TR 351 Mouse Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) PARA-CHLOROANILINE NTP Experiment-Test: 05020-02 Report: PEIRPT03 Study Type: CHRONIC Date: 09/03/94 Route: GAVAGE Time: 19:58:17 Facility: Battelle Columbus Laboratory Chemical CAS #: 106-47-8 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: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund 5 4 3 4 Dead 5 1 3 5 Dosing Accident 1 3 Survivors Terminal Sacrifice 39 42 44 41 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (47) (3) (2) (46) Infiltration Cellular, Multifocal, Lymphocyte 1 (2%) Lumen, Pigmentation, Diffuse 1 (2%) Mucosa, Cyst 1 (2%) Intestine Large, Colon (47) (5) (3) (48) Parasite Metazoan 3 (6%) Intestine Small, Duodenum (46) (4) (3) (48) Inflammation, Chronic, Focal 1 (2%) Ulcer, Chronic, Focal 1 (2%) Intestine Small, Jejunum (46) (4) (2) (48) Necrosis, Acute, Diffuse 1 (2%) Liver (50) (50) (50) (50) Angiectasis, Focal 1 (2%) Basophilic Focus 1 (2%) 1 (2%) Clear Cell Focus 1 (2%) 2 (4%) Cytomegaly, Focal 1 (2%) 1 (2%) Hematopoietic Cell Proliferation, Multifocal 15 (30%) 29 (58%) 24 (48%) 31 (62%) Necrosis, Acute, Multifocal 1 (2%) 1 (2%) 1 (2%) 1 (2%) Thrombosis, Chronic 1 (2%) Vacuolization Cytoplasmic, Focal 1 (2%) 1 (2%) Bile Duct, Cyst 1 (2%) Centrilobular, Necrosis, Acute, Multifocal 1 (2%) Hepatocyte, Karyomegaly, Focal 1 (2%) 1 (2%) Kupffer Cell, Pigmentation, Hemosiderin 1 (2%) 46 (92%) Periportal, Inflammation, Multifocal 1 (2%) Serosa, Inflammation, Chronic, Multifocal, Suppurative 1 (2%) Sinusoid, Infiltration Cellular, Diffuse, Polymorphonuclear 1 (2%) Mesentery (2) (2) (3) (3) Inflammation, Chronic, Multifocal, Suppurative 2 (67%) Inflammation, Chronic Active, Multifocal 2 (100%) 2 (67%) 1 (33%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pancreas (48) (7) (5) (49) Inflammation, Chronic, Multifocal, Suppurative 1 (2%) Inflammation, Chronic Active, Multifocal 1 (14%) 1 (20%) Acinus, Atrophy, Diffuse 1 (2%) Acinus, Atrophy, Focal 1 (2%) 2 (4%) Acinus, Atrophy, Multifocal 1 (2%) 1 (14%) 2 (40%) 5 (10%) Duct, Cyst 1 (14%) 1 (2%) Duct, Cyst, Multiple 1 (2%) Duct, Ectasia, Focal 1 (2%) Duct, Ectasia, Multifocal 1 (20%) Duct, Inflammation, Chronic, Multifocal 1 (2%) Salivary Glands (47) (5) (3) (48) Infiltration Cellular, Multifocal, Lymphocyte 3 (6%) Acinus, Atrophy, Focal 1 (2%) Stomach, Forestomach (48) (5) (3) (46) Acanthosis, Focal 1 (2%) Hyperkeratosis, Focal 1 (2%) Ulcer, Acute, Focal 1 (2%) Stomach, Glandular (48) (5) (3) (47) Cyst 1 (2%) Necrosis, Acute, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (5) (3) (50) Atrium, Inflammation, Chronic, Focal 1 (33%) Coronary Artery, Inflammation, Chronic Active, Multifocal 1 (2%) Epicardium, Inflammation, Acute, Multifocal 1 (20%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (5) (4) (49) Capsule, Cyst 1 (2%) Capsule, Hyperplasia, Cystic, Glandular, Multifocal 1 (2%) Capsule, Hyperplasia, Focal 1 (2%) Capsule, Hyperplasia, Multifocal 48 (96%) 2 (40%) 3 (75%) 48 (98%) Corticomedullary