0.46%) Mean 0.45% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Brain: | | Glioma Malignant 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 7 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 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%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 1/50 (2%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 2/100(2%) 0/60 (0%) 0/50 (0%) 2/100(2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.36% SD 0.81% Total 6/659 (0.91%) Mean 0.91% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Adenoma 7/100(7%) 2/50 (4%) 3/50 (6%) 15/98 (15%) 2/49 (4%) 1/47 (2%) | | 0/50 (0%) 1/50 (2%) 3/48 (6%) 8/46 (17%) 5/49 (10%) 4/49 (8%) | | 0/50 (0%) 13/100(13%) 2/60 (3%) 2/50 (4%) 11/90 (12%) 12/59 (20%) | | 2/50 (4%) 2/50 (4%) 7/50 (14%) 7/49 (14%) | | Overall Incidence Total 35/658 (5.32%) Mean 4.51% SD 3.64% Total 74/636 (11.64%) Mean 11.1% SD 5.93% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma 1/100(1%) 1/50 (2%) 0/50 (0%) 1/98 (1%) 1/49 (2%) 0/47 (0%) | | 5/50 (10%) 2/50 (4%) 3/48 (6%) 2/46 (4%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 2/60 (3%) 0/50 (0%) 0/90 (0%) 2/59 (3%) | | 2/50 (4%) 0/50 (0%) 2/50 (4%) 3/49 (6%) | | Overall Incidence Total 16/658 (2.43%) Mean 2.78% SD 3.2% Total 11/636 (1.73%) Mean 1.9% SD 2.22% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Carcinoma or Adenoma 8/100(8%) 3/50 (6%) 3/50 (6%) 16/98 (16%) 3/49 (6%) 1/47 (2%) | | 5/50 (10%) 3/50 (6%) 6/48 (13%) 10/46 (22%) 5/49 (10%) 4/49 (8%) | | 0/50 (0%) 13/100(13%) 4/60 (7%) 2/50 (4%) 11/90 (12%) 14/59 (24%) | | 4/50 (8%) 2/50 (4%) 8/50 (16%) 10/49 (20%) | | Overall Incidence Total 51/658 (7.75%) Mean 7.29% SD 3.71% Total 84/636 (13.21%) Mean 12.82% SD 7.38% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 1/49 (2%) 0/47 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/90 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/658 (0%) Mean 0% SD 0% Total 1/636 (0.16%) Mean 0.19% SD 0.62% | __________________________________________________________________________________________________________________________________ |*Clitoral/Preputial Gland: | | Schwannoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) 0/47 (0%) | | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/90 (0%) 0/59 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/658 (0.15%) Mean 0.18% SD 0.6% Total 0/636 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 8 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Benign 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 2/100(2%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.36% SD 0.81% Total 2/659 (0.3%) Mean 0.27% SD 0.65% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Polyp Adenomatous 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.33% SD 0.75% Total 2/659 (0.3%) Mean 0.27% SD 0.65% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 9 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 3/99 (3%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 4/50 (8%) 1/50 (2%) 2/49 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 1/50 (2%) 3/99 (3%) 2/60 (3%) 1/49 (2%) 1/100(1%) 1/60 (2%) | | 3/50 (6%) 0/49 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 19/656 (2.9%) Mean 2.86% SD 2.53% Total 7/658 (1.06%) Mean 1.16% SD 1.32% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/99 (0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 2/50 (4%) 4/49 (8%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 1/50 (2%) 1/99 (1%) 0/60 (0%) 1/49 (2%) 1/100(1%) 0/60 (0%) | | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/656 (1.83%) Mean 2.11% SD 2.51% Total 3/658 (0.46%) Mean 0.46% SD 0.84% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/99 (3%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 3/50 (6%) 6/49 (12%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 2/50 (4%) 4/99 (4%) 2/60 (3%) 2/49 (4%) 2/100(2%) 1/60 (2%) | | 5/50 (10%) 0/49 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 31/656 (4.73%) Mean 4.97% SD 4.14% Total 10/658 (1.52%) Mean 1.62% SD 1.77% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.19% SD 0.62% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Pelvis and Transitional | | Epithelium 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.19% SD 0.62% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 