TDMS Study 05203-08 Pathology Tables
NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 RATS, FINAL#1; CORE STUDY Facility: Southern Research Institute Chemical CAS #: 88-72-2 Lock Date: 12/10/98 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice Removal Date Range: All Treatment Groups: Include 002 0 PPM Include 004 625 PPM Include 006 1250 PPM Include 008 2000 PPM Include 001 0 PPM Include 003 625 PPM Include 005 1250 PPM Include 007 2000 PPM a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Moribund Sacrifice 10 11 19 22 Natural Death 3 2 2 5 Survivors Terminal Sacrifice 45 46 39 33 Moribund Sacrifice 1 1 Natural Death 1 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (58) (59) (60) (59) Crypt, Diverticulum 1 (2%) Intestine Large, Rectum (60) (60) (60) (58) Fibrosis 1 (2%) Intestine Large, Cecum (58) (59) (60) (59) Edema 1 (2%) 1 (2%) Liver (60) (59) (60) (60) Angiectasis 2 (3%) 3 (5%) 4 (7%) 4 (7%) Basophilic Focus 51 (85%) 56 (95%) 60 (100%) 54 (90%) Clear Cell Focus 16 (27%) 30 (51%) 28 (47%) 33 (55%) Degeneration, Cystic 1 (2%) 2 (3%) Eosinophilic Focus 5 (8%) 12 (20%) 25 (42%) 32 (53%) Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 3 (5%) Hemorrhage 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 9 (15%) 13 (22%) 10 (17%) 7 (12%) Infiltration Cellular, Mixed Cell 15 (25%) 11 (19%) 6 (10%) 12 (20%) Mixed Cell Focus 6 (10%) 9 (15%) 11 (18%) 28 (47%) Necrosis, Focal 1 (2%) 3 (5%) 5 (8%) Regeneration, Diffuse 1 (2%) Regeneration, Focal 1 (2%) 2 (3%) Bile Duct, Hyperplasia 7 (12%) 2 (3%) Centrilobular, Necrosis 3 (5%) 2 (3%) 2 (3%) Hepatocyte, Vacuolization Cytoplasmic 4 (7%) 2 (3%) 1 (2%) Kupffer Cell, Pigmentation 3 (5%) Mesentery (9) (1) (3) (3) Accessory Spleen 2 (22%) 1 (33%) 1 (33%) Fat, Necrosis 7 (78%) 1 (100%) 2 (67%) Pancreas (60) (59) (60) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Atrophy 13 (22%) 10 (17%) 7 (12%) 4 (7%) Acinus, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (3%) 2 (3%) Salivary Glands (60) (60) (60) (60) Atrophy 2 (3%) 3 (5%) 9 (15%) 48 (80%) Stomach, Forestomach (59) (59) (60) (60) Erosion 1 (2%) 1 (2%) Perforation 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 5 (8%) 3 (5%) 1 (2%) Stomach, Glandular (60) (59) (60) (60) Erosion 1 (2%) 1 (2%) 1 (2%) 3 (5%) Ulcer 2 (3%) 1 (2%) 1 (2%) Tooth (2) Inflammation, Chronic 1 (50%) Malformation 2 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Cardiomyopathy 22 (37%) 16 (27%) 13 (22%) 13 (22%) Thrombosis 1 (2%) Myocardium, Fibrosis 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (59) Accessory Adrenal Cortical Nodule 8 (13%) 10 (17%) 8 (13%) 10 (17%) Degeneration, Fatty 13 (22%) 11 (18%) 17 (28%) 11 (19%) Hyperplasia, Diffuse 3 (5%) 1 (2%) 1 (2%) Hyperplasia, Focal 9 (15%) 6 (10%) 14 (23%) 15 (25%) Hypertrophy, Focal 6 (10%) 7 (12%) 6 (10%) 7 (12%) Necrosis 1 (2%) Adrenal Medulla (60) (60) (60) (58) Hyperplasia 8 (13%) 2 (3%) 3 (5%) 3 (5%) Pituitary Gland (59) (60) (60) (60) Pars Distalis, Angiectasis 6 (10%) 5 (8%) 4 (7%) 4 (7%) Pars Distalis, Cyst 22 (37%) 20 (33%) 22 (37%) 24 (40%) Pars Distalis, Hyperplasia, Focal 12 (20%) 6 (10%) 12 (20%) 9 (15%) Pars Intermedia, Angiectasis 2 (3%) 1 (2%) Pars Intermedia, Cyst 3 (5%) 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (60) (60) (60) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Ultimobranchial Cyst 1 (2%) 1 (2%) 1 (2%) C-Cell, Hyperplasia 22 (37%) 24 (40%) 22 (37%) 9 (15%) Follicle, Cyst 2 (3%) 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (59) (57) (54) (53) Atrophy 1 (2%) 3 (5%) 6 (11%) 25 (47%) Cyst 2 (3%) 4 (7%) 4 (7%) 2 (4%) Hyperplasia 5 (8%) 1 (2%) 4 (7%) 1 (2%) Inflammation, Chronic 4 (7%) 4 (7%) 6 (11%) 5 (9%) Ovary (60) (59) (60) (60) Angiectasis 2 (3%) Cyst 9 (15%) 8 (14%) 11 (18%) 6 (10%) Uterus (60) (59) (60) (60) Angiectasis 1 (2%) Cyst 1 (2%) Hydrometra 7 (12%) 6 (10%) 1 (2%) 3 (5%) Hyperplasia, Cystic 8 (13%) 6 (10%) 9 (15%) 8 (13%) Inflammation, Chronic 2 (3%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hyperplasia 2 (3%) 7 (12%) 15 (25%) 24 (40%) Infiltration Cellular, Histiocyte 2 (3%) 1 (2%) 1 (2%) Myelofibrosis 1 (2%) 2 (3%) Lymph Node (8) (4) (4) (4) Mediastinal, Hemorrhage 1 (13%) 1 (25%) 1 (25%) 3 (75%) Mediastinal, Pigmentation 6 (75%) 1 (25%) 1 (25%) 3 (75%) Renal, Hemorrhage 1 (25%) Renal, Pigmentation 1 (25%) Lymph Node, Mandibular (60) (60) (59) (59) Ectasia 1 (2%) 3 (5%) 4 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hemorrhage 4 (7%) 4 (7%) 1 (2%) 4 (7%) Hyperplasia, Lymphoid 3 (5%) 5 (8%) 6 (10%) 15 (25%) Pigmentation 31 (52%) 33 (55%) 30 (51%) 30 (51%) Lymph Node, Mesenteric (59) (58) (59) (59) Hemorrhage 5 (8%) 3 (5%) 4 (7%) 5 (8%) Hyperplasia, Lymphoid 1 (2%) Pigmentation 4 (7%) 1 (2%) 3 (5%) Spleen (60) (59) (60) (59) Congestion 1 (2%) Fibrosis 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 22 (37%) 38 (64%) 48 (80%) 48 (81%) Necrosis 2 (3%) Pigmentation 36 (60%) 44 (75%) 43 (72%) 46 (78%) Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) Thymus (57) (55) (58) (58) Cyst 1 (2%) 2 (3%) 2 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (59) (60) Dilatation 40 (67%) 30 (50%) 29 (49%) 24 (40%) Galactocele 1 (2%) Hyperplasia 14 (23%) 36 (60%) 30 (51%) 19 (32%) Skin (59) (60) (60) (60) Angiectasis 1 (2%) Ulcer 1 (2%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Cranium, Osteopetrosis 2 (3%) 6 (10%) 6 (10%) 10 (17%) Femur, Osteopetrosis 8 (13%) 9 (15%) 13 (22%) 16 (27%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Compression 6 (10%) 10 (17%) 5 (8%) 3 (5%) Hydrocephalus 2 (3%) 4 (7%) 3 (5%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Hemorrhage 2 (3%) 2 (3%) 2 (3%) 1 (2%) Infiltration Cellular, Histiocyte 52 (87%) 54 (90%) 53 (88%) 55 (92%) Alveolar Epithelium, Hyperplasia 6 (10%) 14 (23%) 16 (27%) 9 (15%) Alveolar Epithelium, Hyperplasia, Atypical 1 (2%) Nose (60) (60) (60) (60) Foreign Body 2 (3%) 7 (12%) Inflammation, Chronic 2 (3%) 1 (2%) 2 (3%) 8 (13%) Respiratory Epithelium, Hyperplasia 2 (3%) 3 (5%) Respiratory Epithelium, Metaplasia, Squamous 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) (3) (2) (1) Cataract 1 (33%) 2 (67%) 1 (50%) 1 (100%) Hemorrhage 1 (33%) Inflammation, Chronic 1 (33%) 1 (33%) Retina, Degeneration 2 (67%) 2 (67%) 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (59) (60) (60) Cyst 1 (2%) 1 (2%) Hydronephrosis 1 (2%) Infarct 2 (3%) 1 (2%) Inflammation, Chronic 2 (3%) 1 (2%) 1 (2%) 1 (2%) Nephropathy 53 (88%) 45 (76%) 48 (80%) 52 (87%) Renal Tubule, Cytoplasmic Alteration 1 (2%) 1 (2%) Renal Tubule, Degeneration, Hyaline 9 (15%) 10 (17%) 4 (7%) 11 (18%) Renal Tubule, Necrosis 2 (3%) Renal Tubule, Pigmentation 9 (15%) 10 (17%) 7 (12%) 17 (28%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Urinary Bladder (60) (59) (60) (60) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 60 60 60 Early Deaths Moribund Sacrifice 18 35 48 53 Natural Death 3 7 6 7 Accidently Killed 3 Survivors Terminal Sacrifice 38 18 3 Natural Death 1 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (60) (60) (60) (58) Edema 1 (2%) Liver (60) (60) (60) (60) Angiectasis 1 (2%) 2 (3%) 2 (3%) Atrophy 1 (2%) 1 (2%) 1 (2%) 4 (7%) Basophilic Focus 38 (63%) 22 (37%) 21 (35%) 25 (42%) Clear Cell Focus 29 (48%) 29 (48%) 34 (57%) 31 (52%) Cyst 1 (2%) Degeneration, Cystic 3 (5%) 3 (5%) 1 (2%) 2 (3%) Eosinophilic Focus 7 (12%) 18 (30%) 29 (48%) 24 (40%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 6 (10%) 2 (3%) 2 (3%) Hemorrhage 2 (3%) 2 (3%) 2 (3%) Hepatodiaphragmatic Nodule 5 (8%) 8 (13%) 8 (13%) 5 (8%) Infiltration Cellular, Mixed Cell 1 (2%) 5 (8%) 11 (18%) 20 (33%) Mixed Cell Focus 5 (8%) 7 (12%) 12 (20%) 6 (10%) Necrosis, Focal 3 (5%) 4 (7%) 6 (10%) 6 (10%) Bile Duct, Hyperplasia 53 (88%) 37 (62%) 7 (12%) Centrilobular, Necrosis 1 (2%) 3 (5%) 8 (13%) 5 (8%) Hepatocyte, Vacuolization Cytoplasmic 4 (7%) 2 (3%) 1 (2%) 1 (2%) Kupffer Cell, Pigmentation 4 (7%) 1 (2%) 3 (5%) Mesentery (16) (6) (5) (4) Accessory Spleen 3 (19%) 3 (75%) Congestion 3 (19%) Hemorrhage 1 (17%) Fat, Necrosis 13 (81%) 3 (50%) 5 (100%) 1 (25%) Oral Mucosa (1) (1) Hyperplasia 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pancreas (60) (60) (60) (60) Atrophy 11 (18%) 14 (23%) 7 (12%) 4 (7%) Acinus, Hyperplasia, Focal 1 (2%) 2 (3%) 3 (5%) 4 (7%) Salivary Glands (60) (60) (59) (60) Atrophy 2 (3%) 18 (31%) 