TDMS Study 05037-03 Pathology Tables
NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 Facility: Southern Research Institute Chemical CAS #: 1825-21-4 Lock Date: None Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include 001 VEHICLE CONTROL Include 004 VEHICLE CONTROL Include 007 40 MG/KG Include 010 40 MG/KG Include 013 20 MG/KG Include 016 20 MG/KG Include 019 10 MG/KG a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 Early Deaths Moribund Sacrifice 17 13 4 Natural Death 4 2 2 Survivors Terminal Sacrifice 29 35 44 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (1) (50) Inflammation, Chronic 1 (2%) Parasite Metazoan 2 (4%) Intestine Large, Colon (49) (1) (49) Inflammation, Chronic 1 (2%) Parasite Metazoan 2 (4%) 2 (4%) Intestine Large, Rectum (50) (1) (49) Edema 1 (2%) Inflammation, Chronic 2 (4%) Parasite Metazoan 7 (14%) 9 (18%) Intestine Small, Ileum (50) (1) (50) Inflammation, Chronic 1 (2%) Intestine Small, Jejunum (50) (1) (50) Inflammation, Chronic 1 (2%) Necrosis 1 (2%) Liver (50) (50) (50) Angiectasis 4 (8%) 2 (4%) Basophilic Focus 42 (84%) 44 (88%) 45 (90%) Clear Cell Focus 5 (10%) 3 (6%) 2 (4%) Developmental Malformation 1 (2%) 5 (10%) Eosinophilic Focus 1 (2%) 2 (4%) Granuloma 29 (58%) 19 (38%) 24 (48%) Hematopoietic Cell Proliferation 2 (4%) 4 (8%) 3 (6%) Hepatodiaphragmatic Nodule 3 (6%) 7 (14%) 5 (10%) Hyperplasia, Focal 4 (8%) 6 (12%) 5 (10%) Inflammation, Chronic 11 (22%) 10 (20%) 12 (24%) Inflammation, Chronic Active 1 (2%) Mixed Cell Focus 4 (8%) 4 (8%) Bile Duct, Hyperplasia 31 (62%) 27 (54%) 17 (34%) Centrilobular, Atrophy 1 (2%) 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%) Hepatocyte, Pigmentation 18 (36%) 24 (48%) Hepatocyte, Vacuolization Cytoplasmic 4 (8%) 3 (6%) 1 (2%) Kupffer Cell, Pigmentation 3 (6%) 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Lobules, Necrosis 2 (4%) 3 (6%) 1 (2%) Oval Cell, Hyperplasia 1 (2%) 1 (2%) Portal, Necrosis 1 (2%) Mesentery (13) (3) (7) Cyst 1 (8%) Necrosis 1 (14%) Fat, Inflammation, Chronic Active 2 (15%) Fat, Necrosis 10 (77%) 3 (100%) 6 (86%) Pancreas (50) (50) Atrophy 11 (22%) 10 (20%) Cytoplasmic Alteration 2 (4%) Hyperplasia, Focal 3 (6%) Inflammation, Chronic 3 (6%) Duct, Hyperplasia 1 (2%) Salivary Glands (50) (50) Atrophy 3 (6%) Duct, Dilatation 1 (2%) 1 (2%) Stomach, Forestomach (50) (1) (50) Edema 3 (6%) 1 (2%) Foreign Body 1 (100%) Inflammation, Chronic Active 1 (2%) 1 (100%) 1 (2%) Ulcer 2 (4%) 1 (2%) Mucosa, Hyperplasia 3 (6%) 1 (100%) 3 (6%) Stomach, Glandular (50) (1) (50) Erosion 2 (4%) Mineralization 3 (6%) Mucosa, Hyperplasia 1 (2%) Tooth (2) (1) Developmental Malformation 1 (100%) Inflammation, Suppurative 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) Cardiomyopathy 