TDMS Study 05092-03 Pathology Tables
NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 Facility: Southern Research Institute Chemical CAS #: 0091-23-6 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: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 20 10 10 10 10 20 Scheduled Sacrifice 10 10 10 8 Early Deaths Natural Death 2 4 Moribund Sacrifice 4 2 12 Survivors Terminal Sacrifice 14 4 Animals Examined Microscopically 20 10 10 10 10 20 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (1) (5) Parasite Metazoan 1 (20%) Liver (20) (10) (10) (10) (10) (20) Basophilic Focus 1 (5%) 5 (50%) 2 (10%) Basophilic Focus, Multiple 14 (70%) 7 (70%) 9 (45%) Eosinophilic Focus 4 (20%) 1 (5%) Eosinophilic Focus, Multiple 1 (5%) 1 (5%) Hematopoietic Cell Proliferation 1 (10%) Hepatodiaphragmatic Nodule 2 (10%) 1 (10%) 3 (15%) Inflammation, Granulomatous, Multifocal 1 (10%) Inflammation, Granulomatous, Multiple 14 (70%) 4 (40%) 5 (50%) 2 (20%) 10 (50%) Mixed Cell Focus 4 (20%) 1 (5%) Vacuolization Cytoplasmic 3 (15%) 1 (10%) Bile Duct, Hyperplasia 5 (25%) 2 (20%) 1 (5%) Hepatocyte, Hypertrophy 3 (30%) 2 (10%) Hepatocyte, Mitotic Alteration 1 (10%) Hepatocyte, Necrosis, Multifocal 1 (10%) Hepatocyte, Kupffer Cell, Pigmentation 8 (40%) 1 (10%) 1 (10%) 2 (10%) Mesentery (1) (1) (2) (2) Fat, Necrosis, Focal 1 (100%) 1 (100%) 2 (100%) 2 (100%) Stomach, Forestomach (5) (9) Diverticulum 1 (20%) Edema 1 (20%) 1 (11%) Ulcer 1 (20%) Epithelium, Hyperplasia 2 (40%) 4 (44%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (2) Inflammation, Chronic 1 (50%) Mineralization, Multifocal 1 (50%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (2) Bilateral, Vacuolization Cytoplasmic 1 (50%) Pituitary Gland (12) (1) (8) Pars Distalis, Cyst 1 (13%) Pars Distalis, Hemorrhage 3 (25%) Pars Distalis, Hyperplasia, Focal 2 (25%) Thyroid Gland (1) (1) C-Cell, Hyperplasia 1 (100%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (3) (2) (5) Inflammation, Suppurative 1 (33%) Duct, Cyst 5 (100%) Ovary (1) (1) (1) Cyst 1 (100%) 1 (100%) 1 (100%) Uterus (19) (10) (10) (10) (10) (20) Atrophy 1 (5%) Dilatation 2 (11%) 1 (10%) 2 (20%) 2 (10%) Fibrosis, Focal 1 (5%) Inflammation, Suppurative 2 (11%) Cervix, Cyst 1 (5%) Cervix, Myometrium, Hypertrophy 1 (5%) 2 (10%) Endometrium, Hyperplasia, Cystic 3 (16%) 2 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (14) (16) Deep Cervical, Angiectasis 1 (7%) Iliac, Hyperplasia, Lymphoid 1 (6%) Mediastinal, Angiectasis 2 (14%) 9 (56%) Mediastinal, Hyperplasia, Lymphoid 1 (7%) 1 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Mediastinal, Pigmentation 3 (21%) 2 (13%) Pancreatic, Angiectasis 2 (14%) Pancreatic, Pigmentation 1 (6%) Lymph Node, Mandibular (7) (2) Cyst 1 (14%) 1 (50%) Cyst, Multiple 1 (14%) Hyperplasia, Lymphoid 2 (29%) Spleen (20) (10) (10) (10) (10) (20) Atrophy 2 (10%) Congestion 11 (55%) 3 (30%) 5 (50%) 7 (35%) Depletion Lymphoid 4 (20%) 5 (25%) Hematopoietic Cell Proliferation 15 (75%) 1 (10%) 4 (40%) 12 (60%) Hyperplasia, Histiocytic, Lymphoid 1 (5%) 1 (5%) Hyperplasia, Lymphoid 1 (5%) Pigmentation 