TDMS Study 05092-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) O-NITROANISOLE NTP Experiment-Test: 05092-02 Report: PEIRPT03 Study Type: CHRONIC Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 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: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 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 5 8 7 Moribund Sacrifice 7 16 10 Survivors Terminal Sacrifice 38 26 33 Animals Examined Microscopically 50 10 50 10 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (10) (48) (48) Cyst 1 (2%) Dilatation 2 (4%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Intestine Large, Cecum (50) (10) (48) (50) Edema 1 (2%) Intestine Large, Colon (49) (10) (48) (50) Edema 1 (2%) Intestine Large, Rectum (50) (10) (50) (50) Inflammation, Chronic 1 (2%) Intestine Small, Duodenum (50) (10) (49) (50) Cyst 1 (10%) Mucosa, Hyperplasia 1 (2%) Intestine Small, Ileum (49) (10) (48) (50) Hyperplasia, Lymphoid 1 (2%) Inflammation, Pyogranulomatous 1 (2%) Lymphoid Tissue, Hyperplasia 1 (10%) Intestine Small, Jejunum (50) (10) (49) (49) Lymphoid Tissue, Hyperplasia 1 (10%) Liver (50) (10) (50) (10) (50) (10) Basophilic Focus 3 (6%) Clear Cell Focus 1 (2%) 4 (8%) 1 (10%) Cytologic Alterations 1 (2%) 1 (2%) Eosinophilic Focus 11 (22%) 6 (12%) 1 (10%) 21 (42%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 5 (10%) 2 (4%) 4 (8%) Hemorrhage 2 (4%) 1 (2%) Hyperplasia, Lymphoid 4 (8%) 3 (6%) 13 (26%) Infarct 1 (2%) Inflammation, Chronic 4 (8%) 10 (20%) 5 (10%) Inflammation, Chronic Active 7 (70%) 4 (40%) 4 (40%) Mineralization 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mixed Cell Focus 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%) Hepatocyte, Cytologic Alterations 8 (16%) 1 (10%) 13 (26%) 9 (90%) Hepatocyte, Vacuolization Cytoplasmic 2 (4%) 1 (2%) 2 (20%) Kupffer Cell, Hyperplasia 3 (6%) 5 (10%) 1 (2%) Kupffer Cell, Pigmentation 3 (6%) Lobules, Necrosis 3 (6%) 8 (16%) 3 (6%) Periportal, Inflammation 1 (2%) Mesentery (9) (1) (7) (5) Accessory Spleen 1 (11%) Inflammation, Suppurative 1 (14%) 1 (20%) Fat, Hemorrhage 1 (20%) Fat, Necrosis 6 (67%) 2 (29%) 1 (20%) Pancreas (50) (10) (50) (50) Atrophy 1 (2%) 1 (10%) 3 (6%) 2 (4%) Cyst 2 (4%) 1 (2%) 1 (2%) Cytoplasmic Alteration 2 (4%) 3 (6%) 3 (6%) Focal Cellular Change 1 (2%) Hyperplasia, Lymphoid 14 (28%) 8 (16%) 13 (26%) Salivary Glands (49) (10) (50) (50) Hyperplasia, Lymphoid 18 (37%) 24 (48%) 19 (38%) Stomach, Forestomach (50) (10) (50) (50) (1) Cyst 1 (2%) 1 (2%) Diverticulum 1 (2%) 3 (6%) 1 (2%) Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) Inflammation, Suppurative 3 (6%) 4 (8%) 3 (6%) Mineralization 1 (2%) Ulcer 1 (2%) Mucosa, Hyperplasia 7 (14%) 6 (12%) 7 (14%) 1 (100%) Stomach, Glandular (50) (10) (50) (50) Cyst 17 (34%) 2 (20%) 20 (40%) 13 (26%) Dysplasia 1 (2%) 1 (2%) Edema 1 (2%) 1 (2%) Erosion 2 (4%) 4 (8%) 2 (4%) Infiltration Cellular, Plasma Cell 1 (2%) Inflammation, Acute 1 (10%) Inflammation, Chronic 1 (2%) 2 (4%) Inflammation, Subacute 1 (2%) Mineralization 1 (2%) Mucosa, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (50) Epicardium, Inflammation, Chronic 1 (2%) Epicardium, Inflammation, Suppurative 1 (2%) 1 (2%) Myocardium, Fibrosis 1 (2%) Myocardium, Inflammation, Chronic 2 (4%) 3 (6%) Myocardium, Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) (50) (50) Accessory Adrenal Cortical Nodule 