TDMS Study 05203-09 Pathology Tables
NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 MICE, FINAL#1 Facility: Southern Research Institute Chemical CAS #: 88-72-2 Lock Date: 03/08/99 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Moribund Sacrifice 4 6 7 22 Natural Death 4 8 6 33 Survivors Terminal Sacrifice 52 46 47 5 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (54) (53) (54) (31) Cyst 1 (2%) 1 (2%) Intestine Large, Cecum (56) (53) (54) (32) Edema 1 (2%) Inflammation, Chronic 1 (3%) Intestine Small, Jejunum (56) (53) (56) (34) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Peyer's Patch, Inflammation, Chronic, Focal, Suppurative 1 (2%) Liver (60) (59) (59) (60) Angiectasis 1 (2%) 3 (5%) Basophilic Focus 1 (2%) 6 (10%) 2 (3%) 6 (10%) Clear Cell Focus 1 (2%) 2 (3%) 4 (7%) Congestion, Focal 1 (2%) 2 (3%) 1 (2%) Cyst 1 (2%) Eosinophilic Focus 2 (3%) 3 (5%) 6 (10%) 28 (47%) Hyperplasia, Focal, Lymphoid 2 (3%) 5 (8%) 2 (3%) 1 (2%) Infiltration Cellular, Mixed Cell 45 (75%) 38 (64%) 37 (63%) 43 (72%) Inflammation, Focal 1 (2%) Mixed Cell Focus 1 (2%) 3 (5%) Necrosis 3 (5%) 2 (3%) 13 (22%) Tension Lipidosis 1 (2%) 1 (2%) Bile Duct, Cyst 1 (2%) Hepatocyte, Fatty Change 1 (2%) Hepatocyte, Fatty Change, Diffuse 2 (3%) Hepatocyte, Necrosis, Focal 6 (10%) Hepatocyte, Tension Lipidosis 1 (2%) Hepatocyte, Vacuolization Cytoplasmic, Diffuse 2 (3%) Hepatocyte, Vacuolization Cytoplasmic, Focal 1 (2%) 2 (3%) 2 (3%) 9 (15%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Periportal, Depletion Glycogen 1 (2%) Hepatocyte, Centrilobular, Fatty Change 2 (3%) 2 (3%) Hepatocyte, Centrilobular, Necrosis 1 (2%) Oval Cell, Hyperplasia 4 (7%) Mesentery (11) (9) (9) (34) Hemorrhage 1 (11%) Inflammation, Chronic 1 (9%) 2 (6%) Artery, Inflammation, Chronic 1 (11%) Fat, Necrosis 6 (55%) 5 (56%) 4 (44%) Pancreas (60) (57) (58) (57) Acinus, Atrophy, Diffuse 2 (4%) 1 (2%) 1 (2%) Acinus, Atrophy, Focal 1 (2%) 1 (2%) Duct, Cyst 2 (3%) 1 (2%) Duct, Inflammation, Chronic, Focal 2 (3%) Stomach, Forestomach (60) (58) (58) (59) Diverticulum 1 (2%) Edema 1 (2%) Inflammation, Focal 1 (2%) 2 (3%) 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 1 (2%) 4 (7%) 6 (10%) 1 (2%) Stomach, Glandular (58) (57) (57) (52) Erosion 1 (2%) Inflammation, Focal 2 (4%) Ulcer 1 (2%) 2 (4%) 1 (2%) Glands, Degeneration, Cystic, Focal 2 (4%) Tooth (8) (4) (2) Peridontal Tissue, Inflammation, Chronic 8 (100%) 4 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (2) (1) (1) Aorta, Mineralization 1 (50%) 1 (100%) Heart (60) (60) (59) (58) Angiectasis 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) 1 (2%) Inflammation, Chronic, Focal 2 (3%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (59) (58) (60) Accessory Adrenal Cortical Nodule 2 (3%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Cyst 2 (3%) Cytoplasmic Alteration, Focal 1 (2%) Hyperplasia, Focal 1 (2%) Adrenal Medulla (59) (57) (58) (59) Hyperplasia 2 (3%) Islets, Pancreatic (60) (57) (60) (56) Atrophy, Diffuse 1 (2%) Parathyroid Gland (57) (55) (57) (50) Cyst 1 (2%) 1 (2%) 1 (2%) Pituitary Gland (58) (58) (53) (53) Pars Distalis, Cyst 1 (2%) Pars Distalis, Cytoplasmic Alteration, Focal 1 (2%) 4 (7%) 3 (6%) Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%) Thyroid Gland (60) (59) (58) (53) Degeneration, Cystic, Focal 14 (23%) 16 (27%) 16 (28%) 13 (25%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic, Focal 2 (3%) 1 (2%) Follicle, Cyst 1 (2%) 2 (4%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (3) (3) Abdominal, Cyst 1 (33%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (58) (57) (57) (58) Degeneration, Cystic 11 (19%) 4 (7%) 5 (9%) 2 (3%) Inflammation, Chronic 3 (5%) 2 (4%) Pigmentation 3 (5%) 2 (4%) 1 (2%) Ovary (59) (56) (56) (56) Angiectasis 3 (5%) 2 (4%) 1 (2%) Cyst 11 (19%) 16 (29%) 12 (21%) 11 (20%) Cyst, Multiple 1 (2%) 2 (4%) 1 (2%) Hemorrhage 1 (2%) 2 (4%) 1 (2%) Hyperplasia, Tubular 1 (2%) Mineralization 1 (2%) Interstitial Cell, Hyperplasia 2 (4%) Periovarian Tissue, Cyst 1 (2%) Periovarian Tissue, Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Uterus (60) (59) (60) (59) Angiectasis 1 (2%) 2 (3%) 1 (2%) Angiectasis, Focal 1 (2%) Atrophy 1 (2%) Congestion 1 (2%) Cyst 1 (2%) 1 (2%) 3 (5%) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Hydrometra 24 (40%) 24 (41%) 22 (37%) 15 (25%) Hyperplasia, Focal, Histiocytic 1 (2%) Inflammation, Suppurative 2 (3%) 1 (2%) 1 (2%) 2 (3%) Pigmentation, Focal 1 (2%) Endometrium, Hyperplasia, Cystic 54 (90%) 51 (86%) 53 (88%) 37 (63%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (58) (60) (60) Hemorrhage, Focal 1 (2%) Hyperplasia 1 (2%) 2 (3%) 2 (3%) Inflammation, Chronic, Focal 1 (2%) Myelofibrosis 2 (3%) Myelofibrosis, Focal 1 (2%) Lymph Node (6) (3) (10) (11) Iliac, Hematopoietic Cell Proliferation 1 (9%) Iliac, Hemorrhage 1 (10%) Iliac, Hyperplasia 1 (10%) Iliac, Hyperplasia, Lymphoid 2 (20%) Inguinal, Hyperplasia 1 (9%) Mediastinal, Hematopoietic Cell Proliferation 1 (9%) Mediastinal, Hemorrhage 3 (27%) Mediastinal, Hyperplasia 1 (9%) Mediastinal, Hyperplasia, Lymphoid 2 (18%) Pancreatic, Hyperplasia, Lymphoid 1 (10%) Renal, Hemorrhage 1 (10%) Renal, Hyperplasia 2 (20%) 1 (9%) Renal, Hyperplasia, Lymphoid 1 (10%) Lymph Node, Mandibular (58) (55) (55) (48) Hyperplasia 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (53) (58) (57) (57) Hemorrhage 1 (2%) 1 (2%) Hyperplasia 2 (4%) 1 (2%) 2 (4%) 4 (7%) Hyperplasia, Lymphoid 6 (11%) 2 (3%) 2 (4%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Mast Cell 1 (2%) Spleen (59) (57) (58) (57) Congestion 2 (3%) Depletion Cellular 1 (2%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 11 (19%) 19 (33%) 21 (36%) 54 (95%) Hyperplasia, Lymphoid 8 (14%) 5 (9%) 4 (7%) 2 (4%) Pigmentation, Focal 1 (2%) Thymus (57) (56) (55) (44) Angiectasis 1 (2%) 1 (2%) 1 (2%) Atrophy 1 (2%) 1 (2%) Cyst 1 (2%) Hyperplasia, Lymphoid 5 (9%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (59) (60) (59) Ectasia 1 (2%) 1 (2%) Skin (60) (60) (60) (60) Subcutaneous Tissue, Angiectasis, Focal 1 (2%) Subcutaneous Tissue, Cyst 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 2 (3%) 4 (7%) Subcutaneous