TR 351 Rat Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) PARA-CHLOROANILINE NTP Experiment-Test: 05020-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/03/94 Route: GAVAGE Time: 18:08:57 Facility: Battelle Columbus Laboratory Chemical CAS #: 000106478 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: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Dead 15 5 11 8 Moribund 8 6 3 5 Survivors Terminal Sacrifice 27 39 36 37 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (8) (12) (50) Foreign Body 6 (12%) 1 (13%) 3 (25%) Inflammation, Chronic Active 1 (2%) Intestine Large, Cecum (40) (4) (3) (46) Inflammation, Chronic Active 1 (25%) Parasite Metazoan 1 (3%) 1 (25%) 1 (2%) Intestine Large, Colon (47) (6) (8) (46) Inflammation, Chronic Active 1 (2%) Inflammation, Necrotizing 1 (13%) Parasite Metazoan 4 (9%) 1 (13%) 3 (7%) Intestine Large, Rectum (45) (3) (6) (47) Parasite Metazoan 3 (7%) 1 (17%) 2 (4%) Liver (50) (50) (50) (50) Basophilic Focus 38 (76%) 45 (90%) 46 (92%) 44 (88%) Clear Cell Focus 1 (2%) 3 (6%) Degeneration, Cystic 1 (2%) Degeneration, Fatty 1 (2%) Fibrosis 1 (2%) Hepatodiaphragmatic Nodule 5 (10%) 2 (4%) 2 (4%) 3 (6%) Inflammation, Chronic 32 (64%) 30 (60%) 32 (64%) 36 (72%) Inflammation, Necrotizing 1 (2%) 1 (2%) 3 (6%) 1 (2%) Necrosis, Coagulative 2 (4%) 1 (2%) Pigmentation, Hemosiderin 1 (2%) Vacuolization Cytoplasmic 3 (6%) 3 (6%) 1 (2%) Bile Duct, Hyperplasia 8 (16%) 3 (6%) 1 (2%) 9 (18%) Portal Vein, Intima, Proliferation 1 (2%) Mesentery (49) (7) (11) (47) Inflammation, Chronic 2 (29%) 2 (18%) 8 (17%) Necrosis 2 (29%) 1 (2%) Pancreas (50) (6) (12) (49) Ectopic Tissue 1 (2%) Inflammation, Chronic 2 (17%) 2 (4%) Acinus, Atrophy 13 (26%) 1 (17%) 3 (25%) 15 (31%) Pharynx (1) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic Active 1 (100%) Salivary Glands (50) (8) (12) (49) Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (50) (5) (9) (48) Acanthosis 1 (2%) Hyperkeratosis 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (20%) 2 (4%) Stomach, Glandular (50) (4) (9) (48) Inflammation, Chronic Active 1 (2%) 1 (2%) Necrosis, Coagulative 1 (2%) 1 (25%) Tooth (50) (4) (10) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (49) (8) (12) (49) Mesenteric Artery, Inflammation, Chronic Active 2 (4%) Heart (50) (7) (10) (50) Cardiomyopathy, Chronic 32 (64%) 2 (29%) 7 (70%) 44 (88%) Inflammation, Chronic Active 1 (2%) Coronary Artery, Inflammation, Chronic Active 1 (2%) 1 (14%) Endocardium, Proliferation 1 (14%) Valve, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 1 (2%) Angiectasis 2 (4%) 1 (2%) Cyst 1 (2%) Degeneration, Fatty 4 (8%) 10 (20%) 9 (18%) 11 (22%) Hyperplasia 13 (26%) 23 (46%) 18 (36%) 20 (40%) Hypertrophy 1 (2%) 2 (4%) Necrosis 3 (6%) Adrenal Gland, Medulla (50) (50) (50) (50) Hyperplasia 4 (8%) 4 (8%) 7 (14%) 24 (48%) Pituitary Gland (50) (33) (35) (50) Pars Distalis, Angiectasis 2 (4%) 1 (3%) Pars Distalis, Atypia Cellular 1 (3%) Pars Distalis, Cyst 2 (4%) 3 (9%) 7 (20%) 12 (24%) Pars Distalis, Degeneration, Cystic 1 (2%) Pars Distalis, Hyperplasia 17 (34%) 18 (55%) 9 (26%) 16 (32%) Pars