TDMS Study 89006-02 Pathology Tables
NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 CORE STUDY Facility: Southern Research Institute Chemical CAS #: 30516-871 Lock Date: 11/01/93 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: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 7 6 5 9 Moribund Sacrifice 7 8 11 12 Dosing Accident 3 2 2 4 Accidently Killed 2 Survivors Terminal Sacrifice 33 32 32 24 Missing 1 Animals Examined Microscopically 50 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (48) Inflammation, Chronic 1 (2%) Perforation 2 (4%) 2 (4%) 1 (2%) 2 (4%) Intestine Large, Colon (50) (48) (50) (49) Parasite Metazoan 1 (2%) Intestine Large, Rectum (50) (50) (50) (49) Parasite Metazoan 1 (2%) Intestine Large, Cecum (50) (49) (50) (48) Edema 1 (2%) 2 (4%) 1 (2%) Parasite Metazoan 1 (2%) 2 (4%) Intestine Small, Duodenum (48) (49) (48) (48) Erosion 1 (2%) Ulcer 1 (2%) Intestine Small, Jejunum (50) (49) (49) (49) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Intestine Small, Ileum (49) (49) (46) (47) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Liver (50) (50) (50) (49) Angiectasis 1 (2%) Basophilic Focus 1 (2%) 3 (6%) Clear Cell Focus 2 (4%) Eosinophilic Focus 5 (10%) 1 (2%) 5 (10%) 3 (6%) Hematopoietic Cell Proliferation 3 (6%) 3 (6%) 4 (8%) 4 (8%) Inflammation, Chronic 6 (12%) 6 (12%) 5 (10%) 7 (14%) Mixed Cell Focus 2 (4%) 1 (2%) 1 (2%) Necrosis, Focal 4 (8%) 6 (12%) 8 (16%) Pigmentation, Focal 1 (2%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) 2 (4%) Bile Duct, Hyperplasia 1 (2%) Centrilobular, Necrosis 1 (2%) Centrilobular, Necrosis, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Karyomegaly 1 (2%) 1 (2%) Hepatocyte, Mixed Cell Focus 1 (2%) Mesentery (10) (11) (9) (6) Fat, Necrosis 8 (80%) 9 (82%) 7 (78%) 3 (50%) Pancreas (50) (50) (50) (49) Cyst 3 (6%) 1 (2%) Acinus, Atrophy, Diffuse 3 (6%) Salivary Glands (50) (49) (49) (48) Inflammation, Chronic 2 (4%) 5 (10%) 2 (4%) 3 (6%) Stomach, Forestomach (50) (50) (50) (49) Edema 1 (2%) Epithelium, Hyperplasia 2 (4%) 2 (4%) 2 (4%) 1 (2%) Stomach, Glandular (50) (50) (50) (49) Edema 2 (4%) 1 (2%) Erosion 3 (6%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (49) Hypertrophy 1 (2%) Inflammation, Chronic 1 (2%) Heart (50) (50) (50) (49) Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%) 1 (2%) Mineralization 3 (6%) Thrombosis 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (49) Accessory Adrenal Cortical Nodule 7 (14%) 5 (10%) 6 (12%) 5 (10%) Hyperplasia, Focal 1 (2%) 2 (4%) 1 (2%) 3 (6%) Hypertrophy, Focal 2 (4%) Capsule, Hyperplasia, Focal 2 (4%) 1 (2%) 2 (4%) Adrenal Medulla (49) (49) (49) (48) Hyperplasia 2 (4%) 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) (49) Hyperplasia 1 (2%) 2 (4%) 3 (6%) 2 (4%) Parathyroid Gland (45) (43) (46) (44) Cyst 3 (7%) 1 (2%) Pituitary Gland (50) (47) (48) (47) Pars Distalis, Angiectasis 3 (6%) 1 (2%) Pars Distalis, Hyperplasia, Focal 3 (6%) 9 (19%) 5 (10%) 4 (9%) Thyroid Gland (50) (50) (50) (49) Degeneration, Cystic, Focal 12 (24%) 15 (30%) 13 (26%) 9 (18%) Follicle, Cyst 8 (16%) 4 (8%) 7 (14%) 9 (18%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicular Cell, Hyperplasia 27 (54%) 16 (32%) 22 (44%) 13 (27%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (49) (49) (49) (49) Angiectasis 5 (10%) 10 (20%) 7 (14%) 6 (12%) Cyst 9 (18%) 6 (12%) 13 (27%) 7 (14%) Hyperplasia, Tubular 1 (2%) Uterus (50) (50) (50) (49) Angiectasis 1 (2%) 1 (2%) 2 (4%) Hydrometra 14 (28%) 17 (34%) 19 (38%) 25 (51%) Inflammation, Suppurative 2 (4%) 2 (4%) 2 (4%) 3 (6%) Endometrium, Hyperplasia, Cystic 35 (70%) 41 (82%) 36 (72%) 31 (63%) Vagina (49) (44) (48) (48) Epithelium, Hyperplasia 4 (9%) 6 (13%) 11 (23%) Epithelium, Hyperplasia, Atypical 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (49) Hyperplasia 10 (20%) 14 (28%) 16 (32%) 14 (29%) Myelofibrosis 2 (4%) 1 (2%) 2 (4%) 3 (6%) Lymph Node (4) (8) (10) (10) Iliac, Hemorrhage 1 (10%) Iliac, Hyperplasia, Lymphoid 2 (20%) Inguinal, Hyperplasia, Lymphoid 1 (10%) 1 (10%) Mediastinal, Hematopoietic Cell Proliferation 1 (10%) Mediastinal, Hyperplasia, Lymphoid 1 (25%) 1 (10%) 1 (10%) Renal, Hemorrhage 1 (10%) Renal, Hyperplasia, Lymphoid 1 (10%) Lymph Node, Mandibular (49) (45) (46) (48) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hemorrhage 2 (4%) Hyperplasia, Lymphoid 2 (4%) 5 (11%) 4 (9%) 2 (4%) Pigmentation 7 (14%) 8 (18%) 12 (26%) 14 (29%) Lymph Node, Mesenteric (50) (47) (49) (49) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 3 (6%) Hemorrhage 5 (10%) 5 (11%) 2 (4%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) 6 (13%) 8 (16%) 2 (4%) Spleen (50) (50) (50) (49) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hematopoietic Cell Proliferation 25 (50%) 28 (56%) 26 (52%) 30 (61%) Hyperplasia, Lymphoid 6 (12%) 17 (34%) 10 (20%) 3 (6%) Pigmentation 1 (2%) 2 (4%) 3 (6%) 2 (4%) Thymus (47) (46) (46) (45) Atrophy 1 (2%) 3 (7%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (49) (50) (49) Hyperplasia 5 (10%) 7 (14%) 2 (4%) Skin (49) (50) (50) (49) Ulcer 1 (2%) Epidermis, Hyperplasia, Focal 1 (2%) 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 3 (6%) 1 (2%) Subcutaneous Tissue, Hemorrhage, Focal 1 (2%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (50) (50) (49) Hyperostosis 40 (82%) 39 (78%) 41 (82%) 34 (69%) Femur, Osteopetrosis 1 (2%) 3 (6%) Skeletal Muscle (50) (50) (50) (49) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (49) Atrophy, Focal 4 (8%) 1 (2%) 3 (6%) 1 (2%) Developmental Malformation 1 (2%) Hydrocephalus 1 (2%) 1 (2%) Necrosis 1 (2%) 1 (2%) 1 (2%) Peripheral Nerve (2) (1) (6) (3) Atrophy 1 (100%) 1 (17%) 1 (33%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (49) Hemorrhage 5 (10%) 2 (4%) 2 (4%) 1 (2%) Infiltration Cellular, Histiocyte 2 (4%) 2 (4%) 1 (2%) Inflammation, Chronic 3 (6%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 3 (6%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 2 (4%) 1 (2%) 1 (2%) Nose (50) (50) (50) (49) Inflammation, Suppurative 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Congestion 1 (2%) Metaplasia, Focal, Osseous 2 (4%) 2 (4%) 1 (2%) Nephropathy 36 (72%) 34 (68%) 30 (60%) 30 (61%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Dilatation 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Hyaline Droplet 1 (2%) Renal Tubule, Necrosis 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Pigmentation 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 13 14 5 9 Natural Death 1 7 4 6 Dosing Accident 2 2 Accidently Killed 1 Survivors Terminal Sacrifice 36 27 38 35 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Inflammation, Chronic 1 (2%) Perforation 2 (4%) 1 (2%) Gallbladder (50) (47) (50) (46) Inflammation, Chronic 1 (2%) Intestine Large, Colon (50) (50) (50) (50) Edema 2 (4%) Parasite Metazoan 1 (2%) Intestine Large, Cecum (50) (50) (50) (49) Edema 1 (2%) 2 (4%) 1 (2%) Parasite Metazoan 3 (6%) 7 (14%) 3 (6%) 5 (10%) Intestine Small, Ileum (50) (48) (49) (50) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) 2 (4%) 1 (2%) Basophilic Focus 4 (8%) 1 (2%) 2 (4%) 1 (2%) Clear Cell Focus 1 (2%) 1 (2%) 1 (2%) 1 (2%) Eosinophilic Focus 2 (4%) 1 (2%) 6 (12%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Inflammation, Chronic 39 (78%) 38 (76%) 38 (76%) 44 (88%) Metaplasia, Osseous 2 (4%) 1 (2%) 1 (2%) Mixed Cell Focus 1 (2%) 2 (4%) 1 (2%) Necrosis, Focal 1 (2%) 7 (14%) 4 (8%) Pigmentation, Focal 2 (4%) 1 (2%) 1 (2%) Vacuolization Cytoplasmic 3 (6%) 2 (4%) 1 (2%) Bile Duct, Hyperplasia 26 (52%) 26 (52%) 26 (52%) 23 (46%) Hepatocyte, Karyomegaly 33 (66%) 31 (62%) 35 (70%) 40 (80%) Mesentery (1) (2) (1) Fat, Necrosis 1 (100%) 1 (100%) Pancreas (50) (50) (50) (50) Cyst 1 (2%) 2 (4%) Acinus, Atrophy, Diffuse 2 (4%) 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Salivary Glands (50) (50) (50) (50) Inflammation, Chronic 1 (2%) 3 (6%) 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Ulcer 1 (2%) 1 (2%) Epithelium, Hyperplasia 2 (4%) 2 (4%) 3 (6%) Stomach, Glandular (50) (50) (50) (50) Edema 2 (4%) Erosion 1 (2%) Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Hypertrophy 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) Heart (50) (50) (50) (50) Fibrosis 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic 5 (10%) 1 (2%) Mineralization 2 (4%) 1 (2%) Thrombosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 7 (14%) 6 (12%) 1 (2%) 1 (2%) Cytoplasmic Alteration, Focal 9 (18%) 7 (14%) 10 (20%) 12 (24%) Hyperplasia, Focal 7 (14%) 3 (6%) 8 (16%) 16 (32%) Hypertrophy, Diffuse 1 (2%) Hypertrophy, Focal 11 (22%) 5 (10%) 14 (28%) 13 (26%) Capsule, Hyperplasia, Focal 4 (8%) 2 (4%) 3 (6%) 4 (8%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia 2 (4%) 1 (2%) 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 4 (8%) 4 (8%) 5 (10%) 7 (14%) Parathyroid Gland (48) (47) (48) (47) Cyst 1 (2%) 1 (2%) 1 (2%) Pituitary Gland (48) (43) (48) (47) Pars Distalis, Cyst 1 (2%) 1 (2%) Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia, Focal 1 (2%) Thyroid Gland (50) (50) (50) (49) Degeneration, Cystic, Focal 12 (24%) 14 (28%) 11 (22%) 14 (29%) Follicle, Cyst 3 (6%) 4 (8%) 7 (14%) 5 (10%) Follicular Cell, Hyperplasia 12 (24%) 15 (30%) 19 (38%) 10 (20%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Granuloma Sperm 2 (4%) Preputial Gland (48) (48) (50) (50) Cyst 10 (21%) 7 (15%) 4 (8%) 4 (8%) Inflammation, Chronic 7 (15%) 13 (27%) 6 (12%) 4 (8%) Testes (50) (50) (50) (50) Atrophy 1 (2%) 1 (2%) 3 (6%) 2 (4%) Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 14 (28%) 23 (46%) 16 (32%) 21 (42%) Lymph Node (5) (8) (5) (5) Bronchial, Hyperplasia, Lymphoid 1 (20%) 1 (20%) Mediastinal, Hemorrhage 1 (13%) Mediastinal, Hyperplasia, Lymphoid 1 (20%) 1 (20%) Pancreatic, Hyperplasia, Lymphoid 1 (20%) Renal, Hemorrhage 1 (13%) Lymph Node, Mandibular (46) (47) (49) (46) Hyperplasia, Lymphoid 2 (4%) 4 (9%) 2 (4%) 2 (4%) Pigmentation 4 (9%) 10 (21%) 13 (27%) 8 (17%) Lymph Node, Mesenteric (50) (48) (50) (47) Hematopoietic Cell Proliferation 7 (14%) 6 (13%) 1 (2%) 7 (15%) Hemorrhage 19 (38%) 15 (31%) 17 (34%) 18 (38%) Hyperplasia, Lymphoid 6 (12%) 5 (10%) 12 (24%) 8 (17%) Spleen (50) (49) (49) (50) Atrophy 1 (2%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 20 (40%) 29 (59%) 17 (35%) 23 (46%) Hyperplasia, Lymphoid 6 (12%) 4 (8%) 4 (8%) 1 (2%) Necrosis, Focal 1 (2%) Pigmentation 1 (2%) 1 (2%) Thymus (45) (40) (42) (43) Atrophy 1 (2%) 3 (8%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Mineralization 1 (2%) Ulcer 2 (4%) 2 (4%) Subcutaneous Tissue, Edema 4 (8%) 4 (8%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Hyperostosis 42 (84%) 31 (62%) 39 (78%) 39 (78%) Femur, Osteopetrosis 1 (2%) Skeletal Muscle (50) (50) (50) (50) Atrophy 2 (4%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Atrophy, Focal 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (50) (50) Hemorrhage 1 (2%) 1 (2%) 5 (10%) 1 (2%) Infiltration Cellular, Histiocyte 6 (12%) 6 (12%) 8 (16%) 4 (8%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Thrombosis 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) Nose (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) 1 (2%) 2 (4%) 5 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (1) Atrophy 1 (100%) 1 (100%) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 89006-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/21/96 Route: GAVAGE Time: 08:14:07 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 500 U 500 U 500 U ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Infarct 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Metaplasia, Focal, Osseous 2 (4%) 1 (2%) Nephropathy 47 (94%) 46 (92%) 44 (88%) 49 (98%) Pelvis, Dilatation 1 (2%) 1 (2%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) Renal Tubule, Hyaline Droplet 1 (2%) Renal Tubule, Necrosis 1 (2%) Renal Tubule, Pigmentation 1 (2%) 1 (2%) 1 (2%) 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------