TDMS Study 05212-05 Pathology Tables
NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 CORE STUDY Facility: Battelle Columbus Laboratory Chemical CAS #: 604-75-1 Lock Date: 05/12/94 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice Removal Date Range: All Treatment Groups: Include 002 0 PPM Include 004 625 PPM Include 008 2500 PPM Include 010 5000 PPM Include 012 10,000 PPM STOP Include 001 0 PPM Include 003 625 PPM Include 007 2500 PPM Include 009 5000 PPM Include 011 10,000 PPM STOP a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 Early Deaths Natural Death 6 6 12 3 6 Moribund Sacrifice 11 18 18 16 19 Accidently Killed 1 Survivors Terminal Sacrifice 32 26 20 31 25 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (49) (1) Periesophageal Tissue, Necrosis 1 (100%) Intestine Large, Colon (50) (48) (49) (50) Parasite Metazoan 2 (4%) 2 (4%) 2 (4%) 2 (4%) Intestine Large, Rectum (50) (49) (49) (50) Cyst 1 (2%) Parasite Metazoan 2 (4%) 2 (4%) 1 (2%) Intestine Small, Duodenum (50) (49) (47) (49) Ulcer 2 (4%) Intestine Small, Jejunum (46) (48) (47) (48) (1) Parasite Metazoan 1 (2%) Ulcer 1 (100%) Liver (50) (50) (50) (50) (49) Basophilic Focus 44 (88%) 41 (82%) 28 (56%) 26 (52%) 16 (33%) Clear Cell Focus 6 (12%) 3 (6%) 11 (22%) 22 (44%) Degeneration, Cystic 2 (4%) Degeneration, Fatty 1 (2%) 2 (4%) Eosinophilic Focus 17 (34%) 18 (36%) 4 (8%) 11 (22%) 11 (22%) Hepatodiaphragmatic Nodule 12 (24%) 2 (4%) 4 (8%) 5 (10%) 6 (12%) Inflammation, Granulomatous 1 (2%) 2 (4%) 3 (6%) Mixed Cell Focus 5 (10%) 15 (30%) 7 (14%) 3 (6%) 2 (4%) Necrosis, Focal 2 (4%) 1 (2%) Centrilobular, Atrophy 1 (2%) Centrilobular, Necrosis 1 (2%) 2 (4%) 1 (2%) Hepatocyte, Centrilobular, Hypertrophy 10 (20%) 31 (62%) Mesentery (10) (9) (4) (6) (13) Accessory Spleen 1 (10%) Fat, Necrosis 8 (80%) 9 (100%) 4 (100%) 6 (100%) 13 (100%) Pancreas (50) (50) (49) (49) Acinus, Atrophy 6 (12%) 6 (12%) 1 (2%) 8 (16%) Stomach, Forestomach (50) (50) (50) (50) (3) Abscess 1 (2%) Foreign Body 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 4 (8%) 1 (2%) Inflammation, Chronic Active 3 (6%) 4 (8%) 1 (2%) Ulcer 1 (2%) 2 (4%) 8 (16%) 6 (12%) 2 (67%) Epithelium, Hyperkeratosis 1 (33%) Epithelium, Hyperplasia 1 (2%) 4 (8%) 8 (16%) 3 (6%) Epithelium, Ulcer 1 (2%) Stomach, Glandular (50) (50) (50) (50) (1) Erosion 2 (4%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) 2 (4%) Ulcer 2 (4%) 2 (4%) 6 (12%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (49) Aorta, Mineralization 1 (2%) Heart (50) (50) (49) (49) Atrium, Thrombosis 1 (2%) Myocardium, Degeneration 32 (64%) 34 (68%) 35 (71%) 32 (65%) Myocardium, Fibrosis, Focal 2 (4%) Myocardium, Mineralization 1 (2%) Pericardium, Inflammation, Chronic 1 (2%) Valve, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) (1) Degeneration 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Diffuse 1 (2%) Hyperplasia, Focal 9 (18%) 8 (16%) 5 (10%) 4 (8%) Hypertrophy, Focal 2 (4%) 1 (2%) Pigmentation, Hemosiderin 1 (2%) 1 (2%) Adrenal Medulla (50) (50) (50) (50) Degeneration 1 (2%) Hyperplasia 8 (16%) 3 (6%) 1 (2%) 4 (8%) Islets, Pancreatic (50) (50) (49) (49) Hyperplasia 2 (4%) 1 (2%) 1 (2%) Pituitary Gland (50) (50) (50) (50) (35) Angiectasis 2 (4%) Cyst 1 (2%) 2 (6%) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Cyst 5 (10%) 2 (4%) 1 (2%) 3 (6%) 2 (6%) Pars Distalis, Degeneration, Cystic 1 (2%) 3 (6%) 5 (14%) Pars Distalis, Hyperplasia 4 (8%) 5 (10%) 3 (6%) 8 (16%) 1 (3%) Pars Distalis, Vacuolization