TDMS Study 05092-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) O-NITROANISOLE NTP Experiment-Test: 05092-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 Facility: Southern Research Institute Chemical CAS #: 0091-23-6 Lock Date: None 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: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 10 Early Deaths Moribund Sacrifice 17 7 18 Natural Death 2 6 Survivors Terminal Sacrifice 33 41 26 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (10) (49) (46) Parasite Metazoan 1 (2%) 3 (6%) 2 (4%) Intestine Large, Colon (50) (10) (49) (46) Parasite Metazoan 3 (6%) 2 (20%) 5 (10%) 1 (2%) Intestine Large, Rectum (50) (10) (49) (46) Parasite Metazoan 3 (6%) 4 (8%) 2 (4%) Intestine Small, Ileum (50) (10) (49) (46) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Liver (50) (10) (50) (10) (50) (10) Basophilic Focus 2 (4%) 2 (20%) 4 (8%) 4 (40%) Basophilic Focus, Multiple 37 (74%) 7 (70%) 41 (82%) 9 (90%) 34 (68%) 5 (50%) Clear Cell Focus 5 (10%) 1 (10%) 3 (6%) Clear Cell Focus, Multiple 1 (2%) 1 (2%) Cytomegaly 1 (2%) Degeneration, Multiple 1 (2%) Eosinophilic Focus 3 (6%) 8 (16%) 5 (10%) 1 (10%) Eosinophilic Focus, Multiple 5 (10%) 2 (4%) 3 (6%) Hepatodiaphragmatic Nodule 4 (8%) 3 (6%) 10 (20%) 1 (10%) Hyperplasia, Nodular 4 (8%) 1 (2%) 3 (6%) Inflammation, Granulomatous, Multiple 36 (72%) 5 (50%) 30 (60%) 5 (50%) 20 (40%) 2 (20%) Karyomegaly 1 (2%) Mixed Cell Focus 2 (4%) 1 (10%) 4 (8%) 2 (4%) 2 (20%) Mixed Cell Focus, Multiple 1 (2%) Necrosis 2 (4%) Pigmentation 1 (2%) Vacuolization Cytoplasmic 10 (20%) 3 (6%) 5 (10%) Bile Duct, Hyperplasia 29 (58%) 3 (30%) 30 (60%) 1 (10%) 34 (68%) 4 (40%) Centrilobular, Degeneration 1 (2%) Serosa, Fibrosis 1 (2%) Serosa, Inflammation, Granulomatous 1 (2%) Mesentery (9) (1) (6) (2) (11) Fat, Inflammation, Focal, Granulomatous 2 (22%) 1 (50%) 1 (9%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fat, Inflammation, Granulomatous 1 (17%) Fat, Necrosis, Focal 7 (78%) 1 (100%) 5 (83%) 1 (50%) 9 (82%) Fat, Necrosis, Focal, Multiple 1 (9%) Pancreas (50) (10) (50) (49) Basophilic Focus 3 (6%) Basophilic Focus, Multiple 1 (2%) 1 (2%) Acinar Cell, Atrophy 14 (28%) 11 (22%) 15 (31%) Acinar Cell, Hyperplasia 6 (12%) 4 (8%) 4 (8%) Pharynx (2) Palate, Epithelium, Hyperplasia 1 (50%) Salivary Glands (50) (10) (49) (50) Cytomegaly 1 (2%) Infiltration Cellular, Lipocyte 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Acinar Cell, Atrophy 1 (2%) 1 (2%) Acinar Cell, Hyperplasia 1 (2%) Stomach, Forestomach (50) (10) (50) (1) (50) Edema 4 (8%) 1 (2%) 5 (10%) Inflammation, Chronic 4 (8%) 2 (4%) 2 (4%) Inflammation, Suppurative 2 (4%) Ulcer 1 (2%) 2 (4%) Ulcer, Multiple 2 (4%) 1 (2%) 2 (4%) Epithelium, Hyperplasia 8 (16%) 8 (16%) 1 (100%) 13 (26%) Stomach, Glandular (50) (10) (50) (1) (50) Edema 1 (2%) Erosion 1 (2%) 1 (2%) Erosion, Multiple 1 (2%) Hyperplasia, Lymphoid 1 (2%) Mineralization 1 (2%) 1 (2%) Necrosis, Focal, Multiple 1 (2%) 1 (2%) Ulcer 1 (2%) Ulcer, Multiple 1 (2%) Epithelium, Hyperplasia 1 (2%) Epithelium, Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (50) Inflammation, Chronic 34 (68%) 1 (10%) 45 (90%) 41 (82%) Atrium, Congestion 1 (2%) Atrium, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) (50) (50) Accessory Adrenal Cortical Nodule 6 (12%) 4 (8%) 2 (4%) Degeneration, Cystic 1 (2%) Hyperplasia, Focal 4 (8%) 10 (20%) 5 (10%) Hyperplasia, Focal, Multiple 1 (2%) Hypertrophy, Focal 7 (14%) 11 (22%) 6 (12%) Hypertrophy, Focal, Multiple 2 (4%) Necrosis, Focal, Multiple 1 (2%) Vacuolization Cytoplasmic 1 (2%) 3 (6%) 2 (4%) Vacuolization Cytoplasmic, Focal 14 (28%) 15 (30%) 8 (16%) Vacuolization Cytoplasmic, Multiple 2 (4%) Bilateral, Hypertrophy, Focal 1 (2%) Bilateral, Vacuolization Cytoplasmic 1 (2%) 1 (2%) Bilateral, Vacuolization Cytoplasmic, Focal 1 (2%) Spindle Cell, Hyperplasia, Focal 1 (2%) 1 (10%) Adrenal Gland, Medulla (50) (10) (50) (50) Degeneration, Cystic, Focal 1 (2%) Hyperplasia, Focal 3 (6%) 4 (8%) 3 (6%) Vacuolization Cytoplasmic, Focal 1 (2%) Parathyroid Gland (49) (10) (46) (49) Cyst 1 (2%) Pituitary Gland (50) (10) (50) (3) (50) (1) Pars Distalis, Cyst 4 (8%) 4 (8%) 3 (6%) Pars Distalis, Cyst, Multiple 4 (8%) 4 (8%) 1 (33%) 1 (2%) 1 (100%) Pars Distalis, Hyperplasia, Focal 5 (10%) 1 (10%) 6 (12%) 6 (12%) Pars Intermedia, Cyst 1 (2%) Thyroid Gland (50) (10) (50) (50) (1) Inflammation, Suppurative 1 (2%) Ultimobranchial Cyst 1 (2%) 2 (4%) C-Cell, Hyperplasia 5 (10%) 3 (6%) 1 (2%) C-Cell, Hyperplasia, Focal 9 (18%) 7 (14%) 5 (10%) Follicle, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (45) (10) (47) (10) (50) (10) Abscess 1 (2%) Atrophy 1 (2%) Cyst 14 (31%) 3 (30%) 23 (49%) 2 (20%) 18 (36%) 3 (30%) Cyst, Multiple 1 (2%) 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Hyperplasia 8 (18%) 1 (2%) Hyperplasia, Focal 1 (2%) 4 (9%) 1 (2%) Inflammation, Suppurative 2 (4%) 1 (2%) 2 (4%) Bilateral, Cyst 7 (16%) 3 (6%) 11 (22%) Ovary (50) (10) (50) (50) Cyst 5 (10%) 1 (10%) 3 (6%) 5 (10%) Inflammation, Granulomatous, Multiple 1 (2%) Bilateral, Cyst 1 (2%) 1 (10%) 1 (2%) Uterus (50) (10) (50) (10) (50) (10) Abscess 1 (2%) Dilatation 2 (4%) 2 (20%) 3 (6%) 1 (10%) 2 (4%) 1 (10%) Hyperplasia, Glandular 2 (4%) 2 (4%) 2 (4%) Infiltration Cellular, Lipocyte 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Cervix, Abscess 1 (10%) Cervix, Cyst 2 (4%) 1 (10%) Cervix, Inflammation, Suppurative 1 (2%) 1 (2%) Endometrium, Hyperplasia, Cystic 7 (14%) 2 (20%) 6 (12%) 1 (10%) 9 (18%) Vagina (3) (1) Inflammation, Suppurative 1 (33%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) (50) (50) Hyperplasia, Reticulum Cell 1 (10%) Myelofibrosis 2 (4%) 1 (2%) Erythroid Cell, Hyperplasia 1 (2%) Lymph Node (50) (10) (50) (50) Inguinal, Hyperplasia, Lymphoid 1 (2%) Mediastinal, Angiectasis 6 (12%) 2 (4%) 5 (10%) Mediastinal, Hemorrhage 1 (2%) Mediastinal, Hyperplasia, Lymphoid 1 (10%) 3 (6%) Mediastinal, Infiltration Cellular, Histiocyte 1 (2%) Mediastinal, Pigmentation 1 (2%) Pancreatic, Angiectasis 2 (4%) Pancreatic, Hyperplasia, Lymphoid 1 (2%) Pancreatic, Pigmentation 1 (10%) Renal, Cyst, Multiple 1 (2%) Lymph Node, Mandibular (48) (10) (49) (50) Angiectasis 1 (2%) 2 (4%) Congestion 1 (2%) Cyst 1 (2%) Cyst, Multiple 3 (6%) 2 (4%) 3 (6%) Hyperplasia, Lymphoid 7 (15%) 2 (4%) 2 (4%) Lymph Node, Mesenteric (48) (10) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Angiectasis 1 (2%) 3 (6%) 2 (4%) Edema 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Spleen (50) (10) (50) (10) (50) (10) Atrophy 1 (2%) 1 (2%) Congestion 2 (4%) Fibrosis, Focal 2 (4%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 10 (100%) 5 (10%) 8 (80%) Inflammation, Granulomatous 2 (4%) Necrosis 1 (2%) Pigmentation 3 (6%) 5 (10%) 10 (100%) 2 (4%) 10 (100%) Capsule, Fibrosis 1 (2%) Capsule, Hypertrophy 1 (2%) 3 (30%) 3 (30%) Capsule, Inflammation, Granulomatous 1 (2%) Thymus (47) (10) (49) (47) Cyst 3 (6%) Cyst, Multiple 1 (2%) Hyperplasia, Lymphoid 1 (10%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) (50) (50) Hyperplasia, Lobular 19 (38%) 26 (52%) 22 (44%) Duct, Cyst 38 (76%) 1 (10%) 36 (72%) 33 (66%) Skin (50) (10) (50) (50) Hyperkeratosis 2 (4%) Parakeratosis 2 (4%) Ulcer 2 (4%) Nipple, Hyperkeratosis 1 (2%) Nipple, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (50) Osteopetrosis 2 (4%) 1 (2%) 1 (2%) Calvarium, Hyperostosis 6 (12%) 1 (10%) 5 (10%) 4 (8%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (50) Compression 10 (20%) 6 (12%) 13 (26%) Embolus Bacterial, Multiple 1 (2%) Hemorrhage 2 (4%) 2 (4%) Hemorrhage, Multiple 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Inflammation, Multiple, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (50) (50) (1) Atelectasis 