9 (18%) 7 (14%) 8 (16%) Basophilic Focus 1 (2%) 2 (4%) 2 (4%) Clear Cell Focus 1 (2%) Cyst 3 (6%) 1 (2%) 2 (4%) Developmental Malformation 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 3 (6%) Hyperplasia, Diffuse 1 (2%) Hyperplasia, Focal 5 (10%) 2 (20%) 6 (12%) 6 (12%) Capsule, Hyperplasia 5 (10%) 2 (4%) Subcapsular, Hyperplasia 6 (60%) X-Zone, Degeneration, Fatty 1 (2%) Adrenal Gland, Medulla (50) (10) (50) (50) Hyperplasia 3 (6%) 4 (8%) Islets, Pancreatic (50) (10) (50) (50) Cyst 1 (10%) Hyperplasia 10 (20%) 2 (20%) 12 (24%) 7 (14%) Hyperplasia, Lymphoid 1 (2%) Parathyroid Gland (50) (9) (48) (49) Cyst 2 (4%) Hyperplasia 1 (2%) 1 (2%) Pituitary Gland (49) (10) (47) (48) (1) Pars Distalis, Angiectasis 3 (6%) 2 (4%) Pars Distalis, Cyst 1 (2%) Pars Distalis, Hyperplasia 9 (18%) 10 (21%) 5 (10%) Thyroid Gland (50) (9) (50) (50) Degeneration, Cystic 23 (46%) 3 (33%) 19 (38%) 25 (50%) Inflammation, Chronic 2 (4%) 4 (8%) 2 (4%) Inflammation, Suppurative 3 (6%) 2 (4%) Follicle, Cyst 3 (6%) 2 (4%) Follicular Cell, Hyperplasia 9 (18%) 7 (14%) 4 (8%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) Bacterium 1 (50%) Inflammation, Suppurative 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (2) (2) Ectasia 2 (100%) 2 (100%) Inflammation, Chronic 1 (50%) 1 (50%) Pigmentation 2 (100%) 1 (50%) Ovary (49) (10) (50) (48) Angiectasis 12 (24%) 11 (22%) 6 (13%) Cyst 20 (41%) 17 (34%) 11 (23%) Fibrosis 1 (2%) Hemorrhage 1 (2%) 2 (4%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 3 (6%) 2 (4%) 4 (8%) Mineralization 1 (2%) Pigmentation 1 (2%) Interstitial Cell, Hyperplasia 1 (2%) Uterus (50) (10) (50) (6) (50) (8) Angiectasis 3 (6%) 3 (6%) 2 (4%) Exudate 8 (16%) 2 (20%) 4 (8%) 2 (33%) 6 (12%) 4 (50%) Hydrometra 9 (18%) 11 (22%) 6 (12%) Hyperplasia 1 (10%) Hyperplasia, Cystic 48 (96%) 9 (90%) 46 (92%) 6 (100%) 48 (96%) 8 (100%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Epithelium, Hyperplasia, Focal 1 (17%) Mucosa, Metaplasia, Squamous 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (10) (50) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) Hypercellularity 3 (6%) 10 (20%) 9 (18%) Myelofibrosis 1 (2%) 1 (2%) Lymph Node (50) (10) (50) (1) (50) Bronchial, Hemorrhage 1 (2%) Bronchial, Hyperplasia, Lymphoid 1 (100%) Iliac, Hematopoietic Cell Proliferation 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Iliac, Hyperplasia, Lymphoid 1 (2%) Iliac, Hyperplasia, Plasma Cell 1 (2%) 4 (8%) Inguinal, Hyperplasia, Lymphoid 1 (2%) Mediastinal, Hyperplasia, Lymphoid 2 (4%) Mediastinal, Hyperplasia, Plasma Cell 3 (6%) 1 (2%) 4 (8%) Mediastinal, Inflammation, Suppurative 2 (4%) Mediastinal, Necrosis 1 (2%) Pancreatic, Hematopoietic Cell Proliferation 1 (2%) Pancreatic, Hemorrhage 1 (2%) Pancreatic, Hyperplasia, Plasma Cell 1 (2%) Renal, Hyperplasia, Lymphoid 1 (2%) Renal, Hyperplasia, Plasma Cell 1 (2%) 4 (8%) Renal, Inflammation, Suppurative 1 (2%) Lymph Node, Mandibular (49) (10) (49) (49) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 2 (4%) 2 (4%) 1 (2%) Hyperplasia, Mast Cell 1 (2%) Hyperplasia, Plasma Cell 1 (2%) 1 (2%) Lymph Node, Mesenteric (47) (10) (47) (48) Depletion Cellular 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 4 (9%) 5 (10%) Hemorrhage 4 (9%) 6 (13%) 9 (19%) Hyperplasia, Lymphoid 2 (4%) 2 (4%) Hyperplasia, Plasma Cell 1 (2%) 2 (4%) Inflammation, Suppurative 1 (2%) Spleen (50) (10) (50) (2) (50) (1) Congestion 2 (4%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 14 (28%) 1 (10%) 25 (50%) 17 (34%) Pigmentation, Hemosiderin 9 (18%) 4 (8%) 1 (50%) 12 (24%) 1 (100%) Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) 1 (2%) Lymphoid Follicle, Hyperplasia 21 (42%) 8 (16%) 1 (50%) 11 (22%) Red Pulp, Atrophy 1 (2%) 2 (4%) Red Pulp, Hyperplasia 4 (8%) 1 (2%) 3 (6%) Thymus (47) (10) (44) (47) Angiectasis 1 (2%) 2 (5%) 1 (2%) Cyst 2 (20%) 9 (20%) 2 (4%) Depletion Cellular 2 (4%) 5 (11%) 5 (11%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) (50) (50) Hyperplasia, Cystic 7 (14%) 7 (14%) 7 (14%) Hyperplasia, Lobular 2 (4%) 1 (2%) 2 (4%) Inflammation, Chronic 1 (2%) Skin (50) (10) (50) (2) (50) Acanthosis 1 (2%) 4 (8%) Hemorrhage 1 (50%) Inflammation, Acute 1 (50%) Inflammation, Chronic 2 (4%) Ulcer 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (50) Hyperostosis 18 (36%) 12 (24%) 13 (26%) Femur, Hyperostosis 1 (10%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (10) (50) (50) Compression 1 (2%) Cyst 1 (2%) Hemorrhage 1 (2%) Hydrocephalus 1 (2%) 1 (2%) 1 (2%) Pigmentation 1 (2%) Cerebrum, Necrosis 1 (2%) Hippocampus, Necrosis 1 (2%) Thalamus, Mineralization 39 (80%) 9 (90%) 45 (90%) 44 (88%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (50) (50) (1) Congestion 3 (6%) 1 (2%) Edema 1 (10%) Hemorrhage 2 (4%) 3 (6%) Hyperplasia, Lymphoid 17 (34%) 19 (38%) 19 (38%) Infiltration Cellular, Histiocyte 4 (8%) 6 (12%) 4 (8%) Inflammation, Suppurative 3 (6%) 1 (2%) 1 (2%) Leukocytosis 1 (2%) Thrombosis 2 (4%) Alveolar Epithelium, Hyperplasia 2 (4%) 3 (6%) Bronchiole, Epithelium, Proliferation 3 (6%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (50) (10) (50) (5) (50) (10) Exudate 6 (12%) 5 (10%) 27 (54%) Glands, Dilatation 9 (18%) 1 (10%) 12 (24%) 36 (72%) 9 (90%) Glands, Hyperplasia 2 (4%) 4 (8%) 34 (68%) 6 (60%) Mucosa, Degeneration, Hyaline 8 (16%) 7 (70%) 7 (14%) 5 (100%) 12 (24%) 6 (60%) Mucosa, Hyperplasia 1 (2%) Olfactory Epithelium, Cyst 2 (4%) Olfactory Epithelium, Metaplasia 1 (2%) 1 (2%) 20 (40%) 7 (70%) Trachea (50) (10) (50) (50) Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Cataract 1 (100%) Phthisis Bulbi 1 (100%) Cornea, Hyperplasia 1 (100%) Cornea, Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) (50) (50) Casts Protein 20 (40%) 2 (20%) 18 (36%) 19 (38%) Cyst 4 (8%) 2 (4%) 4 (8%) Glomerulosclerosis 2 (4%) 1 (2%) Hyperplasia, Lymphoid 22 (44%) 21 (42%) 23 (46%) Inflammation, Chronic 1 (2%) 6 (60%) Inflammation, Suppurative 2 (4%) Metaplasia, Osseous 1 (2%) 1 (2%) 1 (2%) Mineralization 22 (44%) 1 (10%) 18 (36%) 12 (24%) Glomerulus, Hyperplasia 1 (2%) Glomerulus, Necrosis 1 (2%) Interstitial Tissue, Pigmentation 1 (2%) Renal Tubule, Atrophy 2 (4%) 1 (2%) 3 (6%) Renal Tubule, Cytoplasmic Alteration 1 (2%) 2 (4%) Renal Tubule, Dilatation 5 (10%) 5 (10%) 3 (6%) Renal Tubule, Necrosis 1 (2%) 3 (6%) Renal Tubule, Pigmentation 2 (4%) 1 (2%) 1 (2%) Renal Tubule, Regeneration 33 (66%) 2 (20%) 28 (56%) 17 (34%) Urinary Bladder (50) (10) (50) (50) Edema 2 (4%) 3 (6%) Hyperplasia, Lymphoid 27 (54%) 24 (48%) 25 (50%) Inflammation, Chronic 4 (40%) Transitional Epithelium, Degeneration, a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Ballooning 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 Scheduled Sacrifice 10 Early Deaths Moribund Sacrifice 5 Survivors Terminal Sacrifice 45 