NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
TWO-YEAR CHRONIC
Facility: Southern Research Institute
Chemical CAS #: 30516-87-1
Lock Date: 06/04/93
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: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 5 5 9 7
Natural Death 11 6 7 11
Dosing Accident 2 1
Accidently Killed 1
Survivors
Terminal Sacrifice 34 38 31 31
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (49) (50) (50)
Necrosis 1 (2%)
Muscularis, Inflammation, Chronic 1 (2%) 1 (2%)
Intestine Large, Colon (46) (48) (46) (45)
Inflammation, Chronic 1 (2%)
Intestine Large, Cecum (46) (47) (46) (45)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%)
Intestine Small, Duodenum (46) (45) (46) (44)
Erosion 1 (2%)
Intestine Small, Jejunum (46) (46) (44) (42)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Ileum (46) (44) (45) (42)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%) 3 (6%)
Clear Cell Focus 1 (2%) 3 (6%) 1 (2%)
Eosinophilic Focus 6 (12%) 16 (32%) 7 (14%) 7 (14%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%)
Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%) 5 (10%)
Necrosis, Focal 3 (6%) 3 (6%) 2 (4%) 10 (20%)
Vacuolization Cytoplasmic 3 (6%) 4 (8%) 3 (6%) 3 (6%)
Hepatocyte, Karyomegaly 1 (2%) 1 (2%)
Mesentery (13) (17) (8) (11)
Inflammation, Chronic 1 (8%) 1 (9%)
Fat, Necrosis 8 (62%) 16 (94%) 5 (63%) 10 (91%)
Pancreas (50) (49) (49) (48)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Atrophy 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Atrophy, Diffuse 1 (2%)
Inflammation, Chronic 2 (4%)
Necrosis 1 (2%)
Duct, Cyst 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Stomach, Forestomach (49) (49) (49) (49)
Cyst 1 (2%)
Erosion 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%) 2 (4%)
Ulcer 1 (2%) 1 (2%)
Epithelium, Hyperplasia 4 (8%) 9 (18%) 7 (14%) 3 (6%)
Stomach, Glandular (49) (49) (48) (49)
Erosion 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Necrosis 1 (2%)
Glands, Degeneration, Cystic, Focal 1 (2%) 1 (2%) 4 (8%) 4 (8%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (50) (50) (50)
Inflammation, Chronic, Focal 1 (2%) 4 (8%) 3 (6%) 3 (6%)
Mineralization 1 (2%) 1 (2%)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%)
Cyst 1 (2%)
Cytoplasmic Alteration, Focal 4 (8%) 4 (8%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Hypertrophy, Focal 2 (4%) 1 (2%) 4 (8%)
Islets, Pancreatic (49) (49) (50) (47)
Hyperplasia 2 (4%)
Parathyroid Gland (47) (45) (48) (50)
Cyst 1 (2%) 1 (2%)
Pituitary Gland (46) (49) (46) (46)
Angiectasis 1 (2%) 2 (4%) 1 (2%)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Cytoplasmic Alteration, Focal 7 (15%) 1 (2%) 3 (7%)
Pars Distalis, Hyperplasia, Focal 4 (9%) 7 (14%) 6 (13%) 5 (11%)
Pars Intermedia, Hyperplasia, Focal 2 (4%)
Thyroid Gland (49) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Degeneration, Cystic, Focal 25 (51%) 19 (38%) 23 (46%) 20 (40%)
Follicle, Cyst 2 (4%) 6 (12%) 2 (4%) 7 (14%)
Follicular Cell, Hyperplasia 6 (12%) 11 (22%) 5 (10%) 11 (22%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (49) (49) (48)
Degeneration, Cystic 35 (71%) 46 (94%) 33 (67%) 43 (90%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ovary (50) (50) (47) (48)
Angiectasis 1 (2%)
Cyst 10 (20%) 10 (20%) 5 (11%) 10 (21%)
Hemorrhage 3 (6%) 1 (2%) 1 (2%)
Hyperplasia, Tubular 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Bilateral, Cyst 1 (2%)
