TDMS Study 89006-06 Pathology Tables
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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------