20 (40%) 31 (62%) Myocardium, Inflammation, Chronic 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (50) (50) Hypertrophy, Focal 1 (2%) Adrenal Gland, Cortex (50) (50) (50) Accessory Adrenal Cortical Nodule 9 (18%) 13 (26%) 13 (26%) Angiectasis 24 (48%) 30 (60%) 27 (54%) Clear Cell Focus 4 (8%) 4 (8%) 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Cyst 1 (2%) Degeneration, Fatty 1 (2%) Hematopoietic Cell Proliferation 2 (4%) Hyperplasia, Focal 12 (24%) 13 (26%) 12 (24%) Hypertrophy, Focal 1 (2%) 3 (6%) 4 (8%) Necrosis 1 (2%) Vacuolization Cytoplasmic, Diffuse 1 (2%) Adrenal Gland, Medulla (50) (50) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) Hyperplasia 10 (20%) 18 (36%) 25 (50%) Islets, Pancreatic (50) (50) Hyperplasia 2 (4%) Pituitary Gland (49) (50) (50) Pars Distalis, Angiectasis 4 (8%) 7 (14%) 8 (16%) Pars Distalis, Cyst 20 (41%) 27 (54%) 20 (40%) Pars Distalis, Hyperplasia 9 (18%) 8 (16%) 8 (16%) Pars Distalis, Pigmentation 9 (18%) 10 (20%) 9 (18%) Pars Intermedia, Angiectasis 1 (2%) 1 (2%) Pars Intermedia, Cyst 1 (2%) 2 (4%) 1 (2%) Pars Intermedia, Pigmentation 1 (2%) Pars Nervosa, Cyst 1 (2%) Thyroid Gland (50) (2) (50) Ultimobranchial Cyst 3 (6%) 1 (2%) C-Cell, Hyperplasia 5 (10%) 13 (26%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (8) (50) Ectasia 4 (8%) 2 (25%) 2 (4%) Hyperplasia 1 (2%) Inflammation, Chronic 3 (6%) 1 (13%) 5 (10%) Inflammation, Suppurative 3 (6%) 4 (8%) Ovary (50) (5) (50) Cyst 1 (2%) 1 (20%) 6 (12%) Uterus (50) (50) (50) Abscess 2 (4%) 1 (2%) 2 (4%) Angiectasis 1 (2%) Cyst 1 (2%) 2 (4%) Hemorrhage 3 (6%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Hydrometra 7 (14%) 2 (4%) 6 (12%) Hyperplasia, Cystic 13 (26%) 13 (26%) 20 (40%) Inflammation, Suppurative 2 (4%) Necrosis 1 (2%) Myometrium, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) Hypercellularity 1 (2%) 2 (4%) Hyperplasia, Reticulum Cell 3 (6%) 3 (6%) Lymph Node (50) (11) (50) Bronchial, Hemorrhage 1 (2%) Bronchial, Pigmentation 1 (2%) Inguinal, Hyperplasia, Plasma Cell 1 (2%) 1 (9%) Lumbar, Hyperplasia, Plasma Cell 1 (9%) Lumbar, Lymphatic, Dilatation 1 (9%) Mediastinal, Hemorrhage 7 (14%) 2 (4%) Mediastinal, Hyperplasia, Lymphoid 1 (2%) Mediastinal, Hyperplasia, Plasma Cell 1 (9%) 2 (4%) Mediastinal, Pigmentation 10 (20%) 1 (9%) 7 (14%) Pancreatic, Hemorrhage 1 (9%) Pancreatic, Hyperplasia, Plasma Cell 1 (2%) Pancreatic, Infiltration Cellular, Histiocyte 1 (2%) Pancreatic, Lymphatic, Dilatation 1 (2%) Renal, Hemorrhage 1 (2%) Renal, Pigmentation 1 (9%) 1 (2%) Lymph Node, Mandibular (50) (3) (50) Hemorrhage 1 (33%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (33%) 2 (4%) Hyperplasia, Plasma Cell 