Junction, Degeneration, Fatty, Multifocal 1 (2%) Adrenal Gland, Cortex (50) (5) (4) (49) Accessory Adrenal Cortical Nodule 1 (2%) Degeneration, Fatty, Focal 1 (2%) Hematopoietic Cell Proliferation, Multifocal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia, Focal 1 (2%) 1 (2%) Hyperplasia, Multifocal 1 (2%) Hypertrophy, Focal 2 (4%) 2 (4%) Hypertrophy, Multifocal 1 (2%) 1 (2%) Adrenal Gland, Medulla (50) (5) (4) (49) Hyperplasia, Focal 1 (2%) Infiltration Cellular, Focal, Plasma Cell 1 (2%) Pituitary Gland (46) (5) (6) (42) Pars Distalis, Cyst 3 (7%) 1 (2%) Pars Distalis, Cyst, Multiple 1 (2%) Pars Distalis, Hyperplasia, Focal 5 (11%) 1 (17%) 6 (14%) Pars Distalis, Hyperplasia, Multifocal 2 (4%) Thyroid Gland (49) (4) (3) (49) Necrosis, Acute, Focal 1 (2%) Follicular Cell, Hyperplasia 1 (2%) Follicular Cell, Hyperplasia, Focal 1 (2%) 1 (2%) Follicular Cell, Hyperplasia, Multifocal 1 (2%) Interstitium, Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (50) (14) (17) (47) Angiectasis, Focal 1 (2%) Angiectasis, Multifocal 1 (2%) 1 (6%) Inflammation, Chronic, Multifocal, Suppurative 2 (4%) Thrombosis, Chronic Active 1 (2%) 1 (7%) Corpus Luteum, Angiectasis, Multifocal 1 (2%) Follicle, Cyst 10 (20%) 7 (50%) 11 (65%) 14 (30%) Follicle, Cyst, Multiple 3 (6%) 1 (2%) Periovarian Tissue, Cyst 3 (6%) 1 (7%) 5 (29%) 1 (2%) Periovarian Tissue, Infiltration Cellular, Multifocal, Lymphocyte 1 (2%) Periovarian Tissue, Inflammation, Chronic Active, Multifocal 1 (7%) Rete Ovarii, Cyst 1 (2%) Uterus (50) (38) (42) (48) Inflammation, Chronic, Multifocal, Suppurative 1 (3%) 2 (4%) Endometrium, Angiectasis, Multifocal 1 (2%) Endometrium, Hyperplasia, Cystic, Glandular, a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Multifocal 45 (90%) 35 (92%) 41 (98%) 43 (90%) Mucosa, Metaplasia, Multifocal, Squamous 1 (2%) Myometrium, Angiectasis, Multifocal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (1) (2) (3) Neutrophilia 3 (100%) Bone Marrow (48) (5) (3) (49) Femoral, Angiectasis, Focal 1 (2%) Femoral, Hyperplasia, Diffuse, Neutrophil 2 (4%) Femoral, Myelofibrosis, Multifocal 3 (6%) 4 (8%) Lymph Node (48) (5) (7) (47) Mediastinal, Hyperplasia, Diffuse, Lymphoid 2 (4%) Pancreatic, Inflammation, Chronic Active, Multifocal 1 (14%) Renal, Hyperplasia, Diffuse, Lymphoid 1 (2%) Lymph Node, Mandibular (46) (5) (5) (47) Hyperplasia, Diffuse, Lymphoid 1 (2%) Hyperplasia, Multifocal, Plasma Cell 1 (2%) Lymphatic, Angiectasis, Diffuse 1 (20%) Lymph Node, Mesenteric (8) (4) (3) Cyst 1 (25%) Hematopoietic Cell Proliferation, Multifocal 1 (25%) Lymphatic, Ectasia, Focal 1 (13%) Spleen (50) (50) (50) (49) Capsule, Hyperplasia, Multifocal 1 (2%) Capsule, Inflammation, Chronic Active, Multifocal 1 (2%) Lymphoid Follicle, Necrosis, Acute, Multifocal 1 (2%) 2 (4%) Red Pulp, Hematopoietic Cell Proliferation, Diffuse 48 (96%) 50 (100%) 49 (98%) 48 (98%) Red Pulp, Pigmentation, Hemosiderin, Multifocal 45 (90%) 47 (94%) 49 (98%) 49 (100%) Thymus (41) (4) (1) (35) Depletion