15 (75%) 10 (100%) 5 (50%) 5 (50%) 6 (60%) 12 (60%) Capsule, Hypertrophy 9 (45%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (13) (1) (5) Hyperplasia, Lobular 8 (62%) 1 (20%) Duct, Cyst 9 (69%) 3 (60%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (2) (3) Calvarium, Hyperostosis 2 (100%) 3 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (5) (2) Compression 4 (80%) Hydrocephalus 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (2) (1) (1) Congestion 1 (50%) Infiltration Cellular, Histiocyte 1 (50%) Alveolar Epithelium, Hyperplasia 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Cataract 1 (100%) Retina, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (20) (10) (10) (10) (10) (20) Hydronephrosis 2 (10%) Inflammation, Suppurative 1 (5%) Nephropathy, Chronic 18 (90%) 5 (50%) 6 (60%) 12 (60%) Bilateral, Hydronephrosis 1 (5%) Corticomedullary Junction, Mineralization 9 (90%) 2 (20%) Papilla, Necrosis 2 (10%) Pelvis, Hemorrhage 1 (5%) Pelvis, Inflammation, Suppurative 1 (5%) Pelvis, Mineralization 5 (25%) 1 (10%) 2 (20%) 4 (20%) Renal Tubule, Mineralization 17 (85%) 3 (30%) 9 (90%) 8 (80%) 9 (45%) Renal Tubule, Pigmentation 18 (90%) 6 (60%) 9 (90%) 20 (100%) Renal Tubule, Regeneration 2 (10%) Transitional Epithelium, Hyperplasia 5 (25%) Ureter (18) (10) (9) (10) (9) (17) Dilatation 5 (29%) Urinary Bladder (18) (10) (10) (10) (10) (20) Hemorrhage 2 (10%) Inflammation, Suppurative 1 (5%) Metaplasia, Squamous 6 (30%) Necrosis 3 (15%) Transitional Epithelium, Hyperplasia 4 (20%) Wall, Infiltration Cellular, Lipocyte 3 (15%) Wall, Proliferation Connective Tissue 11 (55%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 10 10 10 10 20 10 Scheduled Sacrifice 10 10 10 10 10 Early Deaths Natural Death 5 Moribund Sacrifice 15 Survivors Animals Examined Microscopically 10 10 10 10 20 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (1) (2) (10) Parasite Metazoan 1 (10%) Epithelium, Hyperplasia 1 (10%) Liver (10) (10) (10) (9) (20) (10) Basophilic Focus 2 (20%) 1 (11%) Basophilic Focus, Multiple 2 (22%) Hepatodiaphragmatic Nodule 1 (10%) 1 (5%) 1 (10%) Inflammation, Granulomatous, Multiple 5 (50%) 4 (44%) 15 (75%) Vacuolization Cytoplasmic 1 (10%) Bile Duct, Hyperplasia 1 (5%) Hepatocyte, Hypertrophy 1 (5%) 10 (100%) Hepatocyte, Necrosis, Multifocal 3 (30%) 1 (5%) 10 (100%) Hepatocyte, Vacuolization Cytoplasmic 1 (10%) Hepatocyte, Vacuolization Cytoplasmic, Multifocal 1 (10%) Hepatocyte, Kupffer Cell, Pigmentation 9 (90%) 7 (70%) 2 (22%) 20 (100%) 10 (100%) Kupffer Cell, Pigmentation, Multifocal 1 (10%) Mesentery (1) (5) (2) Fat, Inflammation, Chronic 4 (80%) Fat, Necrosis, Focal 1 (100%) 1 (20%) Pancreas (3) Ectopic Tissue 1 (33%) Stomach, Forestomach (1) (7) Epithelium, Hyperplasia 1 (100%) 1 (14%) Stomach, Glandular (1) (7) Mineralization 1 (14%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (1) (1) Duct, Cyst 1 (100%) 1 (100%) Ovary (1) (1) Cyst 1 (100%) Oviduct (1) Cyst 1 (100%) Uterus (10) (10) (10) (10) (20) (10) Atrophy 10 (100%) 10 (100%) 20 (100%) 10 (100%) Dilatation 3 (30%) 1 (10%) Cervix, Cyst 