Cytoplasmic, a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Focal 1 (3%) Thyroid Gland (50) (50) (48) (49) (50) Ultimobranchial Cyst 1 (2%) C-Cell, Hyperplasia 40 (80%) 43 (86%) 35 (73%) 42 (86%) 43 (86%) Follicle, Cyst 1 (2%) 2 (4%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Inflammation, Granulomatous 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (50) (50) (50) (11) Cyst 1 (2%) Hyperplasia 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 1 (9%) Duct, Cyst 1 (2%) 4 (8%) 6 (12%) 2 (4%) 3 (27%) Ovary (50) (50) (50) (50) (4) Cyst 5 (10%) 6 (12%) 5 (10%) 6 (12%) 4 (100%) Uterus (50) (50) (50) (50) (5) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (20%) Cervix, Cyst 2 (4%) 1 (2%) 1 (2%) 1 (20%) Cervix, Inflammation, Suppurative 1 (20%) Cervix, Myometrium, Hyperplasia 2 (4%) 1 (20%) Endometrium, Hyperplasia, Cystic 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Necrosis 1 (2%) Lymph Node (4) (2) (9) (3) (4) Lumbar, Ectasia 1 (11%) Mediastinal, Pigmentation, Hemosiderin 1 (33%) Pancreatic, Inflammation, Granulomatous 1 (11%) Renal, Ectasia 1 (25%) Lymph Node, Mandibular (50) (48) (48) (49) (3) Ectasia 1 (2%) Lymph Node, Mesenteric (50) (50) (50) (49) (2) Ectasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Inflammation, Acute 1 (2%) Spleen (50) (50) (50) (49) (12) Fibrosis 1 (2%) 2 (4%) 2 (4%) 2 (17%) Hematopoietic Cell Proliferation 3 (6%) 2 (4%) 3 (6%) 1 (2%) Inflammation, Granulomatous 1 (2%) 1 (2%) 1 (8%) Pigmentation, Hemosiderin 25 (50%) 27 (54%) 13 (26%) 22 (45%) Lymphoid Follicle, Atrophy 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (49) (50) (23) Hyperplasia, Cystic 2 (4%) 3 (6%) 1 (2%) 1 (2%) 1 (4%) Metaplasia, Squamous 1 (2%) Skin (50) (50) (50) (50) (6) Hyperkeratosis 1 (17%) Ulcer 2 (4%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Inflammation, Chronic 1 (2%) Subcutaneous Tissue, Inflammation, Suppurative 1 (17%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (1) Hyperostosis 1 (2%) 2 (4%) Inflammation, Chronic 1 (100%) Osteopetrosis 3 (6%) Cranium, Hyperostosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hydrocephalus 7 (14%) 12 (24%) 3 (6%) 3 (6%) Cerebellum, Mineralization 1 (2%) Cerebrum, Degeneration, Focal 1 (2%) Hypothalamus, Hemorrhage 2 (4%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) (49) Congestion 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Infiltration Cellular, Histiocyte 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Inflammation, Granulomatous 2 (4%) 2 (4%) 5 (10%) 8 (16%) Alveolar Epithelium, Hyperplasia 3 (6%) 4 (8%) 1 (2%) 3 (6%) Interstitium, Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) Serosa, Inflammation, Chronic 1 (2%) Nose (50) (50) (50) (50) Inflammation, Suppurative 5 (10%) 2 (4%) 6 (12%) 4 (8%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (1) (2) Choroid, Inflammation, Chronic 1 (100%) Lens, Cataract 2 (100%) 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (1) Inflammation, Chronic Active 1 (2%) Nephropathy 32 (64%) 43 (86%) 41 (82%) 48 (96%) 1 (100%) Pigmentation, Lipofuscin 2 (4%) Renal Tubule, Cyst 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) Urinary Bladder (48) (49) (49) (50) Inflammation, Chronic Active 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 Early Deaths Moribund Sacrifice 25 27 33 43 39 Natural Death 8 12 11 7 11 Survivors Terminal Sacrifice 17 11 6 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (47) (50) (50) (1) Parasite Metazoan 4 (9%) 2 (4%) Serosa, Inflammation, Chronic 