TDMS Study 05212-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
OXAZEPAM
NTP Experiment-Test: 05212-03 Report: PEIRPT03
Study Type: CHRONIC Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
Facility: Battelle Columbus Laboratory
Chemical CAS #: 604-75-1
Lock Date: 02/20/92
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: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Natural Death 3 2 26 35
Moribund Sacrifice 8 7 22 15
Survivors
Terminal Sacrifice 39 41 2
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (60) (60) (60) (60)
Inflammation, Granulomatous 1 (2%)
Intestine Small, Jejunum (60) (60) (60) (60)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (60) (60) (60) (60)
Basophilic Focus 4 (7%)
Clear Cell Focus 2 (3%) 3 (5%)
Congestion 1 (2%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 10 (17%) 19 (32%) 10 (17%) 12 (20%)
Hematopoietic Cell Proliferation, Focal 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Infarct 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Mixed Cell Focus 1 (2%)
Necrosis, Multifocal 2 (3%) 1 (2%)
Thrombosis 2 (3%)
Vacuolization Cytoplasmic 1 (2%)
Bile Duct, Hyperplasia, Focal 1 (2%)
Centrilobular, Hypertrophy 2 (3%) 11 (18%) 29 (48%)
Hepatocyte, Centrilobular, Hypertrophy 10 (17%) 10 (17%)
Mesentery (3) (3)
Artery, Inflammation, Chronic 1 (33%)
Fat, Inflammation, Chronic 1 (33%)
Pancreas (60) (60) (60) (60)
Ectopic Liver 1 (2%)
Infarct, Focal 1 (2%)
Inflammation, Granulomatous 1 (2%)
Acinus, Atrophy 1 (2%) 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Dysplasia 1 (2%)
Hyperplasia, Diffuse, Squamous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hyperplasia, Focal, Squamous 1 (2%) 1 (2%)
Hyperplasia, Multifocal, Squamous 1 (2%)
Ulcer 2 (3%) 1 (2%)
Stomach, Glandular (60) (60) (60) (60)
Congestion, Multifocal 1 (2%)
Cyst Epithelial Inclusion 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (59)
Aorta, Mineralization 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Heart (60) (60) (60) (60)
Mineralization 1 (2%)
Atrium, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Cyst 1 (2%)
Hyperplasia 1 (2%) 1 (2%)
Hypertrophy 2 (3%) 1 (2%) 2 (3%)
Vacuolization Cytoplasmic 2 (3%)
Capsule, Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Pituitary Gland (60) (59) (53) (59)
Pars Distalis, Angiectasis 2 (3%) 2 (3%)
Pars Distalis, Cyst 2 (3%) 1 (2%)
Pars Distalis, Hyperplasia 6 (10%) 9 (15%) 6 (11%) 3 (5%)
Thyroid Gland (60) (60) (60) (60)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic Active, Focal 1 (2%)
Follicular Cell, Hyperplasia 16 (27%) 34 (57%) 59 (98%) 54 (90%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (58) (57) (57) (56)
Duct, Ectasia 1 (2%) 1 (2%)
Ovary (60) (60) (58) (60)
Atrophy 39 (65%) 39 (65%) 44 (76%) 38 (63%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 2 (3%)
Mineralization 1 (2%)
Bilateral, Follicle, Cyst 1 (2%)
Follicle, Cyst 15 (25%) 16 (27%) 4 (7%) 5 (8%)
Periovarian Tissue, Cyst 1 (2%) 1 (2%)
Uterus (60) (60) (60) (59)
Endometrium, Hyperplasia, Cystic 46 (77%) 50 (83%) 19 (32%) 14 (24%)
Endometrium, Hyperplasia, Cystic, Glandular 10 (17%) 10 (17%) 10 (17%) 8 (14%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Myelofibrosis 1 (2%)
Calvarium, Myelofibrosis 1 (2%)
Myeloid Cell, Erythroid Cell, Atrophy 1 (2%)
Lymph Node (3) (2) (1)
Bronchial, Hyperplasia, Lymphoid 1 (33%)
Lymph Node, Mandibular (58) (57) (58) (54)
Atrophy 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (58) (56) (48) (47)
Atrophy 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mediastinal (1) (2) (3)
Angiectasis 1 (33%)
Spleen (60) (60) (60) (59)
Developmental Malformation 1 (2%)
Hematopoietic Cell Proliferation 13 (22%) 4 (7%) 13 (22%) 4 (7%)
Hyperplasia, Focal, Reticulum Cell 1 (2%)
Hyperplasia, Lymphoid 2 (3%) 1 (2%)
Capsule, Mineralization 1 (2%)
Lymphoid Follicle, Atrophy 2 (3%)
Lymphoid Follicle, Degeneration 1 (2%)
Red Pulp, Atrophy 2 (3%) 1 (2%)
Thymus (60) (58) (44) (43)
Atrophy 41 (68%) 44 (76%) 30 (68%) 22 (51%)
Hyperplasia, Focal, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (59) (57) (53)
Hyperplasia, Cystic 1 (2%)
Skin (59) (60) (60) (60)
Ulcer, Multifocal 1 (2%)
Dermis, Sebaceous Gland, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Femur, Hyperostosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Compression 1 (2%)
Peripheral Nerve (2) (3) (2) (1)
Sciatic, Axon, Degeneration 2 (100%) 3 (100%) 1 (50%) 1 (100%)
Spinal Cord (2) (3) (2) (1)
Degeneration 1 (50%) 1 (33%) 1 (50%)
