TDMS Study 89006-04 Pathology Tables
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 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: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 8 7 6 8 Natural Death 5 5 6 9 Dosing Accident 2 Accidently Killed 1 Survivors Terminal Sacrifice 37 37 36 32 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (49) (49) Necrosis 2 (4%) Perforation 2 (4%) Muscularis, Inflammation, Chronic 2 (4%) Periesophageal Tissue, Inflammation, Chronic 1 (2%) Intestine Small, Duodenum (48) (48) (47) (47) Hyperplasia, Adenomatous 1 (2%) Intestine Small, Jejunum (47) (46) (46) (45) Hyperplasia, Adenomatous 1 (2%) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 2 (4%) Intestine Small, Ileum (47) (46) (46) (45) Amyloid Deposition 1 (2%) Hyperplasia, Adenomatous 1 (2%) Liver (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 1 (2%) 1 (2%) Clear Cell Focus 2 (4%) 1 (2%) Congestion 1 (2%) Eosinophilic Focus 4 (8%) 6 (12%) 5 (10%) 2 (4%) Hematopoietic Cell Proliferation 2 (4%) 2 (4%) Hemorrhage 1 (2%) Hyperplasia, Focal, Lymphoid 1 (2%) 1 (2%) Inflammation, Chronic 10 (20%) 6 (12%) 6 (12%) 6 (12%) Mixed Cell Focus 2 (4%) 3 (6%) 2 (4%) 2 (4%) Necrosis, Focal 2 (4%) 2 (4%) 2 (4%) 3 (6%) Vacuolization Cytoplasmic 2 (4%) 6 (12%) 2 (4%) 3 (6%) Bile Duct, Hyperplasia 1 (2%) Centrilobular, Necrosis 1 (2%) Hepatocyte, Karyomegaly 1 (2%) 1 (2%) 1 (2%) Mesentery (10) (12) (9) (10) Hemorrhage 1 (10%) 2 (17%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 1 (10%) 1 (8%) Fat, Necrosis 7 (70%) 9 (75%) 5 (56%) 5 (50%) Pancreas (48) (50) (50) (49) Inflammation, Chronic 1 (2%) Necrosis 1 (2%) Acinus, Atrophy, Diffuse 1 (2%) 1 (2%) Acinus, Atrophy, Focal 2 (4%) 1 (2%) Duct, Cyst 1 (2%) 1 (2%) 3 (6%) Salivary Glands (50) (49) (50) (48) Inflammation, Chronic 1 (2%) Stomach, Forestomach (50) (50) (49) (48) Cyst 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Epithelium, Hyperplasia 3 (6%) 2 (4%) 1 (2%) 1 (2%) Stomach, Glandular (49) (50) (48) (49) Edema 1 (2%) 1 (2%) Mineralization 1 (2%) Glands, Degeneration, Cystic, Focal 5 (10%) 1 (2%) 8 (17%) 8 (16%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Inflammation, Chronic, Focal 2 (4%) 1 (2%) Thrombosis 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (49) Accessory Adrenal Cortical Nodule 1 (2%) 3 (6%) Cyst 1 (2%) 1 (2%) Hyperplasia, Focal 3 (6%) 4 (8%) 1 (2%) 4 (8%) Hypertrophy, Focal 2 (4%) 2 (4%) Islets, Pancreatic (48) (49) (50) (48) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Parathyroid Gland (43) (43) (45) (46) Cyst 1 (2%) Pituitary Gland (49) (44) (48) (44) Angiectasis 4 (8%) 1 (2%) 4 (8%) 3 (7%) Pars Distalis, Cyst 1 (2%) 1 (2%) 3 (7%) Pars Distalis, Cytoplasmic Alteration, Focal 2 (5%) 1 (2%) Pars Distalis, Hyperplasia, Focal 8 (16%) 7 (16%) 8 (17%) 8 (18%) Rathke's Cleft, Cyst 1 (2%) 3 (7%) Thyroid Gland (49) (50) (50) (50) Degeneration, Cystic, Focal 19 (39%) 16 (32%) 14 (28%) 12 (24%) Inflammation, Chronic, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicle, Cyst 7 (14%) 6 (12%) 9 (18%) 7 (14%) Follicular Cell, Hyperplasia 21 (43%) 19 (38%) 17 (34%) 17 (34%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (49) Degeneration, Cystic 3 (6%) 1 (2%) 3 (6%) 3 (6%) Inflammation, Chronic 1 (2%) Ovary (50) (49) (49) (50) Cyst 10 (20%) 6 (12%) 5 (10%) 13 (26%) Hemorrhage 2 (4%) 1 (2%) 4 (8%) Mineralization 1 (2%) 1 (2%) Thrombosis 1 (2%) 1 (2%) Bilateral, Cyst 1 (2%) Uterus (50) (50) (50) (50) Angiectasis 2 (4%) Cyst 1 (2%) 2 (4%) Hemorrhage 1 (2%) 1 (2%) Hydrometra 19 (38%) 21 (42%) 13 (26%) 15 (30%) Thrombosis 1 (2%) 1 (2%) Endometrium, Hyperplasia, Cystic 42 (84%) 37 (74%) 41 (82%) 45 (90%) Vagina (50) (48) (48) (50) Epithelium, Hyperplasia 1 (2%) 3 (6%) 7 (15%) 12 (24%) Epithelium, Hyperplasia, Atypical 1 (2%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (48) Angiectasis 1 (2%) Depletion Cellular 2 (4%) Hyperplasia 1 (2%) 4 (8%) 4 (8%) 4 (8%) Lymph Node (8) (7) (4) (6) Iliac, Hemorrhage 1 (13%) Renal, Hemorrhage 1 (17%) Lymph Node, Mandibular (46) (46) (48) (44) Hemorrhage 1 (2%) 2 (4%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) 3 (6%) 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Lymph Node, Mesenteric (48) (49) (48) (49) Ectasia 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hemorrhage 4 (8%) 2 (4%) 7 (15%) 6 (12%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) Spleen (49) (49) (49) (49) Depletion Cellular 1 (2%) 1 (2%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 23 (47%) 15 (31%) 12 (24%) 17 (35%) Hyperplasia, Lymphoid 5 (10%) 4 (8%) 8 (16%) 3 (6%) Thymus (47) (46) (48) (48) Atrophy 3 (7%) 1 (2%) 2 (4%) Cyst 3 (6%) 4 (9%) 4 (8%) 2 (4%) Hyperplasia, Lymphoid 2 (4%) Inflammation, Granulomatous 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (49) (50) Ectasia 1 (2%) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Skin (50) (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) Edema 3 (6%) 3 (6%) 1 (2%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) 2 (4%) Ulcer 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 2 (4%) Hyperostosis 48 (96%) 40 (80%) 36 (72%) 43 (86%) Cranium, Fibrous Osteodystrophy 1 (2%) Femur, Fibrous Osteodystrophy 1 (2%) 2 (4%) 2 (4%) Femur, Osteopetrosis 1 (2%) Skeletal Muscle (47) (50) (49) (50) Hemorrhage, Focal 1 (2%) Inflammation, Suppurative 1 (2%) Regeneration 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Atrophy, Focal 2 (4%) 4 (8%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) Meninges, Inflammation, Chronic 1 (2%) 1 (2%) Spinal Cord (2) (1) (4) Cyst Epithelial Inclusion 1 (50%) 1 (25%) Hemorrhage, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 2 (4%) Hemorrhage 3 (6%) 2 (4%) 3 (6%) Hyperplasia, Histiocytic 2 (4%) 3 (6%) 1 (2%) 1 (2%) Metaplasia, Osseous 1 (2%) Pigmentation 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%) 2 (4%) Mediastinum, Inflammation, Chronic 1 (2%) Nose (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) 1 (2%) Mucosa, Glands, Dilatation, Focal 3 (6%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) Fibrosis 1 (50%) Cornea, Inflammation, Chronic 1 (100%) Harderian Gland (5) (2) (2) (1) Hyperplasia, Focal 1 (20%) Inflammation, Chronic, Focal 1 (20%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Congestion 1 (2%) Infarct 1 (2%) 1 (2%) 1 (2%) Metaplasia, Focal, Osseous 3 (6%) 2 (4%) Nephropathy 35 (70%) 33 (66%) 39 (78%) 33 (67%) Pelvis, Dilatation 1 (2%) 1 (2%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 1 (2%) Renal Tubule, Atrophy 