Distalis, Inflammation, Chronic 1 (2%) Pars Nervosa, Hyperplasia, Glandular 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Thyroid Gland (49) (6) (11) (48) Cyst 1 (2%) Inflammation, Chronic Active 1 (2%) C-Cell, Hyperplasia 25 (51%) 3 (50%) 2 (18%) 39 (81%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (45) (5) (11) (48) Hyperplasia 2 (4%) 1 (20%) 1 (9%) 5 (10%) Inflammation, Chronic Active 8 (18%) 1 (20%) 1 (9%) 7 (15%) Duct, Dilatation 1 (9%) Ovary (50) (15) (15) (49) Cyst 4 (8%) 4 (27%) 4 (8%) Uterus (50) (14) (20) (50) Dilatation 2 (4%) 2 (14%) 5 (25%) 6 (12%) Hemorrhage, Chronic 1 (2%) Inflammation, Chronic Active 1 (7%) 1 (5%) 1 (2%) Endometrium, Hyperplasia, Cystic, Glandular 9 (18%) 1 (7%) 3 (15%) 8 (16%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (32) (45) (37) (43) Lymphopenia 1 (3%) Neutropenia 1 (3%) Neutrophilia 1 (3%) 2 (4%) 3 (7%) Bone Marrow (50) (48) (50) (47) Femoral, Atrophy 1 (2%) 1 (2%) Femoral, Hemorrhage, Acute 1 (2%) Femoral, Hyperplasia 11 (22%) 12 (25%) 21 (42%) 37 (79%) Femoral, Hyperplasia, Re Cell 4 (9%) Femoral, Hyperplasia, Reticulum Cell 1 (2%) 2 (4%) 7 (14%) 7 (15%) Lymph Node (50) (12) (17) (50) Bronchial, Pigmentation, Hemosiderin 1 (2%) Mediastinal, Cyst 2 (4%) Mediastinal, Infiltration Cellular, Histiocyte 2 (4%) Mediastinal, Inflammation, Suppurative 1 (6%) Mediastinal, Necrosis 1 (2%) Pancreatic, Pigmentation, Hemosiderin 1 (2%) Renal, Cyst 1 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Renal, Inflammation, Chronic Active 1 (6%) Lymph Node, Mandibular (49) (7) (14) (49) Cyst 2 (4%) Hemorrhage 1 (2%) Hyperplasia, Plasma Cell 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Necrosis 1 (2%) Lymph Node, Mesenteric (7) (4) (1) (9) Cyst 1 (25%) 1 (100%) Ectasia 1 (25%) Edema 2 (29%) 1 (100%) Hemorrhage 1 (14%) 1 (100%) Hyperplasia, Lymphoid 1 (11%) Infiltration Cellular, Histiocyte 1 (14%) Necrosis 1 (14%) Spleen (50) (50) (50) (50) Cyst 1 (2%) Depletion Lymphoid 1 (2%) Fibrosis 1 (2%) 2 (4%) 3 (6%) 42 (84%) Hematopoietic Cell Proliferation 41 (82%) 48 (96%) 48 (96%) 32 (64%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Lipocyte 11 (22%) Inflammation, Chronic Active 1 (2%) Necrosis 1 (2%) Pigmentation, Hemosiderin 39 (78%) 49 (98%) 49 (98%) 48 (96%) Capsule, Cyst 3 (6%) Thymus (42) (8) (11) (44) Depletion Lymphoid 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (17) (22) (50) Hyperplasia, Cystic 34 (69%) 11 (65%) 17 (77%) 48 (96%) Skin (50) (20) (21) (50) Inflammation, Chronic Active 1 (2%) Inflammation, Necrotizing 1 (5%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (49) (5) (10) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (5) (10) (50) Compression 4 (8%) 1 (20%) 4 (40%) 5 (10%) Hydrocephalus 3 (6%) 1 (20%) 4 (8%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (5) (11) (50) Granuloma 1 (2%) Hemorrhage, Acute 1 (2%) Inflammation, Chronic Active 5 (10%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) Mediastinum, Inflammation, Chronic Active 1 (2%) 1 (9%) 1 (2%) Nose (49) (4) (11) (49) Foreign Body 1 (2%) Inflammation, Chronic Active 3 (6%) 11 (22%) Nasolacrimal