1 (2%) Congestion 1 (2%) Edema 1 (2%) Embolus Bacterial, Multiple 1 (2%) Hemorrhage, Multiple 1 (2%) Infiltration Cellular, Focal, Histiocyte 1 (2%) 1 (2%) 4 (8%) Infiltration Cellular, Multiple, Histiocyte 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 2 (4%) Inflammation, Focal, Granulomatous 3 (6%) 2 (4%) Inflammation, Multiple, Suppurative 1 (2%) Mineralization, Focal 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 3 (6%) 1 (2%) Nose (50) (10) (50) (3) (50) (6) Metaplasia, Squamous 1 (2%) Lumen, Foreign Body 1 (2%) Lumen, Fungus 4 (8%) 2 (4%) 2 (4%) Lumen, Hyperkeratosis 1 (2%) Lumen, Inflammation, Suppurative 4 (8%) 3 (6%) 2 (4%) Nasolacrimal Duct, Hemorrhage 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) Submucosa, Hemorrhage 2 (4%) Submucosa, Pigmentation 46 (92%) 8 (80%) 48 (96%) 3 (100%) 46 (92%) 6 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (4) (1) Cataract 4 (100%) 1 (100%) Retina, Degeneration 4 (100%) 1 (100%) Harderian Gland (1) (2) Hemorrhage 1 (100%) 2 (100%) Zymbal's Gland (1) (1) Inflammation, Suppurative 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) (50) (10) (50) (10) Cyst 2 (4%) 1 (10%) Fibrosis, Focal 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) Infarct, Multiple 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Chronic, Focal 1 (10%) Inflammation, Suppurative 1 (2%) Mineralization 2 (4%) Nephropathy, Chronic 39 (78%) 3 (30%) 46 (92%) 9 (90%) 46 (92%) 5 (50%) Papilla, Necrosis 1 (2%) Pelvis, Dilatation 1 (2%) Renal Tubule, Dilatation 1 (10%) 6 (60%) Renal Tubule, Mineralization 1 (2%) 1 (10%) 1 (2%) 6 (60%) 3 (6%) 7 (70%) Renal Tubule, Pigmentation 41 (82%) 47 (94%) 45 (90%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) Urinary Bladder (50) (10) (50) (10) (50) (10) Calculus Gross Observation 1 (2%) Hemorrhage 1 (2%) Inflammation, Suppurative 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 Scheduled Sacrifice 9 Early Deaths Moribund Sacrifice 14 1 Natural Death 3 Survivors Terminal Sacrifice 33 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (49) (10) Parasite Metazoan 1 (2%) Intestine Large, Colon (49) (10) Parasite Metazoan 2 (4%) 1 (10%) Intestine Large, Rectum (49) (10) Parasite Metazoan 6 (12%) Intestine Small (50) (10) Wall, Foreign Body 1 (2%) Intestine Small, Jejunum (48) (10) Inflammation, Granulomatous 1 (2%) Ulcer 1 (2%) Liver (50) (10) Angiectasis 1 (2%) Basophilic Focus 3 (6%) 2 (20%) Basophilic Focus, Multiple 26 (52%) 1 (10%) Clear Cell Focus 3 (6%) Clear Cell Focus, Multiple 2 (4%) Eosinophilic Focus 9 (18%) Eosinophilic Focus, Multiple 5 (10%) Hematopoietic Cell Proliferation 1 (2%) Hepatodiaphragmatic Nodule 8 (16%) 1 (10%) Hyperplasia, Nodular 14 (28%) Inflammation, Granulomatous, Multiple 21 (42%) 5 (50%) Mixed Cell Focus 5 (10%) 1 (10%) Necrosis 1 (10%) Vacuolization Cytoplasmic 5 (10%) Bile Duct, Hyperplasia 43 (86%) 4 (40%) Centrilobular, Necrosis 1 (2%) Centrilobular, Vacuolization Cytoplasmic 1 (2%) Hepatocyte, Kupffer Cell, Pigmentation 1 (10%) Vein, Thrombosis 1 (2%) Mesentery (12) (4) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 1 (8%) Fat, Inflammation, Focal, Granulomatous 1 (8%) 3 (75%) Fat, Necrosis, Focal 10 (83%) 2 (50%) Pancreas (50) (10) Basophilic Focus, Multiple 2 (4%) Ectopic Tissue 1 (2%) Acinar Cell, Atrophy 12 (24%) Acinar Cell, Hyperplasia 5 (10%) Salivary Glands (50) (10) Acinar Cell, Atrophy 1 (2%) Acinar Cell, Hyperplasia 1 (2%) Stomach, Forestomach (50) (10) Edema 5 (10%) Inflammation, Chronic 6 (12%) Ulcer 6 (12%) Ulcer, Multiple 1 (2%) Epithelium, Hyperplasia 28 (56%) 1 (10%) Stomach, Glandular (50) (10) Erosion 2 (4%) Ulcer 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) Inflammation, Chronic 39 (78%) 2 (20%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) Accessory