Nerve, Degeneration 1 (50%) 3 (100%) 1 (50%) 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Foreign Body 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%)
Arteriole, Infiltration Cellular, Lymphocyte 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1)
Phthisis Bulbi 1 (50%) 1 (100%)
Harderian Gland (3) (3) (1) (1)
Cyst 1 (33%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Inflammation, Subacute 1 (2%)
Nephropathy, Chronic 17 (28%) 15 (25%) 10 (17%) 5 (8%)
Artery, Pelvis, Inflammation, Chronic 1 (2%)
Renal Tubule, Necrosis, Acute, Diffuse 1 (2%)
Urinary Bladder (60) (60) (60) (60)
Inflammation, Chronic 1 (2%)
Ulcer 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 2 4 22 30
Natural Death 3 2 13 20
Survivors
Terminal Sacrifice 45 44 15
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (59) (60) (60) (60)
Peyer's Patch, Hyperplasia, Lymphoid 2 (3%) 1 (2%)
Liver (59) (60) (60) (60)
Angiectasis 2 (3%)
Basophilic Focus 2 (3%) 1 (2%) 1 (2%)
Clear Cell Focus 9 (15%) 5 (8%) 1 (2%) 1 (2%)
Clear Cell Focus, Multifocal 4 (7%) 1 (2%)
Eosinophilic Focus 18 (31%) 13 (22%) 17 (28%) 10 (17%)
Infarct 1 (2%)
Mixed Cell Focus 2 (3%) 1 (2%) 1 (2%)
Necrosis 2 (3%)
Necrosis, Multifocal 1 (2%)
Thrombosis 1 (2%) 5 (8%)
Vacuolization Cytoplasmic 9 (15%) 8 (13%) 1 (2%) 1 (2%)
Artery, Angiectasis 1 (2%)
Centrilobular, Hypertrophy 2 (3%) 26 (43%) 43 (72%)
Hepatocyte, Centrilobular, Hypertrophy 10 (17%) 10 (17%) 10 (17%)
Mesentery (2) (2) (2) (2)
Congestion 1 (50%)
Fat, Inflammation, Chronic 1 (50%) 1 (50%)
Pancreas (59) (60) (60) (60)
Acinus, Atrophy 1 (2%)
Stomach, Forestomach (60) (60) (60) (60)
Hyperplasia, Focal, Squamous 2 (3%) 4 (7%) 1 (2%)
Hyperplasia, Multifocal, Squamous 1 (2%)
Stomach, Glandular (60) (60) (60) (60)
Necrosis, Multifocal 2 (3%)
Tooth (1) (1)
Gingiva, Hyperplasia, Focal, Squamous 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60)
Angiectasis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (59) (60) (59) (60)
Hypertrophy 13 (22%) 7 (12%) 1 (2%) 2 (3%)
Vacuolization Cytoplasmic 1 (2%)
Capsule, Hyperplasia 3 (5%) 2 (3%) 1 (2%)
Islets, Pancreatic (59) (60) (60) (60)
Hyperplasia, Focal 1 (2%)
Pituitary Gland (58) (60) (52) (47)
Pars Distalis, Cyst 4 (7%) 3 (5%) 3 (6%)
Pars Distalis, Vacuolization Cytoplasmic 3 (6%)
Thyroid Gland (59) (60) (60) (60)
Inflammation, Chronic Active, Focal 1 (2%)
Follicle, Dilatation, Multiple 1 (2%)
Follicular Cell, Hyperplasia 4 (7%) 22 (37%) 54 (90%) 54 (90%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60)
Granuloma Sperm 1 (2%)
Infiltration Cellular, Lymphocyte 2 (3%) 14 (23%) 33 (55%) 21 (35%)
Inflammation, Chronic 1 (2%)
Spermatocele 2 (3%)
Preputial Gland (60) (60) (60) (59)
Ectasia 2 (3%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 7 (12%) 7 (12%) 8 (13%) 5 (8%)
Duct, Ectasia 40 (67%) 31 (52%) 10 (17%) 7 (12%)
Duct, Hemorrhage 1 (2%)
Testes (60) (60) (60) (60)
Atrophy 1 (2%) 25 (42%) 38 (63%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (2) (1) (1) (2)
Inguinal, Hyperplasia, Lymphoid 1 (50%) 1 (50%)
Lumbar, Hyperplasia, Lymphoid 1 (50%)
Lymph Node, Mandibular (54) (54) (52) (52)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (58) (57) (55) (50)
Angiectasis 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (59) (60) (60) (60)
Atrophy 1 (2%)
Hematopoietic Cell Proliferation 3 (5%) 2 (3%) 6 (10%) 7 (12%)
Hyperplasia, Lymphoid 1 (2%)
Thymus (52) (52) (46) (40)
Atrophy 39 (75%) 40 (77%) 35 (76%) 24 (60%)
Cyst 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (60) (60)
Edema, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Cartilage, Vertebra, Fracture 1 (2%)
Joint, Cartilage, Fracture 1 (2%)
Vertebra, Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Peripheral Nerve (1) (2)
Sciatic, Axon, Degeneration 1 (100%) 2 (100%)
Spinal Cord (1) (2)
Nerve, Degeneration 1 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05212-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 09:53:45
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 125 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Multifocal, Histiocyte 1 (2%)
Alveolar Epithelium, Hyperplasia 4 (7%) 2 (3%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (2)
Bilateral, Inflammation, Chronic 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Hydronephrosis 1 (2%)
Nephropathy, Chronic 53 (88%) 50 (83%) 8 (13%) 25 (42%)
Cortex, Cyst 2 (3%) 1 (2%)
Urinary Bladder (59) (60) (60) (59)
Calculus Gross Observation 1 (2%)
Dilatation 1 (2%)
Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
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