TDMS Study 05212-04 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
OXAZEPAM
NTP Experiment-Test: 05212-04 Report: PEIRPT03
Study Type: CHRONIC Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
Facility: Battelle Columbus Laboratory
Chemical CAS #: 604-75-1
Lock Date: 02/06/92
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: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE FEMALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Early Deaths
Moribund Sacrifice 9 13 11
Natural Death 4 18 31
Survivors
Terminal Sacrifice 47 27 17
Natural Death 1
Missing 1 1
Animals Examined Microscopically 60 59 59
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (59) (58) (55)
Amyloid Deposition 6 (10%) 24 (41%) 30 (55%)
Hemorrhage 1 (2%)
Intestine Large, Rectum (59) (56) (56)
Amyloid Deposition 1 (2%) 4 (7%) 12 (21%)
Intestine Large, Cecum (58) (56) (51)
Amyloid Deposition 6 (10%) 23 (41%) 34 (67%)
Hemorrhage 1 (2%)
Ulcer 2 (4%)
Intestine Small, Duodenum (59) (56) (56)
Amyloid Deposition 45 (76%) 40 (71%) 47 (84%)
Ulcer 1 (2%) 2 (4%)
Intestine Small, Jejunum (59) (59) (56)
Amyloid Deposition 28 (47%) 42 (71%) 49 (88%)
Ulcer 3 (5%) 2 (3%)
Intestine Small, Ileum (58) (56) (54)
Amyloid Deposition 52 (90%) 43 (77%) 46 (85%)
Liver (60) (59) (59)
Amyloid Deposition 28 (47%) 31 (53%) 35 (59%)
Eosinophilic Focus 20 (34%) 14 (24%)
Hematopoietic Cell Proliferation 5 (8%) 4 (7%) 2 (3%)
Hepatodiaphragmatic Nodule 1 (2%)
Infarct 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Subacute 4 (7%) 4 (7%)
Necrosis 10 (17%) 8 (14%) 7 (12%)
Centrilobular, Hypertrophy 3 (5%) 51 (86%) 53 (90%)
Mesentery (3) (1) (3)
Inflammation, Granulomatous 1 (33%) 1 (100%) 1 (33%)
Inflammation, Subacute 1 (33%)
Inflammation, Suppurative 1 (33%) 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE FEMALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 1 (33%)
Pancreas (60) (59) (59)
Amyloid Deposition 1 (2%) 3 (5%) 1 (2%)
Ectopic Tissue 1 (2%)
Salivary Glands (60) (59) (59)
Amyloid Deposition 35 (58%) 36 (61%) 40 (68%)
Stomach, Forestomach (59) (59) (57)
Amyloid Deposition 1 (2%) 3 (5%)
Hemorrhage 1 (2%)
Hyperkeratosis 1 (2%) 5 (9%)
Stomach, Glandular (59) (59) (57)
Amyloid Deposition 2 (3%) 17 (29%) 19 (33%)
Mineralization 2 (3%) 3 (5%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (59) (58)
Mineralization 1 (2%)
Heart (60) (59) (59)
Amyloid Deposition 50 (83%) 44 (75%) 53 (90%)
Degeneration 1 (2%)
Atrium, Thrombosis 2 (3%) 23 (39%) 31 (53%)
Coronary Artery, Inflammation, Chronic 1 (2%)
Valve, Inflammation, Chronic 1 (2%)
Valve, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (59) (59)
Amyloid Deposition 24 (40%) 32 (54%) 41 (69%)
Hematopoietic Cell Proliferation 2 (3%) 2 (3%) 3 (5%)
Infiltration Cellular, Mononuclear Cell 1 (2%)
Capsule, Hyperplasia 1 (2%)
Adrenal Medulla (59) (58) (57)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (55) (50) (45)
Amyloid Deposition 24 (44%) 32 (64%) 33 (73%)
Thyroid Gland (60) (59) (59)
Amyloid Deposition 22 (37%) 38 (64%) 46 (78%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE FEMALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (60) (58) (57)
Inflammation, Suppurative 1 (2%) 2 (4%)
Ovary (59) (58) (55)
Amyloid Deposition 24 (41%) 13 (22%) 15 (27%)
Angiectasis 1 (2%) 1 (2%)
Cyst 7 (12%) 5 (9%) 1 (2%)
Arteriole, Inflammation, Chronic 3 (5%) 4 (7%) 4 (7%)
Uterus (60) (59) (57)
Amyloid Deposition 26 (43%) 28 (47%) 40 (70%)
Dilatation 1 (2%)
Infiltration Cellular, Polymorphonuclear 1 (2%)
Inflammation, Suppurative 1 (2%)
Thrombosis 1 (2%)
Endometrium, Hyperplasia, Cystic 13 (22%) 2 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (8) (10) (7)