Adrenal Cortical Nodule 7 (14%) Cyst 1 (2%) Degeneration, Cystic 2 (4%) Hyperplasia, Focal 6 (12%) Hypertrophy, Focal 5 (10%) Vacuolization Cytoplasmic, Focal 11 (22%) Bilateral, Hyperplasia 1 (2%) Bilateral, Vacuolization Cytoplasmic 3 (6%) Bilateral, Vacuolization Cytoplasmic, Focal 1 (2%) Pituitary Gland (50) (10) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Cyst 5 (10%) Pars Distalis, Cyst, Multiple 6 (12%) 1 (10%) Pars Distalis, Hyperplasia 4 (8%) 1 (10%) Pars Distalis, Hyperplasia, Focal 7 (14%) Pars Intermedia, Cyst 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (50) (10) C-Cell, Hyperplasia 2 (4%) C-Cell, Hyperplasia, Focal 5 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (10) Cyst 15 (31%) 1 (10%) Hyperplasia 6 (13%) 2 (20%) Inflammation, Suppurative 2 (4%) Bilateral, Cyst 11 (23%) Ovary (50) (10) Cyst 5 (10%) Cyst, Multiple 1 (2%) Uterus (50) (10) Dilatation 4 (8%) 1 (10%) Fibrosis, Focal 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Glandular 5 (10%) Cervix, Hemorrhage 1 (2%) Cervix, Myometrium, Hyperplasia 3 (6%) Endometrium, Hyperplasia, Cystic 12 (24%) Vein, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (50) (10) Mediastinal, Angiectasis 6 (12%) Mediastinal, Congestion 1 (2%) Mediastinal, Hemorrhage 1 (2%) Mediastinal, Hyperplasia, Lymphoid 2 (4%) Mediastinal, Pigmentation 2 (4%) Pancreatic, Angiectasis 6 (12%) Lymph Node, Mandibular (50) (10) Hyperplasia, Lymphoid 1 (2%) Pigmentation 2 (4%) Lymph Node, Mesenteric (47) (10) Angiectasis 1 (2%) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic 1 (2%) Spleen (50) (10) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 3 (6%) Inflammation, Granulomatous 1 (2%) Pigmentation 1 (2%) 1 (10%) Thymus (48) (10) Congestion 1 (2%) Cyst 1 (2%) Hyperplasia, Lymphoid 1 (2%) Mediastinum, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) Hyperplasia, Lobular 21 (42%) Duct, Cyst 34 (68%) Skin (50) (10) Hyperkeratosis 1 (2%) Epidermis, Hyperplasia 1 (2%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) Osteopetrosis 1 (2%) Calvarium, Hyperostosis 5 (10%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) Compression 6 (12%) Hemorrhage, Multiple 2 (4%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Infiltration Cellular, Focal, Histiocyte 2 (4%) Infiltration Cellular, Multiple, Histiocyte 2 (4%) Inflammation, Focal, Granulomatous 4 (8%) Inflammation, Granulomatous, Multiple 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Alveolar Epithelium, Hyperplasia 2 (4%) Alveolus, Pigmentation 2 (4%) Nose (50) (10) Lumen, Fungus 1 (2%) Lumen, Inflammation, Suppurative 1 (2%) Submucosa, Pigmentation 50 (100%) 10 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (5) Cataract 4 (80%) Inflammation, Suppurative 1 (20%) Retina, Degeneration 4 (80%) Harderian Gland (2) Hemorrhage 1 (50%) Zymbal's Gland (1) Inflammation, Suppurative 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) Nephropathy, Chronic 44 (88%) 4 (40%) Renal Tubule, Dilatation 1 (2%) 8 (80%) Renal Tubule, Mineralization 2 (4%) 6 (60%) Renal Tubule, Necrosis 1 (2%) Renal Tubule, Pigmentation 46 (92%) Urinary Bladder (50) (10) Hemorrhage, Focal 1 (2%) Inflammation, Chronic 2 (4%) Transitional Epithelium, Hyperplasia 6 (12%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 10 Early Deaths Natural Death 2 3 2 Moribund Sacrifice 16 13 24 Survivors Terminal Sacrifice 32 34 24 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (48) (10) (48) (49) Dilatation 1 (2%) Parasite Metazoan 1 (2%) 3 (6%) Intestine Large, Colon (48) (10) (48) (50) Dilatation 1 (2%) Parasite Metazoan 5 (10%) 4 (40%) 4 (8%) 2 (4%) Intestine Large, Rectum (46) (10) (49) (50) Dilatation 1 (2%) Parasite Metazoan 9 (20%) 4 (8%) 13 (26%) Intestine Small, Duodenum (49) (10) (47) (50) Ectopic Tissue 1 (2%) Intestine Small, Ileum (48) (10) (47) (48) Hyperplasia, Lymphoid 1 (2%) 2 (4%) 4 (8%) Liver (50) (10) (50) (10) (50) (10) Angiectasis 1 (2%) Basophilic Focus 3 (6%) 5 (50%) 2 (4%) 1 (10%) 2 (4%) Basophilic Focus, Multiple 29 (58%) 27 (54%) 11 (22%) Clear Cell Focus 6 (12%) 3 (30%) 4 (8%) 1 (2%) 1 (10%) Clear Cell Focus, Multiple 7 (14%) 2 (20%) 6 (12%) 1 (10%) 4 (8%) Degeneration, Cystic 10 (20%) 1 (10%) 10 (20%) 14 (28%) Eosinophilic Focus 6 (12%) 10 (20%) 1 (10%) 15 (30%) 3 (30%) Eosinophilic Focus, Multiple 2 (4%) 8 (16%) 1 (10%) 6 (12%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) Hepatodiaphragmatic Nodule 4 (8%) 3 (6%) 2 (4%) 1 (10%) Hepatodiaphragmatic Nodule, Multiple 1 (10%) Hyperplasia, Nodular 7 (14%) 2 (4%) 18 (36%) Inflammation, Granulomatous, Multiple 2 (4%) 5 (50%) 2 (4%) 4 (40%) 2 (4%) 6 (60%) Mixed Cell Focus 4 (8%) 2 (20%) 2 (4%) Mixed Cell Focus, Multiple 2 (4%) 2 (4%) 1 (2%) Necrosis 1 (2%) Thrombosis, Multiple 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Vacuolization Cytoplasmic 5 (10%) 8 (80%) 4 (8%) 10 (100%) 4 (8%) 8 (80%) Bile Duct, Hyperplasia 46 (92%) 10 (100%) 44 (88%) 10 (100%) 46 (92%) 7 (70%) Centrilobular, Degeneration 2 (4%) 2 (4%) 2 (4%) Mesentery (10) (2) (11) (2) (5) (2) Accessory Spleen 1 (50%) Fat, Hemorrhage, Focal 2 (20%) 1 (50%) Fat, Inflammation, Focal, Granulomatous 1 (10%) 1 (50%) 4 (36%) 1 (50%) Fat, Necrosis, Focal 7 (70%) 9 (82%) 1 (50%) 3 (60%) Pancreas (49) (10) (49) (50) (1) Basophilic Focus 2 (4%) Ectopic Tissue 1 (2%) Edema 1 (2%) 1 (2%) Polyarteritis 1 (2%) 1 (2%) Acinar Cell, Atrophy 18 (37%) 21 (43%) 18 (36%) Acinar Cell, Basophilic Focus 2 (4%) Acinar Cell, Hyperplasia 6 (12%) 10 (20%) 4 (8%) Acinar Cell, Hyperplasia, Focal 1 (2%) Acinar Cell, Vacuolization Cytoplasmic 1 (2%) Salivary Glands (50) (10) (50) (50) Cytomegaly 1 (2%) 8 (16%) 4 (8%) Fibrosis, Focal 1 (2%) Infiltration Cellular, Lipocyte 39 (78%) 6 (12%) Inflammation, Suppurative 1 (2%) Acinar Cell, Atrophy 1 (2%) 1 (2%) Stomach, Forestomach (50) (10) (50) (50) (1) Edema 3 (6%) 3 (6%) 5 (10%) Inflammation, Chronic 2 (4%) 2 (4%) 1 (2%) Mineralization 1 (2%) Perforation 1 (2%) Ulcer 3 (6%) 3 (6%) 6 (12%) Ulcer, Multiple 2 (4%) Epithelium, Hyperplasia 3 (6%) 16 (32%) 25 (50%) 1 (100%) Stomach, Glandular (50) (10) (49) (50) (1) Edema 4 (8%) Erosion, Multiple 1 (2%) Mineralization 1 (2%) 1 (2%) Ulcer 1 (2%) Ulcer, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (1) (50) Inflammation, Chronic 43 (86%) 6 (60%) 46 (92%) 42 (84%) Atrium, Congestion 2 (4%) 1 (2%) Atrium, Thrombosis 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (48) (10) (50) (50) Accessory Adrenal Cortical Nodule 8 (17%) 1 (10%) 5 (10%) 5 (10%) Degeneration, Cystic 1 (2%) Hyperplasia, Focal 3 (6%) 1 (10%) 7 (14%) 4 (8%) Hypertrophy, Focal 5 (10%) 2 (4%) 1 (2%) Vacuolization Cytoplasmic 2 (4%) Vacuolization Cytoplasmic, Focal 9 (19%) 1 (10%) 10 (20%) 11 (22%) Vacuolization Cytoplasmic, Focal, Multiple 2 (4%) Adrenal Gland, Medulla (49) (10) (50) (50) Hyperplasia 1 (2%) Hyperplasia, Focal 4 (8%) 9 (18%) 11 (22%) Bilateral, Hyperplasia, Focal 1 (2%) Islets, Pancreatic (49) (10) (49) (50) Hyperplasia 1 (2%) 2 (4%) 2 (4%) Parathyroid Gland (47) (10) (46) (47) Hyperplasia 2 (4%) 1 (2%) 3 (6%) Pituitary Gland (50) (10) (50) (1) (49) Pars Distalis, Cyst 2 (4%) 1 (2%) 6 (12%) Pars Distalis, Cyst, Multiple 1 (2%) Pars Distalis, Hemorrhage 4 (8%) Pars Distalis, Hyperplasia, Focal 3 (6%) 3 (30%) 9 (18%) 11 (22%) Pars Intermedia, Cyst 2 (4%) Thyroid Gland (49) (10) (50) (50) Ultimobranchial Cyst 1 (2%) Bilateral, C-Cell, Hyperplasia 1 (2%) C-Cell, Hyperplasia 3 (6%) C-Cell, Hyperplasia, Focal 7 (14%) 3 (6%) 3 (6%) Follicle, Cyst 4 (8%) 5 (10%) 6 (12%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) Inflammation, Suppurative 1 (100%) Epididymis (50) (10) (50) (10) (50) (10) Granuloma Sperm 1 (2%) Preputial Gland (50) (10) (50) (10) (50) (9) Abscess 1 (2%) Atrophy 6 (12%) 13 (26%) 16 (32%) 2 (22%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Atrophy, Multiple 3 (6%) 1 (2%) Autolysis 1 (2%) Cyst 7 (14%) 3 (30%) 18 (36%) 2 (20%) 24 (48%) 2 (22%) Cyst, Multiple 2 (4%) 4 (8%) 7 (14%) Hyperplasia 2 (4%) 1 (10%) 5 (10%) Hyperplasia, Focal 1 (2%) 3 (6%) Inflammation, Chronic 2 (4%) 1 (2%) 1 (2%) Inflammation, Suppurative 3 (6%) 5 (10%) 3 (6%) Prostate (50) (10) (50) (50) Cyst 1 (2%) Inflammation, Chronic 4 (8%) 6 (12%) 2 (4%) Inflammation, Suppurative 24 (48%) 3 (30%) 15 (30%) 17 (34%) Epithelium, Hyperplasia 1 (2%) Seminal Vesicle (50) (10) (50) (50) (1) Atrophy 12 (24%) 12 (24%) 7 (14%) 1 (100%) Hyperplasia, Glandular 1 (2%) Testes (50) (10) (50) (10) (50) (10) Atrophy 16 (32%) 13 (26%) 15 (30%) 1 (10%) Bilateral, Atrophy 1 (2%) 2 (4%) Bilateral, Interstitial Cell, Hyperplasia 3 (6%) 6 (60%) 5 (10%) 3 (30%) 3 (6%) 5 (50%) Interstitial Cell, Atrophy 2 (4%) Interstitial Cell, Hyperplasia 16 (32%) 1 (10%) 6 (12%) 4 (40%) 15 (30%) 4 (40%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) (50) (50) Myelofibrosis 1 (2%) 2 (4%) Myeloid Cell, Hyperplasia 1 (2%) Lymph Node (50) (10) (50) (50) (1) Inguinal, Hyperplasia, Lymphoid 3 (6%) 1 (2%) Mediastinal, Angiectasis 9 (18%) 5 (10%) 2 (4%) Mediastinal, Cyst, Multiple 1 (2%) Mediastinal, Hyperplasia, Lymphoid 2 (4%) 1 (10%) 2 (4%) 1 (2%) Mediastinal, Pigmentation 2 (4%) 1 (2%) Pancreatic, Angiectasis 2 (4%) 2 (4%) 2 (4%) Pancreatic, Cyst, Multiple 1 (2%) Pancreatic, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (100%) Pancreatic, Pigmentation 2 (4%) Renal, Hyperplasia, Lymphoid 1 (2%) Renal, Pigmentation 1 (2%) Lymph Node, Mandibular (50) (10) (48) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) Cyst, Multiple 3 (6%) 6 (13%) 3 (6%) Fibrosis 1 (2%) Hyperplasia, Lymphoid 4 (8%) 3 (6%) 3 (6%) Lymph Node, Mesenteric (49) (10) (48) (49) a Number of animals examined microscopically at site and number of animals with lesion Page 17 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Angiectasis 1 (2%) 2 (4%) 1 (2%) Edema 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 6 (13%) 1 (2%) Spleen (50) (10) (49) (10) (50) (10) Congestion 1 (10%) 7 (14%) 1 (10%) Fibrosis, Focal 7 (14%) 5 (10%) 8 (16%) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 1 (2%) Hyperplasia, Histiocytic, Lymphoid 1 (2%) Inflammation, Granulomatous, Multiple 1 (2%) Necrosis 2 (4%) Capsule, Fibrosis, Focal 1 (10%) Capsule, Hypertrophy 1 (2%) 5 (50%) 6 (60%) Thymus (45) (9) (48) (42) Fibrosis 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (10) (49) (47) Hyperplasia, Lobular 10 (21%) 21 (43%) 13 (28%) Duct, Cyst 7 (15%) 17 (35%) 16 (34%) Duct, Hemorrhage 1 (2%) 3 (6%) Skin (50) (10) (50) (1) (50) Cyst Epithelial Inclusion 1 (2%) Hyperkeratosis 1 (2%) Dermis, Fibrosis 1 (2%) Epidermis, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (50) Fibrous Osteodystrophy 1 (2%) 1 (2%) Osteoporosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (50) Compression 6 (12%) 3 (6%) 4 (8%) Hemorrhage 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 18 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (50) (1) (50) Atelectasis, Focal 1 (2%) Erythrophagocytosis 1 (2%) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Focal, Histiocyte 4 (8%) Infiltration Cellular, Multiple, Histiocyte 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Focal, Granulomatous 2 (4%) 1 (2%) Inflammation, Granulomatous, Multiple 3 (6%) Inflammation, Suppurative 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 1 (10%) 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) Nose (50) (10) (50) (50) Lumen, Foreign Body 1 (2%) 3 (6%) 5 (10%) Lumen, Fungus 10 (20%) 9 (18%) 9 (18%) Lumen, Inflammation, Suppurative 9 (18%) 12 (24%) 13 (26%) Respiratory