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (10) Hyperplasia, Lymphoid 3 (6%) Intestine Small, Duodenum (49) (10) Mucosa, Hyperplasia 3 (6%) Intestine Small, Ileum (49) (10) Hyperplasia, Lymphoid 1 (2%) Liver (50) (10) Cytologic Alterations 1 (2%) Eosinophilic Focus 16 (32%) 1 (10%) Hemorrhage 2 (4%) Hyperplasia, Lymphoid 6 (12%) Inflammation, Chronic 13 (26%) Inflammation, Chronic Active 6 (60%) Hepatocyte, Cytologic Alterations 40 (80%) 9 (90%) Kupffer Cell, Pigmentation 3 (6%) Lobules, Necrosis 2 (4%) Mesentery (2) Hyperplasia, Lymphoid 2 (100%) Fat, Necrosis 1 (50%) Pancreas (50) (10) Atrophy 2 (4%) Cyst 2 (4%) Hyperplasia, Lymphoid 7 (14%) Salivary Glands (50) (10) Atrophy 1 (2%) Hyperplasia, Lymphoid 20 (40%) Inflammation, Chronic 1 (10%) Stomach, Forestomach (50) (10) Diverticulum 2 (4%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Mucosa, Hyperplasia 2 (4%) Stomach, Glandular (50) (10) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Cyst 11 (22%) 1 (10%) Edema 1 (2%) Epithelium, Dilatation 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) Myocardium, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) Accessory Adrenal Cortical Nodule 14 (28%) 2 (20%) Cyst 1 (2%) Developmental Malformation 3 (6%) Hyperplasia, Focal 4 (8%) Capsule, Hyperplasia 2 (4%) Subcapsular, Hyperplasia 2 (20%) Adrenal Gland, Medulla (50) (10) Hyperplasia 1 (2%) Islets, Pancreatic (50) (10) Hyperplasia 2 (4%) Parathyroid Gland (49) (10) Cyst 2 (4%) Ectopic Thymus 2 (4%) Hyperplasia 1 (2%) Infiltration Cellular, Histiocyte 1 (10%) Pigmentation 1 (10%) Pituitary Gland (48) (10) Pars Distalis, Cyst 1 (2%) Pars Intermedia, Cyst 1 (2%) Thyroid Gland (50) (10) Degeneration, Cystic 28 (56%) 1 (10%) Inflammation, Chronic 5 (10%) Follicular Cell, Hyperplasia 1 (2%) 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (50) (10) Angiectasis 12 (24%) 1 (10%) Cyst 10 (20%) Hemorrhage 2 (4%) Metaplasia, Osseous 1 (2%) Thrombosis 1 (2%) Corpus Luteum, Hyperplasia 1 (2%) Granulosa Cell, Hyperplasia 1 (2%) Thecal Cell, Hyperplasia 1 (2%) Uterus (50) (10) Angiectasis 1 (2%) Exudate 2 (4%) 3 (30%) Hydrometra 15 (30%) Hyperplasia, Cystic 47 (94%) 5 (50%) Mucosa, Dysplasia 2 (4%) Mucosa, Metaplasia, Squamous 4 (8%) Myometrium, Hyperplasia 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (10) Hypercellularity 2 (4%) Myelofibrosis 1 (2%) Lymph Node, Mesenteric (48) (10) Hemorrhage 5 (10%) Hyperplasia, Lymphoid 1 (2%) Spleen (50) (10) Congestion 1 (2%) Hematopoietic Cell Proliferation 4 (8%) Pigmentation, Hemosiderin 1 (2%) Lymphoid Follicle, Hyperplasia 5 (10%) Thymus (49) (10) Cyst 3 (6%) 2 (20%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (10) Hyperplasia, Cystic 2 (4%) Hyperplasia, Lobular 6 (12%) Skin (50) (10) Acanthosis 1 (2%) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) Hyperostosis 11 (22%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) Cyst 2 (4%) Thalamus, Mineralization 43 (86%) 7 (70%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Hemorrhage 3 (6%) Hyperplasia, Lymphoid 20 (40%) Inflammation, Chronic 2 (4%) Alveolar Epithelium, Hyperplasia 1 (2%) Bronchiole, Epithelium, Proliferation 4 (8%) Mediastinum, Ectopic Tissue 1 (10%) Nose (50) (10) Exudate 49 (98%) 3 (30%) Glands, Dilatation 49 (98%) 10 (100%) Glands, Hyperplasia 50 (100%) 10 (100%) Mucosa, Degeneration, Hyaline 45 (90%) 10 (100%) Olfactory Epithelium, Cyst 