Uterus (50) (50) (49) (50)
Cyst 3 (6%)
Hemorrhage 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Hydrometra 11 (22%) 20 (40%) 22 (45%) 13 (26%)
Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Thrombosis 1 (2%) 2 (4%)
Endometrium, Hyperplasia, Cystic 45 (90%) 45 (90%) 36 (73%) 42 (84%)
Vagina (50) (49) (45) (49)
Cyst 1 (2%)
Fibrosis 1 (2%)
Inflammation, Suppurative 1 (2%)
Epithelium, Hyperplasia 3 (6%) 2 (4%) 7 (14%)
Epithelium, Hyperplasia, Atypical 2 (4%) 4 (8%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Hyperplasia 1 (2%) 3 (6%) 3 (6%) 7 (14%)
Necrosis 1 (2%)
Lymph Node (7) (5) (7) (10)
Bronchial, Hyperplasia 1 (14%)
Iliac, Ectasia 1 (10%)
Iliac, Hematopoietic Cell Proliferation 1 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Iliac, Hemorrhage 1 (20%)
Iliac, Hyperplasia, Histiocytic 1 (14%)
Inguinal, Hyperplasia, Histiocytic 1 (10%)
Inguinal, Hyperplasia, Lymphoid 1 (20%) 1 (14%) 2 (20%)
Mediastinal, Hemorrhage 1 (14%) 1 (20%)
Mediastinal, Hyperplasia, Histiocytic 1 (10%)
Mediastinal, Hyperplasia, Lymphoid 1 (10%)
Renal, Hyperplasia, Lymphoid 1 (10%)
Lymph Node, Mandibular (50) (46) (48) (48)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 3 (6%) 6 (13%)
Infiltration Cellular, Mast Cell 1 (2%) 1 (2%)
Lymph Node, Mesenteric (50) (47) (48) (47)
Ectasia 1 (2%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 3 (6%) 5 (11%) 2 (4%) 5 (11%)
Hyperplasia, Lymphoid 5 (11%) 3 (6%) 5 (11%)
Spleen (49) (48) (49) (50)
Congestion 1 (2%) 2 (4%)
Depletion Cellular 1 (2%) 3 (6%) 1 (2%)
Hematopoietic Cell Proliferation 13 (27%) 12 (25%) 10 (20%) 14 (28%)
Hyperplasia, Lymphoid 8 (16%) 6 (13%) 2 (4%) 6 (12%)
Thymus (48) (46) (49) (46)
Angiectasis 1 (2%)
Cyst 3 (6%) 1 (2%)
Hyperplasia, Lymphoid 4 (8%) 1 (2%) 1 (2%) 4 (9%)
Necrosis 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (47) (47) (48) (47)
Hyperplasia 3 (6%) 1 (2%)
Skin (50) (49) (50) (50)
Inflammation, Chronic, Focal 1 (2%) 1 (2%)
Subcutaneous Tissue, Cyst Epithelial
Inclusion 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fibrous Osteodystrophy 4 (8%)
Hyperostosis 37 (74%) 35 (70%) 33 (66%) 37 (74%)
Cranium, Fibrous Osteodystrophy 1 (2%)
Skeletal Muscle (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Hyperplasia, Focal, Lymphoid 1 (2%)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Atrophy, Focal 1 (2%) 3 (6%)
Hemorrhage 1 (2%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (50) (50) (50)
Congestion 2 (4%) 1 (2%)
Foreign Body 1 (2%) 1 (2%)
Hemorrhage 3 (6%) 3 (6%) 1 (2%)
Hyperplasia, Histiocytic 2 (4%) 1 (2%) 2 (4%)
Infiltration Cellular, Mixed Cell 1 (2%)
Pigmentation 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 4 (8%) 1 (2%)
Mediastinum, Hemorrhage 1 (2%) 1 (2%)
Mediastinum, Inflammation, Chronic 2 (4%) 1 (2%)
Mediastinum, Necrosis 1 (2%)
Nose (50) (50) (50) (50)
Hemorrhage 1 (2%)
Mucosa, Glands, Dilatation, Focal 1 (2%) 2 (4%) 2 (4%)
Nasolacrimal Duct, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (1)
Cataract 1 (33%)
Fibrosis 2 (67%)
Cornea, Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 1 (2%)
Fibrosis, Focal 1 (2%)
Infarct 1 (2%) 2 (4%)
Metaplasia, Focal, Osseous 1 (2%) 2 (4%)
Nephropathy 29 (58%) 30 (60%) 31 (62%) 35 (70%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Pelvis, Dilatation 3 (6%) 3 (6%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 1 (2%)
Renal Tubule, Dilatation 1 (2%) 1 (2%) 3 (6%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 2 (4%) 1 (2%) 2 (4%)