1 (10%) Endometrium, Hyperplasia, Cystic 1 (10%) Epithelium, Hyperplasia, Focal 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (2) (5) Iliac, Hyperplasia, Lymphoid 4 (80%) Mediastinal, Angiectasis 1 (50%) Mediastinal, Hyperplasia, Lymphoid 1 (50%) Mediastinal, Pigmentation 1 (50%) Spleen (10) (10) (10) (10) (20) (10) Congestion 10 (100%) 10 (100%) 10 (100%) 3 (30%) 17 (85%) 10 (100%) Depletion Lymphoid 8 (40%) 10 (100%) Hematopoietic Cell Proliferation 1 (10%) 8 (80%) 15 (75%) Hyperplasia, Lymphoid 1 (5%) Hypertrophy 1 (10%) Pigmentation 10 (100%) 10 (100%) 10 (100%) 7 (70%) 8 (40%) 10 (100%) Capsule, Hypertrophy 10 (100%) 10 (100%) 8 (80%) 9 (90%) 20 (100%) 10 (100%) Capsule, Inflammation, Chronic 6 (60%) 2 (20%) 1 (10%) 17 (85%) 9 (90%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (2) (2) Infiltration Cellular, Multifocal, Lymphocyte 2 (100%) Inflammation, Chronic, Multifocal 2 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) (20) (10) Hydronephrosis 11 (55%) Nephropathy, Chronic 3 (30%) 5 (50%) 2 (10%) Bilateral, Hydronephrosis 3 (15%) Corticomedullary Junction, Mineralization 9 (90%) 9 (90%) Papilla, Necrosis 1 (5%) Pelvis, Dilatation 2 (10%) Pelvis, Inflammation, Suppurative 1 (10%) Pelvis, Mineralization 1 (10%) 2 (20%) 8 (40%) Pelvis, Necrosis 1 (5%) Proximal Convoluted Renal Tubule, Degeneration, Hyaline 1 (10%) Renal Tubule, Mineralization 4 (40%) 8 (80%) 9 (90%) 9 (45%) Renal Tubule, Pigmentation 10 (100%) 10 (100%) 10 (100%) 10 (100%) 20 (100%) 10 (100%) Renal Tubule, Regeneration 1 (10%) 2 (10%) Transitional Epithelium, Hyperplasia 1 (10%) 9 (45%) Ureter (10) (10) (10) (10) (19) (10) Dilatation 1 (10%) 15 (79%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Transitional Epithelium, Hyperplasia 2 (11%) Urinary Bladder (10) (10) (9) (10) (20) (10) Hemorrhage 2 (10%) Inflammation, Subacute 5 (50%) 1 (5%) 8 (80%) Inflammation, Suppurative 1 (10%) 5 (25%) Metaplasia, Squamous 2 (20%) 13 (65%) 10 (100%) Necrosis 1 (10%) 1 (5%) Transitional Epithelium, Hyperplasia 8 (80%) 10 (100%) 9 (100%) 3 (30%) 1 (5%) 10 (100%) Transitional Epithelium, Metaplasia, Squamous 1 (10%) Wall, Infiltration Cellular, Lipocyte 2 (10%) Wall, Proliferation Connective Tissue 2 (20%) 1 (11%) 6 (60%) 14 (70%) 6 (60%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 10 10 10 Scheduled Sacrifice 10 6 Early Deaths Natural Death 2 2 Moribund Sacrifice 2 8 Survivors Animals Examined Microscopically 10 10 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (3) (9) Ulcer 1 (11%) Intestine Large, Colon (3) (9) Autolysis 1 (11%) Intussusception 1 (11%) Necrosis 1 (11%) Parasite Metazoan 1 (33%) Proliferation Connective Tissue 1 (11%) Epithelium, Hyperplasia 1 (33%) 3 (33%) Intestine Large, Rectum (3) (9) Autolysis 1 (11%) Liver (10) (10) (10) Hepatodiaphragmatic Nodule 1 (10%) 1 (10%) Inflammation, Granulomatous, Multiple 5 (50%) 10 (100%) 9 (90%) Hepatocyte, Hypertrophy 10 (100%) 1 (10%) Hepatocyte, Necrosis, Multifocal 10 (100%) Hepatocyte, Vacuolization Cytoplasmic 1 (10%) Hepatocyte, Kupffer Cell, Pigmentation 10 (100%) 10 (100%) 