Lymphoid, Multifocal 1 (3%) Necrosis, Acute, Multifocal 1 (2%) 3 (75%) Medulla, Thymocyte, Hyperplasia, Diffuse 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (38) (5) (3) (44) Hyperplasia, Cystic, Multifocal 2 (67%) Skin (50) (7) (7) (49) Parasite External 3 (6%) Ulcer 2 (29%) Subcutaneous Tissue, Fibrosis, Multifocal 1 (14%) Subcutaneous Tissue, Inflammation, Chronic Active, Multifocal 2 (29%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (6) (3) (50) Bilateral, Joint, Tarsal, Hyperostosis 1 (2%) Bilateral, Joint, Tarsal, Metaplasia, Multifocal, Osseous 1 (2%) Cranium, Fibrous Osteodystrophy 1 (2%) Cranium, Hyperostosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (5) (3) (49) Hemorrhage, Multifocal 1 (2%) Necrosis, Acute, Multifocal 1 (33%) Hypothalamus, Compression, Focal 1 (2%) Meninges, Infiltration Cellular, Multifocal, Lymphocyte 1 (2%) 2 (4%) Meninges, Inflammation, Chronic Active, Multifocal 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (8) (7) (50) Alveolar Epithelium, Hyperplasia, Focal 1 (13%) 3 (6%) Alveolus, Hemorrhage, Multifocal 1 (14%) 1 (2%) Interstitium, Inflammation, Chronic, Multifocal 2 (4%) Interstitium, Inflammation, Chronic Active, Focal 1 (2%) Interstitium, Inflammation, Chronic Active, Multifocal 1 (2%) Mediastinum, Foreign Body, Multifocal 1 (2%) 3 (38%) Perivascular, Hyperplasia, Lymphoid, Multifocal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Perivascular, Inflammation, Chronic, Multifocal 1 (2%) Pleura, Inflammation, Acute, Diffuse 1 (13%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (1) Degeneration, Diffuse 1 (100%) Cornea, Inflammation, Chronic Active, Diffuse, Necrotizing 1 (100%) Harderian Gland (48) (4) (3) (47) Inflammation, Chronic Active, Diffuse 1 (2%) Acinus, Hyperplasia, Multifocal 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (7) (4) (49) Inflammation, Chronic Active, Multifocal 1 (25%) Mineralization, Multifocal 1 (2%) Nephropathy, Chronic, Diffuse 1 (2%) Nephropathy, Chronic, Focal 3 (6%) 1 (2%) Nephropathy, Chronic, Multifocal 1 (2%) 1 (2%) Capsule, Fibrosis, Chronic, Focal 1 (25%) Glomerulus, Amyloid Deposition, Multifocal 1 (2%) Glomerulus, Inflammation, Chronic, Multifocal 3 (6%) Perivascular, Infiltration Cellular, Multifocal, Plasma Cell 1 (2%) Renal Tubule, Cytoplasmic Alteration, Diffuse 1 (14%) Renal Tubule, Dilatation, Diffuse 1 (2%) Renal Tubule, Pigmentation, Hemosiderin, Multifocal 38 (78%) Renal Tubule, Regeneration, Focal 3 (6%) Renal Tubule, Regeneration, Multifocal 4 (8%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund 3 6 12 9 Dead 4 7 9 6 Survivors Terminal Sacrifice 43 36 29 35 Missing 1 Animals Examined Microscopically 50 49 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (45) (4) (47) Necrosis, Acute, Multifocal 1 (25%) Lumen, Crystals, Diffuse 1 (2%) Submucosa, Fibrosis, Diffuse 1 (25%) Intestine Large, Colon (48) (6) (7) (48) Inflammation, Acute, Multifocal, Necrotizing 1 (17%) Parasite Metazoan 1 (17%) 3 (6%) Intestine Large, Rectum (46) (1) (5) (50) Parasite Metazoan 2 (4%) Liver (50) (49) (50) (50) Amyloid Deposition, Multifocal 1 (2%) Angiectasis, Focal 1 (2%) 2 (4%) Angiectasis, Multifocal 3 (6%) Clear Cell Focus, Focal 1 (2%) Cyst 1 (2%) 1 (2%) Hematopoietic Cell Proliferation, Diffuse 1 (2%) 2 (4%) Hematopoietic Cell Proliferation, Focal 1 (2%) Hematopoietic Cell Proliferation, Multifocal 6 (12%) 4 (8%) 6 (12%) 3 (6%) Inflammation 1 (2%) Inflammation, Acute, Multifocal 1 (2%) Inflammation, Chronic, Multifocal 2 (4%) Inflammation, Chronic Active, Multifocal 1 (2%) Necrosis, Acute, Multifocal 1 (2%) Necrosis, Chronic Active, Focal 1 (2%) Necrosis, Chronic Active, Multifocal 1 (2%) 1 (2%) 6 (12%) Necrosis, Coagulative, Focal 1 (2%) Thrombosis, Chronic 2 (4%) Vacuolization Cytoplasmic, Focal 1 (2%) Bile Duct, Hyperplasia, Multifocal 2 (4%) Centrilobular, Necrosis, Acute, Multifocal 1 (2%) Centrilobular, Vacuolization Cytoplasmic, Diffuse 4 (8%) 4 (8%) Hepatocyte, Cytomegaly, Diffuse 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Hyperplasia, Focal 1 (2%) Kupffer Cell, Pigmentation, Hemosiderin 50 (100%) Pancreas (49) (3) (7) (49) Inflammation, Chronic, Multifocal 1 (2%) Acinus, Atrophy, Focal 1 (2%) Acinus, Atrophy, Multifocal 6 (12%) 4 (8%) Tooth (50) (5) (7) (50) Incisor, Dysplasia, Multifocal 1 (2%) Molar, Dysplasia 1 (2%) 1 (2%) Peridontal Tissue, Foreign Body, Focal 2 (4%) Peridontal Tissue, Foreign Body, Multifocal 1 (2%) Peridontal Tissue, Inflammation, Chronic Active, Focal 3 (6%) 4 (8%) Peridontal Tissue, Inflammation, Chronic Active, Multifocal 6 (12%) 3 (6%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (5) (8) (50) Coronary Artery, Inflammation, Chronic Active, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (49) (5) (7) (50) Capsule, Ectopic Tissue 2 (4%) Capsule, Hyperplasia, Focal 2 (4%) 1 (20%) 1 (2%) Capsule, Hyperplasia, Multifocal 44 (90%) 1 (20%) 4 (57%) 44 (88%) Adrenal Gland, Cortex (49) (5) (7) (50) Cyst 2 (4%) Hyperplasia, Focal 11 (22%) 5 (10%) Hyperplasia, Multifocal 1 (2%) Hypertrophy, Focal 9 (18%) 10 (20%) Hypertrophy, Multifocal 5 (10%) Necrosis, Acute, Focal 1 (2%) Vacuolization Cytoplasmic, Focal 1 (2%) Adrenal Gland, Medulla (49) (4) (7) (50) Hyperplasia, Focal 1 (2%) Parathyroid Gland (36) (4) (1) (38) Cyst 1 (3%) Pituitary Gland (40) (4) (4) (41) Pars Distalis, Cyst 1 (3%) 2 (5%) Pars Distalis, Cyst, Multiple 1 (2%) Pars Distalis, Hyperplasia, Focal 1 (2%) Thyroid Gland (50) (5) (7) (48) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Inflammation, Chronic Active, Multifocal 1 (2%) Follicle, Cyst, Multiple 1 (2%) Follicular Cell, Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (5) (7) (49) Infiltration Cellular, Multifocal, Lymphocyte 2 (4%) Inflammation, Chronic, Multifocal 1 (2%) Inflammation, Chronic Active, Multifocal 4 (8%) Penis (1) (2) Concretion, Chronic Active, Multifocal 1 (100%) Inflammation, Chronic Active, Multifocal 1 (100%) Preputial Gland (2) (3) (5) (5) Atrophy, Diffuse 2 (100%) Atrophy, Multifocal 