Tissue, Hemorrhage, Focal 1 (2%) Subcutaneous Tissue, Inflammation, Chronic, Focal 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Callus 1 (2%) Fibrous Osteodystrophy 1 (2%) Hyperostosis 2 (3%) Femur, Callus 1 (2%) Maxilla, Hyperostosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (59) (58) Atrophy, Focal 1 (2%) 1 (2%) Compression, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (59) (57) Congestion 1 (2%) 2 (3%) 1 (2%) 1 (2%) Edema, Focal 1 (2%) Hemorrhage 2 (3%) 1 (2%) 1 (2%) 2 (4%) Hyperplasia, Focal, Histiocytic 2 (3%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (3%) 1 (2%) Infiltration Cellular, Mixed Cell 9 (16%) Metaplasia, Osseous 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) Artery, Mediastinum, Inflammation, Chronic 1 (2%) Bronchus, Glands, Cyst 1 (2%) Nose (60) (60) (59) (57) Hemorrhage 1 (2%) Mucosa, Glands, Dilatation, Focal 3 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (59) (56) (58) (59) Atrophy, Focal 2 (3%) Congestion 2 (3%) 3 (5%) 3 (5%) 1 (2%) Cyst 2 (3%) 2 (3%) 1 (2%) Hydronephrosis 1 (2%) Hyperplasia, Lymphoid 4 (7%) 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Suppurative 1 (2%) Mineralization, Focal 1 (2%) Nephropathy 9 (15%) 14 (25%) 10 (17%) 11 (19%) Pigmentation 1 (2%) Artery, Inflammation, Chronic 1 (2%) Bilateral, Atrophy, Focal 1 (2%) Bilateral, Fibrosis, Focal 1 (2%) Bilateral, Inflammation, Chronic, Focal 1 (2%) Pelvis, Dilatation 1 (2%) 1 (2%) Pelvis, Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 3 (5%) 2 (3%) 10 (17%) Renal Tubule, Casts Protein 6 (10%) 8 (14%) 7 (12%) 6 (10%) Renal Tubule, Dilatation 1 (2%) Renal Tubule, Necrosis 1 (2%) Renal Tubule, Pigmentation 1 (2%) 3 (5%) 35 (59%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) Urinary Bladder (59) (54) (57) (54) Transitional Epithelium, Hyperplasia, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Natural Death 5 21 39 29 Moribund Sacrifice 3 5 21 31 Survivors Terminal Sacrifice 52 34 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (54) (42) (31) (35) Fibrosis 1 (2%) Intestine Large, Cecum (56) (49) (36) (44) Epithelium, Degeneration, Mucoid 1 (2%) Intestine Small, Jejunum (56) (43) (35) (40) Inflammation, Focal 1 (2%) Ulcer 1 (2%) Epithelium, Degeneration, Cystic, Focal 1 (2%) Epithelium, Hyperplasia, Focal, Adenomatous 1 (2%) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Peyer's Patch, Inflammation, Chronic 1 (2%) Liver (60) (59) (57) (60) Amyloid Deposition 1 (2%) Angiectasis 1 (2%) 2 (4%) 1 (2%) Basophilic Focus 6 (10%) 4 (7%) Clear Cell Focus 3 (5%) 2 (3%) Congestion, Focal 2 (3%) 1 (2%) Eosinophilic Focus 3 (5%) 14 (24%) 1 (2%) 1 (2%) Fibrosis, Focal 1 (2%) 1 (2%) Infiltration Cellular, Mixed Cell 46 (77%) 40 (68%) 24 (42%) 29 (48%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) Inflammation, Focal, Suppurative 1 (2%) Mineralization, Focal 1 (2%) Mixed Cell Focus 2 (3%) Necrosis 1 (2%) 15 (25%) 27 (47%) 30 (50%) Artery, Angiectasis 1 (2%) Artery, Inflammation, Chronic 1 (2%) Hepatocyte, Fatty Change, Diffuse 2 (3%) Hepatocyte, Necrosis, Focal 2 (3%) Hepatocyte, Syncytial