Epithelium, Hyperkeratosis 1 (2%) Respiratory Epithelium, Hyperplasia 1 (2%) Septum, Inflammation, Chronic 1 (2%) Submucosa, Inflammation, Suppurative 1 (2%) Submucosa, Pigmentation 45 (90%) 37 (74%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (2) (1) Cataract 1 (100%) 1 (100%) 1 (100%) Retina, Degeneration 1 (100%) 1 (100%) 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (10) (50) (10) (50) (10) Cyst 1 (2%) 2 (4%) 2 (4%) Cyst, Multiple 1 (2%) Fibrosis, Focal 1 (10%) Nephropathy, Chronic 49 (100%) 10 (100%) 50 (100%) 10 (100%) 50 (100%) 10 (100%) Pelvis, Dilatation 1 (10%) Renal Tubule, Hyperplasia 3 (6%) Renal Tubule, Mineralization 2 (4%) Renal Tubule, Pigmentation 45 (92%) 41 (82%) 48 (96%) a Number of animals examined microscopically at site and number of animals with lesion Page 19 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Transitional Epithelium, Hyperplasia 7 (14%) 9 (18%) 9 (18%) a Number of animals examined microscopically at site and number of animals with lesion Page 20 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 Scheduled Sacrifice 9 Early Deaths Moribund Sacrifice 35 1 Natural Death 6 Survivors Natural Death 1 Terminal Sacrifice 8 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (47) (10) Parasite Metazoan 1 (2%) Intestine Large, Colon (48) (10) Mineralization 1 (2%) Parasite Metazoan 9 (19%) 4 (40%) Intestine Large, Rectum (49) (10) Dilatation 1 (2%) Edema 1 (2%) Parasite Metazoan 8 (16%) Intestine Small, Jejunum (48) (10) Parasite Metazoan 1 (10%) Artery, Thrombosis 1 (2%) Wall, Inflammation, Chronic 1 (2%) Liver (50) (10) Angiectasis 1 (2%) Basophilic Focus 4 (8%) 1 (10%) Basophilic Focus, Multiple 3 (6%) Clear Cell Focus 2 (4%) 1 (10%) Clear Cell Focus, Multiple 3 (6%) Degeneration, Cystic 24 (48%) Eosinophilic Focus 13 (26%) Eosinophilic Focus, Multiple 14 (28%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage, Focal 1 (10%) Hepatodiaphragmatic Nodule 4 (8%) 2 (20%) Hyperplasia, Nodular 14 (28%) Inflammation, Granulomatous, Multiple 7 (70%) Mixed Cell Focus 2 (4%) Necrosis 2 (4%) 1 (10%) Vacuolization Cytoplasmic 1 (2%) 8 (80%) Bile Duct, Hyperplasia 40 (80%) 9 (90%) a Number of animals examined microscopically at site and number of animals with lesion Page 21 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Centrilobular, Degeneration 2 (4%) Centrilobular, Necrosis 1 (2%) Vein, Thrombosis 1 (2%) Mesentery (9) Polyarteritis 2 (22%) Thrombosis, Multiple 1 (11%) Fat, Hemorrhage, Focal 2 (22%) Fat, Necrosis, Focal 3 (33%) Pancreas (48) (10) Ectopic Tissue 2 (4%) Fibrosis, Focal 1 (2%) Inflammation, Chronic 1 (2%) Polyarteritis 2 (4%) Acinar Cell, Atrophy 13 (27%) Acinar Cell, Hyperplasia 6 (13%) Acinus, Atrophy 1 (10%) Stomach, Forestomach (50) (10) Edema 11 (22%) Inflammation, Chronic 12 (24%) Mineralization 1 (2%) Ulcer 15 (30%) Ulcer, Multiple 1 (2%) Epithelium, Hyperplasia 32 (64%) 2 (20%) Stomach, Glandular (50) (10) Edema 1 (2%) Erosion 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 6 (12%) Polyarteritis 1 (2%) Ulcer 1 (2%) Artery, Thrombosis 1 (2%) Mucosa, Pigmentation, Focal 1 (2%) Serosa, Fibrosis, Focal 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) Aorta, Mineralization 1 (100%) Mesenteric Artery, Mineralization 1 (100%) Heart (50) (10) Inflammation, Chronic 40 (80%) 5 (50%) Mineralization 1 (2%) Atrium, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 22 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (10) Accessory Adrenal Cortical Nodule 2 (4%) 1 (10%) Degeneration, Cystic 1 (2%) Hyperplasia, Focal 2 (4%) Hypertrophy, Focal 1 (2%) Hypertrophy, Multiple 1 (2%) Vacuolization Cytoplasmic 11 (22%) Vacuolization Cytoplasmic, Focal 8 (16%) Vacuolization Cytoplasmic, Focal, Multiple 1 (2%) Spindle Cell, Hyperplasia, Focal 1 (2%) Adrenal Gland, Medulla (49) (10) Hemorrhage 1 (2%) Hyperplasia, Focal 10 (20%) Parathyroid Gland (48) (10) Hyperplasia 14 (29%) Pituitary Gland (49) (10) Pars Distalis, Cyst 2 (4%) Pars Distalis, Hyperplasia, Focal 5 (10%) 2 (20%) Pars Intermedia, Cyst 1 (2%) Thyroid Gland (50) (10) Ultimobranchial Cyst 1 (2%) Artery, Polyarteritis 1 (2%) C-Cell, Hyperplasia 1 (2%) 1 (10%) C-Cell, Hyperplasia, Focal 3 (6%) Follicle, Cyst 5 (10%) 1 (10%) Follicle, Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (10) Depletion Cellular 1 (10%) Preputial Gland (49) (10) Abscess 1 (2%) Atrophy 13 (27%) Cyst 16 (33%) 1 (10%) Cyst, Multiple 1 (2%) Hyperplasia 2 (4%) Inflammation, Suppurative 2 (4%) Bilateral, Atrophy 4 (8%) Prostate (50) (10) a Number of animals examined microscopically at site and number of animals with lesion Page 23 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Cyst 3 (6%) Granuloma 1 (10%) Inflammation, Chronic 3 (6%) Inflammation, Suppurative 17 (34%) 2 (20%) Seminal Vesicle (50) (10) Atrophy 2 (4%) Testes (50) (10) Atrophy 17 (34%) 3 (30%) Degeneration 2 (20%) Necrosis 1 (2%) 1 (10%) Arteriole, Inflammation, Chronic 1 (2%) Bilateral, Atrophy 1 (2%) Bilateral, Interstitial Cell, Hyperplasia 5 (10%) 1 (10%) Interstitial Cell, Hyperplasia 10 (20%) 5 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (10) Myelofibrosis 2 (4%) Lymph Node (50) (10) Iliac, Cyst 1 (2%) Inguinal, Hyperplasia, Lymphoid 3 (6%) Mediastinal, Angiectasis 2 (4%) Mediastinal, Pigmentation 4 (8%) Pancreatic, Angiectasis 1 (2%) Pancreatic, Hyperplasia, Lymphoid 3 (6%) Renal, Angiectasis 4 (8%) Renal, Hyperplasia, Lymphoid 1 (2%) Lymph Node, Mandibular (50) (10) Angiectasis 1 (2%) Cyst 1 (2%) Hyperplasia, Lymphoid 2 (4%) Lymph Node, Mesenteric (48) (10) Angiectasis 1 (2%) Edema 1 (2%) Hyperplasia, Lymphoid 1 (2%) Spleen (50) (10) Congestion 3 (30%) Fibrosis, Focal 9 (18%) Hematopoietic Cell Proliferation 1 (2%) Necrosis 1 (2%) Pigmentation 1 (2%) Capsule, Hypertrophy 8 (80%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 24 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) Hyperplasia, Lobular 23 (46%) Duct, Cyst 7 (14%) Skin (50) (10) Inflammation, Suppurative 1 (2%) Ulcer 1 (2%) Epidermis, Hyperplasia 1 (2%) Subcutaneous Tissue, Cyst Epithelial Inclusion 1 (10%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) Calvarium, Hyperostosis 1 (2%) Femur, Fibrous Osteodystrophy 4 (8%) Maxilla, Fibrous Osteodystrophy 3 (6%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) Compression 2 (4%) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Hemorrhage, Multiple 1 (2%) Inflammation, Focal, Granulomatous 2 (20%) Inflammation, Granulomatous, Multiple 1 (2%) Mineralization 1 (2%) Alveolus, Pigmentation 1 (2%) Mediastinum, Polyarteritis, Multiple 1 (2%) Mediastinum, Thrombosis, Multiple 1 (2%) Nose (50) (10) Metaplasia, Squamous 2 (4%) Lumen, Foreign Body 2 (4%) Lumen, Fungus 14 (28%) 1 (10%) Lumen, Inflammation, Suppurative 14 (28%) 1 (10%) Submucosa, Pigmentation 45 (90%) 7 (70%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 25 NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 15:57:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.200% 0.200% 15 SSAC ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) Cataract 1 (50%) Retina, Degeneration 1 (50%) Harderian Gland (2) Hemorrhage 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (10) Cyst 6 (12%) Cyst, Multiple 7 (14%) Hydronephrosis 1 (2%) Nephropathy, Chronic 49 (100%) 10 (100%) Renal Tubule, Hyperplasia 2 (4%) Renal Tubule, Pigmentation 46 (94%) Transitional Epithelium, Hyperplasia 30 (61%) Ureter (1) Transitional Epithelium, Hyperplasia 1 (100%) Urinary Bladder (50) (10) Inflammation, Chronic 1 (2%) Transitional Epithelium, Hyperplasia 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 26 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------