TR 388 Rat Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) ETHYLENETHIOUREA NTP Experiment-Test: 05076-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-45-7 Lock Date: None 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: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 50 Early Deaths Moribund Sacrifice 20 15 13 8 10 13 Natural Death 6 5 3 9 13 4 Survivors Moribund Sacrifice 2 1 Terminal Sacrifice 23 30 34 30 26 32 Natural Death 1 1 1 Animals Examined Microscopically 50 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (49) (50) (49) (50) Foreign Body 1 (2%) Intestine Large, Cecum (46) (46) (48) (42) (39) (46) Artery, Necrosis, Fibrinoid 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Intestine Large, Colon (47) (47) (50) (45) (43) (47) Parasite Metazoan 1 (2%) 1 (2%) 1 (2%) 1 (2%) Intestine Large, Rectum (48) (46) (49) (43) (41) (47) Parasite Metazoan 2 (4%) 6 (13%) 4 (8%) 2 (5%) 7 (17%) 4 (9%) Intestine Small, Duodenum (49) (49) (50) (48) (48) (49) Inflammation, Chronic Active 1 (2%) 2 (4%) Liver (50) (50) (50) (50) (50) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Basophilic Focus 36 (72%) 31 (62%) 34 (68%) 31 (62%) 23 (46%) 28 (56%) Clear Cell Focus 2 (4%) 4 (8%) 2 (4%) 1 (2%) 1 (2%) 1 (2%) Degeneration, Cystic 1 (2%) 2 (4%) 1 (2%) 2 (4%) 1 (2%) 1 (2%) Eosinophilic Focus 1 (2%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hepatodiaphragmatic Nodule 2 (4%) 1 (2%) 1 (2%) 2 (4%) 1 (2%) Hyperplasia 1 (2%) 1 (2%) Inflammation, Chronic 14 (28%) 17 (34%) 21 (42%) 18 (36%) 16 (32%) 20 (40%) Leukocytosis 1 (2%) Necrosis, Coagulative 2 (4%) 1 (2%) 2 (4%) 3 (6%) 3 (6%) 1 (2%) Thrombosis 1 (2%) Vacuolization Cytoplasmic 8 (16%) 4 (8%) 9 (18%) 1 (2%) Hepatocyte, Hyperplasia 1 (2%) Mesentery (3) (2) (2) (1) (4) (8) Inflammation, Chronic Active 1 (33%) 1 (50%) 1 (50%) 1 (100%) 2 (50%) 5 (63%) Artery, Inflammation, Chronic Active 1 (25%) Artery, Necrosis, Fibrinoid 1 (25%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pancreas (50) (49) (50) (49) (49) (50) Cyst 1 (2%) Ectopic Liver 1 (2%) Acinus, Atrophy 16 (32%) 12 (24%) 17 (34%) 15 (31%) 14 (29%) 17 (34%) Artery, Necrosis, Fibrinoid 1 (2%) Perivascular, Inflammation, Chronic Active 3 (6%) Salivary Glands (50) (50) (50) (50) (50) (49) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 1 (2%) Stomach, Forestomach (49) (49) (50) (49) (48) (50) Acanthosis 2 (4%) 3 (6%) 3 (6%) 1 (2%) Hyperkeratosis 2 (4%) 3 (6%) 3 (6%) 1 (2%) Hyperplasia, Focal, Squamous 1 (2%) Inflammation, Chronic Active 3 (6%) 3 (6%) 5 (10%) 3 (6%) 1 (2%) 2 (4%) Necrosis, Coagulative 2 (4%) Stomach, Glandular (48) (49) (50) (48) (48) (50) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic Active 4 (8%) 4 (8%) 3 (6%) 9 (19%) 9 (19%) 5 (10%) Mineralization 1 (2%) 3 (6%) 5 (10%) 2 (4%) 4 (8%) 6 (12%) Necrosis, Coagulative 1 (2%) Mucosa, Degeneration, Chronic 1 (2%) Tooth (50) (49) (50) (49) (50) (49) Caries 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) (50) (50) Bacterium 1 (2%) Cardiomyopathy, Chronic 30 (60%) 25 (50%) 27 (54%) 38 (76%) 33 (66%) 35 (70%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) 1 (2%) 1 (2%) Artery, Necrosis, Fibrinoid 1 (2%) Atrium, Thrombosis 2 (4%) 1 (2%) 2 (4%) 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Ventricle, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (49) (50) (50) (49) (50) Capsule, Inflammation, Chronic 1 (2%) Adrenal Gland, Cortex (50) (49) (49) (48) (49) (50) Accessory Adrenal Cortical Nodule 1 (2%) Atypia Cellular 2 (4%) 1 (2%) 1 (2%) Degeneration, Fatty 