Transitional Epithelium, Hyperplasia 1 (2%)
Urinary Bladder (50) (50) (49) (49)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 12 6 9 4
Moribund Sacrifice 6 9 9 4
Accidently Killed 2
Dosing Accident 1
Survivors
Terminal Sacrifice 32 35 29 42
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (49) (50)
Necrosis 1 (2%)
Muscularis, Inflammation, Chronic 1 (2%)
Gallbladder (41) (42) (46) (44)
Cyst 1 (2%)
Intestine Large, Cecum (47) (48) (45) (49)
Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Duodenum (48) (48) (47) (47)
Cyst 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Intestine Small, Jejunum (47) (48) (45) (47)
Hyperplasia, Adenomatous 1 (2%)
Intestine Small, Ileum (47) (48) (45) (47)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 3 (6%) 1 (2%)
Basophilic Focus 5 (10%) 1 (2%) 3 (6%) 3 (6%)
Clear Cell Focus 4 (8%) 3 (6%) 4 (8%)
Eosinophilic Focus 12 (24%) 12 (24%) 7 (14%) 12 (24%)
Inflammation, Chronic 17 (34%) 24 (48%) 24 (48%) 16 (32%)
Mixed Cell Focus 2 (4%) 4 (8%) 7 (14%) 4 (8%)
Necrosis, Focal 8 (16%) 8 (16%) 9 (18%) 3 (6%)
Vacuolization Cytoplasmic 3 (6%) 1 (2%) 4 (8%) 3 (6%)
Bile Duct, Cyst 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%) 9 (18%) 4 (8%) 3 (6%)
Hepatocyte, Karyomegaly 7 (14%) 10 (20%) 15 (30%) 5 (10%)
Mesentery (1) (4) (5) (2)
Hemorrhage 1 (20%)
Inflammation, Chronic 1 (20%)
Inflammation, Granulomatous 1 (100%)
Thrombosis 1 (25%)
Artery, Inflammation, Chronic 1 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 2 (50%) 2 (40%) 2 (100%)
Pancreas (50) (49) (49) (50)
Atrophy 1 (2%) 3 (6%) 3 (6%)
Inflammation, Granulomatous 1 (2%)
Necrosis 1 (2%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Duct, Cyst 1 (2%) 1 (2%)
Stomach, Forestomach (50) (48) (49) (50)
Erosion 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 2 (4%) 1 (2%)
Ulcer 2 (4%) 1 (2%)
Epithelium, Hyperplasia 7 (14%) 4 (8%) 3 (6%) 1 (2%)
Stomach, Glandular (50) (48) (49) (50)
Erosion 1 (2%) 4 (8%)
Mineralization 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Pigmentation, Focal 1 (2%)
Glands, Degeneration, Cystic, Focal 2 (4%) 1 (2%) 2 (4%)
Tooth (2) (2) (7) (1)
Developmental Malformation 2 (100%) 2 (100%) 7 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (48) (50) (50)
Inflammation, Chronic 1 (2%) 2 (4%)
Heart (50) (50) (50) (50)
Fibrosis 1 (2%)
Inflammation, Chronic, Focal 2 (4%) 4 (8%) 1 (2%)
Mineralization 1 (2%)
Thrombosis 1 (2%) 2 (4%) 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (49) (49)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Cyst 1 (2%) 1 (2%)
Cytoplasmic Alteration, Focal 5 (10%) 11 (22%) 8 (16%) 18 (37%)
Hyperplasia, Focal 3 (6%) 1 (2%) 3 (6%) 5 (10%)
Hypertrophy, Focal 10 (20%) 17 (35%) 8 (16%) 7 (14%)
Inflammation, Chronic, Focal 1 (2%)
Capsule, Hyperplasia, Focal 3 (6%) 2 (4%) 1 (2%)
Adrenal Medulla (50) (49) (48) (49)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (46) (45) (45) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Cyst 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (40) (46) (42) (47)
Pars Distalis, Cyst 1 (3%) 2 (4%) 1 (2%) 3 (6%)
Pars Distalis, Cytoplasmic Alteration, Focal 1 (2%)
Pars Distalis, Hyperplasia, Focal 1 (2%)
Thyroid Gland (50) (49) (48) (50)
Degeneration, Cystic, Focal 15 (30%) 18 (37%) 11 (23%) 16 (32%)
Follicle, Cyst 8 (16%) 4 (8%) 2 (4%) 5 (10%)