1 (20%) 1 (20%) Inflammation, Chronic Active, Diffuse 1 (50%) Inflammation, Chronic Active, Multifocal 2 (67%) 1 (20%) 1 (20%) Inflammation, Multifocal, Suppurative 2 (40%) Duct, Dilatation, Focal 1 (33%) 1 (20%) Duct, Dilatation, Multifocal 1 (50%) 2 (40%) Prostate (48) (4) (7) (50) Inflammation, Acute, Diffuse 1 (2%) Inflammation, Chronic Active, Multifocal 1 (25%) 1 (2%) Epithelium, Hyperplasia, Focal 1 (2%) Testes (49) (5) (7) (50) Germinal Epithelium, Degeneration, Chronic, Multifocal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Blood (2) (2) Neutrophilia 2 (100%) 1 (50%) Bone Marrow (50) (3) (7) (50) Hyperplasia, Diffuse, Neutrophil 3 (6%) 1 (14%) 5 (10%) Hyperplasia, Multifocal, Neutrophil 1 (2%) Thrombosis, Chronic Active 1 (2%) Femoral, Angiectasis, Focal 2 (4%) Lymph Node (49) (25) (28) (49) Mediastinal, Hematopoietic Cell a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Proliferation, Diffuse 1 (2%) Mediastinal, Hematopoietic Cell Proliferation, Multifocal 2 (4%) 1 (2%) Pancreatic, Hematopoietic Cell Proliferation, Multifocal 1 (2%) Renal, Hyperplasia, Multifocal, Plasma Cell 1 (2%) Lymph Node, Mandibular (48) (8) (9) (49) Depletion Lymphoid, Diffuse 1 (13%) Hematopoietic Cell Proliferation, Multifocal 1 (2%) Hyperplasia, Lymphoid, Multifocal 2 (4%) 3 (38%) 1 (11%) Hyperplasia, Multifocal, Plasma Cell 2 (4%) 1 (11%) 3 (6%) Lymphocyte, Necrosis, Multifocal 1 (2%) Lymph Node, Mesenteric (22) (19) (20) (17) Angiectasis, Multifocal 1 (5%) Hematocyst, Chronic Active 1 (6%) Hematopoietic Cell Proliferation, Multifocal 10 (45%) 18 (95%) 18 (90%) 14 (82%) Hemorrhage, Multifocal 4 (18%) Hyperplasia, Diffuse, Lymphoid 1 (5%) Hyperplasia, Lymphoid, Multifocal 1 (6%) Inflammation, Chronic, Multifocal 1 (6%) Inflammation, Focal, Granulomatous 1 (5%) Inflammation, Multifocal, Suppurative 1 (5%) Spleen (50) (47) (49) (49) Amyloid Deposition, Multifocal 1 (2%) Angiectasis, Focal 1 (2%) 2 (4%) Angiectasis, Multifocal 1 (2%) Lymphoid Follicle, Depletion Lymphoid, Multifocal 1 (2%) Lymphoid Follicle, Necrosis, Acute, Multifocal 1 (2%) Red Pulp, Angiectasis, Focal 1 (2%) Red Pulp, Fibrosis 1 (2%) Red Pulp, Fibrosis, Multifocal 1 (2%) 1 (2%) Red Pulp, Hematopoietic Cell Proliferation, Diffuse 50 (100%) 47 (100%) 49 (100%) 48 (98%) Red Pulp, Pigmentation, Hemosiderin, Multifocal 37 (74%) 47 (100%) 45 (92%) 48 (98%) Thymus (36) (3) (27) Cyst, Multiple 1 (4%) Depletion Lymphoid, Multifocal 1 (4%) Necrosis, Acute, Multifocal 1 (3%) 2 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (27) (28) (49) Acanthosis, Diffuse 1 (2%) 3 (11%) 5 (18%) 4 (8%) Acanthosis, Focal 2 (7%) 1 (2%) Acanthosis, Multifocal 9 (18%) 4 (15%) 2 (7%) 7 (14%) Alopecia 1 (2%) Hyperkeratosis, Multifocal 1 (2%) 1 (2%) Inflammation, Chronic Active, Multifocal 1 (4%) Parasite External 7 (14%) 12 (24%) Ulcer 6 (12%) 9 (33%) 8 (29%) 5 (10%) Ulcer, Multiple 4 (8%) Sebaceous Gland, Hyperplasia, Focal 1 (4%) Subcutaneous Tissue, Fibrosis, Diffuse 1 (2%) 1 (4%) 4 (14%) 3 (6%) Subcutaneous