16 (32%) 20 (41%) 23 (47%) 22 (46%) 20 (41%) 23 (46%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hematocyst 1 (2%) 2 (4%) 1 (2%) Hyperplasia 25 (50%) 33 (67%) 26 (53%) 31 (65%) 27 (55%) 36 (72%) Hypertrophy 3 (6%) 11 (22%) 8 (16%) 7 (15%) 8 (16%) 4 (8%) Hypertrophy, Focal 1 (2%) Necrosis, Coagulative 2 (4%) 1 (2%) 2 (4%) 2 (4%) Adrenal Gland, Medulla (50) (49) (49) (49) (49) (50) Hematocyst 1 (2%) Hyperplasia 11 (22%) 16 (33%) 8 (16%) 14 (29%) 15 (31%) 13 (26%) Infiltration Cellular, Lymphocyte 1 (2%) Islets, Pancreatic (50) (49) (50) (50) (50) (50) Hyperplasia 1 (2%) Parathyroid Gland (46) (47) (48) (46) (46) (47) Hyperplasia 2 (4%) 3 (6%) 1 (2%) 1 (2%) 1 (2%) 2 (4%) Pituitary Gland (50) (50) (49) (49) (49) (49) Pars Distalis, Angiectasis 1 (2%) 1 (2%) 2 (4%) Pars Distalis, Atypia Cellular 1 (2%) Pars Distalis, Cyst 27 (54%) 17 (34%) 27 (55%) 28 (57%) 29 (59%) 31 (63%) Pars Distalis, Fibrosis 1 (2%) Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia 18 (36%) 12 (24%) 13 (27%) 13 (27%) 12 (24%) 12 (24%) Pars Distalis, Vacuolization Cytoplasmic 1 (2%) Pars Intermedia, Angiectasis 1 (2%) Pars Intermedia, Cyst 1 (2%) 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (50) (48) (49) (44) (46) (47) Inflammation, Chronic Active 1 (2%) Ultimobranchial Cyst 1 (2%) 3 (6%) 1 (2%) 3 (7%) 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) Artery, Necrosis, Fibrinoid 1 (2%) C-Cell, Hyperplasia 31 (62%) 36 (75%) 41 (84%) 35 (80%) 33 (72%) 39 (83%) Follicular Cell, Hyperplasia 8 (17%) 15 (31%) 33 (75%) 30 (65%) 41 (87%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (50) (49) (47) (49) (45) Hyperplasia 3 (6%) 4 (8%) 3 (6%) 3 (6%) 2 (4%) Inflammation, Chronic Active 11 (23%) 11 (22%) 9 (18%) 15 (32%) 8 (16%) 14 (31%) Duct, Dilatation 11 (23%) 14 (28%) 8 (16%) 8 (17%) 6 (12%) 13 (29%) Ovary (50) (50) (50) (50) (50) (50) Atrophy 2 (4%) 3 (6%) 3 (6%) 2 (4%) 1 (2%) Cyst 11 (22%) 19 (38%) 18 (36%) 21 (42%) 14 (28%) 13 (26%) Inflammation, Chronic Active 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Uterus (50) (50) (50) (50) (50) (50) Dilatation 5 (10%) 3 (6%) 6 (12%) 1 (2%) 1 (2%) Hemorrhage 2 (4%) 1 (2%) 3 (6%) 2 (4%) Inflammation, Chronic Active 3 (6%) 1 (2%) 1 (2%) 1 (2%) Prolapse 1 (2%) Cervix, Diverticulum 1 (2%) 3 (6%) 1 (2%) 1 (2%) 1 (2%) Cervix, Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 1 (2%) Endometrium, Hyperplasia, Cystic, Glandular 12 (24%) 12 (24%) 10 (20%) 14 (28%) 11 (22%) 15 (30%) Vagina (2) (1) Dilatation 1 (100%) Epithelium, Hyperplasia 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) (47) (50) Femoral, Hyperplasia, Reticulum Cell 1 (2%) 1 (2%) 2 (4%) 1 (2%) Femoral, Myelofibrosis 1 (2%) 1 (2%) 1 (2%) Lymph Node (50) (49) (50) (50) (50) (50) Mandibular, Cyst 1 (2%) Mediastinal, Infiltration Cellular, Histiocyte 1 (2%) Spleen (50) (50) (50) (50) (50) (50) Atrophy 1 (2%) 1 (2%) 1 (2%) Fibrosis 1 (2%) 2 (4%) 2 (4%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 4 (8%) 1 (2%) 1 (2%) 2 (4%) Necrosis, Coagulative 1 (2%) 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (47) (50) (50) (50) (50) Hyperplasia, Cystic 48 (96%) 45 (96%) 50 (100%) 47 (94%) 49 (98%) 47 (94%) Inflammation, Chronic Active 2 (4%) 1 (2%) Skin (50) (49) (50) (50) (50) (48) Alopecia 1 (2%) 1 (2%) Cyst Epithelial Inclusion 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (50) (50) (50) (50) Cranium, Fibrous Osteodystrophy 1 (2%) 2 (4%) 2 (4%) 1 (2%) 1 (2%) Femur, Fibrous Osteodystrophy 1 (2%) 2 (4%) 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) (50) Compression 