10 (100%) Pancreas (1) Acinus, Atrophy 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Uterus (10) (10) (10) Atrophy 10 (100%) 7 (70%) 4 (40%) Dilatation 1 (10%) 2 (20%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (3) (5) Iliac, Hyperplasia, Lymphoid 3 (60%) Mediastinal, Hyperplasia, Lymphoid 1 (20%) Pancreatic, Hyperplasia, Lymphoid 1 (33%) Lymph Node, Mesenteric (1) Angiectasis 1 (100%) Spleen (10) (10) (10) Atrophy 1 (10%) Congestion 10 (100%) 6 (60%) 6 (60%) Depletion Lymphoid 10 (100%) 2 (20%) 6 (60%) Hematopoietic Cell Proliferation 6 (60%) 4 (40%) Pigmentation 9 (90%) 7 (70%) 4 (40%) Capsule, Hypertrophy 10 (100%) 10 (100%) 9 (90%) Capsule, Inflammation, Chronic 10 (100%) 10 (100%) 9 (90%) Thymus (2) Atrophy 1 (50%) Congestion 1 (50%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM None ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Cornea, Edema 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) Hydronephrosis 1 (10%) 3 (30%) Nephropathy, Chronic 4 (40%) Corticomedullary Junction, Mineralization 2 (20%) Papilla, Necrosis 1 (10%) Pelvis, Mineralization 3 (30%) 4 (40%) Pelvis, Necrosis 1 (10%) Renal Tubule, Mineralization 7 (70%) 5 (50%) Renal Tubule, Pigmentation 10 (100%) 10 (100%) 10 (100%) Renal Tubule, Regeneration 1 (10%) Transitional Epithelium, Hyperplasia 2 (20%) 3 (30%) 5 (50%) Ureter (10) (10) (10) Dilatation 3 (30%) 3 (30%) Urinary Bladder (10) (10) (10) Hemorrhage 1 (10%) 2 (20%) Inflammation, Subacute 10 (100%) 1 (10%) Inflammation, Suppurative 3 (30%) 2 (20%) Metaplasia, Squamous 10 (100%) 8 (80%) 8 (80%) Wall, Proliferation Connective Tissue 10 (100%) 5 (50%) 5 (50%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 20 10 10 10 10 20 Scheduled Sacrifice 10 10 10 9 Early Deaths Moribund Sacrifice 6 1 19 Natural Death 1 Survivors Terminal Sacrifice 13 1 Animals Examined Microscopically 20 10 10 10 10 20 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (1) (15) Edema 2 (13%) Parasite Metazoan 1 (7%) Submucosa, Proliferation Connective Tissue 1 (7%) Intestine Large, Colon (1) (15) Edema 1 (7%) Fibrosis 1 (7%) Hemorrhage 2 (13%) Serosa, Inflammation, Chronic 1 (7%) Intestine Large, Rectum (1) (15) Hemorrhage 1 (7%) Liver (20) (10) (10) (10) (10) (20) Basophilic Focus 1 (5%) 1 (10%) 3 (30%) 2 (10%) Basophilic Focus, Multiple 8 (40%) 1 (10%) 3 (15%) Clear Cell Focus 1 (5%) 1 (10%) 1 (5%) Clear Cell Focus, Multiple 4 (20%) Degeneration, Cystic 1 (5%) Eosinophilic Focus 5 (25%) 1 (10%) 2 (10%) Eosinophilic Focus, Multiple 2 (10%) 1 (5%) Hematopoietic Cell Proliferation 1 (10%) 2 (10%) Hepatodiaphragmatic Nodule 2 (10%) 2 (20%) 1 (10%) 1 (5%) Hyperplasia, Nodular 5 (25%) Inflammation, Granulomatous, Multiple 4 (20%) 3 (30%) 7 (70%) 6 (30%) Mixed Cell Focus 1 (5%) 1 (5%) Mixed Cell Focus, Multiple 1 (5%) Necrosis, Focal 1 (10%) Thrombosis 1 (5%) Vacuolization Cytoplasmic 1 (5%) 4 (40%) 2 (10%) Bile Duct, Hyperplasia 20 (100%) 6 (60%) 9 (90%) 7 (35%) Centrilobular, Degeneration 1 (5%) Hepatocyte, Necrosis, Multiple 1 (10%) 1 (5%) Hepatocyte, Kupffer Cell, Pigmentation 1 