TDMS Study 05067-10 Pathology Tables
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 CORE STUDY Facility: Southern Research Institute Chemical CAS #: 58-55-9 Lock Date: 07/14/93 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: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 7 4 11 9 Natural Death 6 9 5 8 Survivors Terminal Sacrifice 37 37 34 33 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Muscularis, Inflammation, Chronic 1 (2%) Gallbladder (46) (48) (47) (49) Inflammation, Chronic 1 (2%) 1 (2%) Intestine Large, Colon (48) (49) (47) (48) Inflammation, Chronic 1 (2%) Polyp Inflammatory 1 (2%) Intestine Large, Cecum (48) (45) (47) (47) Inflammation, Chronic 1 (2%) Intestine Small, Jejunum (47) (46) (47) (43) Peyer's Patch, Hyperplasia, Lymphoid 2 (4%) Liver (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 1 (2%) 1 (2%) Eosinophilic Focus 6 (12%) 7 (14%) 5 (10%) 3 (6%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 1 (2%) Hyperplasia, Focal, Lymphoid 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic 3 (6%) 5 (10%) 2 (4%) Inflammation, Focal 1 (2%) 1 (2%) Mixed Cell Focus 2 (4%) 1 (2%) 2 (4%) 2 (4%) Necrosis, Focal 2 (4%) 4 (8%) 2 (4%) 1 (2%) Pigmentation, Focal 2 (4%) 1 (2%) Vacuolization Cytoplasmic 6 (12%) 8 (16%) 5 (10%) 2 (4%) Bile Duct, Cyst 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%) Hepatocyte, Karyomegaly 1 (2%) Mesentery (10) (8) (6) (5) Hemorrhage 1 (13%) Inflammation, Chronic 1 (13%) Fat, Necrosis 8 (80%) 4 (50%) 2 (33%) 2 (40%) Pancreas (50) (49) (49) (49) Inflammation, Chronic 1 (2%) 1 (2%) Necrosis 1 (2%) Acinus, Atrophy, Focal 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Duct, Cyst 1 (2%) 3 (6%) Salivary Glands (50) (49) (50) (50) Fibrosis 1 (2%) 1 (2%) 1 (2%) Mineralization 1 (2%) Vacuolization Cytoplasmic 1 (2%) 1 (2%) Stomach, Forestomach (50) (49) (49) (50) Cyst 1 (2%) Edema 1 (2%) 1 (2%) Ulcer 2 (4%) Epithelium, Hyperplasia 6 (12%) 6 (12%) 12 (24%) 5 (10%) Stomach, Glandular (49) (49) (48) (50) Edema 1 (2%) Erosion 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 4 (8%) 3 (6%) 5 (10%) 9 (18%) Glands, Degeneration, Cystic, Focal 11 (22%) 5 (10%) 4 (8%) 3 (6%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Inflammation, Chronic 1 (2%) Heart (50) (50) (50) (50) Inflammation, Chronic, Focal 2 (4%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) Thrombosis 1 (2%) Artery, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (49) Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) 2 (4%) Cyst 1 (2%) 1 (2%) Cytoplasmic Alteration, Focal 1 (2%) 3 (6%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) Hypertrophy, Focal 1 (2%) 3 (6%) 1 (2%) Adrenal Medulla (50) (48) (50) (49) Hyperplasia 1 (2%) 3 (6%) Islets, Pancreatic (50) (49) (49) (49) Hyperplasia 1 (2%) 1 (2%) Parathyroid Gland (49) (47) (42) (45) Cyst 1 (2%) 1 (2%) 2 (5%) 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) Pituitary Gland (49) (45) (50) (48) Angiectasis 3 (6%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hemorrhage 1 (2%) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Cyst 1 (2%) 4 (9%) 1 (2%) Pars Distalis, Cytoplasmic Alteration, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%) Pars Distalis, Hyperplasia, Focal 4 (8%) 7 (16%) 14 (28%) 