11 (22%) 7 (14%) 8 (16%) 9 (18%) 3 (6%) 5 (10%) Hemorrhage 1 (2%) 4 (8%) Hydrocephalus 10 (20%) 6 (12%) 9 (18%) 8 (16%) 3 (6%) 4 (8%) Inflammation, Chronic Active 1 (2%) Thrombosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Artery, Necrosis, Fibrinoid 1 (2%) Spinal Cord (1) (1) (1) Hemorrhage 1 (100%) White Matter, Degeneration 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) (50) Inflammation, Chronic Active 7 (14%) 11 (22%) 13 (26%) 12 (24%) 10 (20%) 9 (18%) Leukocytosis 1 (2%) Necrosis, Coagulative 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) Artery, Mediastinum, Mineralization 1 (2%) Artery, Mediastinum, Necrosis, Fibrinoid 1 (2%) Bronchiole, Epithelium, Hyperplasia 1 (2%) Mediastinum, Perivascular, Inflammation, Chronic Active 1 (2%) 2 (4%) Nose (50) (50) (49) (50) (49) (50) Foreign Body 1 (2%) Fungus 2 (4%) 1 (2%) Inflammation, Chronic Active 3 (6%) 3 (6%) 1 (2%) 4 (8%) 3 (6%) Nasolacrimal Duct, Inflammation, Suppurative 7 (14%) 4 (8%) 5 (10%) 4 (8%) 7 (14%) 6 (12%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (8) (9) (7) (7) (12) (10) Hemorrhage 3 (38%) 1 (14%) Inflammation, Chronic Active 1 (14%) 1 (14%) 1 (10%) Lens, Cataract 6 (75%) 7 (78%) 4 (57%) 6 (86%) 11 (92%) 9 (90%) Retina, Atrophy 6 (75%) 8 (89%) 5 (71%) 6 (86%) 10 (83%) 7 (70%) Harderian Gland (50) (50) (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) (50) (50) (50) Cyst 1 (2%) 1 (2%) 2 (4%) Fibrosis 1 (2%) Hydronephrosis 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Necrosis, Coagulative 1 (2%) 2 (4%) Nephropathy, Chronic 49 (98%) 43 (88%) 46 (92%) 43 (86%) 41 (82%) 45 (90%) Urinary Bladder (49) (48) (50) (47) (48) (50) Dilatation 1 (2%) 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 7 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 Early Deaths Moribund Sacrifice 26 30 Natural Death 4 6 Survivors Terminal Sacrifice 20 13 Natural Death 1 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (46) (48) Inflammation, Chronic Active 1 (2%) Parasite Metazoan 1 (2%) Intestine Large, Colon (46) (49) Parasite Metazoan 2 (4%) 2 (4%) Intestine Large, Rectum (45) (49) Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (48) (50) Hyperplasia, Glandular 1 (2%) Liver (50) (50) Basophilic Focus 16 (32%) 11 (22%) Clear Cell Focus 2 (4%) 4 (8%) Cyst 1 (2%) Degeneration, Cystic 3 (6%) Hepatodiaphragmatic Nodule 3 (6%) Inflammation, Chronic 15 (30%) 15 (30%) Leukocytosis 3 (6%) Necrosis, Coagulative 4 (8%) 4 (8%) Vacuolization Cytoplasmic 4 (8%) 2 (4%) Bile Duct, Hyperplasia 1 (2%) Mesentery (2) Inflammation, Chronic Active 2 (100%) Pancreas (49) (50) Acinus, Atrophy 14 (29%) 10 (20%) Salivary Glands (50) (50) Granuloma 1 (2%) Stomach, Forestomach (50) (50) Acanthosis 1 (2%) Hyperkeratosis 1 (2%) Inflammation, Chronic Active 5 (10%) 6 (12%) Stomach, Glandular (50) (50) Inflammation, Chronic Active 6 (12%) 6 (12%) Mineralization 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Tooth (50) (50) Inflammation, Chronic Active 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) Cardiomyopathy, Chronic 29 (58%) 27 (55%) Inflammation, Chronic Active 1 (2%) 1 (2%) Atrium, Thrombosis 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) Atypia Cellular 1 (2%) Degeneration, Fatty 22 (44%) 15 (30%) Hyperplasia 22 (44%) 23 (46%) Hypertrophy 4 (8%) 3 (6%) Necrosis, Coagulative 1 (2%) Adrenal Gland, Medulla (50) (50) Hyperplasia 8 (16%) 10 (20%) Parathyroid Gland (37) (42) Hyperplasia 3 (8%) 2 (5%) Pituitary Gland (50) (50) Pars Distalis, Atypia Cellular 2 (4%) Pars