Tissue, Fibrosis, Focal 1 (2%) 2 (7%) 1 (4%) 1 (2%) Subcutaneous Tissue, Fibrosis, Multifocal 5 (10%) 4 (15%) 1 (4%) 2 (4%) Subcutaneous Tissue, Inflammation, Acute, Multifocal 1 (4%) Subcutaneous Tissue, Inflammation, Chronic Active, Diffuse 1 (4%) 2 (7%) Subcutaneous Tissue, Inflammation, Chronic Active, Focal 2 (7%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active, Multifocal 2 (4%) 5 (19%) 1 (4%) 7 (14%) Subcutaneous Tissue, Inflammation, Multifocal 1 (4%) Subcutaneous Tissue, Mineralization, Multifocal 1 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (28) (26) (50) Bilateral, Joint, Radius, Hyperostosis 1 (2%) Bilateral, Joint, Tarsal, Hyperostosis 10 (20%) 21 (75%) 16 (62%) 11 (22%) Bilateral, Joint, Tarsal, Metaplasia, Multifocal, Osseous 10 (20%) 21 (75%) 16 (62%) 11 (22%) Joint, Tarsal, Hyperostosis 11 (22%) 2 (7%) 4 (15%) 9 (18%) Joint, Tarsal, Metaplasia, Multifocal, Osseous 11 (22%) 2 (7%) 4 (15%) 9 (18%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (10) (14) (50) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (7%) 4 (8%) Interstitium, Inflammation, Acute, Diffuse 1 (2%) Interstitium, Inflammation, Acute, Multifocal 1 (2%) Interstitium, Inflammation, Chronic Active, Focal 1 (2%) Interstitium, Inflammation, Chronic Active, Multifocal 1 (2%) 1 (10%) Nose (50) (5) (7) (50) Respiratory Epithelium, Inflammation, Acute, Multifocal 1 (14%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (3) Cataract 1 (50%) 1 (33%) Inflammation, Chronic, Multifocal 1 (33%) Lens, Cataract, Multifocal 1 (100%) Retina, Atrophy, Multifocal 1 (100%) Harderian Gland (50) (5) (7) (40) Inflammation, Chronic Active, Multifocal 1 (14%) Acinus, Dilatation, Diffuse 1 (2%) Acinus, Hyperplasia, Multifocal 1 (3%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (6) (10) (49) Amyloid Deposition, Multifocal 1 (10%) Cyst 1 (2%) Infarct, Chronic, Focal 1 (17%) 1 (10%) Inflammation, Acute, Multifocal, Suppurative 3 (50%) Mineralization, Focal 1 (17%) Nephropathy, Chronic, Focal 3 (6%) 1 (2%) Nephropathy, Chronic, Multifocal 2 (4%) 3 (30%) 7 (14%) Bilateral, Hydronephrosis, Acute, Multifocal 1 (2%) Cortex, Inflammation, Chronic, Multifocal 1 (2%) Perivascular, Infiltration Cellular, Multifocal, Lymphocyte 1 (2%) Renal Tubule, Atypia Cellular, Multifocal 1 (2%) Renal Tubule, Degeneration, Multifocal 1 (2%) Renal Tubule, Pigmentation, Hemosiderin, Multifocal 4 (8%) Renal Tubule, Regeneration, Focal 1 (2%) Renal Tubule, Regeneration, Multifocal 33 (66%) 30 (61%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05020-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PARA-CHLOROANILINE Date: 09/03/94 Route: GAVAGE Time: 19:58:17 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Urinary Bladder (49) (8) (11) (50) Dilatation 1 (2%) 4 (36%) Dilatation, Diffuse 7 (88%) Submucosa, Congestion, Multifocal 1 (2%) Submucosa, Necrosis, Acute, Multifocal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 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