14 (28%) 1 (33%) 20 (40%) Infiltration Cellular, Mast Cell 1 (2%) Pigmentation 1 (2%) Lymphatic, Dilatation 1 (2%) 1 (33%) 5 (10%) Lymph Node, Mesenteric (49) (3) (50) Hemorrhage 2 (4%) 1 (33%) 1 (2%) Hyperplasia, Lymphoid 3 (6%) Lymphatic, Dilatation 1 (2%) Spleen (50) (10) (50) Congestion 2 (4%) Developmental Malformation 1 (10%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 15 (30%) 4 (40%) 6 (12%) Hyperplasia, Re Cell 1 (2%) Necrosis 1 (2%) 1 (10%) Pigmentation, Hemosiderin 5 (10%) 2 (20%) 7 (14%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lymphoid Follicle, Hyperplasia 2 (4%) Thymus (47) (48) Cyst 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (21) (50) Hyperplasia, Cystic 38 (79%) 15 (71%) 33 (66%) Hyperplasia, Lobular 4 (8%) 2 (10%) 2 (4%) Skin (50) (3) (50) Hemorrhage 1 (33%) Inflammation, Chronic 1 (2%) Inflammation, Granulomatous 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (6) (50) Calvarium, Osteopetrosis 5 (10%) 6 (100%) Femur, Osteopetrosis 6 (12%) 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (4) (50) Compression 6 (12%) 3 (75%) 4 (8%) Degeneration, Focal 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hydrocephalus 4 (8%) 1 (25%) 4 (8%) Necrosis 1 (2%) Pigmentation 1 (2%) Meninges, Fibrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (7) (50) Congestion 2 (4%) 1 (14%) 1 (2%) Edema 2 (4%) Hemorrhage 1 (2%) Infiltration Cellular, Histiocyte 24 (48%) 4 (57%) 31 (62%) Inflammation, Chronic 12 (24%) 1 (14%) 18 (36%) Inflammation, Suppurative 1 (14%) 1 (2%) Pigmentation, Cholesterol 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 2 (29%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Smooth Muscle, Hyperplasia 1 (2%) Nose (49) (50) (50) Developmental Malformation 1 (2%) Exudate 3 (6%) 8 (16%) 7 (14%) Foreign Body 1 (2%) 3 (6%) 1 (2%) Fungus 1 (2%) 5 (10%) 1 (2%) Inflammation, Chronic 5 (10%) 13 (26%) 11 (22%) Glands, Hyperplasia 1 (2%) Glands, Necrosis 1 (2%) Mucosa, Hyperplasia 5 (10%) 2 (4%) Mucosa, Metaplasia, Squamous 4 (8%) Olfactory Epithelium, Pigmentation 46 (92%) 50 (100%) Trachea (50) (50) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (4) (8) Cataract 1 (100%) 3 (75%) 8 (100%) Phthisis Bulbi 1 (25%) Cornea, Inflammation, Chronic Active 1 (13%) Cornea, Mineralization 1 (13%) Retina, Atrophy 1 (100%) 3 (75%) 8 (100%) Sclera, Mineralization 2 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Cyst 1 (2%) 1 (2%) 1 (2%) Hydronephrosis 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic 7 (14%) 11 (22%) 10 (20%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Mineralization 21 (42%) 24 (48%) 15 (30%) Nephropathy 41 (82%) 48 (96%) 42 (84%) Renal Tubule, Atrophy 1 (2%) Renal