TDMS Study 89006-08 Pathology Tables
NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 Facility: Southern Research Institute Chemical CAS #: 76543-88-9 Lock Date: 09/03/93 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: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 13 13 9 11 Natural Death 12 5 15 8 Dosing Accident 1 Survivors Terminal Sacrifice 25 32 25 31 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (47) (50) (50) (49) Artery, Inflammation, Chronic 1 (2%) Intestine Small, Jejunum (47) (50) (49) (48) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Liver (49) (50) (50) (50) Angiectasis 1 (2%) 2 (4%) 3 (6%) Basophilic Focus 3 (6%) 1 (2%) Clear Cell Focus 1 (2%) 1 (2%) 1 (2%) Congestion 1 (2%) Eosinophilic Focus 1 (2%) 8 (16%) 8 (16%) 8 (16%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 3 (6%) 1 (2%) Hyperplasia, Focal, Lymphoid 1 (2%) Inflammation, Chronic 4 (8%) 6 (12%) 10 (20%) 9 (18%) Mixed Cell Focus 4 (8%) 4 (8%) 1 (2%) Necrosis, Focal 3 (6%) 5 (10%) 5 (10%) 3 (6%) Pigmentation, Focal 2 (4%) 2 (4%) 1 (2%) 1 (2%) Vacuolization Cytoplasmic 5 (10%) 2 (4%) 3 (6%) 3 (6%) Artery, Inflammation, Chronic 1 (2%) Bile Duct, Cyst 1 (2%) 1 (2%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) Hepatocyte, Karyomegaly 2 (4%) 1 (2%) 1 (2%) Mesentery (21) (21) (18) (16) Accessory Spleen 1 (5%) Angiectasis 1 (5%) Fibrosis, Focal 1 (6%) Infiltration Cellular, Mixed Cell 1 (6%) Inflammation, Chronic 1 (5%) 3 (17%) Artery, Inflammation, Chronic 1 (5%) 2 (13%) Fat, Necrosis 13 (62%) 12 (57%) 12 (67%) 10 (63%) Pancreas (48) (50) (50) (50) Inflammation, Chronic 1 (2%) Necrosis, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy, Diffuse 2 (4%) Acinus, Atrophy, Focal 1 (2%) 1 (2%) Duct, Cyst 3 (6%) Salivary Glands (50) (50) (48) (49) Inflammation, Chronic 1 (2%) Stomach, Forestomach (48) (50) (50) (46) Diverticulum 2 (4%) Edema 1 (2%) Erosion 5 (10%) 3 (6%) 1 (2%) Inflammation, Chronic 3 (6%) 3 (6%) 3 (7%) Epithelium, Cyst 1 (2%) Epithelium, Hyperplasia 7 (15%) 4 (8%) 4 (9%) Stomach, Glandular (48) (50) (50) (46) Erosion 1 (2%) 1 (2%) 1 (2%) 1 (2%) Mineralization 1 (2%) Pigmentation, Focal 1 (2%) 2 (4%) 2 (4%) Artery, Inflammation, Chronic 1 (2%) Glands, Degeneration, Cystic, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (49) Inflammation, Chronic 1 (2%) Pulmonary Vein, Intima, Mineralization, Focal 1 (2%) Heart (50) (50) (50) (50) Inflammation, Chronic, Focal 1 (2%) 1 (2%) Thrombosis 1 (2%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (49) Accessory Adrenal Cortical Nodule 3 (6%) 1 (2%) Cyst 1 (2%) Cytoplasmic Alteration, Focal 1 (2%) Hyperplasia 1 (2%) Hypertrophy, Focal 1 (2%) Capsule, Hyperplasia, Focal 1 (2%) 2 (4%) 1 (2%) 2 (4%) Adrenal Medulla (50) (49) (50) (49) Hyperplasia 2 (4%) Islets, Pancreatic (48) (50) (50) (50) Hyperplasia 1 (2%) Parathyroid Gland (44) (46) (46) (47) Cyst 1 (2%) 1 (2%) Pituitary Gland (46) (47) (44) (43) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Angiectasis 