6 (12%) Olfactory Epithelium, Metaplasia 49 (98%) 10 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) Casts Protein 30 (60%) 4 (40%) Fibrosis 1 (2%) Hyperplasia, Lymphoid 14 (28%) Inflammation, Chronic 4 (40%) Metaplasia, Osseous 6 (12%) Mineralization 9 (18%) 3 (30%) Renal Tubule, Regeneration 12 (24%) 1 (10%) Urinary Bladder (50) (10) Edema 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Hyperplasia, Lymphoid 23 (46%) Inflammation, Chronic 1 (10%) Inflammation, Granulomatous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 50 10 50 10 Scheduled Sacrifice 10 10 9 Early Deaths Moribund Sacrifice 14 5 8 Natural Death 1 2 3 Survivors Terminal Sacrifice 35 43 39 Other 1 Animals Examined Microscopically 50 10 50 10 50 9 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (49) (9) (45) (47) Dilatation 1 (2%) 1 (2%) Intestine Large, Cecum (49) (10) (49) (49) Hyperplasia, Lymphoid 1 (2%) Intestine Small, Duodenum (50) (10) (48) (49) Inflammation, Chronic 1 (2%) Metaplasia, Squamous 1 (2%) Intestine Small, Ileum (49) (10) (48) (47) Hyperplasia, Lymphoid 1 (2%) Liver (50) (10) (50) (10) (50) (9) Angiectasis 1 (2%) Basophilic Focus 3 (6%) 1 (10%) 1 (2%) 1 (2%) Clear Cell Focus 9 (18%) 7 (14%) 1 (10%) 9 (18%) Eosinophilic Focus 1 (2%) 15 (30%) 16 (32%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hemorrhage 1 (2%) 4 (8%) 20 (40%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Chronic 1 (2%) 3 (6%) 1 (2%) Inflammation, Chronic Active 2 (20%) 5 (56%) Mixed Cell Focus 1 (2%) 3 (6%) Regeneration, Focal 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) Hepatocyte, Cytologic Alterations 44 (88%) 7 (70%) 49 (98%) 9 (100%) Hepatocyte, Cytomegaly 1 (2%) Hepatocyte, Vacuolization Cytoplasmic 6 (12%) 4 (40%) 7 (14%) 2 (20%) 3 (33%) Kupffer Cell, Hyperplasia 2 (4%) Kupffer Cell, Pigmentation 3 (6%) Lobules, Necrosis 3 (6%) 13 (26%) 27 (54%) 2 (22%) Oval Cell, Hyperplasia 1 (2%) Mesentery (4) (2) (2) (4) Hemorrhage 1 (25%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Pyogranulomatous 1 (50%) Fat, Inflammation, Chronic 1 (50%) Fat, Necrosis 2 (50%) 1 (50%) 1 (50%) 1 (25%) Pancreas (50) (10) (49) (49) Atrophy 1 (2%) Focal Cellular Change 1 (2%) Hyperplasia, Focal 1 (2%) Hyperplasia, Lymphoid 2 (4%) 3 (6%) Inflammation, Chronic 1 (10%) Duct, Hyperplasia 1 (2%) Salivary Glands (50) (10) (50) (50) Hyperplasia, Lymphoid 16 (32%) 21 (42%) 20 (40%) Inflammation, Chronic 1 (2%) 1 (10%) Stomach, Forestomach (50) (10) (50) (50) Cyst 2 (4%) Diverticulum 4 (8%) 1 (2%) 1 (2%) Erosion 1 (2%) Inflammation, Chronic 2 (4%) Inflammation, Suppurative 2 (4%) Mucosa, Hyperplasia 6 (12%) 2 (4%) Stomach, Glandular (50) (10) (50) (49) Cyst 7 (14%) 1 (10%) 15 (30%) 11 (22%) Dysplasia 1 (2%) 1 (2%) Erosion 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Subacute 1 (2%) Mucosa, Hyperplasia 1 (2%) Tooth (11) (20) (12) Dysplasia 10 (91%) 18 (90%) 12 (100%) Inflammation, Suppurative 1 (9%) 2 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) (50) (50) Thrombosis 1 (2%) 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) Myocardium, Degeneration 2 (4%) Myocardium, Inflammation, Chronic 2 (4%) 1 (10%) 2 (4%) 1 (2%) Myocardium, Mineralization 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (10) (50) (50) Accessory Adrenal Cortical Nodule 8 (16%) 1 (2%) 5 (10%) Angiectasis 1 (2%) Basophilic Focus 1 (2%) Clear Cell Focus 1 (2%) 3 (6%) 6 (12%) Developmental Malformation 2 (4%) Hyperplasia, Focal 24 (48%) 21 (42%) 23 (46%) Hypertrophy, Focal 1 (10%) Capsule, Hyperplasia 6 (12%) 6 (12%) 5 (10%) Subcapsular, Hyperplasia 4 (40%) Adrenal Gland, Medulla (50) (10) (49) (50) Hyperplasia 1 (2%) Islets, Pancreatic (50) (10) (49) (49) Hyperplasia 21 (42%) 3 (30%) 20 (41%) 9 (18%) Parathyroid Gland (50) (10) (49) (50) Cyst 2 (4%) 2 (20%) 3 (6%) 2 (4%) Hyperplasia 1 (2%) Pigmentation 1 (2%) Pituitary Gland (47) (8) (46) (49) Pars Distalis, Cyst 1 (2%) 4 (9%) 7 (14%) Pars Distalis, Hyperplasia 1 (2%) 1 (2%) Thyroid Gland (49) (10) (49) (50) Degeneration, Cystic 12 (24%) 1 (10%) 11 (22%) 9 (18%) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Follicle, Dilatation 1 (10%) Follicular Cell, Hyperplasia 3 (6%) 6 (12%) 6 (12%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (4) (1) Dilatation 2 (50%) Epididymis (50) (10) (50) (50) Atypia Cellular 1 (2%) Fibrosis 3 (6%) Granuloma Sperm 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic 1 (2%) 5 (10%) Preputial Gland (24) (3) (24) (1) (25) (2) a Number of animals examined microscopically at site and number of animals with lesion Page 17 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Atrophy 2 (67%) 1 (100%) 1 (50%) Ectasia 18 (75%) 3 (100%) 20 (83%) 1 (100%) 24 (96%) 2 (100%) Fibrosis 1 (4%) Inflammation, Chronic 13 (54%) 2 (67%) 7 (29%) 13 (52%) 1 (50%) Inflammation, Suppurative 6 (25%) 4 (17%) 4 (16%) Prostate (50) (10) (50) (50) Inflammation, Suppurative 1 (2%) Seminal Vesicle (50) (10) (50) (50) Dilatation 6 (12%) 3 (6%) 1 (2%) Testes (50) (10) (50) (50) Granuloma Sperm 1 (2%) Hypospermia 2 (4%) 1 (2%) Mineralization 1 (2%) 2 (4%) Interstitial Cell, Hyperplasia 2 (4%) Seminiferous Tubule, Atrophy 3 (6%) 1 (2%) 4 (8%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (10) (50) (50) Angiectasis 2 (4%) Hypercellularity 1 (2%) 10 (20%) 6 (12%) Lymph Node (50) (10) (50) (1) (50) (1) Inguinal, Hyperplasia, Lymphoid 2 (4%) 1 (2%) Inguinal, Pigmentation 1 (2%) 1 (2%) Mediastinal, Hemorrhage 1 (2%) Mediastinal, Inflammation, Suppurative 1 (2%) Mediastinal, Inflammation, Pyogranulomatous 1 (2%) Pancreatic, Hemorrhage 1 (2%) 1 (2%) Lymph Node, Mandibular (48) (10) (49) (49) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (10%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Lymph Node, Mesenteric (47) (10) (49) (1) (46) (1) Hematopoietic Cell Proliferation 4 (9%) 16 (33%) 6 (13%) Hemorrhage 19 (40%) 1 (10%) 23 (47%) 21 (46%) 1 (100%) Hyperplasia, Histiocytic 1 (2%) 2 (4%) Hyperplasia, Lymphoid 4 (9%) 4 (8%) 4 (9%) Hyperplasia, Reticulum Cell 1 (2%) Infiltration Cellular, Mast Cell 2 (4%) 1 (2%) Spleen (50) (10) (50) (49) Congestion 1 (2%) 3 (6%) Hematopoietic Cell Proliferation 10 (20%) 12 (24%) 10 (20%) Pigmentation, Hemosiderin 1 (2%) Lymphoid Follicle, Atrophy 1 (2%) Lymphoid Follicle, Hyperplasia 3 (6%) 7 (14%) 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 18 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Red Pulp, Atrophy 1 (2%) 1 (2%) Red Pulp, Hyperplasia 2 (4%) Thymus (47) (10) (47) (45) Cyst 8 (17%) 3 (30%) 7 (15%) 6 (13%) Depletion Cellular 1 (2%) 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (10) (50) (50) (1) Acanthosis 4 (8%) 1 (2%) 4 (8%) Inflammation, Acute 1 (2%) Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%) Inflammation, Suppurative 2 (4%) Subcutaneous Tissue, Edema 