Distalis, Cyst 17 (34%) 25 (50%) Pars Distalis, Hyperplasia 12 (24%) 11 (22%) Pars Intermedia, Cyst 1 (2%) 3 (6%) Pars Nervosa, Cyst 1 (2%) Thyroid Gland (49) (50) Ultimobranchial Cyst 1 (2%) C-Cell, Hyperplasia 33 (67%) 27 (54%) Follicular Cell, Hyperplasia 45 (92%) 47 (94%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) Hyperplasia 2 (4%) 1 (2%) Inflammation, Chronic Active 9 (19%) 8 (17%) Duct, Dilatation 6 (13%) 9 (19%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Ovary (50) (50) Atrophy 1 (2%) Cyst 9 (18%) 16 (32%) Uterus (50) (50) Dilatation 1 (2%) Inflammation, Chronic Active 1 (2%) Cervix, Diverticulum 2 (4%) 1 (2%) Cervix, Inflammation, Suppurative 2 (4%) 1 (2%) Endometrium, Hyperplasia, Cystic, Glandular 4 (8%) 8 (16%) Vagina (1) Inflammation, Suppurative 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (50) (50) Lumbar, Inflammation, Chronic Active 1 (2%) Mandibular, Hyperplasia, Lymphoid 1 (2%) Mandibular, Hyperplasia, Plasma Cell 1 (2%) Pancreatic, Cyst 1 (2%) Spleen (50) (50) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 2 (4%) Thymus (41) (44) Cyst 2 (5%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) Hyperplasia, Cystic 47 (94%) 49 (98%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) Cranium, Fibrous Osteodystrophy 2 (4%) 1 (2%) Femur, Fibrous Osteodystrophy 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) Compression 7 (14%) 13 (26%) Hemorrhage 1 (2%) 1 (2%) Hydrocephalus 8 (16%) 11 (22%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Fungus 1 (2%) Inflammation, Chronic Active 5 (10%) 10 (20%) Leukocytosis 2 (4%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) Artery, Mediastinum, Inflammation, Chronic Active 1 (2%) Artery, Mediastinum, Necrosis, Fibrinoid 1 (2%) Mediastinum, Hemorrhage 1 (2%) Nose (50) (50) Foreign Body 1 (2%) Fungus 2 (4%) 2 (4%) Hemorrhage 1 (2%) Inflammation, Chronic Active 4 (8%) 6 (12%) Mucosa, Nasolacrimal Duct, Hyperplasia 1 (2%) Nasolacrimal Duct, Dilatation 1 (2%) Nasolacrimal Duct, Hyperkeratosis 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 5 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (12) (8) Hemorrhage 1 (8%) Lens, Cataract 9 (75%) 5 (63%) Retina, Atrophy 8 (67%) 5 (63%) Harderian Gland (50) (50) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Cyst 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) Necrosis, Coagulative 1 (2%) Nephropathy, Chronic 48 (96%) 47 (94%) Urinary Bladder (49) (50) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 50 Early Deaths Natural Death 10 5 8 7 7 10 Moribund Sacrifice 21 27 20 26 23 25 Survivors Terminal Sacrifice 18 15 17 15 18 14 Natural Death 1 1 3 1 1 Moribund Sacrifice 2 2 2 1 Animals Examined Microscopically 50 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) (50) (50) Hemorrhage 1 (2%) Intestine Large, Cecum (45) (47) (40) (44) (43) (43) Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (5%) 1 (2%) Parasite Metazoan 1 (3%) 1 (2%) Perivascular, Inflammation, Chronic Active 5 (11%) Intestine Large, Colon (48) (49) (42) (45) (45) (50) Necrosis, Coagulative 1 (2%) Parasite Metazoan 3 (6%) 1 (2%) 3 (7%) 3 (7%) 2 (4%) 3 (6%) Intestine Large, Rectum (47) (46) (40) (43) (44) (45) Edema 1 (2%) Inflammation, Chronic Active 1 (2%) Parasite Metazoan 7 (15%) 2 (4%) 3 (8%) 9 (21%) 5 (11%) 5 (11%) Artery, Necrosis, Fibrinoid 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (48) (49) (46) (47) (49) (49) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Necrosis, Coagulative 1 (2%) Intestine Small, Ileum (45) (47) (42) (43) (45) (46) Edema 1 (2%) Necrosis, Coagulative 1 (2%) Intestine Small, Jejunum (48) (49) (44) (46) (47) (50) Dilatation 1 (2%) Edema 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Metaplasia, Osseous 1 (2%) Liver (50) (50) (50) (50) (50) (50) Basophilic Focus 12 (24%) 4 (8%) 9 (18%) 7 (14%) 14 (28%) 5 (10%) Clear Cell Focus 1 (2%) 2 (4%) 2 (4%) 2 (4%) 1 (2%) Cyst 1 (2%) Degeneration, Cystic 17 (34%) 19 (38%) 18 (36%) 13 (26%) 20 (40%) 21 (42%) Eosinophilic Focus 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hematopoietic Cell Proliferation 1 (2%) Hepatodiaphragmatic Nodule 1 (2%) Hepatodiaphragmatic Nodule, Multiple 1 (2%) Hyperplasia 1 (2%) 2 (4%) Inflammation, Chronic 2 (4%) 3 (6%) 7 (14%) 3 (6%) 1 (2%) 1 (2%) Leukocytosis 1 (2%) 1 (2%) Necrosis, Coagulative 2 (4%) 4 (8%) 3 (6%) 4 (8%) 6 (12%) Vacuolization Cytoplasmic 1 (2%) 1 (2%) 2 (4%) 2 (4%) Bile Duct, Hyperplasia 4 (8%) 1 (2%) 1 (2%) Mesentery (3) (5) (6) (2) (2) (3) Hemorrhage 1 (17%) Inflammation, Chronic Active 3 (100%) 2 (40%) 4 (67%) 1 (50%) 1 (50%) 1 (33%) Thrombosis 1 (50%) Pancreas (48) (50) (50) (50) (49) (50) Cyst 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Acinus, Atrophy 20 (42%) 30 (60%) 24 (48%) 24 (48%) 27 (55%) 18 (36%) Acinus, Hyperplasia 1 (2%) Acinus, Hyperplasia, Focal 1 (2%) 1 (2%) Artery, Necrosis, Fibrinoid 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) 3 (6%) 1 (2%) 1 (2%) 5 (10%) Salivary Glands (50) (49) (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) Stomach, Forestomach (49) (50) (47) (50) (48) (49) Acanthosis 4 (8%) 3 (6%) 2 (4%) 4 (8%) 3 (6%) Hyperkeratosis 4 (8%) 3 (6%) 2 (4%) 4 (8%) 3 (6%) Hyperplasia 1 (2%) Hyperplasia, Squamous 1 (2%) 1 (2%) Inflammation, Chronic Active 3 (6%) 4 (8%) 3 (6%) 5 (10%) 6 (13%) 3 (6%) Stomach, Glandular (49) (50) (47) (49) (49) (49) Cyst Epithelial Inclusion 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) 3 (6%) 4 (8%) 6 (12%) Mineralization 2 (4%) 4 (8%) 1 (2%) 2 (4%) 2 (4%) 3 (6%) Necrosis, Coagulative 1 (2%) 1 (2%) Tooth (50) (50) (49) (50) (50) (50) Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) (50) (50) Cardiomyopathy, Chronic 46 (92%) 44 (88%) 47 (94%) 41 (82%) 44 (88%) 47 (94%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Mineralization 2 (4%) 1 (2%) 2 (4%) 1 (2%) 3 (6%) Atrium, Thrombosis 3 (6%) 8 (16%) 1 (2%) 7 (14%) 1 (2%) 4 (8%) Ventricle, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) (49) (50) (49) (50) Accessory Adrenal Cortical Nodule 1 (2%) Degeneration, Fatty 14 (28%) 15 (30%) 11 (22%) 15 (30%) 13 (27%) 10 (20%) Hyperplasia 15 (30%) 18 (36%) 19 (39%) 17 (34%) 21 (43%) 16 (32%) Hypertrophy 4 (8%) 2 (4%) 5 (10%) 2 (4%) 5 (10%) 5 (10%) Necrosis, Coagulative 1 (2%) 1 (2%) Adrenal Gland, Medulla (50) (50) (49) (49) (49) (50) Hematocyst 1 (2%) Hyperplasia 21 (42%) 21 (42%) 23 (47%) 21 (43%) 30 (61%) 21 (42%) Necrosis, Coagulative 1 (2%) Islets, Pancreatic (48) (50) (50) (50) (49) (50) Hyperplasia, Focal 1 (2%) Parathyroid Gland (44) (46) (48) (45) (45) (47) Hyperplasia 8 (18%) 5 (11%) 3 (6%) 4 (9%) 6 (13%) 5 (11%) Pituitary Gland (50) (50) (48) (47) (49) (49) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Cyst 4 (8%) 3 (6%) 4 (8%) 4 (9%) 7 (14%) 3 (6%) Pars Distalis, Hemorrhage 2 (4%) 4 (8%) Pars Distalis, Hyperplasia 12 (24%) 9 (18%) 12 (25%) 9 (19%) 10 (20%) 12 (24%) Pars Distalis, Vacuolization Cytoplasmic 1 (2%) Pars Intermedia, Cyst 1 (2%) 2 (4%) 3 (6%) 4 (9%) 5 (10%) 4 (8%) Rathke's Cleft, Cyst 1 (2%) Thyroid Gland (49) (49) (46) (46) (47) (50) Inflammation, Chronic