1/50 (2%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 1/658 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 2/658 (0.3%) Mean 0.28% SD 0.67% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 11 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) | | 1/50 (2%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 3/658 (0.46%) Mean 0.37% SD 0.83% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Fibroma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | 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%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/658 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 2/60 (3%) 1/50 (2%) 0/100(0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 5/659 (0.76%) Mean 0.76% SD 1.18% Total 4/659 (0.61%) Mean 0.7% SD 0.97% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 0/100(0%) 0/50 (0%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/659 (0.76%) Mean 0.88% SD 1.36% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 0/50 (0%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/659 (0.76%) Mean 0.88% SD 1.36% Total 0/659 (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: 12 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 0/100(0%) 1/50 (2%) 2/50 (4%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Hepatocellular Adenoma 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 3/60 (5%) 1/50 (2%) 0/100(0%) 1/60 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 10/659 (1.52%) Mean 1.64% SD 1.92% Total 4/659 (0.61%) Mean 0.7% SD 0.97% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 0/100(0%) 1/50 (2%) 2/50 (4%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Hepatocellular Adenoma, or 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Hepatoblastoma 0/50 (0%) 1/100(1%) 3/60 (5%) 1/50 (2%) 0/100(0%) 1/60 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 10/659 (1.52%) Mean 1.64% SD 1.92% Total 4/659 (0.61%) Mean 0.7% SD 0.97% | __________________________________________________________________________________________________________________________________ |*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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/49 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 3/100(3%) 0/50 (0%) 2/50 (4%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 6/50 (12%) 2/49 (4%) 3/50 (6%) 0/50 (0%) 1/49 (2%) | | 4/50 (8%) 3/100(3%) 1/60 (2%) 0/49 (0%) 3/100(3%) 1/60 (2%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 24/659 (3.64%) Mean 3.8% SD 3.51% Total 12/658 (1.82%) Mean 1.7% SD 2% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/49 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.52% SD 0.89% Total 3/658 (0.46%) Mean 0.36% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 3/100(3%) 0/50 (0%) 2/50 (4%) 3/100(3%) 0/50 (0%) 0/50 (0%) | | Alveolar/Bronchiolar Adenoma 2/50 (4%) 7/50 (14%) 2/49 (4%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | | 4/50 (8%) 3/100(3%) 2/60 (3%) 0/49 (0%) 4/100(4%) 1/60 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 27/659 (4.1%) Mean 4.31% SD 3.76% Total 15/658 (2.28%) Mean 2.06% SD 2.03% | __________________________________________________________________________________________________________________________________ |*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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/49 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/658 (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: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Carcinoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 1/50 (2%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 7/659 (1.06%) Mean 1.18% SD 1.33% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 3/50 (6%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 2/50 (4%) 2/100(2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.37% SD 0.82% Total 15/659 (2.28%) Mean 2.56% SD 2.23% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 3/100(3%) 0/50 (0%) 0/50 (0%) 0/100(0%) 3/50 (6%) 2/50 (4%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) 0/50 (0%) 3/49 (6%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 3/50 (6%) 3/100(3%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 4/659 (0.61%) Mean 0.46% SD 1.04% Total 20/659 (3.03%) Mean 3.37% SD 2.55% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroadenoma 8/100(8%) 2/50 (4%) 3/50 (6%) 53/100(53%) 21/50 (42%) 15/50 (30%) | | 3/50 (6%) 2/50 (4%) 0/49 (0%) 21/50 (42%) 20/50 (40%) 17/49 (35%) | | 2/50 (4%) 6/100(6%) 0/60 (0%) 16/50 (32%) 56/100(56%) 23/60 (38%) | | 0/50 (0%) 0/50 (0%) 14/50 (28%) 28/50 (56%) | | Overall Incidence Total 26/659 (3.95%) Mean 3.45% SD 2.98% Total 284/659 (43.1%) Mean 41.09% SD 10.07% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 9/100(9%) 2/50 (4%) 3/50 (6%) 53/100(53%) 21/50 (42%) 16/50 (32%) | | 3/50 (6%) 2/50 (4%) 0/49 (0%) 23/50 (46%) 20/50 (40%) 17/49 (35%) | | 2/50 (4%) 6/100(6%) 0/60 (0%) 17/50 (34%) 56/100(56%) 23/60 (38%) | | 0/50 (0%) 0/50 (0%) 14/50 (28%) 28/50 (56%) | | Overall Incidence Total 27/659 (4.1%) Mean 3.55% SD 3.14% Total 288/659 (43.7%) Mean 41.82% SD 9.8% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 11/100(11%) 2/50 (4%) 3/50 (6%) 53/100(53%) 23/50 (46%) 16/50 (32%) | | or Adenoma 3/50 (6%) 2/50 (4%) 1/49 (2%) 23/50 (46%) 20/50 (40%) 18/49 (37%) | | 2/50 (4%) 6/100(6%) 0/60 (0%) 19/50 (38%) 58/100(58%) 23/60 (38%) | | 0/50 (0%) 0/50 (0%) 14/50 (28%) 30/50 (60%) | | Overall Incidence Total 30/659 (4.55%) Mean 3.91% SD 3.36% Total 297/659 (45.07%) Mean 43.28% SD 10.35% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Myoepithelioma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | 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%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.37% SD 0.82% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Nose: | | Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/658 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*Nose: | | Chondroma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/100(0%) 0/60 (0%) 1/50 (2%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/658 (0.15%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% Total 2/659 (0.3%) Mean 0.27% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | 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%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 2/659 (0.3%) Mean 0.36% SD 0.81% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 2/100(2%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.36% SD 0.81% Total 4/659 (0.61%) Mean 0.64% SD 1.29% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#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%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Malignant 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 2/49 (4%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.55% SD 1.32% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/100(0%) 1/50 (2%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/659 (0.61%) Mean 0.73% SD 1.37% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa-Theca Tumor Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/49 (2%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.37% SD 0.82% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Tubulostromal Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 3/100(3%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.27% SD 0.9% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Adenoma 2/100(2%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 3/98 (3%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 11/657 (1.67%) Mean 1.52% SD 1.37% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/98 (0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/657 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Carcinoma or Adenoma 2/100(2%) 2/50 (4%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 3/98 (3%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 12/657 (1.83%) Mean 1.71% SD 1.28% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Fibroma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/98 (0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/657 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Parathyroid Gland: | | Adenoma 0/93 (0%) 0/46 (0%) 0/46 (0%) 2/86 (2%) 1/48 (2%) 0/45 (0%) | | 0/45 (0%) 1/44 (2%) 0/45 (0%) 0/46 (0%) 0/40 (0%) 0/42 (0%) | | 0/49 (0%) 0/85 (0%) 0/58 (0%) 0/45 (0%) 1/88 (1%) 0/57 (0%) | | 0/48 (0%) 0/46 (0%) 0/46 (0%) 0/48 (0%) | | Overall Incidence Total 1/605 (0.17%) Mean 0.21% SD 0.69% Total 4/591 (0.68%) Mean 