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Serosa, Fibrosis 1 (5%) Mesentery (2) (1) (2) (2) Thrombosis 1 (50%) Fat, Necrosis, Focal 2 (100%) 1 (100%) 2 (100%) Pancreas (1) (4) Edema 1 (25%) Polyarteritis 1 (100%) Acinar Cell, Atrophy 1 (25%) Acinar Cell, Hyperplasia 1 (25%) Stomach, Forestomach (3) (1) (9) Abscess 2 (22%) Edema 1 (11%) Inflammation, Suppurative 1 (33%) Mineralization 1 (11%) Ulcer 2 (67%) Ulcer, Multiple 1 (33%) Epithelium, Hyperplasia 1 (33%) 4 (44%) Stomach, Glandular (3) (1) (9) Erosion, Multiple 1 (33%) Mineralization 2 (22%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) Aorta, Mineralization 1 (100%) Heart (4) (2) (2) Inflammation, Chronic 4 (100%) 2 (100%) Mineralization 1 (50%) Atrium, Congestion 1 (25%) 2 (100%) Atrium, Dilatation 1 (25%) Atrium, Thrombosis 2 (50%) 1 (50%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (2) (2) Vacuolization Cytoplasmic 1 (50%) Vacuolization Cytoplasmic, Focal 1 (50%) Parathyroid Gland (2) Hyperplasia 2 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (20) (10) (10) (10) (10) (20) Depletion Cellular 17 (85%) 12 (60%) Preputial Gland (6) (1) (6) Atrophy 2 (33%) 3 (50%) Hyperplasia 1 (17%) Inflammation, Suppurative 2 (33%) Necrosis 1 (17%) Duct, Cyst 2 (33%) 4 (67%) Duct, Cyst, Multiple 1 (17%) Prostate (1) Inflammation, Chronic 1 (100%) Seminal Vesicle (2) Atrophy 2 (100%) Testes (20) (10) (10) (10) (10) (20) Degeneration, Focal 1 (10%) Bilateral, Interstitial Cell, Hyperplasia 2 (20%) Interstitial Cell, Hyperplasia 2 (10%) 4 (40%) 9 (45%) Seminiferous Tubule, Atrophy 20 (100%) 13 (65%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (13) (2) (14) Deep Cervical, Angiectasis 1 (8%) Iliac, Hyperplasia, Lymphoid 1 (7%) Mediastinal, Angiectasis 2 (15%) 3 (21%) Mediastinal, Congestion 1 (7%) Mediastinal, Hemorrhage 2 (15%) Mediastinal, Pigmentation 3 (21%) Pancreatic, Angiectasis 1 (8%) 1 (7%) Pancreatic, Edema 1 (7%) Pancreatic, Hemorrhage 1 (8%) Pancreatic, Hyperplasia, Lymphoid 1 (50%) 1 (7%) Renal, Angiectasis 1 (8%) 1 (7%) Renal, Inflammation, Granulomatous 1 (7%) Lymph Node, Mandibular (5) (1) (7) Hemorrhage 1 (20%) Hyperplasia, Lymphoid 1 (100%) 3 (43%) Lymph Node, Mesenteric (5) (1) (8) Angiectasis 2 (25%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Congestion 1 (13%) Cyst 2 (25%) Edema 3 (38%) Hemorrhage 1 (20%) Hyperplasia, Lymphoid 1 (20%) 1 (100%) Spleen (20) (10) (10) (10) (10) (20) Congestion 5 (25%) 7 (70%) 11 (55%) Depletion Lymphoid 1 (5%) Fibrosis 1 (5%) 1 (5%) Fibrosis, Focal 1 (5%) Hematopoietic Cell Proliferation 9 (45%) 4 (40%) 14 (70%) Inflammation, Granulomatous 1 (5%) Pigmentation 5 (25%) 10 (100%) 10 (100%) 7 (70%) 11 (55%) Capsule, Hypertrophy 9 (45%) Capsule, Inflammation, Chronic 1 (5%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (1) (1) Duct, Cyst 1 (100%) Skin (2) (2) (1) Epidermis, Fibrosis, Focal 1 (50%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (1) (1) Calvarium, Hyperostosis 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (5) Compression 2 (40%) Hemorrhage, Multiple 1 (20%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (7) (1) (1) Inflammation, Granulomatous 1 (14%) Alveolar Epithelium, Hyperplasia 1 (14%) Alveolus, Pigmentation 1 (14%) Nose (1) Lumen, Hyperkeratosis 1 (100%) Lumen, Inflammation, Suppurative 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.0% 0.0% 0.0% 0.0% 0.600% 3 SSAC 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Cataract 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (20) (10) (10) (10) (10) (20) Nephropathy 2 (20%) Nephropathy, Chronic 20 (100%) 2 (20%) 4 (40%) 10 (100%) 10 (100%) 20 (100%) Cortex, Cyst 1 (5%) Pelvis, Inflammation, Suppurative 1 (10%) Pelvis, Mineralization 16 (80%) 4 (40%) 3 (30%) 20 (100%) Renal Tubule, Hyperplasia 1 (5%) Renal Tubule, Pigmentation 19 (95%) 2 (20%) 10 (100%) 10 (100%) 20 (100%) Transitional Epithelium, Hyperplasia 5 (25%) 20 (100%) Ureter (18) (9) (10) (10) (10) (20) Dilatation 1 (10%) 3 (15%) Transitional Epithelium, Hyperplasia 1 (5%) Urethra (2) Bulbourethral Gland, Cyst, Multiple 1 (50%) Urinary Bladder (20) (9) (10) (10) (10) (20) Hemorrhage 1 (5%) Metaplasia, Squamous 1 (5%) Necrosis 1 (5%) Transitional Epithelium, Hyperplasia 6 (30%) a Number of animals examined microscopically at site and number of animals with lesion Page 17 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 10 10 10 10 20 10 Scheduled Sacrifice 10 10 10 3 10 Early Deaths Moribund Sacrifice 7 14 Natural Death 6 Survivors Animals Examined Microscopically 10 10 10 10 20 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (2) (9) (18) Dilatation 1 (6%) Intestine Large, Colon (2) (9) (18) Hemorrhage 2 (11%) Intussusception 4 (22%) Parasite Metazoan 1 (6%) Epithelium, Hyperplasia 4 (22%) Serosa, Inflammation, Chronic 1 (6%) Wall, Proliferation Connective Tissue 1 (6%) Intestine Large, Rectum (2) (9) (18) Epithelium, Hyperplasia 1 (6%) Liver (10) (10) (10) (10) (20) (10) Basophilic Focus 1 (10%) Eosinophilic Focus 1 (5%) Hematopoietic Cell Proliferation 1 (5%) Hepatodiaphragmatic Nodule 1 (10%) 1 (5%) Inflammation, Granulomatous, Multifocal 1 (10%) Inflammation, Granulomatous, Multiple 1 (10%) 9 (90%) 9 (90%) 8 (40%) Vacuolization Cytoplasmic 3 (30%) 1 (5%) Artery, Inflammation, Chronic, Focal 1 (10%) Hepatocyte, Hypertrophy 2 (10%) 10 (100%) Hepatocyte, Necrosis, Multifocal 1 (10%) 1 (5%) 10 (100%) Hepatocyte, Vacuolization Cytoplasmic 3 (30%) Hepatocyte, Vacuolization Cytoplasmic, Multifocal 3 (30%) Hepatocyte, Kupffer Cell, Pigmentation 3 (30%) 1 (10%) 18 (90%) 10 (100%) Stomach, Forestomach (2) (1) (5) Inflammation, Suppurative 1 (20%) Ulcer 1 (20%) Epithelium, Hyperplasia 1 (20%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 18 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (10) (10) (10) (10) (20) (10) Depletion Cellular 5 (25%) 10 (100%) Preputial Gland (1) Hyperplasia 1 (100%) Prostate (3) (1) Inflammation, Suppurative 1 (33%) 1 (100%) Seminal Vesicle (1) (1) Adventitia, Edema 1 (100%) Testes (10) (10) (10) (10) (20) (10) Atrophy 9 (90%) Degeneration 10 (100%) Edema 7 (70%) Bilateral, Interstitial Cell, Hyperplasia 1 (10%) Interstitial Cell, Hyperplasia 2 (20%) 3 (30%) Seminiferous Tubule, Atrophy 15 (75%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (1) (3) (3) Bronchial, Hyperplasia, Lymphoid 1 (33%) Iliac, Angiectasis 1 (33%) Mediastinal, Hyperplasia, Lymphoid 2 (67%) Pancreatic, Hyperplasia 1 (100%) Renal, Angiectasis 1 (33%) Lymph Node, Mesenteric (2) (1) Cyst 1 (50%) Fibrosis 1 (100%) Hyperplasia, Lymphoid 1 (50%) Spleen (10) (10) (10) (10) (20) (10) a Number of animals examined microscopically at site and number of animals with lesion Page 19 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Congestion 9 (90%) 10 (100%) 10 (100%) 5 (50%) 16 (80%) 10 (100%) Depletion Lymphoid 13 (65%) 10 (100%) Fibrosis 3 (15%) Hematopoietic Cell Proliferation 2 (20%) 7 (70%) 7 (35%) Hyperplasia, Lymphoid 2 (20%) Pigmentation 10 (100%) 10 (100%) 10 (100%) 5 (50%) 12 (60%) 10 (100%) Capsule, Hypertrophy 10 (100%) 7 (70%) 8 (80%) 8 (80%) 20 (100%) 10 (100%) Capsule, Inflammation, Chronic 1 (10%) 2 (20%) 5 (50%) 20 (100%) 10 (100%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (2) (2) (2) (1) (1) Congestion 2 (100%) Infiltration Cellular, Multifocal, Lymphocyte 2 (100%) 1 (50%) 1 (100%) Inflammation 1 (50%) Inflammation, Chronic 1 (50%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Cornea, Edema 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) (20) (10) Hydronephrosis 5 (25%) Infarct 3 (15%) Nephropathy, Chronic 10 (100%) 10 (100%) 10 (100%) 10 (100%) 14 (70%) 7 (70%) Pigmentation 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 20 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.600% 0.600% 0.600% 0.600% 1.80% 1.80% 3 SSAC 6 SSAC 9 SSAC 15 SSAC 3 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Bilateral, Hydronephrosis 2 (20%) Papilla, Necrosis 1 (5%) Pelvis, Dilatation 1 (10%) 1 (5%) Pelvis, Mineralization 9 (90%) 10 (100%) 10 (100%) 13 (65%) Renal Tubule, Degeneration 10 (100%) Renal Tubule, Dilatation 1 (5%) Renal Tubule, Mineralization 10 (100%) 1 (10%) 2 (10%) Renal Tubule, Necrosis 10 (100%) 1 (5%) Renal Tubule, Pigmentation 9 (90%) 9 (90%) 10 (100%) 9 (90%) 20 (100%) 10 (100%) Renal Tubule, Regeneration 10 (100%) 3 (30%) 3 (15%) Transitional Epithelium, Hyperplasia 7 (70%) 7 (70%) 11 (55%) Ureter (10) (10) (10) (8) (20) (10) Dilatation 2 (25%) 6 (30%) Urethra (1) Transitional Epithelium, Hyperplasia 1 (100%) Urinary Bladder (9) (10) (10) (10) (20) (10) Hemorrhage 3 (15%) Inflammation, Subacute 10 (100%) Inflammation, Suppurative 1 (10%) 3 (15%) Metaplasia, Squamous 2 (20%) 18 (90%) 10 (100%) Transitional Epithelium, Hyperplasia 10 (100%) 9 (90%) 4 (40%) 1 (5%) 9 (90%) Wall, Proliferation Connective Tissue 1 (10%) 2 (20%) 15 (75%) 10 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 21 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 10 10 10 Scheduled Sacrifice 10 6 Early Deaths Moribund Sacrifice 3 6 Natural Death 1 4 Survivors Animals Examined Microscopically 10 10 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (3) (5) (9) Dilatation 1 (11%) Intestine Large, Colon (3) (5) (9) Hemorrhage 2 (22%) Intussusception 2 (22%) Necrosis 1 (11%) Parasite