Axillary, Hematopoietic Cell Proliferation 1 (10%)
Inguinal, Hyperplasia, Lymphoid 1 (13%) 1 (14%)
Mediastinal, Hematopoietic Cell Proliferation 1 (10%)
Renal, Hematopoietic Cell Proliferation 1 (10%)
Lymph Node, Mandibular (58) (57) (58)
Amyloid Deposition 3 (5%) 23 (40%) 35 (60%)
Hematopoietic Cell Proliferation 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (60) (57) (56)
Amyloid Deposition 16 (27%) 30 (53%) 35 (63%)
Cyst 1 (2%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Lymphoid 5 (8%) 6 (11%)
Inflammation, Suppurative 1 (2%)
Spleen (60) (59) (59)
Amyloid Deposition 12 (20%) 20 (34%) 39 (66%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 5 (8%) 4 (7%) 2 (3%)
Hyperplasia, Lymphoid 14 (23%) 5 (8%) 1 (2%)
Thymus (56) (57) (55)
Amyloid Deposition 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE FEMALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (59) (59)
Hyperkeratosis 1 (2%) 1 (2%) 1 (2%)
Ulcer 2 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (60) (59) (59)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Peripheral Nerve (4) (5) (5)
Axon, Degeneration 2 (50%) 1 (20%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (59) (59)
Fibrosis 1 (2%) 14 (24%) 8 (14%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Inflammation, Chronic 3 (5%) 2 (3%) 6 (10%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Subacute 4 (7%) 4 (7%) 3 (5%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 6 (10%) 3 (5%) 2 (3%)
Alveolus, Infiltration Cellular, Mononuclear
Cell 2 (3%) 16 (27%) 26 (44%)
Nose (60) (59) (59)
Amyloid Deposition 1 (2%)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE FEMALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (59) (59)
Cyst 1 (2%)
Infarct 1 (2%)
Necrosis 1 (2%)
Glomerulus, Amyloid Deposition 48 (80%) 39 (66%) 39 (66%)
Interstitium, Amyloid Deposition 5 (8%) 5 (8%) 7 (12%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE MALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Early Deaths
Moribund Sacrifice 10 13 24
Natural Death 5 28 26
Survivors
Terminal Sacrifice 45 19 10
Animals Examined Microscopically 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (59) (60) (59)
Amyloid Deposition 3 (5%) 29 (48%) 29 (49%)
Lumen, Hemorrhage 1 (2%)
Intestine Large, Rectum (59) (58) (59)
Amyloid Deposition 5 (9%) 9 (15%)
Intestine Large, Cecum (59) (59) (55)
Amyloid Deposition 6 (10%) 24 (41%) 29 (53%)
Ulcer 1 (2%) 1 (2%)
Lumen, Hemorrhage 1 (2%)
Intestine Small, Duodenum (60) (57) (58)
Amyloid Deposition 39 (65%) 49 (86%) 50 (86%)
Ulcer 1 (2%)
Intestine Small, Jejunum (59) (59) (56)
Amyloid Deposition 31 (53%) 49 (83%) 48 (86%)
Ulcer 1 (2%) 1 (2%)
Intestine Small, Ileum (59) (58) (54)
Amyloid Deposition 46 (78%) 48 (83%) 43 (80%)
Inflammation, Granulomatous 1 (2%)
Liver (60) (60) (60)
Amyloid Deposition 22 (37%) 31 (52%) 28 (47%)
Basophilic Focus 1 (2%) 1 (2%)
Eosinophilic Focus 22 (37%) 22 (37%)
Fatty Change 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 2 (3%)
Infarct 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 2 (3%) 1 (2%)
Inflammation, Subacute 1 (2%) 1 (2%)
Necrosis 10 (17%) 13 (22%) 8 (13%)
Centrilobular, Hypertrophy 12 (20%) 46 (77%) 47 (78%)
Oval Cell, Hyperplasia 1 (2%)
Pancreas (60) (60) (60)
Amyloid Deposition 1 (2%)
Duct, Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE MALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Salivary Glands (60) (60) (60)
Amyloid Deposition 32 (53%) 44 (73%) 44 (73%)
Stomach, Forestomach (60) (60) (60)
Acanthosis 1 (2%)
Amyloid Deposition 4 (7%)
Hyperkeratosis 3 (5%) 1 (2%)
Stomach, Glandular (60) (59) (60)
Amyloid Deposition 8 (13%) 29 (49%) 22 (37%)
Mineralization 3 (5%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60)