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (10) (50) (50) Hyperostosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) (50) (50) Cyst 1 (2%) Inflammation, Chronic 1 (2%) Thalamus, Mineralization 41 (82%) 8 (80%) 43 (86%) 44 (88%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (50) (4) (50) Congestion 1 (2%) Hemorrhage 2 (4%) 1 (10%) 1 (2%) 2 (4%) Hyperplasia, Lymphoid 5 (10%) 6 (12%) Infiltration Cellular, Histiocyte 5 (10%) 5 (10%) 1 (25%) 1 (2%) Inflammation, Chronic 2 (4%) 1 (2%) 1 (2%) Inflammation, Suppurative 3 (6%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 5 (10%) 4 (8%) 2 (4%) Bronchiole, Epithelium, Proliferation 2 (4%) 13 (26%) Nose (50) (10) (50) (50) (2) Exudate 4 (8%) 4 (8%) 6 (12%) Glands, Dilatation 3 (6%) 2 (20%) 6 (12%) 12 (24%) 2 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 19 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.0% 0.0% 0.0666% 0.0666% 0.200% 0.200% 15 SSAC 15 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Glands, Hyperplasia 1 (2%) 2 (4%) 12 (24%) Olfactory Epithelium, Metaplasia 7 (14%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) Cataract 1 (33%) Cornea, Hyperplasia 2 (67%) Cornea, Inflammation, Chronic Active 2 (67%) Cornea, Mineralization 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) (50) (50) Casts Protein 12 (24%) 14 (28%) 18 (36%) Cyst 27 (54%) 1 (10%) 30 (60%) 16 (32%) Fibrosis 1 (2%) Glomerulosclerosis 2 (4%) 1 (2%) 1 (2%) Hydronephrosis 6 (12%) Hyperplasia, Lymphoid 20 (40%) 16 (32%) 25 (50%) Inflammation, Chronic 1 (2%) 2 (20%) 1 (2%) Inflammation, Suppurative 1 (2%) Metaplasia, Osseous 2 (4%) 3 (6%) Mineralization 41 (82%) 4 (40%) 48 (96%) 50 (100%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) Renal Tubule, Atrophy 1 (2%) Renal Tubule, Cytoplasmic Alteration 1 (2%) Renal Tubule, Dilatation 3 (6%) Renal Tubule, Hyperplasia 1 (2%) 2 (4%) Renal Tubule, Pigmentation 5 (10%) Renal Tubule, Regeneration 48 (96%) 10 (100%) 46 (92%) 48 (96%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) Urinary Bladder (50) (10) (50) (49) Dilatation 3 (6%) 1 (2%) Edema 1 (2%) Hyperplasia, Lymphoid 1 (2%) 4 (8%) 5 (10%) Inflammation, Chronic 1 (10%) Mucosa, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 20 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 10 Scheduled Sacrifice 10 Early Deaths Moribund Sacrifice 7 Natural Death 3 Survivors Terminal Sacrifice 40 Animals Examined Microscopically 50 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (49) (10) Edema 1 (2%) Intestine Small, Duodenum (50) (9) Mucosa, Hyperplasia 3 (6%) Intestine Small, Ileum (49) (10) Hyperplasia, Lymphoid 2 (4%) Liver (50) (10) Angiectasis 1 (2%) Clear Cell Focus 2 (4%) Eosinophilic Focus 13 (26%) 1 (10%) Hemorrhage 28 (56%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 3 (30%) Hepatocyte, Cytologic Alterations 49 (98%) 10 (100%) Kupffer Cell, Pigmentation 16 (32%) Lobules, Necrosis 34 (68%) 4 (40%) Oval Cell, Hyperplasia 1 (2%) Pancreas (50) (10) Atrophy 1 (10%) Hyperplasia, Lymphoid 5 (10%) Infiltration Cellular, Histiocyte 1 (2%) Acinar Cell, Vacuolization Cytoplasmic 1 (2%) Salivary Glands (50) (10) Hyperplasia, Lymphoid 10 (20%) Acinar Cell, Vacuolization Cytoplasmic 1 (2%) Stomach, Forestomach (50) (10) Cyst 1 (2%) Diverticulum 1 (2%) Erosion 1 (2%) Mucosa, Hyperplasia 4 (8%) Stomach, Glandular (50) (10) Cyst 8 (16%) a Number of animals