Metazoan 1 (20%) Epithelium, Hyperplasia 1 (33%) 1 (20%) 5 (56%) Liver (10) (10) (10) Cyst 1 (10%) Eosinophilic Focus, Multiple 1 (10%) Inflammation, Granulomatous, Multiple 1 (10%) 8 (80%) 5 (50%) Hepatocyte, Hypertrophy 10 (100%) 1 (10%) 3 (30%) Hepatocyte, Necrosis, Multifocal 10 (100%) Hepatocyte, Vacuolization Cytoplasmic 6 (60%) Hepatocyte, Kupffer Cell, Pigmentation 10 (100%) 9 (90%) 8 (80%) Stomach, Forestomach (2) Epithelium, Hyperplasia 2 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 22 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (10) (10) (10) Depletion Cellular 10 (100%) 3 (30%) 2 (20%) Prostate (4) Inflammation, Suppurative 2 (50%) Proliferation Connective Tissue 1 (25%) Epithelium, Hyperplasia 1 (25%) Seminal Vesicle (1) Epithelium, Hyperplasia 1 (100%) Testes (10) (10) (10) Atrophy 10 (100%) Degeneration 10 (100%) Seminiferous Tubule, Atrophy 5 (50%) 4 (40%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (3) Iliac, Hyperplasia, Lymphoid 1 (33%) Pancreatic, Hyperplasia, Lymphoid 2 (67%) Spleen (10) (10) (10) Congestion 10 (100%) 6 (60%) 6 (60%) Depletion Lymphoid 10 (100%) 2 (20%) 5 (50%) Fibrosis 2 (20%) 1 (10%) Hematopoietic Cell Proliferation 6 (60%) 4 (40%) Inflammation, Chronic 1 (10%) Pigmentation 8 (80%) 3 (30%) 5 (50%) Thrombosis 1 (10%) Capsule, Hypertrophy 10 (100%) 10 (100%) 10 (100%) Capsule, Inflammation, Chronic 10 (100%) 10 (100%) 9 (90%) Thymus (2) Atrophy 2 (100%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 23 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM None ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) Fibrosis 1 (10%) Hydronephrosis 4 (40%) 3 (30%) Nephropathy, Chronic 10 (100%) 9 (90%) 7 (70%) Pigmentation 1 (10%) Bilateral, Hydronephrosis 1 (10%) Pelvis, Dilatation 1 (10%) Pelvis, Mineralization 1 (10%) 2 (20%) 7 (70%) Pelvis, Necrosis 1 (10%) Renal Tubule, Mineralization 1 (10%) 1 (10%) Renal Tubule, Pigmentation 9 (90%) 10 (100%) 10 (100%) Renal Tubule, Regeneration 10 (100%) 4 (40%) 1 (10%) Transitional Epithelium, Hemorrhage 1 (10%) Transitional Epithelium, Hyperplasia 5 (50%) 4 (40%) 7 (70%) Ureter (9) (10) (10) Dilatation 4 (40%) 5 (50%) Hemorrhage 1 (10%) Inflammation, Chronic 1 (10%) Transitional Epithelium, Hyperplasia 1 (11%) 1 (10%) Urinary Bladder (10) (10) (10) Cyst, Multiple 1 (10%) Hemorrhage 2 (20%) 1 (10%) Inflammation, Subacute 7 (70%) 3 (30%) Inflammation, Suppurative 3 (30%) Metaplasia, Squamous 10 (100%) 6 (60%) 10 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 24 NTP Experiment-Test: 05092-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SPECIAL STUDY O-NITROANISOLE Date: 04/08/97 Route: DOSED FEED Time: 13:45:49 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 1.80% 1.80% 1.80% 6 SSAC 9 SSAC 15 SSAC ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Transitional Epithelium, Hyperplasia 1 (10%) Wall, Proliferation Connective Tissue 9 (90%) 7 (70%) 6 (60%) a Number of animals examined microscopically at site and number of animals with lesion Page 25 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------