1 (2%) 3 (6%) 1 (2%) 3 (7%) Pars Distalis, Cytoplasmic Alteration, Focal 1 (2%) 3 (6%) 4 (9%) 2 (5%) Pars Distalis, Hyperplasia, Focal 1 (2%) 2 (4%) 1 (2%) 1 (2%) Thyroid Gland (50) (50) (49) (50) Angiectasis 1 (2%) Degeneration, Cystic, Focal 8 (16%) 9 (18%) 10 (20%) 8 (16%) Inflammation, Chronic, Focal 2 (4%) 1 (2%) 1 (2%) C-Cell, Hyperplasia 1 (2%) 1 (2%) Follicle, Cyst 2 (4%) 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 17 (34%) 21 (42%) 18 (37%) 14 (28%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) (1) Infiltration Cellular, Histiocyte 1 (50%) Infiltration Cellular, Mixed Cell 1 (100%) Tissue NOS (1) (1) (2) Hemorrhage 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (49) (47) (49) Degeneration, Cystic 3 (6%) 3 (6%) 2 (4%) 6 (12%) Ovary (46) (48) (49) (48) Angiectasis 2 (4%) 3 (6%) Atrophy 1 (2%) Cyst 10 (22%) 11 (23%) 7 (14%) 8 (17%) Inflammation, Suppurative 1 (2%) Thrombosis 1 (2%) Bilateral, Cyst 1 (2%) 2 (4%) 1 (2%) Oviduct (1) Inflammation, Suppurative 1 (100%) Uterus (50) (50) (50) (50) Angiectasis 1 (2%) Hydrometra 10 (20%) 11 (22%) 11 (22%) 20 (40%) Inflammation, Suppurative 1 (2%) 2 (4%) 1 (2%) 1 (2%) Thrombosis 1 (2%) Endometrium, Hyperplasia, Cystic 48 (96%) 49 (98%) 46 (92%) 48 (96%) Vagina (48) (50) (47) (46) Inflammation, Chronic 1 (2%) Inflammation, Focal, Granulomatous 1 (2%) Epithelium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Depletion Cellular 1 (2%) Hyperplasia 2 (4%) 2 (4%) Lymph Node (12) (13) (9) (11) Iliac, Hemorrhage 1 (8%) Iliac, Hyperplasia 1 (9%) Iliac, Hyperplasia, Lymphoid 1 (8%) Inguinal, Hyperplasia 2 (17%) Inguinal, Hyperplasia, Lymphoid 1 (11%) 1 (9%) Mediastinal, Hyperplasia 1 (8%) 2 (22%) 1 (9%) Mediastinal, Hyperplasia, Lymphoid 1 (8%) 2 (15%) 1 (11%) Mediastinal, Inflammation, Focal, Suppurative 1 (11%) 1 (9%) Pancreatic, Hyperplasia, Lymphoid 1 (8%) Renal, Hemorrhage 1 (8%) Renal, Hyperplasia, Lymphoid 1 (8%) 1 (9%) Lymph Node, Mandibular (49) (49) (47) (48) Hemorrhage 1 (2%) Hyperplasia 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) 1 (2%) 2 (4%) Lymph Node, Mesenteric (45) (50) (50) (47) Angiectasis 1 (2%) 1 (2%) Ectasia 2 (4%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 2 (4%) 2 (4%) 1 (2%) Hyperplasia 2 (4%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 3 (7%) 4 (8%) 3 (6%) 2 (4%) Inflammation, Focal, Suppurative 1 (2%) Pigmentation 1 (2%) Spleen (47) (50) (50) (49) Hematopoietic Cell Proliferation 21 (45%) 24 (48%) 26 (52%) 20 (41%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 3 (6%) 4 (8%) 2 (4%) 5 (10%) Necrosis, Focal 1 (2%) Thymus (41) (48) (48) (39) Cyst 1 (2%) 2 (4%) 2 (4%) Hyperplasia, Histiocytic 1 (3%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (48) (50) (50) Ectasia 1 (2%) 1 (2%) 2 (4%) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Skin (50) (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) Inflammation, Chronic, Focal 1 (2%) Ulcer 1 (2%) Artery, Subcutaneous