1 (2%) Renal Tubule, Dilatation 1 (2%) 1 (2%) 2 (4%) Renal Tubule, Mineralization 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Necrosis 1 (2%) Renal Tubule, Pigmentation 1 (2%) Urinary Bladder (50) (50) (50) (50) 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: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 10 3 5 10 Moribund Sacrifice 9 11 9 6 Dosing Accident 1 1 Survivors Terminal Sacrifice 31 35 35 34 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Necrosis 1 (2%) Perforation 1 (2%) Muscularis, Inflammation, Chronic 1 (2%) 1 (2%) Gallbladder (44) (46) (45) (42) Inflammation, Chronic 1 (2%) Intestine Small, Duodenum (46) (48) (48) (46) Hyperplasia, Adenomatous 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 1 (2%) 1 (2%) Clear Cell Focus 1 (2%) 6 (12%) 2 (4%) 2 (4%) Congestion 1 (2%) Degeneration, Cystic 1 (2%) Eosinophilic Focus 6 (12%) 7 (14%) 3 (6%) 3 (6%) Hemorrhage 2 (4%) 1 (2%) Inflammation, Chronic 45 (90%) 43 (86%) 38 (76%) 41 (82%) Inflammation, Focal 1 (2%) Mixed Cell Focus 3 (6%) 3 (6%) 6 (12%) 4 (8%) Necrosis, Focal 2 (4%) 2 (4%) 3 (6%) 8 (16%) Pigmentation, Focal 1 (2%) Vacuolization Cytoplasmic 6 (12%) 7 (14%) 2 (4%) 6 (12%) Bile Duct, Cyst 1 (2%) 1 (2%) 2 (4%) Bile Duct, Hyperplasia 29 (58%) 31 (62%) 33 (66%) 29 (58%) Centrilobular, Necrosis 1 (2%) Hepatocyte, Karyomegaly 37 (74%) 32 (64%) 31 (62%) 32 (64%) Mesentery (3) (5) (1) (1) Inflammation, Chronic 1 (20%) Thrombosis 1 (20%) Artery, Inflammation, Chronic 1 (33%) 1 (20%) Fat, Necrosis 1 (33%) 1 (100%) Pancreas (48) (50) (50) (50) Inflammation, Chronic 1 (2%) Acinus, Atrophy, Diffuse 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy, Focal 2 (4%) Duct, Cyst 1 (2%) 1 (2%) Stomach, Forestomach (49) (50) (50) (47) Cyst 1 (2%) 1 (2%) Diverticulum 1 (2%) Edema 1 (2%) Inflammation, Chronic 1 (2%) Ulcer 3 (6%) Epithelium, Hyperplasia 3 (6%) 2 (4%) 5 (10%) 3 (6%) Stomach, Glandular (49) (50) (50) (47) Edema 1 (2%) Erosion 1 (2%) Hyperplasia, Adenomatous 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) 1 (2%) 3 (6%) 2 (4%) Necrosis 1 (2%) Glands, Degeneration, Cystic, Focal 4 (8%) 4 (8%) 1 (2%) Tooth (2) (2) (2) (1) Developmental Malformation 2 (100%) 2 (100%) 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (49) (50) (49) Inflammation, Chronic 1 (2%) Heart (50) (50) (50) (50) Inflammation, Chronic, Focal 1 (2%) Mineralization 2 (4%) Thrombosis 1 (2%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (50) Cytoplasmic Alteration, Focal 3 (6%) 10 (20%) 6 (12%) 18 (36%) Hyperplasia, Focal 2 (4%) 7 (14%) 3 (6%) Hypertrophy, Focal 7 (14%) 11 (22%) 9 (18%) 11 (22%) Capsule, Hyperplasia, Focal 2 (4%) 2 (4%) 3 (6%) 2 (4%) Adrenal Medulla (48) (50) (50) (50) Hyperplasia 1 (2%) Islets, Pancreatic (48) (50) (50) (50) Hyperplasia 2 (4%) 1 (2%) 1 (2%) Parathyroid Gland (50) (45) (48) (46) Cyst 3 (6%) 1 (2%) 1 (2%) Pituitary Gland (47) (43) (48) (43) Pars Distalis, Cyst 1 (2%) 3 (6%) 2 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (50) (50) (50) (49) Degeneration, Cystic, Focal 7 (14%) 11 (22%) 14 (28%) 10 (20%) Inflammation, Chronic, Focal 1 (2%) C-Cell, Hyperplasia 1 (2%) Follicle, Cyst 5 (10%) 5 (10%) 6 (12%) 6 (12%) Follicular Cell, Hyperplasia 13 (26%) 14 (28%) 7 (14%) 10 (20%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Granuloma Sperm 2 (4%) Inflammation, Suppurative 1 (2%) Spermatocele 1 (2%) Preputial Gland (50) (49) (47) (50) Degeneration, Cystic 44 (88%) 41 (84%) 42 (89%) 48 (96%) Inflammation, Chronic 2 (4%) 2 (4%) Prostate (49) (49) (50) (49) Inflammation, Chronic 1 (2%) Seminal Vesicle (50) (50) (50) (49) Angiectasis 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Testes (50) (50) (50) (50) Germinal Epithelium, Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 1 (2%) 7 (14%) 1 (2%) 1 (2%) Lymph Node (2) (4) (5) (2) Mediastinal, Hyperplasia, Lymphoid 1 (20%) Mediastinal, Necrosis 1 (20%) Pancreatic, Hyperplasia, Lymphoid 1 (25%) Lymph Node, Mandibular (45) (46) (44) (47) Hyperplasia, Lymphoid 1 (2%) 2 (4%) Lymph Node, Mesenteric (46) (50) (50) (50) Ectasia 3 (6%) 1 (2%) 2 (4%) Hemorrhage 17 (37%) 21 (42%) 12 (24%) 13 (26%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 3 (7%) 1 (2%) 1 (2%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Inflammation, Chronic 2 (4%) Spleen (48) (50) (50) (49) Angiectasis 1 (2%) Congestion 3 (6%) 1 (2%) 2 (4%) Depletion Cellular 2 (4%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 18 (38%) 16 (32%) 12 (24%) 14 (29%) Hyperplasia, Lymphoid 3 (6%) 3 (6%) Necrosis, Focal 1 (2%) Capsule, Fibrosis 1 (2%) Thymus (42) (45) (46) (42) Atrophy 3 (7%) 2 (4%) 3 (7%) Cyst 2 (5%) 6 (13%) 8 (17%) 7 (17%) Necrosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (49) (50) (50) Cyst Epithelial Inclusion 2 (4%) Edema 1 (2%) 1 (2%) 7 (14%) 3 (6%) Infiltration Cellular, Mast Cell 1 (2%) Inflammation, Chronic, Focal 1 (2%) 3 (6%) 1 (2%) 2 (4%) Ulcer 2 (4%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Foreign Body 1 (2%) Subcutaneous Tissue, Hemorrhage 1 (2%) Subcutaneous Tissue, Inflammation, Focal, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Hyperostosis 40 (80%) 26 (52%) 36 (72%) 31 (62%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (49) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96 Route: GAVAGE Time: 09:06:20 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG CONTROL 5000 U 5000 U 5000 U ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 2 (4%) 1 (2%) Foreign Body 2 (4%) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Histiocytic 4 (8%) 1 (2%) 1 (2%) 2 (4%) Pigmentation 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 1 (2%) 3 (6%) Mediastinum, Inflammation, Chronic 1 (2%) Nose (50) (50) (50) (50) Hemorrhage 1 (2%) Inflammation, Suppurative 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (1) (1) External Ear, Inflammation, Chronic 1 (100%) Eye (1) (6) (2) Cataract 2 (33%) 1 (50%) Fibrosis 1 (17%) Cornea, Inflammation, Chronic 1 (100%) 5 (83%) 2 (100%) Harderian Gland (4) (9) (4) (4) Hyperplasia, Focal 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Cyst 3 (6%) 3 (6%) 2 (4%) Infarct 1 (2%) 5 (10%) 4 (8%) Metaplasia, Focal, Osseous 1 (2%) Nephropathy 49 (100%) 50 (100%) 47 (94%) 44 (88%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) Renal Tubule, Dilatation 1 (2%) Renal Tubule, Hyperplasia, Focal 2 (4%) Renal Tubule, Necrosis 1 (2%) Renal Tubule, Pigmentation 1 (2%) Urethra (3) (2) (2) (6) Inflammation, Chronic 1 (17%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------