Duct, Inflammation, Chronic Active 2 (4%) Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 4 (8%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (12) (32) (31) (31) Inflammation, Chronic 1 (8%) 1 (3%) 1 (3%) Anterior Chamber, Inflammation, Suppurative 1 (3%) Cornea, Inflammation, Chronic 1 (3%) Lens, Cataract 10 (83%) 30 (94%) 30 (97%) 30 (97%) Retina, Atrophy 11 (92%) 32 (100%) 31 (100%) 31 (100%) Harderian Gland (42) (6) (11) (44) Atrophy 1 (2%) Inflammation, Chronic 1 (2%) 6 (14%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 1 (2%) Inflammation, Chronic Active 1 (2%) Nephropathy, Chronic 39 (78%) 39 (78%) 45 (90%) 41 (82%) Renal Tubule, Pigmentation, Hemosiderin 44 (88%) 48 (96%) 50 (100%) 50 (100%) Urinary Bladder (50) (5) (8) (49) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 49 50 50 50 Early Deaths Dead 5 5 9 17 Dosing Accident 2 1 Moribund 26 13 7 11 Survivors Dead 1 Terminal Sacrifice 18 32 32 20 Animals Examined Microscopically 49 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (49) (5) (13) (50) Foreign Body 1 (2%) 2 (15%) 1 (2%) Inflammation, Necrotizing 1 (20%) 2 (15%) 1 (2%) Intestine Large, Cecum (46) (5) (6) (44) Dilatation 1 (2%) Inflammation, Chronic Active 1 (2%) Parasite Metazoan 1 (2%) Intestine Large, Colon (46) (5) (9) (45) Parasite Metazoan 1 (2%) 2 (4%) Intestine Large, Rectum (47) (5) (8) (44) Inflammation, Chronic Active 2 (4%) Parasite Metazoan 2 (4%) 1 (13%) 4 (9%) Intestine Small, Ileum (46) (5) (6) (39) Dilatation 1 (3%) Inflammation, Chronic Active 1 (3%) Intestine Small, Jejunum (46) (6) (8) (41) Dilatation 1 (2%) Metaplasia, Osseous 1 (17%) 1 (13%) Necrosis 1 (17%) Liver (49) (50) (49) (49) Angiectasis 1 (2%) 2 (4%) Basophilic Focus 14 (29%) 23 (46%) 31 (63%) 21 (43%) Clear Cell Focus 2 (4%) Degeneration, Cystic 10 (20%) 16 (32%) 10 (20%) 12 (24%) Eosinophilic Focus 3 (6%) 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 3 (6%) 8 (16%) 2 (4%) 2 (4%) Inflammation, Chronic 8 (16%) 15 (30%) 19 (39%) 9 (18%) Inflammation, Necrotizing 4 (8%) 2 (4%) 5 (10%) 4 (8%) Necrosis, Coagulative 6 (12%) 4 (8%) 3 (6%) 9 (18%) Pigmentation, Hemosiderin 1 (2%) 26 (53%) Vacuolization Cytoplasmic 6 (12%) 4 (8%) 9 (18%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Bile Duct, Hyperplasia 41 (84%) 45 (90%) 43 (88%) 47 (96%) Mesentery (47) (11) (11) (48) Ectopic Tissue 1 (2%) Inflammation, Chronic 6 (13%) 6 (55%) 2 (18%) 5 (10%) Necrosis 3 (6%) 4 (36%) Pigmentation, Hemosiderin 1 (9%) 1 (2%) Pancreas (48) (8) (14) (47) Inflammation, Chronic 1 (2%) Pigmentation, Hemosiderin 1 (13%) 1 (7%) Acinus, Atrophy 18 (38%) 3 (38%) 3 (21%) 13 (28%) Acinus, Hyperplasia 1 (7%) 1 (2%) Duct, Ectasia 1 (2%) 1 (13%) Salivary Glands (49) (6) (11) (49) Granuloma 1 (2%) Stomach, Forestomach (47) (6) (11) (46) Acanthosis 1 (2%) 1 (9%) 1 (2%) Hyperkeratosis 1 (2%) 1 (9%) 1 (2%) Inflammation, Chronic Active 2 (4%) 2 (18%) Inflammation, Necrotizing 1 (17%) Stomach, Glandular (48) (6) (11) (45) Inflammation, Chronic Active 1 (2%) 1 (9%) Mineralization 1 (2%) Necrosis, Coagulative 1 (2%) 2 (33%) 4 (9%) Tongue (2) (1) (1) Foreign Body 2 (100%) 1 (100%) Inflammation, Chronic Active 2 (100%) 1 (100%) 1 (100%) Tooth (49) (5) (10) (49) Peridontal Tissue, Foreign Body 1 (2%) Peridontal Tissue, Inflammation, Chronic Active 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (49) (8) (12) (50) Mesenteric Artery, Inflammation, Chronic Active 1 (2%) Mesenteric Artery, Necrosis, Fibrinoid 1 (2%) Mesenteric Artery, Intima, Proliferation 1 (2%) Pulmonary Artery, Thrombosis 1 (13%) Heart (49) (18) (23) (50) Cardiomyopathy, Chronic 44 (90%) 15 (83%) 22 (96%) 42 (84%) Mineralization 1 (2%) Atrium, Thrombosis 5 (10%) 1 (6%) 8 (16%) Endocardium, Proliferation 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (50) (49) (49) Degeneration, Fatty 10 (20%) 11 (22%) 10 (20%) 16 (33%) Hematocyst 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 17 (35%) 13 (26%) 19 (39%) 17 (35%) Hypertrophy 1 (2%) 1 (2%) Necrosis, Coagulative 2 (4%) 1 (2%) 1 (2%) Adrenal Gland, Medulla (49) (49) (48) (48) Cyst 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 15 (31%) 22 (45%) 15 (31%) 17 (35%) Mineralization 1 (2%) Islets, Pancreatic (48) (4) (10) (46) Degeneration 1 (2%) Parathyroid Gland (48) (7) (10) (45) Hyperplasia 1 (14%) Pituitary Gland (47) (18) (19) (46) Craniopharyngeal Duct, Cyst 1 (2%) Pars Distalis, Angiectasis 1 (6%) 1 (5%) Pars Distalis, Cyst 3 (6%) 1 (2%) Pars Distalis, Hemorrhage, Acute 1 (5%) Pars Distalis, Hyperplasia 11 (23%) 2 (11%) 2 (11%) 13 (28%) Pars Distalis, Pigmentation, Hemosiderin 1 (6%) Pars Intermedia, Angiectasis 1 (6%) Thyroid Gland (48) (8) (10) (45) Inflammation, Necrotizing 1 (2%) Ultimobranchial Cyst 1 (2%) C-Cell, Hyperplasia 19 (40%) 4 (50%) 4 (40%) 24 (53%) Follicular Cell, Hyperplasia 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (20) (26) (50) Atrophy, Diffuse 1 (2%) Penis (1) Concretion 1 (100%) Preputial Gland (46) (12) (15) (48) Hyperplasia 2 (4%) 1 (7%) 3 (6%) Inflammation, Chronic Active 45 (98%) 6 (50%) 7 (47%) 43 (90%) Prostate (49) (6) (13) (48) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Abscess 1 (2%) Inflammation, Chronic Active 32 (65%) 4 (67%) 11 (85%) 29 (60%) Seminal Vesicle (36) (3) (5) (23) Inflammation, Chronic Active 3 (8%) Testes (49) (46) (50) (50) Interstitial Cell, Hyperplasia 26 (53%) 29 (63%) 23 (46%) 25 (50%) Seminiferous Tubule, Atrophy 33 (67%) 44 (96%) 39 (78%) 46 (92%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (44) (45) (39) (31) Leukocytosis 1 (2%) Neutrophilia 2 (4%) 1 (3%) 6 (19%) Bone Marrow (49) (50) (49) (50) Hyperplasia 1 (2%) 2 (4%) Thrombosis 1 (2%) Femoral, Hyperplasia 26 (53%) 36 (72%) 35 (71%) 46 (92%) Femoral, Hyperplasia, Reticulum Cell 3 (6%) Femoral, Myelofibrosis 1 (2%) Lymph Node (49) (16) (15) (49) Mediastinal, Cyst 2 (4%) Mediastinal, Edema 1 (2%) Mediastinal, Hemorrhage, Acute 1 (2%) Mediastinal, Hyperplasia, Plasma Cell 1 (6%) Mediastinal, Infiltration Cellular, Mast Cell 1 (7%) 1 (2%) Mediastinal, Infiltration Cellular, Histiocyte 1 (2%) Mediastinal, Pigmentation, Hemosiderin 2 (4%) Pancreatic, Ectopic Tissue 1 (2%) Pancreatic, Infiltration Cellular, Histiocyte 2 (4%) Pancreatic, Pigmentation, Hemosiderin 2 (4%) Renal, Cyst 