Alteration, Focal 16 (27%) 26 (44%) 43 (75%) 39 (65%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Tension Lipidosis 1 (2%) Hepatocyte, Vacuolization Cytoplasmic, Diffuse 10 (17%) 4 (7%) Hepatocyte, Vacuolization Cytoplasmic, Focal 4 (7%) 5 (8%) 2 (4%) 1 (2%) Hepatocyte, Periportal, Atrophy 1 (2%) Hepatocyte, Centrilobular, Depletion Glycogen 1 (2%) 3 (5%) Hepatocyte, Centrilobular, Fatty Change 1 (2%) 2 (3%) 5 (9%) 1 (2%) Hepatocyte, Midzonal, Fatty Change 1 (2%) Oval Cell, Hyperplasia 2 (3%) Mesentery (12) (12) (42) (38) Inflammation, Chronic 3 (25%) 2 (17%) 2 (5%) Inflammation, Chronic, Focal 1 (2%) Artery, Inflammation, Chronic 3 (25%) 1 (8%) Fat, Necrosis 6 (50%) 1 (8%) 1 (2%) Pancreas (59) (59) (59) (58) Amyloid Deposition 1 (2%) Acinus, Atrophy, Focal 1 (2%) 1 (2%) 1 (2%) Duct, Cyst 1 (2%) 1 (2%) Duct, Inflammation, Chronic, Focal 1 (2%) Stomach, Forestomach (60) (60) (58) (60) Inflammation, Focal 1 (2%) 3 (5%) 1 (2%) Necrosis, Focal 1 (2%) Ulcer 1 (2%) 3 (5%) 1 (2%) Epithelium, Cyst 1 (2%) Epithelium, Hyperplasia 2 (3%) 5 (8%) 6 (10%) 3 (5%) Stomach, Glandular (57) (54) (53) (55) Erosion 2 (4%) Inflammation, Chronic, Focal 1 (2%) Inflammation, Focal 1 (2%) 1 (2%) Pigmentation, Focal 1 (2%) Tooth (14) (9) (2) Malformation 5 (36%) Peridontal Tissue, Inflammation, Chronic 10 (71%) 9 (100%) 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Infiltration Cellular, Mixed Cell 1 (2%) 3 (5%) 1 (2%) Inflammation, Chronic, Focal 1 (2%) 4 (7%) 1 (2%) Mineralization 2 (3%) 1 (2%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (58) (60) Accessory Adrenal Cortical Nodule 1 (2%) Cyst 2 (3%) Cytoplasmic Alteration, Focal 7 (12%) 2 (3%) Fibrosis 1 (2%) Hypertrophy, Focal 1 (2%) Inflammation, Chronic, Focal 1 (2%) Parathyroid Gland (55) (54) (57) (56) Amyloid Deposition 1 (2%) Cyst 1 (2%) Pituitary Gland (53) (50) (50) (46) Pars Distalis, Cyst 2 (4%) 1 (2%) Pars Distalis, Hyperplasia, Focal 1 (2%) Rathke's Cleft, Cyst 1 (2%) Thyroid Gland (59) (59) (59) (59) Degeneration, Cystic, Focal 10 (17%) 11 (19%) 3 (5%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) (2) (3) Pelvic, Inflammation, Chronic, Focal 1 (33%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (2) (1) Inflammation, Chronic 1 (50%) 1 (100%) Epididymis (60) (60) (60) (60) Inflammation, Chronic 1 (2%) Preputial Gland (60) (59) (59) (60) Degeneration, Cystic 28 (47%) 27 (46%) 16 (27%) 1 (2%) Inflammation, Chronic 1 (2%) 5 (8%) 1 (2%) Prostate (60) (59) (57) (58) Inflammation, Chronic 1 (2%) 7 (12%) 4 (7%) Seminal Vesicle (60) (60) (60) (60) Congestion 1 (2%) 1 (2%) Dilatation 2 (3%) 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Depletion Cellular 1 (2%) Hemorrhage, Focal 2 (3%) 1 (2%) Hyperplasia 3 (5%) 2 (3%) Thrombosis 1 (2%) Erythroid Cell, Depletion Cellular 1 (2%) Lymph Node (3) (4) (7) (1) Iliac, Hematopoietic Cell Proliferation 1 (14%) Iliac, Hyperplasia 1 (14%) Mediastinal, Hemorrhage 1 (33%) 1 (25%) 3 (43%) Mediastinal, Hyperplasia 1 (25%) 1 (14%) Mediastinal, Pigmentation 1 (25%) Pancreatic, Hemorrhage 1 (25%) Lymph Node, Mandibular (59) (55) (50) (54) Hyperplasia, Lymphoid 1 (2%) Lymph Node, Mesenteric (60) (55) (56) (53) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) 2 (4%) Hyperplasia 1 (2%) Hyperplasia, Lymphoid 1 (2%) Spleen (60) (60) (58) (60) Amyloid Deposition 1 (2%) Depletion Cellular 1 (2%) 7 (12%) 2 (3%) Hematopoietic Cell Proliferation 13 (22%) 24 (40%) 49 (84%) 60 (100%) Hyperplasia, Lymphoid 2 (3%) 3 (5%) Pigmentation, Focal 1 (2%) Thymus (57) (52) (45) (54) Atrophy 3 (6%) 3 (7%) 6 (11%) Cyst 4 (7%) 3 (6%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (60) (60) (60) Ulcer, Chronic, Focal 1 (2%) Artery, Subcutaneous Tissue, Inflammation, Chronic 2 (3%) Prepuce, Subcutaneous Tissue, Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Subcutaneous Tissue, Edema 3 (5%) 14 (23%) 22 (37%) Subcutaneous Tissue, Hemorrhage, Focal 1 (2%) 2 (3%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) 1 (2%) 2 (3%) Subcutaneous Tissue, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Fracture 1 (2%) Skeletal Muscle (1) (6) (35) (47) Hemorrhage, Focal 2 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Congestion 1 (2%) 1 (2%) 1 (2%) Cyst 1 (2%) Hemorrhage 1 (2%) 1 (2%) 5 (8%) Hyperplasia, Histiocytic 2 (3%) 1 (2%) Infiltration Cellular, Polymorphonuclear 1 (2%) Infiltration Cellular, Mixed Cell 4 (7%) 9 (15%) 3 (5%) Inflammation, Chronic, Focal 3 (5%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Bronchus, Glands, Cyst 1 (2%) Nose (60) (60) (60) (60) Mucosa, Glands, Dilatation, Focal 1 (2%) Nasolacrimal Duct, Inflammation 1 (2%) Sinus, Foreign Body 1 (2%) Sinus, Inflammation, Chronic, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Atrophy 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05203-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROTOLUENE Date: 11/16/00 Route: DOSED FEED Time: 09:50:01 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 1250 PPM 2500 PPM 5000 PPM ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Inflammation, Chronic 1 (100%) Cornea, Necrosis, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (58) (59) (58) (60) Amyloid Deposition 1 (2%) Atrophy 1 (2%) 1 (2%) Atrophy, Focal 2 (3%) Congestion 5 (9%) 3 (5%) Cyst 2 (3%) 4 (7%) 1 (2%) 1 (2%) Fibrosis, Focal 2 (3%) Hyperplasia, Lymphoid 1 (2%) 3 (5%) Infarct 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Inflammation, Chronic, Focal 1 (2%) Inflammation, Focal, Suppurative 1 (2%) Inflammation, Suppurative 1 (2%) 3 (5%) Metaplasia, Focal, Osseous 1 (2%) Nephropathy 56 (97%) 53 (90%) 34 (59%) 18 (30%) Artery, Inflammation, Chronic 2 (3%) Papilla, Necrosis 1 (2%) Pelvis, Dilatation 2 (3%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 2 (3%) 5 (9%) 3 (5%) Renal Tubule, Dilatation 1 (2%) 4 (7%) Renal Tubule, Necrosis 1 (2%) 2 (3%) Renal Tubule, Pigmentation 1 (2%) 6 (10%) 32 (55%) 35 (58%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) 1 (2%) Urethra (1) (2) Inflammation, Focal 1 (100%) 2 (100%) Urinary Bladder (59) (59) (59) (60) Calculus Micro Observation Only 1 (2%) Inflammation, Chronic 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------