Tissue, Inflammation, Chronic 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 2 (4%) Subcutaneous Tissue, Hemorrhage, Focal 1 (2%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 1 (2%) Osteoporosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) (50) Atrophy, Focal 2 (4%) 2 (4%) 1 (2%) 1 (2%) Hemorrhage, Focal 1 (2%) Spinal Cord (2) (2) (4) (1) Hemorrhage, Focal 1 (25%) Meninges, Inflammation, Focal 1 (25%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 2 (4%) 2 (4%) 2 (4%) 1 (2%) Hyperplasia, Histiocytic 4 (8%) 2 (4%) 1 (2%) 3 (6%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Pigmentation, Focal 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%) 2 (4%) 1 (2%) Bronchus, Glands, Cyst 1 (2%) Mediastinum, Infiltration Cellular, Mixed Cell 1 (2%) Mediastinum, Inflammation, Chronic 1 (2%) 1 (2%) Mediastinum, Necrosis, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) Mucosa, Glands, Dilatation, Focal 41 (82%) 42 (84%) 41 (82%) 40 (80%) Nasolacrimal Duct, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) (1) Atrophy 1 (33%) Inflammation, Chronic 1 (33%) Anterior Chamber, Infiltration Cellular, Polymorphonuclear 1 (33%) Cornea, Inflammation, Chronic 2 (67%) 1 (100%) Cornea, Necrosis, Focal 1 (33%) Harderian Gland (3) (8) (4) (3) Hyperplasia, Focal 1 (13%) 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (50) (49) (50) Cyst 1 (2%) 1 (2%) Metaplasia, Focal, Osseous 3 (6%) 1 (2%) 2 (4%) Nephropathy 29 (60%) 38 (76%) 31 (63%) 31 (62%) Artery, Inflammation, Chronic 1 (2%) Pelvis, Dilatation 2 (4%) 1 (2%) Renal Tubule, Accumulation, Hyaline Droplet 3 (6%) 1 (2%) 2 (4%) Renal Tubule, Dilatation 2 (4%) 3 (6%) Renal Tubule, Hyperplasia, Focal 1 (2%) Renal Tubule, Necrosis 1 (2%) 1 (2%) Renal Tubule, Pigmentation 2 (4%) 2 (4%) Urethra (1) (1) Inflammation, Chronic 1 (100%) Artery, Inflammation, Chronic 1 (100%) Urinary Bladder (50) (50) (50) (50) Artery, Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 10 15 11 13 Moribund Sacrifice 13 7 10 10 Dosing Accident 1 Survivors Terminal Sacrifice 27 28 28 27 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (45) (45) (48) (43) Inflammation, Chronic 1 (2%) Intestine Large, Cecum (49) (49) (49) (50) Congestion 1 (2%) 1 (2%) Liver (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) 1 (2%) Basophilic Focus 1 (2%) 2 (4%) 1 (2%) Clear Cell Focus 1 (2%) 1 (2%) 6 (12%) 2 (4%) Congestion 1 (2%) Eosinophilic Focus 9 (18%) 3 (6%) 4 (8%) 5 (10%) Hematopoietic Cell Proliferation 1 (2%) Infarct 1 (2%) Inflammation, Chronic 15 (30%) 17 (34%) 18 (36%) 20 (40%) Mixed Cell Focus 1 (2%) 4 (8%) 2 (4%) Necrosis, Focal 4 (8%) 1 (2%) 5 (10%) 7 (14%) Pigmentation, Focal 2 (4%) 1 (2%) 3 (6%) Vacuolization Cytoplasmic 1 (2%) 2 (4%) 1 (2%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 8 (16%) 9 (18%) 8 (16%) 7 (14%) Centrilobular, Necrosis 1 (2%) Hepatocyte, Karyomegaly 12 (24%) 14 (28%) 8 (16%) 12 (24%) Mesentery (7) (5) (6) (9) Angiectasis 1 (14%) 1 (20%) Inflammation, Chronic 1 (14%) 1 (20%) 2 (33%) 3 (33%) Artery, Inflammation, Chronic 2 (29%) 1 (17%) 4 (44%) Fat, Necrosis 1 (14%) Pancreas (49) (49) (49) (49) Inflammation, Chronic 1 (2%) 1 (2%) Acinus, Atrophy, Diffuse 2 (4%) Duct, Cyst 1 (2%) Stomach, Forestomach (50) (48) (49) (50) Diverticulum 1 (2%) 1 (2%) 1 (2%) Erosion 2 (4%) 2 (4%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 3 (6%) 2 (4%) 4 (8%) 1 (2%) Epithelium, Cyst 1 (2%) Epithelium, Hyperplasia 5 (10%) 3 (6%) 5 (10%) 2 (4%) Muscularis, Serosa, Inflammation, Suppurative 1 (2%) Stomach, Glandular (50) (48) (49) (50) Erosion 2 (4%) 1 (2%) Inflammation, Chronic 2 (4%) Metaplasia, Hepatocyte 1 (2%) 1 (2%) Mineralization 1 (2%) Pigmentation, Focal 1 (2%) 2 (4%) 3 (6%) Epithelium, Hyperplasia 2 (4%) Glands, Degeneration, Cystic, Focal 2 (4%) 2 (4%) 1 (2%) Muscularis, Serosa, Inflammation, Suppurative 1 (2%) Tooth (24) (14) (24) (20) Developmental Malformation 24 (100%) 14 (100%) 24 (100%) 20 (100%) Inflammation, Chronic, Suppurative 1 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (48) (50) Mineralization 1 (2%) Heart (50) (50) (50) (50) Mineralization 1 (2%) Thrombosis 1 (2%) 1 (2%) 1 (2%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (50) (49) Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) 1 (2%) Angiectasis 1 (2%) Cyst 1 (2%) 1 (2%) Cytoplasmic Alteration, Focal 3 (6%) 2 (4%) 5 (10%) 1 (2%) Hyperplasia, Focal 1 (2%) 1 (2%) Inflammation, Chronic, Focal 1 (2%) Capsule, Hyperplasia, Focal 3 (6%) 10 (20%) 3 (6%) 6 (12%) Adrenal Medulla (49) (49) (50) (49) Hyperplasia 6 (12%) 1 (2%) 1 (2%) 3 (6%) Islets, Pancreatic (50) (48) (50) (50) Hyperplasia 1 (2%) Parathyroid Gland (49) (41) (45) (43) Cyst 1 (2%) 2 (4%) 1 (2%) Pituitary Gland (45) (47) (47) (41) Pars Distalis, Cyst 2 (4%) 1 (2%) 2 (4%) 1 (2%) Pars Distalis, Cytoplasmic Alteration, Focal 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Hyperplasia, Focal 1 (2%) Thyroid Gland (50) (49) (50) (50) Degeneration, Cystic, Focal 3 (6%) 3 (6%) 7 (14%) 4 (8%) Inflammation, Chronic, Focal 1 (2%) C-Cell, Hyperplasia 1 (2%) Follicle, Cyst 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 7 (14%) 6 (12%) 11 (22%) 8 (16%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (2) Inflammation, Chronic 1 (50%) Epididymis (50) (50) (50) (50) Granuloma Sperm 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Mineralization, Focal 1 (2%) Spermatocele 1 (2%) 1 (2%) Preputial Gland (50) (50) (50) (50) Degeneration, Cystic 17 (34%) 16 (32%) 14 (28%) 11 (22%) Inflammation, Chronic 2 (4%) 3 (6%) 6 (12%) 5 (10%) Prostate (49) (49) (50) (49) Inflammation, Chronic, Focal 2 (4%) 2 (4%) 4 (8%) Epithelium, Hyperplasia, Focal 1 (2%) Seminal Vesicle (50) (50) (50) (50) Inflammation, Chronic 1 (2%) 1 (2%) Testes (50) (50) (50) (50) Cyst 1 (2%) Mineralization, Focal 2 (4%) Germinal Epithelium, Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Angiectasis 1 (2%) Hyperplasia 2 (4%) 1 (2%) Hyperplasia, Focal, Histiocytic 