1 (100%) Intestine Large, Rectum (50) (48) (49) (50) (1) Congestion 1 (2%) Edema 1 (2%) Parasite Metazoan 1 (2%) 2 (4%) Serosa, Inflammation, Chronic 1 (100%) Intestine Large, Cecum (50) (48) (49) (50) (1) Congestion 1 (2%) Edema 1 (2%) Serosa, Inflammation, Chronic 1 (100%) Intestine Small, Duodenum (50) (48) (49) (50) Erosion 2 (4%) 6 (12%) 3 (6%) Ulcer 3 (6%) 3 (6%) 5 (10%) 13 (26%) Intestine Small, Ileum (50) (47) (46) (49) Ulcer 1 (2%) Liver (50) (50) (49) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 21 (42%) 11 (22%) 4 (8%) 2 (4%) 13 (26%) Clear Cell Focus 2 (4%) 4 (8%) Degeneration, Cystic 3 (6%) 1 (2%) 1 (2%) Degeneration, Fatty 1 (2%) 1 (2%) Eosinophilic Focus 8 (16%) 5 (10%) 5 (10%) 6 (12%) 2 (4%) Hepatodiaphragmatic Nodule 1 (2%) 3 (6%) 1 (2%) 2 (4%) 3 (6%) Mixed Cell Focus 2 (4%) 4 (8%) 2 (4%) 1 (2%) 1 (2%) Necrosis, Focal 1 (2%) 5 (10%) 4 (8%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) Centrilobular, Congestion 1 (2%) Centrilobular, Degeneration 1 (2%) 1 (2%) 1 (2%) Centrilobular, Necrosis 3 (6%) 1 (2%) 4 (8%) 3 (6%) 2 (4%) Hepatocyte, Centrilobular, Hypertrophy 1 (2%) 8 (16%) 14 (28%) Serosa, Fibrosis 1 (2%) Serosa, Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (7) (6) (4) (4) (5) Accessory Spleen 1 (14%) 1 (17%) 1 (20%) Necrosis, Acute, Focal 1 (17%) Fat, Necrosis 6 (86%) 3 (50%) 3 (75%) 4 (100%) 4 (80%) Pancreas (50) (48) (49) (50) Acinus, Atrophy 17 (34%) 10 (21%) 14 (29%) 1 (2%) Acinus, Hyperplasia 1 (2%) Artery, Inflammation, Granulomatous 1 (2%) 1 (2%) Salivary Glands (50) (49) (50) (50) Parotid Gland, Degeneration 1 (2%) Parotid Gland, Hyperplasia, Focal 1 (2%) Stomach, Forestomach (50) (48) (50) (50) (10) Hyperplasia 1 (2%) Inflammation, Acute 1 (2%) 2 (4%) Inflammation, Chronic 1 (2%) 1 (2%) 4 (8%) 3 (6%) Inflammation, Chronic Active 1 (2%) 2 (4%) 5 (10%) 5 (10%) 1 (10%) Mineralization 1 (2%) Ulcer 9 (18%) 12 (25%) 17 (34%) 11 (22%) 7 (70%) Epithelium, Hyperkeratosis 2 (20%) Epithelium, Hyperplasia 1 (2%) 3 (6%) 11 (22%) 11 (22%) Stomach, Glandular (50) (48) (50) (50) (4) Erosion 2 (4%) 1 (2%) 4 (8%) 3 (6%) Mineralization 3 (6%) 1 (2%) 4 (8%) 2 (50%) Ulcer 2 (4%) 6 (13%) 13 (26%) 5 (10%) 2 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (49) (50) (50) (50) Aorta, Mineralization 1 (2%) 3 (6%) Aorta, Thrombosis 1 (2%) Heart (50) (50) (50) (50) (7) Atrium, Thrombosis 7 (14%) 1 (2%) 5 (71%) Myocardium, Degeneration 46 (92%) 40 (80%) 43 (86%) 37 (74%) 1 (14%) Myocardium, Mineralization 1 (2%) 2 (4%) 1 (2%) 4 (57%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Degeneration, Cystic 1 (2%) Hyperplasia, Focal 5 (10%) 10 (20%) 8 (16%) 6 (12%) Hypertrophy, Focal 1 (2%) Necrosis, Focal 1 (2%) Adrenal Medulla (50) (50) (50) (50) (1) Hyperplasia 9 (18%) 9 (18%) 15 (30%) 16 (32%) Islets, Pancreatic (50) (48) (49) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 3 (6%) 2 (4%) 1 (2%) Parathyroid Gland (39) (41) (46) (40) (13) Hyperplasia 3 (8%) 6 (15%) 9 (20%) 16 (40%) 13 (100%) Pituitary Gland (49) (50) (50) (48) (5) Cyst 1 (2%) Degeneration, Cystic 1 (2%) Pars Distalis, Cyst 2 (4%) 1 (2%) Pars Distalis, Hyperplasia 9 (18%) 5 (10%) 3 (6%) 1 (2%) Pars Distalis, Thrombosis 1 (2%) Pars Nervosa, Gliosis, Focal 1 (2%) Thyroid Gland (50) (49) (50) (50) (50) Mineralization 1 (2%) C-Cell, Hyperplasia 33 (66%) 36 (73%) 38 (76%) 38 (76%) 41 (82%) Follicle, Cyst 4 (8%) 2 (4%) 4 (8%) 6 (12%) 9 (18%) Follicle, Hyperplasia 1 (2%) Follicle, Ultimobranchial Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) (1) (1) (2) (1) Inflammation, Chronic 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (49) (50) (50) (1) Cyst 1 (2%) Inflammation, Chronic 1 (2%) Preputial Gland (48) (50) (50) (49) (14) Cyst 1 (2%) Hyperplasia 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) 4 (8%) 3 (21%) Duct, Cyst 1 (2%) 4 (8%) 4 (8%) 3 (6%) 1 (7%) Prostate (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) Seminal Vesicle (50) (50) (50) (50) (1) Atrophy 1 (100%) Cyst 1 (2%) 1 (2%) Fibrosis 1 (2%) Hyperplasia 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Testes (50) (50) (50) (50) (48) Germinal Epithelium, Atrophy 2 (4%) 2 (4%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Necrosis 1 (2%) Thrombosis 1 (2%) Lymph Node (5) (8) (8) (1) (9) Renal, Ectasia 1 (13%) Renal, Pigmentation 1 (11%) Lymph Node, Mesenteric (49) (49) (50) (47) (4) Congestion 1 (2%) Inflammation, Chronic Active 1 (2%) Spleen (50) (50) (50) (50) (33) Fibrosis 7 (14%) 3 (6%) 3 (6%) 4 (8%) 8 (24%) Hematopoietic Cell Proliferation 6 (12%) 1 (2%) 3 (6%) 5 (10%) Necrosis 1 (2%) 1 (2%) Pigmentation, Hemosiderin 1 (2%) 3 (6%) 2 (4%) Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) Red Pulp, Congestion 1 (2%) 1 (2%) 2 (4%) Thymus (49) (47) (49) (47) Ectopic Parathyroid Gland 2 (4%) Ectopic Thyroid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (44) (48) (48) (2) Hyperplasia, Cystic 3 (6%) Inflammation, Suppurative 1 (2%) Skin (50) (49) (49) (50) (8) Ulcer 2 (4%) Epidermis, Cyst 1 (2%) Epidermis, Inflammation, Suppurative 1 (13%) Hair Follicle, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (4) Fibrosis 1 (25%) Fibrous Osteodystrophy 1 (2%) 6 (12%) 8 (16%) 3 (75%) Hyperostosis 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (2) Hydrocephalus 6 (12%) 2 (4%) 1 (2%) Necrosis, Focal 1 (2%) Hypothalamus, Degeneration 1 (2%) Medulla, Gliosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (3) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) Inflammation, Acute, Focal 1 (2%) Inflammation, Chronic, Focal 1 (2%) Inflammation, Granulomatous 1 (2%) 2 (4%) 3 (6%) Metaplasia, Squamous 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Interstitium, Inflammation, Acute 1 (2%) Interstitium, Inflammation, Chronic 2 (4%) 3 (6%) Interstitium, Inflammation, Chronic, Focal 1 (2%) Interstitium, Mineralization 1 (2%) 1 (2%) Mediastinum, Inflammation, Chronic 1 (2%) Vein, Thrombosis 1 (2%) Nose (50) (50) (50) (50) Inflammation, Suppurative 13 (26%) 14 (28%) 9 (18%) 7 (14%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (3) (2) (1) (2) Cataract 1 (33%) Inflammation, Suppurative 1 (100%) Anterior Chamber, Inflammation, Acute 1 (33%) 1 (50%) Anterior Chamber, Inflammation, Suppurative 1 (50%) Lens, Cataract 2 (100%) 1 (33%) 1 (50%) 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (42) Amyloid Deposition 1 (2%) Fibrosis, Focal 1 (2%) Infarct 1 (2%) Nephropathy 49 (98%) 44 (88%) 49 (98%) 50 (100%) 42 (100%) Renal Tubule, Cyst 1 (2%) 1 (2%) 6 (12%) 8 (16%) 3 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05212-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXAZEPAM Date: 07/19/96 Route: DOSED FEED Time: 15:50:37 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 PPM STOP ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Hyperplasia 1 (2%) 3 (6%) 1 (2%) Renal Tubule, Pigmentation, Lipofuscin 1 (2%) Urinary Bladder (50) (50) (50) (50) (1) Hemorrhage 1 (2%) Ulcer 1 (100%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------