43 (72%) Stomach, Forestomach (59) (60) (60) (60) Edema 4 (7%) 2 (3%) 1 (2%) Ulcer 2 (3%) 2 (3%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 6 (10%) 2 (3%) 1 (2%) 2 (3%) Stomach, Glandular (59) (60) (60) (60) Edema 1 (2%) Erosion 4 (7%) 2 (3%) 7 (12%) 7 (12%) Infiltration Cellular, Lymphoid 1 (2%) Ulcer 1 (2%) 2 (3%) 3 (5%) Tongue (1) (1) Epithelium, Hyperplasia 1 (100%) Tooth (1) Malformation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Cardiomyopathy 40 (67%) 43 (72%) 43 (72%) 37 (62%) Thrombosis 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Accessory Adrenal Cortical Nodule 13 (22%) 12 (20%) 13 (22%) 10 (17%) Degeneration, Fatty 16 (27%) 10 (17%) 11 (18%) 4 (7%) Hyperplasia, Diffuse 1 (2%) 3 (5%) Hyperplasia, Focal 6 (10%) 2 (3%) 6 (10%) 3 (5%) Hypertrophy, Focal 3 (5%) 2 (3%) 2 (3%) Adrenal Medulla (60) (60) (60) (59) Hyperplasia 7 (12%) 4 (7%) 2 (3%) Islets, Pancreatic (60) (60) (60) (60) Hyperplasia 2 (3%) 2 (3%) Pigmentation 1 (2%) 2 (3%) Parathyroid Gland (58) (55) (59) (58) Hyperplasia 1 (2%) Pituitary Gland (59) (60) (58) (59) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Angiectasis 3 (5%) 7 (12%) 2 (3%) Pars Distalis, Cyst 2 (3%) 6 (10%) 3 (5%) 4 (7%) Pars Distalis, Cytoplasmic Alteration 1 (2%) 1 (2%) 4 (7%) Pars Distalis, Hyperplasia, Focal 10 (17%) 13 (22%) 13 (22%) 10 (17%) Pars Intermedia, Cyst 1 (2%) 1 (2%) Thyroid Gland (59) (60) (60) (60) Ultimobranchial Cyst 1 (2%) 2 (3%) 3 (5%) C-Cell, Hyperplasia 10 (17%) 11 (18%) 9 (15%) 7 (12%) Follicle, Cyst 3 (5%) 2 (3%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (3) (21) (33) (46) Mesothelium, Hyperplasia 1 (33%) 1 (5%) 4 (12%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (59) (60) Atypia Cellular 39 (65%) 32 (53%) 27 (46%) 21 (35%) Fibrosis 2 (3%) Inflammation, Chronic 1 (2%) Preputial Gland (60) (59) (58) (56) Atrophy 7 (12%) 9 (15%) 35 (60%) 41 (73%) Cyst 1 (2%) 4 (7%) 1 (2%) Hyperplasia 1 (2%) Inflammation, Chronic 40 (67%) 43 (73%) 36 (62%) 27 (48%) Prostate (60) (59) (60) (60) Inflammation, Chronic 24 (40%) 14 (24%) 18 (30%) 9 (15%) Ventral, Hyperplasia 18 (30%) 3 (5%) 9 (15%) 1 (2%) Testes (60) (60) (60) (60) Angiectasis 2 (3%) Germinal Epithelium, Atrophy 13 (22%) 21 (35%) 12 (20%) 19 (32%) Interstitial Cell, Hyperplasia 10 (17%) 14 (23%) 13 (22%) 31 (52%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hyperplasia 2 (3%) 25 (42%) 43 (72%) 45 (75%) Lymph Node (16) (14) (4) (9) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Iliac, Hyperplasia, Lymphoid 1 (11%) Mediastinal, Atrophy 1 (11%) Mediastinal, Hemorrhage 2 (13%) 3 (21%) 1 (25%) 2 (22%) Mediastinal, Pigmentation 6 (38%) 9 (64%) 3 (75%) 8 (89%) Pancreatic, Pigmentation 1 (6%) 1 (7%) Renal, Ectasia 1 (25%) Renal, Pigmentation 1 (6%) 1 (25%) Lymph Node, Mandibular (58) (59) (58) (59) Atrophy 1 (2%) Ectasia 2 (3%) Hemorrhage 2 (3%) 2 (3%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 3 (5%) 4 (7%) 3 (5%) 2 (3%) Pigmentation 9 (16%) 2 (3%) 6 (10%) 12 (20%) Lymph Node, Mesenteric (60) (60) (59) (58) Atrophy 1 (2%) 2 (3%) 1 (2%) Hemorrhage 2 (3%) 6 (10%) 3 (5%) 2 (3%) Pigmentation 3 (5%) 3 (5%) Spleen (60) (60) (60) (60) Fibrosis 6 (10%) 6 (10%) 9 (15%) 7 (12%) Hematopoietic Cell Proliferation 7 (12%) 33 (55%) 38 (63%) 47 (78%) Hemorrhage 2 (3%) Pigmentation 9 (15%) 8 (13%) 13 (22%) 16 (27%) Capsule, Fibrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (57) (47) (46) (43) Dilatation 3 (5%) 10 (21%) 1 (2%) 1 (2%) Galactocele 2 (4%) Hyperplasia 6 (11%) 2 (4%) 2 (4%) 2 (5%) Skin (60) (60) (60) (60) Cyst 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Cranium, Osteopetrosis 1 (2%) 2 (3%) Skeletal Muscle (1) (5) (3) Atrophy 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Hemorrhage 1 (20%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Compression 6 (10%) 3 (5%) 2 (3%) 1 (2%) Developmental Malformation 1 (2%) Gliosis 1 (2%) Hemorrhage 1 (2%) Hydrocephalus 3 (5%) 1 (2%) 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Congestion 1 (2%) Hemorrhage 3 (5%) 1 (2%) Infiltration Cellular, Histiocyte 25 (42%) 42 (70%) 40 (67%) 22 (37%) Metaplasia, Osseous 1 (2%) 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 2 (3%) 8 (13%) 3 (5%) 7 (12%) Nose (60) (60) (60) (60) Foreign Body 9 (15%) 13 (22%) 10 (17%) 11 (18%) Inflammation, Chronic 9 (15%) 9 (15%) 8 (13%) 9 (15%) Inflammation, Suppurative 2 (3%) Respiratory Epithelium, Hyperplasia 6 (10%) 5 (8%) 7 (12%) 8 (13%) Respiratory Epithelium, Metaplasia, Squamous 2 (3%) 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (2) (1) Atrophy 1 (50%) Cataract 1 (100%) 1 (50%) 1 (100%) Inflammation, Chronic 1 (50%) Retina, Degeneration 1 (50%) 1 (100%) 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Cyst 1 (2%) 3 (5%) 2 (3%) Infarct 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05203-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:23:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 1250 PPM 2000 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Chronic 1 (2%) Mineralization 1 (2%) Nephropathy 56 (93%) 59 (98%) 56 (93%) 56 (93%) Renal Tubule, Degeneration, Hyaline 3 (5%) 3 (5%) 1 (2%) Renal Tubule, Dilatation 1 (2%) 3 (5%) 2 (3%) Renal Tubule, Necrosis 1 (2%) 1 (2%) Renal Tubule, Pigmentation 5 (8%) 12 (20%) 14 (23%) 9 (15%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) Urinary Bladder (60) (60) (60) (59) Fibrosis 1 (2%) 2 (3%) Inflammation, Chronic 2 (3%) Transitional Epithelium, Hyperplasia 2 (3%) 2 (3%) 3 (5%) Transitional Epithelium, Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------