examined microscopically at site and number of animals with lesion Page 21 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Erosion 1 (2%) Inflammation, Chronic 1 (2%) Tooth (3) Dysplasia 3 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (10) Myocardium, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (48) (10) Accessory Adrenal Cortical Nodule 9 (19%) 1 (10%) Hyperplasia, Diffuse 1 (2%) Hyperplasia, Focal 21 (44%) Hypertrophy, Focal 1 (10%) Infiltration Cellular, Mononuclear Cell 1 (2%) Capsule, Hyperplasia 4 (8%) Subcapsular, Hyperplasia 1 (10%) Adrenal Gland, Medulla (48) (10) Hyperplasia 2 (4%) Islets, Pancreatic (50) (10) Hyperplasia 2 (4%) Parathyroid Gland (48) (10) Cyst 3 (6%) 1 (10%) Infiltration Cellular, Histiocyte 1 (2%) Pituitary Gland (48) (9) Pars Distalis, Cyst 1 (2%) Pars Intermedia, Cytoplasmic Alteration 1 (2%) Thyroid Gland (50) (10) Degeneration, Cystic 6 (12%) 1 (10%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 22 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (10) Atypia Cellular 1 (2%) Thrombosis 1 (2%) Preputial Gland (10) Ectasia 10 (100%) Inflammation, Chronic 4 (40%) Inflammation, Suppurative 1 (10%) Testes (50) (10) Hypospermia 1 (2%) Mineralization 2 (4%) Interstitial Cell, Hyperplasia 1 (2%) Seminiferous Tubule, Atrophy 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (10) Angiectasis 1 (2%) Hypercellularity 7 (14%) Lymph Node (50) (10) Inguinal, Hyperplasia, Lymphoid 1 (2%) Lymph Node, Mesenteric (50) (10) Hematopoietic Cell Proliferation 3 (6%) Hemorrhage 14 (28%) Hyperplasia, Lymphoid 7 (14%) Spleen (48) (10) Angiectasis 3 (6%) Congestion 1 (2%) Hematopoietic Cell Proliferation 7 (15%) Lymphoid Follicle, Atrophy 1 (2%) Lymphoid Follicle, Hyperplasia 2 (4%) Red Pulp, Atrophy 1 (2%) Thymus (48) (10) Cyst 6 (13%) 1 (10%) Depletion Cellular 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (10) Acanthosis 1 (2%) Hair Follicle, Atrophy 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 23 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (10) Pigmentation 2 (4%) Thalamus, Mineralization 40 (80%) 6 (60%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) Congestion 1 (2%) Hemorrhage 6 (12%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Megakaryocyte 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic 2 (4%) Alveolar Epithelium, Hyperplasia 2 (4%) Bronchiole, Epithelium, Proliferation 14 (28%) Nose (50) (10) Exudate 49 (98%) 1 (10%) Glands, Dilatation 49 (98%) 10 (100%) Glands, Hyperplasia 49 (98%) 10 (100%) Olfactory Epithelium, Cyst 18 (36%) Olfactory Epithelium, Metaplasia 46 (92%) 10 (100%) Olfactory Epithelium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (10) Casts Protein 5 (10%) Cyst 4 (8%) 1 (10%) Fibrosis 1 (2%) Hyperplasia, Lymphoid 8 (16%) Inflammation, Chronic 1 (10%) Mineralization 36 (72%) 2 (20%) Renal Tubule, Pigmentation 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 24 NTP Experiment-Test: 05092-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94 Route: DOSED FEED Time: 19:16:19 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0.600% 0.600% 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Regeneration 32 (64%) 5 (50%) Urinary Bladder (50) (10) Hyperplasia, Lymphoid 5 (10%) Inflammation, Chronic 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 25 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------