0.5% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 17/100(17%) 17/50 (34%) 11/50 (22%) 29/100(29%) 12/50 (24%) 23/50 (46%) | | Adenoma 13/50 (26%) 36/49 (73%) 31/49 (63%) 24/50 (48%) 30/50 (60%) 23/49 (47%) | | 35/50 (70%) 34/98 (35%) 11/59 (19%) 31/49 (63%) 61/99 (62%) 19/59 (32%) | | 15/48 (31%) 11/50 (22%) 15/50 (30%) 27/50 (54%) | | Overall Incidence Total 231/653 (35.38%)Mean 37.48% SD 21.12% Total 294/656 (44.82%) Mean 45% SD 14.2% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Carcinoma 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/98 (0%) 0/59 (0%) 0/49 (0%) 3/99 (3%) 0/59 (0%) | | 1/48 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/653 (0.46%) Mean 0.56% SD 0.95% Total 4/656 (0.61%) Mean 0.46% SD 1.04% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 17/100(17%) 17/50 (34%) 11/50 (22%) 29/100(29%) 13/50 (26%) 23/50 (46%) | | Carcinoma or Adenoma 13/50 (26%) 37/49 (76%) 31/49 (63%) 24/50 (48%) 30/50 (60%) 23/49 (47%) | | 35/50 (70%) 34/98 (35%) 11/59 (19%) 31/49 (63%) 64/99 (65%) 19/59 (32%) | | 16/48 (33%) 12/50 (24%) 15/50 (30%) 27/50 (54%) | | Overall Incidence Total 234/653 (35.83%)Mean 38.04% SD 21.28% Total 298/656 (45.43%) Mean 45.46% SD 14.29% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/98 (0%) 0/59 (0%) 0/49 (0%) 0/99 (0%) 1/59 (2%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/653 (0.15%) Mean 0.09% SD 0.3% Total 3/656 (0.46%) Mean 0.34% SD 0.75% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/100(1%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/98 (0%) 0/59 (0%) 0/49 (0%) 0/99 (0%) 1/59 (2%) | | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/653 (0.15%) Mean 0.09% SD 0.3% Total 3/656 (0.46%) Mean 0.34% SD 0.75% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 18 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 2/60 (3%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 1.03% SD 1.53% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 2/60 (3%) | | 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 1.03% SD 1.53% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/99 (0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/657 (0%) Mean 0% SD 0% Total 1/658 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or 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%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/99 (0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/657 (0%) Mean 0% SD 0% Total 1/658 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Schwannoma Malignant 0/100(0%) 2/50 (4%) 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/99 (0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 5/657 (0.76%) Mean 0.91% SD 1.64% Total 0/658 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.15% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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: 19 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.37% SD 0.82% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.46% SD 0.83% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 3/100(3%) 2/60 (3%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.03% SD 1.32% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 3/100(3%) 2/60 (3%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.03% SD 1.32% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 2/100(2%) 0/50 (0%) 2/50 (4%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | Trichoepithelioma 0/50 (0%) 3/100(3%) 2/60 (3%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 10/659 (1.52%) Mean 1.3% SD 1.59% Total 2/659 (0.3%) Mean 0.36% SD 0.81% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 20 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal 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%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 2/659 (0.3%) Mean 0.36% SD 0.81% | __________________________________________________________________________________________________________________________________ |#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 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | NOS) 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 2/659 (0.3%) Mean 0.36% SD 0.81% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 2/100(2%) 0/50 (0%) 2/50 (4%) 0/100(0%) 1/50 (2%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 3/100(3%) 2/60 (3%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | Trichoepithelioma 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 11/659 (1.67%) Mean 1.48% SD 1.54% Total 4/659 (0.61%) Mean 0.73% SD 1.35% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 11/100(11%) 2/50 (4%) 6/50 (12%) 1/100(1%) 2/50 (4%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 3/50 (6%) 2/50 (4%) 4/49 (8%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | | B), Basal Cell Adenoma, Adenoma, 5/50 (10%) 14/100(14%) 7/60 (12%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | Papilloma, Sq Papilloma, 4/50 (8%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 61/659 (9.26%) Mean 8.62% SD 3.38% Total 10/659 (1.52%) Mean 1.64% SD 1.91% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.36% SD 1.21% Total 1/659 (0.15%) Mean 0.19% SD 0.62% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.52% SD 0.89% Total 0/659 (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: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 8/100(8%) 1/50 (2%) 3/50 (6%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 2/50 (4%) 4/49 (8%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 4/50 (8%) 10/100(10%) 5/60 (8%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 43/659 (6.53%) Mean 6.05% SD 2.57% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |#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%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.37% SD 1.29% Total 5/659 (0.76%) Mean 0.73% SD 1.01% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 2/659 (0.3%) Mean 0.36% SD 0.81% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.36% SD 0.81% Total 4/659 (0.61%) Mean 0.73% SD 1.35% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/100(1%) 0/50 (0%) 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 1/50 (2%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 0.91% SD 0.94% Total 3/659 (0.46%) Mean 0.46% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/100(1%) 0/50 (0%) 1/50 (2%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 1/50 (2%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 0.91% SD 0.94% Total 3/659 (0.46%) Mean 0.46% SD 0.83% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 9/100(9%) 2/50 (4%) 4/50 (8%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | Papilloma, Squamous Cell 2/50 (4%) 2/50 (4%) 4/49 (8%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | | Carcinoma or Keratoacanthoma 5/50 (10%) 11/100(11%) 5/60 (8%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 50/659 (7.59%) Mean 7.14% SD 2.49% Total 6/659 (0.91%) Mean 0.91% SD 0.95% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 9/100(9%) 1/50 (2%) 4/50 (8%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 2/50 (4%) 2/50 (4%) 4/49 (8%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 5/50 (10%) 11/100(11%) 5/60 (8%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 49/659 (7.44%) Mean 6.95% SD 2.79% Total 4/659 (0.61%) Mean 0.55% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Trichoepithelioma 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma 2/100(2%) 3/50 (6%) 2/50 (4%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 5/49 (10%) 1/50 (2%) 3/50 (6%) 0/49 (0%) | | 2/50 (4%) 12/100(12%) 5/60 (8%) 1/50 (2%) 4/100(4%) 3/60 (5%) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 35/659 (5.31%) Mean 4.96% SD 3.78% Total 14/659 (2.12%) Mean 2% SD 2.14% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 8/100(8%) 3/50 (6%) 3/50 (6%) 1/100(1%) 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 1/50 (2%) 2/50 (4%) 7/49 (14%) 1/50 (2%) 3/50 (6%) 1/49 (2%) | | Histiocytoma 6/50 (12%) 13/100(13%) 5/60 (8%) 1/50 (2%) 6/100(6%) 3/60 (5%) | | 2/50 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 52/659 (7.89%) Mean 7.42% SD 4.11% Total 22/659 (3.34%) Mean 3.28% SD 2.19% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 2/100(2%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 1/100(1%) 0/60 (0%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 8/659 (1.21%) Mean 1.19% SD 1.35% Total 4/659 (0.61%) Mean 0.64% SD 0.92% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 5/100(5%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous 1/50 (2%) 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | Histiocytoma 4/50 (8%) 1/100(1%) 0/60 (0%) 0/50 (0%) 