INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
O-NITROANISOLE
NTP Experiment-Test: 05092-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
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: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10 50 10 50 10
Scheduled Sacrifice 10 10 10
Early Deaths
Moribund Sacrifice 17 7 18
Natural Death 2 6
Survivors
Terminal Sacrifice 33 41 26
Animals Examined Microscopically 50 10 50 10 50 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (10) (49) (46)
Parasite Metazoan 1 (2%) 3 (6%) 2 (4%)
Intestine Large, Colon (50) (10) (49) (46)
Parasite Metazoan 3 (6%) 2 (20%) 5 (10%) 1 (2%)
Intestine Large, Rectum (50) (10) (49) (46)
Parasite Metazoan 3 (6%) 4 (8%) 2 (4%)
Intestine Small, Ileum (50) (10) (49) (46)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (50) (10) (50) (10) (50) (10)
Basophilic Focus 2 (4%) 2 (20%) 4 (8%) 4 (40%)
Basophilic Focus, Multiple 37 (74%) 7 (70%) 41 (82%) 9 (90%) 34 (68%) 5 (50%)
Clear Cell Focus 5 (10%) 1 (10%) 3 (6%)
Clear Cell Focus, Multiple 1 (2%) 1 (2%)
Cytomegaly 1 (2%)
Degeneration, Multiple 1 (2%)
Eosinophilic Focus 3 (6%) 8 (16%) 5 (10%) 1 (10%)
Eosinophilic Focus, Multiple 5 (10%) 2 (4%) 3 (6%)
Hepatodiaphragmatic Nodule 4 (8%) 3 (6%) 10 (20%) 1 (10%)
Hyperplasia, Nodular 4 (8%) 1 (2%) 3 (6%)
Inflammation, Granulomatous, Multiple 36 (72%) 5 (50%) 30 (60%) 5 (50%) 20 (40%) 2 (20%)
Karyomegaly 1 (2%)
Mixed Cell Focus 2 (4%) 1 (10%) 4 (8%) 2 (4%) 2 (20%)
Mixed Cell Focus, Multiple 1 (2%)
Necrosis 2 (4%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic 10 (20%) 3 (6%) 5 (10%)
Bile Duct, Hyperplasia 29 (58%) 3 (30%) 30 (60%) 1 (10%) 34 (68%) 4 (40%)
Centrilobular, Degeneration 1 (2%)
Serosa, Fibrosis 1 (2%)
Serosa, Inflammation, Granulomatous 1 (2%)
Mesentery (9) (1) (6) (2) (11)
Fat, Inflammation, Focal, Granulomatous 2 (22%) 1 (50%) 1 (9%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Inflammation, Granulomatous 1 (17%)
Fat, Necrosis, Focal 7 (78%) 1 (100%) 5 (83%) 1 (50%) 9 (82%)
Fat, Necrosis, Focal, Multiple 1 (9%)
Pancreas (50) (10) (50) (49)
Basophilic Focus 3 (6%)
Basophilic Focus, Multiple 1 (2%) 1 (2%)
Acinar Cell, Atrophy 14 (28%) 11 (22%) 15 (31%)
Acinar Cell, Hyperplasia 6 (12%) 4 (8%) 4 (8%)
Pharynx (2)
Palate, Epithelium, Hyperplasia 1 (50%)
Salivary Glands (50) (10) (49) (50)
Cytomegaly 1 (2%)
Infiltration Cellular, Lipocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%)
Acinar Cell, Atrophy 1 (2%) 1 (2%)
Acinar Cell, Hyperplasia 1 (2%)
Stomach, Forestomach (50) (10) (50) (1) (50)
Edema 4 (8%) 1 (2%) 5 (10%)
Inflammation, Chronic 4 (8%) 2 (4%) 2 (4%)
Inflammation, Suppurative 2 (4%)
Ulcer 1 (2%) 2 (4%)
Ulcer, Multiple 2 (4%) 1 (2%) 2 (4%)
Epithelium, Hyperplasia 8 (16%) 8 (16%) 1 (100%) 13 (26%)
Stomach, Glandular (50) (10) (50) (1) (50)
Edema 1 (2%)
Erosion 1 (2%) 1 (2%)
Erosion, Multiple 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Mineralization 1 (2%) 1 (2%)
Necrosis, Focal, Multiple 1 (2%) 1 (2%)
Ulcer 1 (2%)