6 (13%) Thyroid Gland (50) (50) (50) (50) Degeneration, Cystic, Focal 12 (24%) 13 (26%) 10 (20%) 15 (30%) Inflammation, Chronic, Focal 1 (2%) Follicle, Cyst 2 (4%) 11 (22%) 5 (10%) 7 (14%) Follicular Cell, Hyperplasia 7 (14%) 8 (16%) 8 (16%) 11 (22%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (49) (49) Degeneration, Cystic 7 (14%) 3 (6%) 1 (2%) 6 (12%) Inflammation, Chronic 1 (2%) 1 (2%) Ovary (50) (50) (50) (50) Angiectasis 1 (2%) Cyst 6 (12%) 5 (10%) 5 (10%) 9 (18%) Hemorrhage 1 (2%) 2 (4%) 5 (10%) 1 (2%) Inflammation, Suppurative 2 (4%) Uterus (50) (50) (50) (50) Angiectasis 1 (2%) Cyst 1 (2%) 2 (4%) 1 (2%) Hemorrhage 2 (4%) 1 (2%) 1 (2%) Hydrometra 20 (40%) 19 (38%) 18 (36%) 13 (26%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Endometrium, Hyperplasia, Cystic 48 (96%) 41 (82%) 43 (86%) 40 (80%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Depletion Cellular 1 (2%) Hyperplasia 4 (8%) 4 (8%) 4 (8%) 2 (4%) Myelofibrosis 1 (2%) Necrosis 1 (2%) Lymph Node (6) (8) (7) (6) Hyperplasia 1 (14%) Iliac, Inflammation, Chronic 1 (14%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Inguinal, Hyperplasia, Lymphoid 1 (17%) Mediastinal, Hemorrhage 1 (17%) Lymph Node, Mandibular (48) (49) (44) (43) Ectasia 1 (2%) Hemorrhage 2 (4%) 2 (4%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (48) (46) (48) (45) Atrophy 1 (2%) Ectasia 1 (2%) Hemorrhage 2 (4%) 1 (2%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Spleen (50) (50) (49) (48) Congestion 1 (2%) Depletion Cellular 2 (4%) Fibrosis, Focal 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 13 (26%) 21 (42%) 19 (39%) 12 (25%) Hyperplasia, Lymphoid 5 (10%) 3 (6%) 2 (4%) 4 (8%) Infarct 1 (2%) Necrosis, Focal 1 (2%) Thymus (47) (44) (49) (47) Atrophy 2 (4%) 3 (7%) 2 (4%) 2 (4%) Cyst 1 (2%) 1 (2%) 2 (4%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Necrosis 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (50) (49) Ectasia 1 (2%) 1 (2%) 2 (4%) 1 (2%) Hyperplasia 1 (2%) 3 (6%) 2 (4%) Skin (49) (50) (50) (50) Inflammation, Chronic, Focal 2 (4%) 2 (4%) 2 (4%) Ulcer 2 (4%) Dermis, Fibrosis 2 (4%) 3 (6%) Epidermis, Hyperplasia, Focal 2 (4%) 1 (2%) Pinna, Ulcer 1 (2%) Subcutaneous Tissue, Edema 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 9 (18%) 6 (12%) 11 (22%) 17 (34%) Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Atrophy, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%) Hemorrhage 1 (2%) 1 (2%) Necrosis 2 (4%) Spinal Cord (2) (1) (1) (1) Hemorrhage, Focal 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Histiocytic 2 (4%) Pigmentation 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) Nose (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) Mucosa, Glands, Dilatation, Focal 2 (4%) 2 (4%) 1 (2%) Nasolacrimal Duct, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (2) Atrophy 1 (100%) Cornea, Inflammation, Chronic 1 (100%) 2 (100%) Harderian Gland (6) (6) (8) (2) Hyperplasia, Focal 1 (17%) Inflammation, Chronic, Focal 2 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Congestion 1 (2%) Hyperplasia, Lymphoid 1 (2%) Infarct 1 (2%) Metaplasia, Focal, Osseous 2 (4%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG CONTROL MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Nephropathy 25 (50%) 27 (54%) 27 (54%) 25 (50%) Thrombosis 1 (2%) Pelvis, Dilatation 1 (2%) Renal Tubule, Accumulation, Hyaline Droplet 3 (6%) Renal Tubule, Casts Protein 1 (2%) Renal Tubule, Degeneration 3 (6%) 1 (2%) 4 (8%) Renal Tubule, Dilatation 1 (2%) 1 (2%) Renal Tubule, Mineralization 1 (2%) 1 (2%) Renal Tubule, Pigmentation 1 (2%) 1 (2%) Urinary Bladder (49) (49) (49) (50) Hyperplasia, Lymphoid 2 (4%) 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150 CONTROL MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 5 6 4 15 Moribund Sacrifice 9 9 2 9 Survivors Terminal Sacrifice 36 35 44 26 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (49) (49) (48) (43) Inflammation, Chronic 1 (2%) Intestine Small, Duodenum (48) (49) (49) (41) Inflammation, Chronic, Focal 1 (2%) Necrosis, Focal 1 (2%) Intestine Small, Jejunum (48) (47) (47) (41) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Intestine Small, Ileum (48) (48) (47) (38) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) Basophilic Focus 1 (2%) 1 (2%) Clear Cell Focus 2 (4%) 2 (4%) 3 (6%) Congestion 1 (2%) Eosinophilic Focus 6 (12%) 6 (12%) 9 (18%) Hepatodiaphragmatic Nodule 1 (2%) Inflammation, Chronic 24 (48%) 25 (50%) 16 (32%) 3 (6%) Mineralization, Focal 1 (2%) Mixed Cell Focus 1 (2%) Necrosis, Focal 5 (10%) 6 (12%) 3 (6%) 2 (4%) Vacuolization Cytoplasmic 10 (20%) 11 (22%) 6 (12%) 1 (2%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 1 (2%) 2 (4%) 2 (4%) Hepatocyte, Hypertrophy 1 (2%) 1 (2%) Hepatocyte, Karyomegaly 15 (30%) 14 (28%) 12 (24%) 2 (4%) Mesentery (10) (4) (2) Hemorrhage 2 (20%) Inflammation, Chronic 1 (10%) 1 (25%) Thrombosis 1 (10%) Artery, Inflammation, Chronic 3 (30%) 1 (25%) Artery, Thrombosis 1 (10%) Fat, Necrosis 2 (20%) 1 (25%) 1 (50%) Pancreas (50) (49) (49) (50) Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150 CONTROL MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy, Diffuse 2 (4%) Acinus, Atrophy, Focal 1 (2%) 1 (2%) 1 (2%) Artery, Hypertrophy 1 (2%) Duct, Cyst 1 (2%) 2 (4%) Salivary Glands (50) (50) (50) (49) Vacuolization Cytoplasmic 1 (2%) Stomach, Forestomach (50) (50) (50) (49) Inflammation, Chronic 1 (2%) 3 (6%) 1 (2%) Ulcer 1 (2%) 3 (6%) Epithelium, Hyperplasia 14 (28%) 12 (24%) 16 (32%) 13 (27%) Stomach, Glandular (50) (49) (49) (43) Edema 1 (2%) Erosion 1 (2%) Hyperplasia 1 (2%) Mineralization 1 (2%) 4 (8%) 3 (6%) 1 (2%) Glands, Degeneration, Cystic, Focal 2 (4%) 7 (14%) 1 (2%) 2 (5%) Tooth (10) (5) Developmental Malformation 10 (100%) 5 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Hemorrhage 1 (2%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) Mineralization 1 (2%) Thrombosis 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) Cyst 1 (2%) Cytoplasmic Alteration, Focal 1 (2%) 1 (2%) 2 (4%) Hyperplasia, Focal 1 (2%) 2 (4%) Hypertrophy, Focal 6 (12%) 7 (14%) 9 (18%) 7 (14%) Capsule, Hyperplasia, Focal 2 (4%) 2 (4%) Adrenal Medulla (49) (50) (49) (49) Hyperplasia 1 (2%) 1 (2%) Islets, Pancreatic (50) (49) (50) (50) Hyperplasia 4 (8%) 2 (4%) Parathyroid Gland (48) (49) (49) (46) Cyst 1 (2%) 1 (2%) 2 (4%) Pituitary Gland (49) (50) (48) (44) Angiectasis 1 (2%) 1 (2%) Pars Distalis, Cyst 2 (4%) 2 (4%) 3 (6%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150 CONTROL MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Cytoplasmic Alteration, Focal 2 (4%) Pars Distalis, Hyperplasia, Focal 1 (2%) 3 (6%) 2 (4%) 2 (5%) Thyroid Gland (50) (50) (50) (50) Degeneration, Cystic, Focal 6 (12%) 11 (22%) 10 (20%) 13 (26%) Follicle, Cyst 1 (2%) 6 (12%) 3 (6%) 2 (4%) Follicular Cell, Hyperplasia 3 (6%) 1 (2%) 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (50) (50) (50) Granuloma Sperm 1 (2%) 2 (4%) Inflammation, Chronic 1 (2%) Spermatocele 1 (2%) Penis (1) Angiectasis 1 (100%) Preputial Gland (49) (48) (50) (50) Degeneration, Cystic 23 (47%) 31 (65%) 31 (62%) 12 (24%) Inflammation, Chronic 10 (20%) 8 (17%) 1 (2%) 3 (6%) Inflammation, Suppurative 1 (2%) 1 (2%) Prostate (50) (49) (50) (50) Inflammation, Chronic 1 (2%) 1 (2%) Epithelium, Hyperplasia, Focal 1 (2%) Seminal Vesicle (50) (50) (50) (50) Cyst 1 (2%) Inflammation, Chronic 2 (4%) Testes (50) (50) (50) (50) Cyst 1 (2%) Mineralization, Focal 1 (2%) 1 (2%) Germinal Epithelium, Degeneration 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (49) Angiectasis 1 (2%) Depletion Cellular 1 (2%) Hyperplasia 5 (10%) 2 (4%) Lymph Node (5) (6) (5) (3) Bronchial, Hyperplasia, Lymphoid 1 (33%) Inguinal, Hyperplasia, Lymphoid 1 (20%) 2 (33%) 1 (33%) Inguinal, Pigmentation 1 (33%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150 CONTROL MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Mediastinal, Hemorrhage 1 (20%) Pancreatic, Hyperplasia, Lymphoid 2 (33%) Renal, Hyperplasia 1 (17%) Lymph Node, Mandibular (42) (47) (47) (47) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) Necrosis 1 (2%) Lymph Node, Mesenteric (50) (46) (50) (48) Atrophy 2 (4%) Ectasia 3 (6%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 17 (34%) 13 (28%) 9 (18%) 6 (13%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) 2 (4%) Pigmentation 1 (2%) Spleen (50) (49) (50) (49) Depletion Cellular 1 (2%) 12 (24%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 20 (40%) 27 (55%) 25 (50%) 13 (27%) Hyperplasia, Lymphoid 1 (2%) Thymus (43) (42) (44) (46) Atrophy 2 (5%) 6 (14%) 4 (9%) 5 (11%) Cyst 6 (14%) 6 (14%) 5 (11%) 3 (7%) Necrosis 1 (2%) 1 (2%) 11 (24%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Inflammation, Chronic, Focal 1 (2%) Dermis, Fibrosis 1 (2%) Epidermis, Hyperplasia, Focal 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Cranium, Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96 Route: GAVAGE Time: 13:10:54 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150 CONTROL MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 4 (8%) Foreign Body 1 (2%) Hemorrhage 3 (6%) 1 (2%) 1 (2%) Hyperplasia, Histiocytic 4 (8%) 4 (8%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%) Nose (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (1) (4) (2) (2) Inflammation, Chronic, Focal 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) (50) Congestion 1 (2%) 1 (2%) Cyst 2 (4%) 1 (2%) 2 (4%) Infarct 2 (4%) 2 (4%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Metaplasia, Focal, Osseous 1 (2%) 2 (4%) 1 (2%) Nephropathy 46 (92%) 46 (94%) 45 (90%) 29 (58%) Papilla, Necrosis 1 (2%) Renal Tubule, Degeneration 7 (14%) Renal Tubule, Dilatation 4 (8%) Urethra (3) (3) (1) Inflammation, Chronic 1 (33%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------