Tubule, Degeneration 1 (2%) Renal Tubule, Dilatation 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Pigmentation 43 (86%) 45 (90%) Transitional Epithelium, Hyperplasia 4 (8%) 2 (4%) Urethra (1) Inflammation, Chronic 1 (100%) Necrosis 1 (100%) Urinary Bladder (50) (1) (49) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Chronic 1 (2%) Inflammation, Subacute 2 (4%) Mucosa, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 23 21 14 5 Natural Death 3 5 7 27 Dosing Accident 4 2 Accidently Killed 5 2 Survivors Terminal Sacrifice 24 20 24 14 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Ulcer 1 (2%) Intestine Large, Cecum (50) (49) (48) (50) Edema 1 (2%) 1 (2%) 1 (2%) Parasite Metazoan 2 (4%) 3 (6%) Ulcer 2 (4%) 1 (2%) Intestine Large, Colon (50) (50) (49) (49) Parasite Metazoan 5 (10%) 2 (4%) 5 (10%) Intestine Large, Rectum (50) (50) (49) (47) Edema 1 (2%) Parasite Metazoan 5 (10%) 6 (12%) 3 (6%) 3 (6%) Lymphatic, Dilatation 1 (2%) Liver (50) (50) (50) (50) Angiectasis 4 (8%) 1 (2%) 2 (4%) Basophilic Focus 27 (54%) 27 (54%) 26 (52%) 8 (16%) Clear Cell Focus 14 (28%) 7 (14%) 6 (12%) 4 (8%) Congestion 2 (4%) 2 (4%) 13 (26%) Degeneration, Cystic 2 (4%) 5 (10%) 9 (18%) 6 (12%) Eosinophilic Focus 3 (6%) 9 (18%) 9 (18%) 1 (2%) Granuloma 19 (38%) 10 (20%) 6 (12%) 8 (16%) Hematopoietic Cell Proliferation 4 (8%) 2 (4%) 2 (4%) Hepatodiaphragmatic Nodule 2 (4%) 2 (4%) 1 (2%) Hyperplasia, Focal 7 (14%) 5 (10%) 2 (4%) Inflammation, Chronic 6 (12%) 8 (16%) 9 (18%) 4 (8%) Inflammation, Chronic Active 1 (2%) Mixed Cell Focus 1 (2%) 3 (6%) 1 (2%) Bile Duct, Hyperplasia 45 (90%) 45 (90%) 44 (88%) 26 (52%) Centrilobular, Atrophy 2 (4%) 5 (10%) Centrilobular, Necrosis 6 (12%) 6 (12%) 17 (34%) Hepatocyte, Pigmentation 1 (2%) 4 (8%) Hepatocyte, Vacuolization Cytoplasmic 8 (16%) 2 (4%) 1 (2%) 2 (4%) Kupffer Cell, Hyperplasia 3 (6%) 1 (2%) 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Kupffer Cell, Pigmentation 1 (2%) Lobules, Necrosis 2 (4%) 4 (8%) 1 (2%) 1 (2%) Periportal, Inflammation, Chronic Active 1 (2%) Portal, Necrosis 1 (2%) Mesentery (11) (11) (5) (9) Accessory Spleen 1 (9%) 1 (9%) Fat, Inflammation, Pyogranulomatous 1 (9%) Fat, Necrosis 6 (55%) 5 (45%) 4 (80%) 3 (33%) Pancreas (49) (49) (49) (50) Atrophy 14 (29%) 17 (35%) 19 (39%) 9 (18%) Cytoplasmic Alteration 3 (6%) 2 (4%) 1 (2%) Edema 1 (2%) Fibrosis 1 (2%) Focal Cellular Change 1 (2%) 3 (6%) Hyperplasia, Focal 19 (39%) 17 (35%) 8 (16%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Salivary Glands (50) (50) (48) (50) Atrophy 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Dysplasia 1 (2%) Edema 1 (2%) 2 (4%) 4 (8%) Erosion 2 (4%) 2 (4%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Ulcer 