2/100(2%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 16/659 (2.43%) Mean 2.37% SD 2.47% Total 8/659 (1.21%) Mean 1.28% SD 1.62% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrous Histiocytoma 2/100(2%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 2/50 (4%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 0.91% SD 1.38% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | or NOS) 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 1/50 (2%) 0/100(0%) 0/60 (0%) 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% Total 3/659 (0.46%) Mean 0.46% SD 0.83% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma NOS 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.18% SD 0.6% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Spleen: | | 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.19% SD 0.62% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (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: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Leiomyosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% Total 0/659 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 96/100(96%) 40/50 (80%) 41/50 (82%) | | 47/50 (94%) 40/50 (80%) 38/49 (78%) | | 36/50 (72%) 93/100(93%) 55/60 (92%) | | 49/50 (98%) 39/50 (78%) | | Overall Incidence Total 574/659 (87.1%) Mean 85.66% SD 8.98% | __________________________________________________________________________________________________________________________________ |*Testes: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/97 (0%) 0/49 (0%) 0/46 (0%) 0/96 (0%) 0/48 (0%) 0/46 (0%) | | 0/50 (0%) 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/45 (0%) 0/46 (0%) | | 0/49 (0%) 2/97 (2%) 0/56 (0%) 0/49 (0%) 0/95 (0%) 0/57 (0%) | | 0/49 (0%) 1/49 (2%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 3/636 (0.47%) Mean 0.37% SD 0.83% Total 0/627 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Malignant 0/97 (0%) 0/49 (0%) 0/46 (0%) 0/96 (0%) 0/48 (0%) 0/46 (0%) | | 0/50 (0%) 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/45 (0%) 0/46 (0%) | | 0/49 (0%) 0/97 (0%) 0/56 (0%) 0/49 (0%) 0/95 (0%) 0/57 (0%) | | 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/48 (2%) | | Overall Incidence Total 0/636 (0%) Mean 0% SD 0% Total 1/627 (0.16%) Mean 0.19% SD 0.63% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/97 (0%) 0/49 (0%) 0/46 (0%) 0/96 (0%) 0/48 (0%) 0/46 (0%) | | 0/50 (0%) 0/47 (0%) 0/47 (0%) 0/49 (0%) 0/45 (0%) 0/46 (0%) | | 0/49 (0%) 2/97 (2%) 0/56 (0%) 0/49 (0%) 0/95 (0%) 0/57 (0%) | | 0/49 (0%) 1/49 (2%) 0/48 (0%) 1/48 (2%) | | Overall Incidence Total 3/636 (0.47%) Mean 0.37% SD 0.83% Total 1/627 (0.16%) Mean 0.19% SD 0.63% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Adenoma 12/100(12%) 9/50 (18%) 8/50 (16%) 21/100(21%) 3/50 (6%) 5/50 (10%) | | 12/50 (24%) 5/49 (10%) 9/46 (20%) 7/50 (14%) 6/47 (13%) 4/47 (9%) | | 1/50 (2%) 15/99 (15%) 10/59 (17%) 2/50 (4%) 15/100(15%) 9/60 (15%) | | 11/50 (22%) 3/50 (6%) 6/50 (12%) 2/49 (4%) | | Overall Incidence Total 95/653 (14.55%) Mean 14.72% SD 6.68% Total 80/653 (12.25%) Mean 11.12% SD 5.23% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 26 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 4/100(4%) 1/50 (2%) 0/50 (0%) 0/100(0%) 2/50 (4%) 2/50 (4%) | | 2/50 (4%) 1/49 (2%) 1/46 (2%) 2/50 (4%) 3/47 (6%) 3/47 (6%) | | 0/50 (0%) 1/99 (1%) 0/59 (0%) 1/50 (2%) 5/100(5%) 1/60 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | | Overall Incidence Total 11/653 (1.68%) Mean 1.57% SD 1.51% Total 20/653 (3.06%) Mean 3.22% SD 2.26% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 16/100(16%) 10/50 (20%) 8/50 (16%) 21/100(21%) 5/50 (10%) 7/50 (14%) | | 14/50 (28%) 6/49 (12%) 10/46 (22%) 9/50 (18%) 8/47 (17%) 7/47 (15%) | | 1/50 (2%) 16/99 (16%) 10/59 (17%) 3/50 (6%) 19/100(19%) 10/60 (17%) | | 11/50 (22%) 4/50 (8%) 6/50 (12%) 3/49 (6%) | | Overall Incidence Total 106/653 (16.23%)Mean 16.28% SD 7.09% Total 98/653 (15.01%) Mean 14.06% SD 5.03% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 3/100(3%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/49 (0%) 0/46 (0%) 1/50 (2%) 0/47 (0%) 0/47 (0%) | | 0/50 (0%) 1/99 (1%) 0/59 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 6/653 (0.92%) Mean 0.73% SD 1.1% Total 2/653 (0.31%) Mean 0.36% SD 0.81% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/46 (0%) 1/50 (2%) 1/47 (2%) 1/47 (2%) | | 0/50 (0%) 0/99 (0%) 1/59 (2%) 2/50 (4%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 3/653 (0.46%) Mean 0.43% SD 0.77% Total 8/653 (1.23%) Mean 1.39% SD 1.3% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 4/100(4%) 1/50 (2%) 0/50 (0%) 1/100(1%) 1/50 (2%) 1/50 (2%) | | 2/50 (4%) 0/49 (0%) 0/46 (0%) 2/50 (4%) 1/47 (2%) 1/47 (2%) | | 0/50 (0%) 1/99 (1%) 1/59 (2%) 2/50 (4%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | | Overall Incidence Total 9/653 (1.38%) Mean 1.16% SD 1.59% Total 10/653 (1.53%) Mean 1.75% SD 1.43% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 0/659 (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: 27 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 2/659 (0.3%) Mean 0.27% SD 0.65% | __________________________________________________________________________________________________________________________________ |#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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | | 0/49 (0%) 0/99 (0%) 0/60 (0%) 1/50 (2%) 0/99 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/655 (0%) Mean 0% SD 0% Total 1/656 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/49 (0%) 1/99 (1%) 1/60 (2%) 1/50 (2%) 0/99 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 4/655 (0.61%) Mean 0.62% SD 0.9% Total 4/656 (0.61%) Mean 0.73% SD 1.02% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) | | 1/49 (2%) 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | | 0/49 (0%) 1/99 (1%) 1/60 (2%) 0/50 (0%) 0/99 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 4/655 (0.61%) Mean 0.62% SD 0.9% Total 3/656 (0.46%) Mean 0.55% SD 0.95% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.09% SD 0.3% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/659 (0.46%) Mean 0.55% SD 1.29% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 1/100(1%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.27% SD 0.65% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 2/100(2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/659 (0.3%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 19/100(19%) 7/50 (14%) 10/50 (20%) | | 7/50 (14%) 10/50 (20%) 15/49 (31%) | | 6/50 (12%) 13/100(13%) 11/60 (18%) | | 6/50 (12%) 11/50 (22%) | | Overall Incidence Total 115/659 (17.45%) Mean 17.72% SD 5.59% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma NOS 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/100(0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 12/20/00 Tumor Incidence for Selected Control Animal Groups Contract/Lab: All Laboratories Route: VARIOUS Date of Species: RATS Vehicle: NTP 2000 DIET Input File: 20-DEC-2000 Strain: FISCHER344 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 19/100(19%) 7/50 (14%) 11/50 (22%) | | 7/50 (14%) 10/50 (20%) 15/49 (31%) | | 6/50 (12%) 13/100(13%) 11/60 (18%) | | 6/50 (12%) 11/50 (22%) | | Overall Incidence Total 116/659 (17.6%) Mean 17.9% SD 5.7% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Schwannoma Malignant 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 3/100(3%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/659 (0.61%) Mean 0.45% SD 1.04% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.15% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Vagina: | | Leiomyosarcoma 0/100(0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/659 (0.15%) Mean 0.18% SD 0.6% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | 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%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/60 (0%) 0/50 (0%) 0/100(0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/659 (0%) Mean 0% SD 0% Total 1/659 (0.15%) Mean 0.15% SD 0.5% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 1/60 (2%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 0.91% SD 1.3% Total 4/659 (0.61%) Mean 0.7% SD 1.34% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/100(1%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | | 0/50 (0%) 1/100(1%) 0/60 (0%) 0/50 (0%) 0/100(0%) 2/60 (3%) | | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/659 (0.91%) Mean 0.91% SD 1.3% Total 5/659 (0.76%) Mean 0.86% SD 1.54% | __________________________________________________________________________________________________________________________________