Follicular Cell, Hyperplasia 8 (16%) 10 (20%) 11 (23%) 9 (18%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (49) (50) (50)
Granuloma Sperm 1 (2%)
Spermatocele 1 (2%) 1 (2%)
Preputial Gland (48) (50) (50) (49)
Degeneration, Cystic 39 (81%) 46 (92%) 44 (88%) 45 (92%)
Inflammation, Chronic 4 (8%) 5 (10%) 2 (4%)
Prostate (50) (49) (50) (50)
Inflammation, Chronic 3 (6%)
Inflammation, Chronic, Focal 3 (6%) 2 (4%)
Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%)
Seminal Vesicle (50) (49) (50) (50)
Angiectasis 1 (2%) 1 (2%) 4 (8%)
Congestion 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Testes (50) (49) (50) (50)
Germinal Epithelium, Degeneration 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (50)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Hyperplasia 2 (4%) 6 (12%) 6 (12%) 1 (2%)
Lymph Node (6) (7) (5) (1)
Inguinal, Hyperplasia, Lymphoid 1 (20%)
Inguinal, Pigmentation 1 (17%) 2 (29%) 1 (20%)
Mediastinal, Hyperplasia, Lymphoid 1 (17%) 1 (20%)
Mediastinal, Inflammation, Granulomatous 1 (17%)
Pancreatic, Hyperplasia, Lymphoid 1 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mandibular (49) (48) (49) (50)
Hemorrhage 1 (2%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Mast Cell 1 (2%)
Lymph Node, Mesenteric (48) (49) (49) (49)
Ectasia 5 (10%) 4 (8%) 1 (2%) 3 (6%)
Fibrosis 1 (2%)
Hemorrhage 20 (42%) 31 (63%) 21 (43%) 25 (51%)
Hyperplasia, Lymphoid 3 (6%) 3 (6%) 3 (6%) 4 (8%)
Inflammation, Granulomatous 1 (2%)
Spleen (50) (49) (48) (50)
Angiectasis 1 (2%)
Depletion Cellular 1 (2%) 1 (2%) 6 (12%)
Hematopoietic Cell Proliferation 18 (36%) 16 (33%) 14 (29%) 11 (22%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Necrosis, Focal 1 (2%)
Thymus (41) (44) (41) (35)
Cyst 6 (15%) 11 (25%) 5 (12%) 4 (11%)
Mineralization 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (15) (10) (15) (5)
Inflammation, Chronic 1 (10%)
Skin (50) (50) (50) (50)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 30 (60%) 36 (72%) 28 (56%) 41 (82%)
Skeletal Muscle (50) (50) (50) (50)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (49) (50)
Hemorrhage 1 (2%)
Spinal Cord (1) (1)
Degeneration 1 (100%)
Hemorrhage, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 89006-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT Date: 05/31/96
Route: GAVAGE Time: 12:30:48
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Hemorrhage 2 (4%) 1 (2%) 2 (4%) 3 (6%)
Hyperplasia, Histiocytic 2 (4%) 2 (4%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Mixed Cell 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 6 (12%) 3 (6%) 1 (2%) 8 (16%)
Nose (50) (50) (49) (50)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Inflammation, Chronic 1 (100%)
Harderian Gland (3) (7) (2) (10)
Hyperplasia, Focal 1 (14%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (48) (49) (50)
Cyst 2 (4%) 1 (2%)
Infarct 1 (2%) 2 (4%) 1 (2%) 2 (4%)
Metaplasia, Focal, Osseous 1 (2%) 3 (6%) 1 (2%)
Nephropathy 45 (90%) 44 (92%) 44 (90%) 49 (98%)
Thrombosis 1 (2%)
Papilla, Necrosis 1 (2%)
Pelvis, Dilatation 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%)
Renal Tubule, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Hyperplasia, Focal 1 (2%)
Renal Tubule, Pigmentation 2 (4%) 1 (2%) 1 (2%)
Urethra (1) (1) (1)
Inflammation, Chronic 1 (100%) 1 (100%) 1 (100%)
Urinary Bladder (50) (50) (50) (50)
Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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