3 (6%) 4 (8%) 2 (4%) Mucosa, Hyperplasia 6 (12%) 7 (14%) 5 (10%) Stomach, Glandular (50) (50) (50) (50) Edema 1 (2%) 1 (2%) Erosion 3 (6%) 1 (2%) 2 (4%) Hemorrhage 1 (2%) Inflammation, Chronic Active 2 (4%) Mineralization 4 (8%) 3 (6%) 1 (2%) 1 (2%) Ulcer 3 (6%) 1 (2%) 1 (2%) 3 (6%) Mucosa, Hyperplasia 1 (2%) Tooth (2) (1) Developmental Malformation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (4) (4) (5) (5) Polyarteritis 4 (100%) 4 (100%) 4 (80%) 5 (100%) Heart (50) (50) (49) (50) Angiectasis 1 (2%) Cardiomyopathy 33 (66%) 37 (74%) 36 (73%) 21 (42%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Thrombosis 1 (2%) 1 (2%) Epicardium, Inflammation, Chronic 1 (2%) Myocardium, Inflammation, Chronic 2 (4%) 3 (6%) 3 (6%) 7 (14%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (50) (50) (50) Accessory Adrenal Cortical Nodule 14 (29%) 11 (22%) 8 (16%) 6 (12%) Angiectasis 4 (8%) 2 (4%) 2 (4%) 4 (8%) Clear Cell Focus 4 (8%) 5 (10%) 5 (10%) 3 (6%) Congestion 2 (4%) 2 (4%) Cyst 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 1 (2%) Hemorrhage 5 (10%) Hyperplasia, Diffuse 1 (2%) Hyperplasia, Focal 7 (14%) 10 (20%) 7 (14%) 2 (4%) Necrosis 2 (4%) 1 (2%) Vacuolization Cytoplasmic, Diffuse 3 (6%) 2 (4%) 1 (2%) 2 (4%) Adrenal Gland, Medulla (50) (50) (50) (48) Angiectasis 1 (2%) 1 (2%) Cyst 1 (2%) Hyperplasia 23 (46%) 26 (52%) 16 (32%) 9 (19%) Infiltration Cellular, Lymphocyte 1 (2%) Islets, Pancreatic (49) (49) (49) (50) Cyst 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia 8 (16%) 7 (14%) 8 (16%) 3 (6%) Pituitary Gland (49) (50) (48) (50) Pars Distalis, Angiectasis 1 (2%) 1 (2%) 1 (2%) 2 (4%) Pars Distalis, Cyst 5 (10%) 2 (4%) 4 (8%) 2 (4%) Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia 9 (18%) 9 (18%) 5 (10%) 2 (4%) Pars Distalis, Necrosis 1 (2%) Pars Distalis, Pigmentation 2 (4%) 1 (2%) Pars Intermedia, Angiectasis 1 (2%) 1 (2%) 1 (2%) Pars Intermedia, Hyperplasia 2 (4%) Pars Nervosa, Cyst 1 (2%) Thyroid Gland (50) (50) (49) (50) Ultimobranchial Cyst 3 (6%) C-Cell, Hyperplasia 9 (18%) 12 (24%) 5 (10%) 4 (8%) Follicle, Cyst 4 (8%) 6 (12%) 1 (2%) 2 (4%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Edema 1 (2%) Inflammation, Chronic 1 (2%) Preputial Gland (50) (48) (50) (50) Ectasia 4 (8%) 1 (2%) 1 (2%) Foreign Body 1 (2%) 1 (2%) Inflammation, Chronic 28 (56%) 23 (48%) 29 (58%) 15 (30%) Inflammation, Suppurative 11 (22%) 7 (15%) 7 (14%) 3 (6%) Prostate (50) (50) (50) (50) Cyst 2 (4%) 1 (2%) Edema 1 (2%) Fibrosis 2 (4%) 1 (2%) Inflammation, Chronic 7 (14%) 2 (4%) 5 (10%) 4 (8%) Inflammation, Suppurative 25 (50%) 26 (52%) 20 (40%) 15 (30%) Seminal Vesicle (50) (50) (49) (50) Edema 1 (2%) Inflammation, Suppurative 1 (2%) Testes (50) (50) (50) (50) Mineralization 26 (52%) 21 (42%) 29 (58%) 14 (28%) Interstitial Cell, Hyperplasia 2 (4%) 2 (4%) 2 (4%) 2 (4%) Seminiferous Tubule, Atrophy 5 (10%) 4 (8%) 7 (14%) 5 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Angiectasis 1 (2%) Hypercellularity 2 (4%) 3 (6%) 6 (12%) Hyperplasia, Reticulum Cell 1 (2%) 1 (2%) Hypocellularity 1 (2%) 1 (2%) 2 (4%) Myelofibrosis 2 (4%) Lymph Node (50) (50) (50) (50) Inguinal, Hyperplasia, Lymphoid 1 (2%) Inguinal, Hyperplasia, Plasma Cell 1 (2%) 1 (2%) Inguinal, Lymphatic, Dilatation 1 (2%) Mediastinal, Congestion 1 (2%) Mediastinal, Hemorrhage 8 (16%) 6 (12%) 10 (20%) 1 (2%) Mediastinal, Hyperplasia, Lymphoid 1 (2%) Mediastinal, Hyperplasia, Plasma Cell 5 (10%) 1 (2%) 1 (2%) Mediastinal, Pigmentation 4 (8%) 8 (16%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pancreatic, Hemorrhage 1 (2%) Pancreatic, Hyperplasia, Lymphoid 2 (4%) Renal, Hyperplasia, Lymphoid 1 (2%) Renal, Lymphatic, Dilatation 1 (2%) Lymph Node, Mandibular (50) (49) (49) (49) Congestion 1 (2%) 2 (4%) 5 (10%) Hemorrhage 2 (4%) 1 (2%) Hyperplasia, Lymphoid 2 (4%) 4 (8%) 2 (4%) 3 (6%) Hyperplasia, Plasma Cell 19 (38%) 18 (37%) 17 (35%) 5 (10%) Hyperplasia, Reticulum Cell 1 (2%) Infiltration Cellular, Polymorphonuclear 1 (2%) Lymphatic, Dilatation 2 (4%) 6 (12%) 10 (20%) 2 (4%) Lymph Node, Mesenteric (50) (50) (49) (48) Congestion 1 (2%) Erythrophagocytosis 1 (2%) 2 (4%) Hemorrhage 1 (2%) 1 (2%) 6 (12%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Reticulum Cell 1 (2%) Necrosis 1 (2%) 2 (4%) Pigmentation 1 (2%) Lymphatic, Dilatation 1 (2%) 1 (2%) Spleen (50) (49) (50) (50) Congestion 2 (4%) 2 (4%) 1 (2%) 1 (2%) Degeneration, Fatty 1 (2%) Developmental Malformation 1 (2%) Fibrosis 2 (4%) 3 (6%) 1 (2%) Hematopoietic Cell Proliferation 9 (18%) 6 (12%) 7 (14%) 2 (4%) Hemorrhage 1 (2%) Hyperplasia, Mononuclear Cell 1 (2%) Hyperplasia, Re Cell 2 (4%) 2 (4%) Necrosis 1 (2%) 1 (2%) 3 (6%) 1 (2%) Pigmentation, Hemosiderin 5 (10%) 7 (14%) 8 (16%) Lymphoid Follicle, Atrophy 1 (2%) Red Pulp, Hyperplasia 1 (2%) Thymus (46) (47) (47) (47) Congestion 1 (2%) 5 (11%) 13 (28%) Cyst 3 (7%) 4 (9%) 1 (2%) 1 (2%) Ectopic Parathyroid Gland 1 (2%) Hemorrhage 5 (11%) 21 (45%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (49) (50) (47) Hyperplasia, Cystic 17 (35%) 13 (27%) 11 (22%) 4 (9%) Hyperplasia, Lobular 2 (4%) 2 (4%) Skin (50) (49) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Acanthosis 2 (4%) 1 (2%) 1 (2%) Angiectasis 1 (2%) Cyst Epithelial Inclusion 1 (2%) 1 (2%) 2 (4%) 1 (2%) Exudate 1 (2%) 1 (2%) Fibrosis 1 (2%) Foreign Body 1 (2%) Hyperkeratosis 1 (2%) 1 (2%) Hyperplasia, Basal Cell 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Ulcer 