Active 1 (2%) Ultimobranchial Cyst 3 (6%) C-Cell, Hyperplasia 29 (59%) 33 (67%) 22 (48%) 30 (65%) 35 (74%) 27 (54%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 4 (8%) 12 (24%) 13 (28%) 30 (65%) 35 (74%) 47 (94%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (3) Inflammation, Chronic Active 2 (67%) Epididymis (50) (50) (50) (50) (49) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Preputial Gland (49) (49) (49) (49) (46) (50) Hyperplasia 3 (6%) 1 (2%) 1 (2%) 1 (2%) 2 (4%) Hypertrophy 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 45 (92%) 45 (92%) 46 (94%) 46 (94%) 42 (91%) 47 (94%) Duct, Dilatation 1 (2%) 1 (2%) 1 (2%) Prostate (50) (50) (50) (50) (50) (49) Cyst 1 (2%) 3 (6%) 1 (2%) Inflammation, Chronic Active 29 (58%) 27 (54%) 23 (46%) 24 (48%) 21 (42%) 25 (51%) Epithelium, Hyperplasia 1 (2%) 2 (4%) Seminal Vesicle (1) (1) (4) (1) Inflammation, Chronic Active 1 (25%) 1 (100%) Testes (50) (50) (50) (50) (50) (50) Cyst 1 (2%) Inflammation, Chronic Active 1 (2%) Necrosis, Coagulative 1 (2%) 1 (2%) Interstitial Cell, Hyperplasia 9 (18%) 12 (24%) 9 (18%) 7 (14%) 4 (8%) 5 (10%) Seminiferous Tubule, Atrophy 9 (18%) 8 (16%) 11 (22%) 11 (22%) 8 (16%) 6 (12%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) (49) (50) Femoral, Hyperplasia, Reticulum Cell 1 (2%) 1 (2%) Femoral, Myelofibrosis 1 (2%) 1 (2%) 1 (2%) 1 (2%) Femoral, Myeloid Cell, Atrophy 1 (2%) Femoral, Myeloid Cell, Hyperplasia 1 (2%) Lymph Node (50) (50) (50) (50) (48) (50) Inguinal, Necrosis 1 (2%) Mandibular, Cyst 1 (2%) 2 (4%) 1 (2%) 3 (6%) 2 (4%) Mandibular, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Mandibular, Hyperplasia, Plasma Cell 2 (4%) 1 (2%) 1 (2%) Mandibular, Necrosis 1 (2%) 1 (2%) Mediastinal, Cyst 2 (4%) 1 (2%) Mediastinal, Inflammation, Chronic Active 1 (2%) Mediastinal, Inflammation, Suppurative 1 (2%) Renal, Infiltration Cellular, Histiocyte 1 (2%) Lymph Node, Mesenteric (2) (10) (14) (10) (9) (10) Cyst 1 (10%) Necrosis 1 (10%) Spleen (50) (50) (50) (50) (50) (50) Fibrosis 6 (12%) 8 (16%) 2 (4%) 4 (8%) 3 (6%) 4 (8%) Hematopoietic Cell Proliferation 1 (2%) 3 (6%) 1 (2%) 1 (2%) 2 (4%) Necrosis, Coagulative 2 (4%) 1 (2%) 1 (2%) 1 (2%) Thrombosis 1 (2%) 2 (4%) Thymus (40) (39) (45) (42) (40) (38) Cyst 1 (2%) Ectopic Parathyroid Gland 1 (3%) Necrosis 1 (3%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (42) (40) (42) (37) (45) (41) Hyperplasia, Cystic 42 (100%) 36 (90%) 39 (93%) 35 (95%) 40 (89%) 37 (90%) Skin (50) (49) (50) (50) (49) (50) Abscess 1 (2%) Acanthosis 1 (2%) 1 (2%) Cyst Epithelial Inclusion 1 (2%) 1 (2%) Hyperkeratosis 1 (2%) Hyperplasia, Basal Cell 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) Vein, Dilatation 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) (50) Cranium, Fibrous Osteodystrophy 4 (8%) 4 (8%) 3 (6%) 1 (2%) 6 (12%) 3 (6%) Femur, Fibrous Osteodystrophy 4 (8%) 4 (8%) 3 (6%) 1 (2%) 6 (12%) 3 (6%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) (50) Compression 5 (10%) 5 (10%) 1 (2%) 5 (10%) 3 (6%) Hemorrhage 1 (2%) 2 (4%) 1 (2%) 3 (6%) 3 (6%) 1 (2%) Hydrocephalus 4 (8%) 5 (10%) 2 (4%) 5 (10%) 3 (6%) Necrosis 1 (2%) 1 (2%) Peripheral Nerve (2) (1) (1) Sciatic, Degeneration 1 (100%) Spinal Cord (2) (1) (2) Hemorrhage 1 (50%) White Matter, Degeneration 2 (100%) 1 (100%) 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) (50) Granuloma 1 (2%) Hemorrhage 1 (2%) 1 (2%) Inflammation, Chronic Active 9 (18%) 4 (8%) 5 (10%) 5 (10%) 5 (10%) 3 (6%) Leukocytosis 1 (2%) Metaplasia, Osseous 1 (2%) 1 (2%) Mineralization 1 (2%) Necrosis, Coagulative 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Artery, Mediastinum, Necrosis, Fibrinoid 1 (2%) Mediastinum, Mineralization 1 (2%) Mediastinum, Perivascular, Inflammation, Chronic Active 1 (2%) 1 (2%) Nose (50) (50) (50) (50) (49) (50) Cyst 1 (2%) Fungus 5 (10%) 1 (2%) 5 (10%) 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic Active 15 (30%) 10 (20%) 12 (24%) 11 (22%) 13 (27%) 13 (26%) Nasolacrimal Duct, Hyperkeratosis 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 6 (12%) 4 (8%) 7 (14%) 5 (10%) 8 (16%) 5 (10%) Trachea (50) (50) (50) (50) (50) (50) Cyst 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (11) (10) (6) (8) (4) (5) Hemorrhage 1 (9%) 1 (20%) Inflammation, Chronic Active 1 (9%) 1 (20%) Lens, Cataract 9 (82%) 7 (70%) 4 (67%) 6 (75%) 3 (75%) 3 (60%) Retina, Atrophy 10 (91%) 9 (90%) 4 (67%) 6 (75%) 3 (75%) 3 (60%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (49) (50) (50) (50) Bacterium 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Necrosis, Coagulative 2 (4%) Nephropathy, Chronic 49 (98%) 50 (100%) 47 (96%) 49 (98%) 49 (98%) 50 (100%) Artery, Necrosis, Fibrinoid 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Mineralization 1 (2%) Renal Tubule, Epithelium, Hyperplasia 3 (6%) 1 (2%) 3 (6%) Urethra (1) Transitional Epithelium, Hyperplasia 1 (100%) Urinary Bladder (49) (50) (48) (49) (48) (50) Dilatation 1 (2%) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 17 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 0 PPM 25 PPM 83 PPM 83 PPM 83 PPM 0-0 10-0 1-1 0-3 3-3 10-3 ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Chronic Active 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 18 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 Early Deaths Moribund Sacrifice 23 30 Natural Death 8 14 Accidently Killed 5 Survivors Moribund Sacrifice 1 Natural Death 1 Terminal Sacrifice 14 4 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) Inflammation, Chronic Active 1 (2%) Intestine Large, Cecum (44) (39) Artery, Inflammation, Chronic Active 1 (3%) Intestine Large, Colon (47) (47) Parasite Metazoan 2 (4%) 3 (6%) Intestine Large, Rectum (43) (45) Parasite Metazoan 4 (9%) 3 (7%) Artery, Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (50) (49) Inflammation, Chronic Active 1 (2%) Necrosis, Coagulative 1 (2%) Liver (50) (50) Angiectasis 2 (4%) 2 (4%) Basophilic Focus 15 (30%) 3 (6%) Clear Cell Focus 4 (8%) Degeneration, Cystic 25 (50%) 17 (34%) Inflammation, Chronic 10 (20%) 3 (6%) Leukocytosis 1 (2%) Necrosis, Coagulative 6 (12%) 4 (8%) Thrombosis 1 (2%) Vacuolization Cytoplasmic 2 (4%) 1 (2%) Mesentery (2) (3) Inflammation, Chronic Active 2 (100%) Artery, Inflammation, Chronic Active 1 (33%) Pancreas (49) (50) Necrosis, Coagulative 1 (2%) Acinus, Atrophy 17 (35%) 19 (38%) Artery, Inflammation, Chronic Active 1 (2%) Salivary Glands (50) (49) Inflammation, Chronic Active 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 19 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Necrosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (49) (50) Necrosis, Coagulative 3 (6%) Stomach, Glandular (49) (49) Inflammation, Chronic Active 2 (4%) Mineralization 1 (2%) 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) Tooth (49) (50) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) Cardiomyopathy, Chronic 39 (78%) 43 (86%) Mineralization 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Atrium, Thrombosis 3 (6%) 4 (8%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) Degeneration, Fatty 14 (28%) 