Amyloid Deposition 43 (72%) 52 (87%) 52 (87%)
Degeneration 2 (3%)
Inflammation, Subacute 1 (2%)
Atrium, Thrombosis 1 (2%) 34 (57%) 35 (58%)
Valve, Thrombosis 1 (2%) 2 (3%)
Ventricle, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60)
Amyloid Deposition 17 (28%) 37 (62%) 41 (68%)
Hyperplasia 4 (7%)
Capsule, Hyperplasia 3 (5%)
Adrenal Medulla (60) (58) (56)
Hyperplasia 2 (3%)
Islets, Pancreatic (60) (60) (60)
Hyperplasia 4 (7%)
Parathyroid Gland (54) (52) (52)
Amyloid Deposition 10 (19%) 39 (75%) 42 (81%)
Thyroid Gland (60) (60) (60)
Amyloid Deposition 19 (32%) 48 (80%) 48 (80%)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE MALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (60) (59) (58)
Cyst 1 (2%)
Inflammation, Suppurative 5 (8%) 3 (5%) 1 (2%)
Seminal Vesicle (60) (59) (60)
Fibrosis 1 (2%)
Testes (60) (60) (60)
Edema 1 (2%)
Germinal Epithelium, Atrophy 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (7) (7) (4)
Inguinal, Hyperplasia, Lymphoid 1 (14%)
Mediastinal, Hyperplasia, Lymphoid 1 (14%)
Pancreatic, Inflammation, Granulomatous 1 (14%)
Renal, Hyperplasia, Lymphoid 2 (29%)
Lymph Node, Mandibular (57) (56) (55)
Amyloid Deposition 8 (14%) 29 (52%) 29 (53%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Lymph Node, Mesenteric (59) (55) (57)
Amyloid Deposition 25 (42%) 36 (65%) 35 (61%)
Cyst 2 (3%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%) 2 (4%)
Infiltration Cellular, Plasma Cell 1 (2%)
Necrosis 1 (2%)
Spleen (60) (60) (60)
Amyloid Deposition 16 (27%) 32 (53%) 30 (50%)
Hematopoietic Cell Proliferation 3 (5%) 2 (3%)
Hyperplasia, Lymphoid 7 (12%) 4 (7%) 3 (5%)
Necrosis 1 (2%)
Capsule, Fibrosis 1 (2%)
Thymus (59) (57) (51)
Amyloid Deposition 1 (2%)
Vein, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (60) (59)
Edema 1 (2%)
Hyperkeratosis 2 (3%)
Ulcer 3 (5%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE MALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Peripheral Nerve (7) (7) (9)
Axon, Degeneration 2 (29%) 1 (14%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60)
Fibrosis 27 (45%) 25 (42%)
Inflammation, Chronic 6 (10%) 3 (5%) 2 (3%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Subacute 1 (2%) 2 (3%) 11 (18%)
Thrombosis 1 (2%) 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 4 (7%) 3 (5%)
Alveolus, Infiltration Cellular, Mononuclear
Cell 1 (2%) 31 (52%) 37 (62%)
Alveolus, Metaplasia, Osseous 1 (2%)
Alveolus, Metaplasia, Squamous 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (4) (1) (6)
External Ear, Ulcer 1 (25%)
Eye (2) (1) (1)
Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60)
Cyst 1 (2%)
Hydronephrosis 1 (2%)
Infarct 2 (3%) 1 (2%) 1 (2%)
Inflammation, Granulomatous 2 (3%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Artery, Thrombosis 1 (2%)
Glomerulus, Amyloid Deposition 42 (70%) 35 (58%) 42 (70%)
Interstitium, Amyloid Deposition 3 (5%) 14 (23%) 10 (17%)
Renal Tubule, Necrosis 1 (2%)
Urethra (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05212-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXAZEPAM Date: 09/18/94
Route: DOSED FEED Time: 11:54:31
____________________________________________________________________________________________________________________________________
SWISS WEBSTER MICE MALE 0 PPM 2500 PPM 5000 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (60) (59) (59)
Calculus Gross Observation 1 (2%)
Calculus Micro Observation Only 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Suppurative 2 (3%)
Transitional Epithelium, Hyperplasia 1 (2%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
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