1 (2%) Lip, Hemorrhage 1 (2%) Scrotum, Congestion 1 (2%) 13 (26%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Femur, Osteopetrosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 6 (12%) 4 (8%) 3 (6%) 2 (4%) Congestion 1 (2%) 4 (8%) 21 (42%) Degeneration, Focal 1 (2%) Hemorrhage 1 (2%) 2 (4%) 4 (8%) Hydrocephalus 1 (2%) 4 (8%) 1 (2%) Mineralization 1 (2%) 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Atelectasis 1 (2%) Congestion 2 (4%) 3 (6%) 6 (12%) 30 (60%) Edema 3 (6%) 2 (4%) 1 (2%) 5 (10%) Foreign Body 3 (6%) 2 (4%) Hemorrhage 1 (2%) 3 (6%) 2 (4%) 2 (4%) Infiltration Cellular, Histiocyte 33 (66%) 30 (60%) 28 (56%) 23 (46%) Inflammation, Chronic 7 (14%) 14 (28%) 10 (20%) 6 (12%) Inflammation, Subacute 1 (2%) Inflammation, Suppurative 1 (2%) 2 (4%) 1 (2%) Leukocytosis 4 (8%) Metaplasia, Osseous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05037-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PENTACHLOROANISOLE Date: 06/23/97 Route: GAVAGE Time: 11:29:25 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 10 MG/KG 20 MG/KG 40 MG/KG CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Alveolar Epithelium, Hyperplasia 6 (12%) 3 (6%) 1 (2%) Mediastinum, Inflammation, Granulomatous 1 (2%) Nose (50) (50) (50) (50) Congestion 3 (6%) Exudate 17 (34%) 17 (34%) 12 (24%) 9 (18%) Foreign Body 8 (16%) 6 (12%) 5 (10%) 2 (4%) Fungus 14 (28%) 15 (30%) 11 (22%) 6 (12%) Inflammation, Chronic 2 (4%) 7 (14%) 11 (22%) 5 (10%) Pigmentation 1 (2%) Mucosa, Erosion 1 (2%) Mucosa, Hyperplasia 8 (16%) 7 (14%) 7 (14%) 3 (6%) Mucosa, Metaplasia, Squamous 5 (10%) 8 (16%) 9 (18%) 5 (10%) Nerve, Hypertrophy 1 (2%) 1 (2%) Olfactory Epithelium, Pigmentation 29 (58%) 40 (80%) 25 (50%) Trachea (50) (49) (50) (50) Exudate 1 (2%) Mucosa, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (7) (2) (2) Cataract 1 (50%) 6 (86%) 1 (50%) 1 (50%) Phthisis Bulbi 1 (50%) Cornea, Hyperplasia 1 (14%) Retina, Atrophy 2 (100%) 6 (86%) 1 (50%) 1 (50%) Sclera, Mineralization 1 (50%) 4 (57%) 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Congestion 1 (2%) Cyst 2 (4%) 1 (2%) 3 (6%) 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) 1 (2%) Inflammation, Chronic 38 (76%) 35 (70%) 30 (60%) 20 (40%) Inflammation, Suppurative 10 (20%) 15 (30%) 20 (40%) 14 (28%) Mineralization 20 (40%) 13 (26%) 15 (30%) 8 (16%) Nephropathy 49 (98%) 49 (98%) 46 (92%) 27 (54%) Artery, Hypertrophy 1 (2%) Renal Tubule, Pigmentation 1 (2%) 23 (46%) 22 (44%) 16 (32%) Transitional Epithelium, Hyperplasia 2 (4%) 2 (4%) 1 (2%) Urethra (2) Bulbourethral Gland, Ectasia 1 (50%) Urinary Bladder (50) (50) (50) (50) Edema 1 (2%) 1 (2%) Mucosa, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------