1 (6%) 1 (2%) Lymph Node, Mandibular (48) (7) (12) (48) Cyst 4 (8%) 4 (8%) Ectasia 1 (14%) 1 (8%) Lymph Node, Mesenteric (10) (5) (2) (10) Cyst 2 (20%) 2 (40%) 1 (50%) 2 (20%) Ectasia 1 (50%) Fibrosis 1 (20%) Infiltration Cellular, Histiocyte 1 (20%) 1 (10%) Pigmentation, Hemosiderin 1 (10%) Spleen (49) (50) (50) (50) Cyst 1 (2%) Fibrosis 3 (6%) 11 (22%) 12 (24%) 41 (82%) Granuloma 1 (2%) Hematopoietic Cell Proliferation 31 (63%) 48 (96%) 42 (84%) 26 (52%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Infarct, Acute 1 (2%) 1 (2%) Infiltration Cellular, Lipocyte 24 (48%) Pigmentation, Hemosiderin 37 (76%) 39 (78%) 48 (96%) 21 (42%) Sinusoid, Ectasia 1 (2%) Thymus (43) (5) (13) (36) Cyst 1 (2%) 1 (3%) Inflammation, Chronic Active 1 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (32) (6) (13) (36) Hyperplasia, Cystic 25 (78%) 6 (100%) 10 (77%) 29 (81%) Skin (47) (18) (19) (49) Inflammation, Chronic Active 1 (2%) 1 (5%) Inflammation, Necrotizing 1 (6%) Inflammation, Suppurative 1 (6%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (48) (50) (49) (50) Femur, Fibrous Osteodystrophy 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (5) (10) (50) Compression 4 (8%) 2 (20%) 1 (2%) Hemorrhage, Acute 1 (2%) 1 (10%) Hydrocephalus 5 (10%) 1 (20%) 1 (10%) 2 (4%) Infarct, Chronic 1 (2%) Mineralization 1 (2%) Spinal Cord (4) (2) (1) Degeneration 1 (25%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (7) (11) (50) Granuloma 1 (2%) Hemorrhage, Acute 3 (6%) Inflammation, Chronic 2 (4%) 1 (14%) 4 (8%) Inflammation, Suppurative 2 (4%) Pigmentation, Hemosiderin 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 2 (4%) Mediastinum, Inflammation, Chronic Active 1 (14%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05020-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 18:08:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (48) (5) (10) (46) Inflammation, Chronic Active 6 (13%) 8 (17%) Inflammation, Suppurative 1 (20%) 1 (2%) Nasolacrimal Duct, Inflammation, Chronic Active 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 1 (10%) 3 (7%) Septum, Thrombosis, Multiple 1 (2%) Trachea (49) (5) (13) (49) Inflammation, Necrotizing 2 (15%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (7) (11) (13) (14) Hemorrhage, Acute 1 (9%) Inflammation, Chronic 1 (7%) Cornea, Inflammation, Chronic Active 1 (9%) Lens, Cataract 4 (57%) 11 (100%) 12 (92%) 13 (93%) Retina, Atrophy 5 (71%) 11 (100%) 13 (100%) 13 (93%) Harderian Gland (46) (4) (9) (43) Inflammation, Chronic 3 (7%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (50) (49) (50) Inflammation, Hemorrhagic 1 (2%) Nephropathy, Chronic 46 (96%) 50 (100%) 48 (98%) 46 (92%) Renal Tubule, Degeneration 1 (2%) Renal Tubule, Pigmentation, Hemosiderin 47 (98%) 49 (98%) 47 (96%) 50 (100%) Urethra (21) (3) (1) (11) Inflammation, Hemorrhagic 1 (33%) Transitional Epithelium, Hyperplasia 1 (100%) Urinary Bladder (47) (7) (12) (46) Dilatation 1 (14%) 1 (2%) Hemorrhage, Acute 1 (2%) Inflammation, Chronic Active 2 (4%) Inflammation, Hemorrhagic 1 (14%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------