TDMS Study 88122-07 Pathology Tables
NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 FINAL/MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 37319-17-8 Lock Date: 04/14/00 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: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 8 6 10 9 Moribund Sacrifice 4 5 3 7 Accidently Killed 1 Dosing Accident 1 Survivors Terminal Sacrifice 37 37 37 34 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (49) Inflammation, Chronic Active 1 (2%) Necrosis 1 (2%) Gallbladder (39) (40) (38) (38) Cyst 2 (5%) 1 (3%) 1 (3%) Degeneration, Hyaline 1 (3%) 1 (3%) 3 (8%) 2 (5%) Intestine Large, Colon (45) (44) (44) (46) Necrosis 1 (2%) Intestine Large, Rectum (45) (45) (44) (46) Infiltration Cellular, Histiocyte 2 (5%) 10 (22%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 2 (5%) 32 (70%) Metaplasia, Squamous 1 (2%) 26 (57%) Myxomatous Change 3 (7%) 21 (48%) 31 (67%) Necrosis 1 (2%) 24 (52%) Intestine Large, Cecum (41) (43) (44) (43) Inflammation, Granulomatous 1 (2%) Necrosis 1 (2%) Ulcer 1 (2%) Intestine Small, Jejunum (43) (44) (42) (42) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) 1 (2%) Intestine Small, Ileum (42) (44) (42) (42) Infiltration Cellular, Mixed Cell 1 (2%) Liver (50) (49) (50) (49) Angiectasis 1 (2%) 1 (2%) 1 (2%) Basophilic Focus 5 (10%) 6 (12%) 8 (16%) 12 (24%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Clear Cell Focus 4 (8%) 1 (2%) 21 (43%) Cyst 1 (2%) 1 (2%) Eosinophilic Focus 10 (20%) 6 (12%) 7 (14%) 15 (31%) Fatty Change 4 (8%) 2 (4%) 1 (2%) 12 (24%) Hematopoietic Cell Proliferation 3 (6%) 7 (14%) 5 (10%) 7 (14%) Infarct 1 (2%) Inflammation, Chronic 40 (80%) 37 (76%) 40 (80%) 38 (78%) Mineralization 1 (2%) 1 (2%) Tension Lipidosis 2 (4%) 1 (2%) Bile Duct, Hyperplasia 1 (2%) Centrilobular, Degeneration 1 (2%) 1 (2%) Centrilobular, Necrosis 1 (2%) Mesentery (30) (34) (32) (42) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (3%) Thrombosis 1 (2%) Artery, Inflammation, Chronic Active 1 (3%) Fat, Necrosis 29 (97%) 33 (97%) 31 (97%) 41 (98%) Pancreas (46) (45) (46) (46) Atrophy 1 (2%) 1 (2%) Basophilic Focus 2 (4%) 1 (2%) Inflammation, Acute 1 (2%) Lipomatosis 1 (2%) Artery, Inflammation 1 (2%) Salivary Glands (49) (49) (50) (48) Atrophy 1 (2%) Basophilic Focus 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 2 (4%) Stomach, Forestomach (47) (48) (49) (48) Hyperplasia, Squamous 2 (4%) 2 (4%) 2 (4%) Inflammation, Acute 1 (2%) Ulcer 3 (6%) Artery, Inflammation, Chronic Active 1 (2%) Stomach, Glandular (46) (45) (44) (46) Hyperplasia 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (2) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Aorta, Mineralization 1 (50%) Heart (50) (50) (50) (50) Cardiomyopathy 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (49) (49) (48) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 5 (10%) 3 (6%) 2 (4%) 2 (4%) Hypertrophy 1 (2%) 3 (6%) 3 (6%) 12 (25%) Necrosis 1 (2%) Pituitary Gland (48) (47) (45) (48) Hyperplasia 1 (2%) Pars Distalis, Hyperplasia 11 (23%) 8 (17%) 10 (22%) 11 (23%) Pars Intermedia, Hypertrophy 1 (2%) Thyroid Gland (46) (47) (49) (46) Necrosis 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (39) (44) (42) (35) Cyst 1 (2%) Inflammation, Chronic Active 1 (3%) 1 (2%) Ovary (47) (46) (47) (48) Angiectasis 1 (2%) 2 (4%) Cyst 10 (21%) 12 (26%) 8 (17%) 7 (15%) Thrombosis 1 (2%) Uterus (48) (49) (50) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) 1 (2%) Hydrometra 27 (56%) 21 (43%) 25 (50%) 20 (40%) Hyperplasia, Cystic 8 (17%) 9 (18%) 8 (16%) 10 (20%) Inflammation, Suppurative 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (48) (50) (49) Atrophy 1 (2%) Necrosis 1 (2%) Lymph Node (6) (10) (5) (10) Bronchial, Hyperplasia, Lymphoid 1 (10%) Mediastinal, Hyperplasia, Lymphoid 1 (10%) 1 (20%) Pancreatic, Hyperplasia, Lymphoid 1 (10%) Renal, Hyperplasia, Lymphoid 1 (10%) Lymph Node, Mandibular (33) (38) (37) (39) Hyperplasia, Lymphoid 1 (3%) 1 (3%) 3 (8%) Infiltration Cellular, Plasma Cell 1 (3%) 1 (3%) 2 (5%) Infiltration Cellular, Histiocyte 3 (8%) Lymph Node, Mesenteric (47) (44) (42) (45) Hemorrhage 1 (2%) 3 (7%) Hyperplasia, Lymphoid 3 (6%) 1 (2%) 3 (7%) Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%) 2 (4%) Infiltration Cellular, Histiocyte 23 (52%) 35 (83%) 25 (56%) Spleen (47) (48) (47) (46) Congestion 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 10 (21%) 19 (40%) 15 (32%) 18 (39%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) Infiltration Cellular, Histiocyte 3 (6%) 12 (26%) 28 (61%) Metaplasia, Osseous 2 (4%) Thymus (43) (38) (43) (36) Hyperplasia, Lymphoid 1 (2%) Necrosis 1 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Edema 1 (2%) Inflammation, Chronic Active 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Subcutaneous Tissue, Necrosis, Fatty 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 4 (8%) 1 (2%) 5 (10%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Skeletal Muscle (2) (2) Degeneration 1 (50%) Mineralization 1 (50%) Artery, Inflammation, Chronic Active 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (50) (50) Artery, Inflammation, Chronic Active 1 (2%) Meninges, Infiltration Cellular, Mononuclear Cell 1 (2%) Meninges, Inflammation, Chronic 1 (2%) Peripheral Nerve (1) Infiltration Cellular, Mast Cell 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Thrombosis 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 5 (10%) 3 (6%) 1 (2%) 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 2 (4%) 2 (4%) Mediastinum, Inflammation, Acute 1 (2%) Nose (50) (50) (50) (50) Inflammation, Suppurative 2 (4%) 2 (4%) 2 (4%) Olfactory Epithelium, Atrophy 1 (2%) 1 (2%) 1 (2%) Olfactory Epithelium, Metaplasia 2 (4%) 1 (2%) Trachea (46) (48) (46) (48) Metaplasia, Squamous 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Degeneration 1 (100%) Cornea, Inflammation, Acute 1 (50%) Cornea, Inflammation, Chronic 1 (50%) Harderian Gland (48) (41) (50) (46) Atrophy 1 (2%) 1 (2%) Hyperplasia 3 (6%) 3 (7%) 2 (4%) 4 (9%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (49) (48) (46) Cyst 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Metaplasia, Osseous 3 (7%) Mineralization 3 (6%) 2 (4%) 1 (2%) 1 (2%) Nephropathy 19 (40%) 17 (35%) 22 (46%) 27 (59%) Artery, Inflammation, Chronic Active 1 (2%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) Urinary Bladder (43) (46) (47) (46) Artery, Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 4 5 8 15 Moribund Sacrifice 7 4 4 3 Dosing Accident 1 2 Survivors Terminal Sacrifice 39 40 38 30 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Hyperplasia, Squamous 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) Gallbladder (40) (38) (39) (34) Cyst 1 (3%) 1 (3%) Degeneration, Hyaline 3 (8%) 1 (3%) 1 (3%) Inflammation, Chronic Active 1 (3%) Epithelium, Hyperplasia 1 (3%) Intestine Large, Colon (50) (47) (47) (42) Necrosis 1 (2%) Intestine Large, Rectum (49) (47) (46) (44) Infiltration Cellular, Histiocyte 6 (14%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 1 (2%) 8 (18%) Metaplasia, Squamous 5 (11%) Myxomatous Change 13 (30%) Necrosis 5 (11%) Intestine Large, Cecum (49) (47) (46) (39) Inflammation, Chronic Active 2 (5%) Necrosis 1 (3%) Intestine Small, Jejunum (47) (47) (44) (38) Hyperplasia, Lymphoid 1 (3%) Mineralization 1 (2%) Necrosis 1 (2%) Intestine Small, Ileum (46) (47) (43) (38) Inflammation, Acute 1 (3%) Liver (50) (50) (50) (50) Basophilic Focus 14 (28%) 10 (20%) 5 (10%) 10 (20%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Clear Cell Focus 21 (42%) 23 (46%) 19 (38%) 15 (30%) Eosinophilic Focus 13 (26%) 11 (22%) 9 (18%) 12 (24%) Fatty Change 9 (18%) 12 (24%) 8 (16%) 13 (26%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Infarct 1 (2%) Inflammation, Chronic 11 (22%) 15 (30%) 23 (46%) 33 (66%) Mineralization 1 (2%) Necrosis 2 (4%) 2 (4%) 2 (4%) 5 (10%) Tension Lipidosis 2 (4%) 2 (4%) 2 (4%) Vacuolization Cytoplasmic, Focal 1 (2%) Bile Duct, Cyst 1 (2%) Centrilobular, Degeneration 1 (2%) 3 (6%) 4 (8%) Mesentery (10) (4) (20) (10) Mineralization 1 (10%) Fat, Necrosis 10 (100%) 3 (75%) 19 (95%) 10 (100%) Pancreas (50) (50) (49) (50) Atrophy 1 (2%) 1 (2%) 1 (2%) Cyst 1 (2%) Artery, Inflammation 1 (2%) Stomach, Forestomach (49) (50) (50) (50) Hyperplasia, Squamous 6 (12%) 2 (4%) 3 (6%) Inflammation, Acute 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) Stomach, Glandular (49) (49) (48) (46) Hyperplasia 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) 1 (2%) Tooth (33) (27) (30) (23) Inflammation, Chronic Active 6 (18%) 6 (22%) 5 (17%) 6 (26%) Malformation 29 (88%) 22 (81%) 27 (90%) 20 (87%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) (1) Angiectasis 1 (100%) Thrombosis 1 (100%) Heart (50) (50) (50) (50) Cardiomyopathy 3 (6%) 1 (2%) 2 (4%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) 1 (2%) 2 (4%) Artery, Inflammation, Chronic Active 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) Hyperplasia 5 (10%) 8 (16%) 8 (16%) 13 (27%) Hypertrophy 27 (54%) 27 (54%) 23 (46%) 15 (31%) Adrenal Medulla (50) (50) (50) (49) Hyperplasia 3 (6%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) Pituitary Gland (47) (48) (49) (48) Pars Distalis, Hyperplasia 3 (6%) 2 (4%) Thyroid Gland (48) (49) (50) (49) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (49) (50) (49) (50) Ectasia 3 (6%) 3 (6%) 5 (10%) 3 (6%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) 2 (4%) 3 (6%) Prostate, NOS (50) (49) (50) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Seminal Vesicle (50) (50) (50) (49) Congestion 1 (2%) Dilatation 5 (10%) Inflammation, Chronic Active 1 (2%) 2 (4%) Inflammation, Suppurative 1 (2%) Testes (50) (50) (49) (50) Atrophy 1 (2%) Germinal Epithelium, Degeneration 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Angiectasis 1 (2%) 1 (2%) Lymph Node (1) (1) (1) (1) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Mediastinal, Infiltration Cellular, Histiocyte 1 (100%) Lymph Node, Mesenteric (48) (46) (45) (41) Angiectasis 3 (6%) 3 (7%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) Infiltration Cellular, Histiocyte 15 (33%) 34 (76%) 37 (90%) Spleen (49) (50) (49) (49) Amyloid Deposition 1 (2%) Hematopoietic Cell Proliferation 10 (20%) 8 (16%) 15 (31%) 15 (31%) Infiltration Cellular, Mast Cell 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 23 (47%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Mineralization 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 7 (14%) 4 (8%) 4 (8%) Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 2 (4%) Mediastinum, Hemorrhage 1 (2%) Mediastinum, Inflammation, Acute 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 88122-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ELMIRON Date: 09/26/01 Route: GAVAGE Time: 14:40:32 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 56 MG/KG 168 504 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (50) (50) (50) (47) Inflammation, Suppurative 5 (10%) 11 (22%) 2 (4%) Polyp, Inflammatory 1 (2%) Glands, Degeneration, Hyaline 1 (2%) Olfactory Epithelium, Atrophy 3 (6%) 1 (2%) Olfactory Epithelium, Hyperplasia 1 (2%) Olfactory Epithelium, Metaplasia 3 (6%) 1 (2%) 1 (2%) Sinus, Inflammation, Chronic Active 1 (2%) Trachea (50) (50) (49) (50) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) (1) Cornea, Inflammation, Chronic 1 (100%) 2 (100%) Harderian Gland (49) (48) (49) (48) Atrophy 1 (2%) 1 (2%) Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Cyst 3 (6%) 1 (2%) Hydronephrosis 1 (2%) 1 (2%) Infarct 1 (2%) 3 (6%) 4 (8%) Infiltration Cellular, Mast Cell 1 (2%) Inflammation, Suppurative 3 (6%) 3 (6%) 1 (2%) Metaplasia, Osseous 1 (2%) 1 (2%) Mineralization 1 (2%) Nephropathy 43 (86%) 41 (82%) 47 (94%) 41 (84%) Papilla, Necrosis 1 (2%) Renal Tubule, Hyperplasia 2 (4%) Urinary Bladder (50) (49) (49) (49) Artery, Inflammation, Chronic Active 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------