1 (2%) Lymph Node (3) (3) (6) (3) Iliac, Hyperplasia 1 (33%) Inguinal, Hyperplasia 1 (17%) 1 (33%) Inguinal, Hyperplasia, Lymphoid 1 (17%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Inguinal, Pigmentation 1 (33%) Lymph Node, Mandibular (47) (46) (45) (45) Hyperplasia 1 (2%) 1 (2%) Lymph Node, Mesenteric (50) (48) (46) (50) Angiectasis 3 (6%) 2 (4%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 3 (6%) 3 (7%) 5 (10%) Hemorrhage 13 (26%) 9 (19%) 15 (33%) 12 (24%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) 4 (9%) 4 (8%) Spleen (49) (49) (49) (50) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 21 (43%) 19 (39%) 16 (33%) 15 (30%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Thymus (38) (38) (35) (39) Cyst 2 (5%) 5 (13%) 4 (11%) 2 (5%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (49) (50) (50) Cyst Epithelial Inclusion 1 (2%) Inflammation, Chronic, Focal 1 (2%) Artery, Subcutaneous Tissue, Inflammation, Chronic 1 (2%) Hair Follicle, Atrophy 2 (4%) Subcutaneous Tissue, Angiectasis, Focal 1 (2%) Subcutaneous Tissue, Edema 2 (4%) 3 (6%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fracture 1 (2%) Hyperostosis 1 (2%) Skeletal Muscle (50) (50) (50) (50) Hemorrhage, Focal 1 (2%) Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Spinal Cord (1) (2) (4) (2) Hemorrhage, Focal 1 (25%) 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 1 (2%) 2 (4%) 2 (4%) Hyperplasia, Histiocytic 4 (8%) 2 (4%) 1 (2%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Chronic 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%) Bronchus, Glands, Cyst 3 (6%) 1 (2%) Mediastinum, Hemorrhage 1 (2%) Nose (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) 1 (2%) 2 (4%) 1 (2%) Mucosa, Polyp, Inflammatory 2 (4%) 2 (4%) Mucosa, Glands, Dilatation, Focal 25 (50%) 24 (48%) 26 (52%) 26 (52%) Nasolacrimal Duct, Cyst 1 (2%) Nasolacrimal Duct, Dilatation 1 (2%) Nasopharyngeal Duct, Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (4) (6) (8) (4) Degeneration, Cystic, Focal 1 (13%) Hyperplasia, Focal 1 (13%) Inflammation, Chronic, Focal 1 (25%) 1 (13%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (49) (49) (50) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) Infarct 2 (4%) 2 (4%) Metaplasia, Focal, Osseous 2 (4%) 4 (8%) Nephropathy 46 (94%) 44 (90%) 46 (94%) 49 (98%) Artery, Inflammation, Chronic 1 (2%) Pelvis, Dilatation 2 (4%) 3 (6%) 1 (2%) Renal Tubule, Dilatation 1 (2%) 2 (4%) 3 (6%) Renal Tubule, Pigmentation 1 (2%) 2 (4%) Urethra (9) (14) (16) (15) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 89006-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC INTERFERON A/INTERFERON AD Date: 12/23/96 Route: SUBCUTANEOUS Time: 17:05:47 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 500 U 5000 U 5000 U A CONTROL A/D A/D ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Chronic 2 (22%) 6 (43%) 4 (25%) 2 (13%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------