13 (26%) Hyperplasia 9 (18%) 6 (12%) Hypertrophy, Focal 1 (2%) Necrosis, Coagulative 1 (2%) Vacuolization Cytoplasmic 1 (2%) Adrenal Gland, Medulla (50) (50) Hyperplasia 14 (28%) 17 (34%) Necrosis, Coagulative 1 (2%) Islets, Pancreatic (50) (50) Hyperplasia 3 (6%) Necrosis, Coagulative 1 (2%) Pituitary Gland (50) (49) Pars Distalis, Atypia Cellular 1 (2%) Pars Distalis, Cyst 8 (16%) Pars Distalis, Hyperplasia 6 (12%) 16 (33%) Pars Distalis, Vacuolization Cytoplasmic 1 (2%) Thyroid Gland (50) (50) Inflammation, Chronic Active 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) C-Cell, Hyperplasia 12 (24%) 9 (18%) Follicular Cell, Hyperplasia 41 (82%) 39 (78%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 20 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (50) Mineralization 1 (2%) Preputial Gland (49) (50) Inflammation, Chronic Active 41 (84%) 42 (84%) Prostate (49) (50) Cyst 2 (4%) 1 (2%) Inflammation, Chronic Active 27 (55%) 27 (54%) Seminal Vesicle (2) Artery, Inflammation, Chronic Active 1 (50%) Testes (50) (50) Artery, Inflammation, Chronic Active 1 (2%) Interstitial Cell, Hyperplasia 6 (12%) 8 (16%) Seminiferous Tubule, Atrophy 8 (16%) 7 (14%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (50) Femoral, Myelofibrosis 1 (2%) Lymph Node (50) (49) Mandibular, Hyperplasia, Plasma Cell 2 (4%) 3 (6%) Lymph Node, Mesenteric (14) (10) Cyst 1 (7%) Spleen (50) (50) Fibrosis 8 (16%) 6 (12%) Hematopoietic Cell Proliferation 1 (2%) Necrosis, Coagulative 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) Thymus (43) (44) Ectopic Parathyroid Gland 1 (2%) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (36) (37) Hyperplasia, Cystic 31 (86%) 37 (100%) Skin (49) (49) Hyperkeratosis 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 21 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (50) Femur, Fibrous Osteodystrophy 1 (2%) Skeletal Muscle (5) (2) Artery, Inflammation, Chronic Active 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) Compression 1 (2%) Hemorrhage 1 (2%) Hydrocephalus 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Peripheral Nerve (6) Sciatic, Degeneration 2 (33%) Spinal Cord (7) White Matter, Degeneration 2 (29%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Congestion 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic Active 6 (12%) 10 (20%) Thrombosis 1 (2%) 1 (2%) Artery, Mediastinum, Inflammation, Chronic Active 1 (2%) Vein, Mediastinum, Thrombosis 1 (2%) Nose (50) (50) Foreign Body 1 (2%) Fungus 1 (2%) 5 (10%) Hemorrhage 3 (6%) Inflammation, Chronic Active 9 (18%) 16 (32%) Nasolacrimal Duct, Foreign Body 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 7 (14%) 6 (12%) Trachea (50) (50) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 22 NTP Experiment-Test: 05076-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC ETHYLENETHIOUREA Date: 09/09/94 Route: DOSED FEED Time: 20:34:58 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 250 PPM 250 PPM 0-10 10-10 ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (11) (10) Lens, Cataract 5 (45%) 9 (90%) Retina, Atrophy 5 (45%) 8 (80%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Necrosis, Coagulative 1 (2%) 1 (2%) Nephropathy, Chronic 45 (90%) 50 (100%) Artery, Inflammation, Chronic Active 1 (2%) Renal Tubule, Epithelium, Hyperplasia 7 (14%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 23 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------ --multipart-boundary Content-type: text/plain Range: bytes 152765-152765/152765 --multipart-boundary--