Ulcer, Multiple 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Epithelium, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10) (50) (50)
Inflammation, Chronic 34 (68%) 1 (10%) 45 (90%) 41 (82%)
Atrium, Congestion 1 (2%)
Atrium, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (10) (50) (50)
Accessory Adrenal Cortical Nodule 6 (12%) 4 (8%) 2 (4%)
Degeneration, Cystic 1 (2%)
Hyperplasia, Focal 4 (8%) 10 (20%) 5 (10%)
Hyperplasia, Focal, Multiple 1 (2%)
Hypertrophy, Focal 7 (14%) 11 (22%) 6 (12%)
Hypertrophy, Focal, Multiple 2 (4%)
Necrosis, Focal, Multiple 1 (2%)
Vacuolization Cytoplasmic 1 (2%) 3 (6%) 2 (4%)
Vacuolization Cytoplasmic, Focal 14 (28%) 15 (30%) 8 (16%)
Vacuolization Cytoplasmic, Multiple 2 (4%)
Bilateral, Hypertrophy, Focal 1 (2%)
Bilateral, Vacuolization Cytoplasmic 1 (2%) 1 (2%)
Bilateral, Vacuolization Cytoplasmic, Focal 1 (2%)
Spindle Cell, Hyperplasia, Focal 1 (2%) 1 (10%)
Adrenal Gland, Medulla (50) (10) (50) (50)
Degeneration, Cystic, Focal 1 (2%)
Hyperplasia, Focal 3 (6%) 4 (8%) 3 (6%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Parathyroid Gland (49) (10) (46) (49)
Cyst 1 (2%)
Pituitary Gland (50) (10) (50) (3) (50) (1)
Pars Distalis, Cyst 4 (8%) 4 (8%) 3 (6%)
Pars Distalis, Cyst, Multiple 4 (8%) 4 (8%) 1 (33%) 1 (2%) 1 (100%)
Pars Distalis, Hyperplasia, Focal 5 (10%) 1 (10%) 6 (12%) 6 (12%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (50) (10) (50) (50) (1)
Inflammation, Suppurative 1 (2%)
Ultimobranchial Cyst 1 (2%) 2 (4%)
C-Cell, Hyperplasia 5 (10%) 3 (6%) 1 (2%)
C-Cell, Hyperplasia, Focal 9 (18%) 7 (14%) 5 (10%)
Follicle, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (45) (10) (47) (10) (50) (10)
Abscess 1 (2%)
Atrophy 1 (2%)
Cyst 14 (31%) 3 (30%) 23 (49%) 2 (20%) 18 (36%) 3 (30%)
Cyst, Multiple 1 (2%) 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hyperplasia 8 (18%) 1 (2%)
Hyperplasia, Focal 1 (2%) 4 (9%) 1 (2%)
Inflammation, Suppurative 2 (4%) 1 (2%) 2 (4%)
Bilateral, Cyst 7 (16%) 3 (6%) 11 (22%)
Ovary (50) (10) (50) (50)
Cyst 5 (10%) 1 (10%) 3 (6%) 5 (10%)
Inflammation, Granulomatous, Multiple 1 (2%)
Bilateral, Cyst 1 (2%) 1 (10%) 1 (2%)
Uterus (50) (10) (50) (10) (50) (10)
Abscess 1 (2%)
Dilatation 2 (4%) 2 (20%) 3 (6%) 1 (10%) 2 (4%) 1 (10%)
Hyperplasia, Glandular 2 (4%) 2 (4%) 2 (4%)
Infiltration Cellular, Lipocyte 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%)
Cervix, Abscess 1 (10%)
Cervix, Cyst 2 (4%) 1 (10%)
Cervix, Inflammation, Suppurative 1 (2%) 1 (2%)
Endometrium, Hyperplasia, Cystic 7 (14%) 2 (20%) 6 (12%) 1 (10%) 9 (18%)
Vagina (3) (1)
Inflammation, Suppurative 1 (33%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (10) (50) (50)
Hyperplasia, Reticulum Cell 1 (10%)
Myelofibrosis 2 (4%) 1 (2%)
Erythroid Cell, Hyperplasia 1 (2%)
Lymph Node (50) (10) (50) (50)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Angiectasis 6 (12%) 2 (4%) 5 (10%)
Mediastinal, Hemorrhage 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (10%) 3 (6%)
Mediastinal, Infiltration Cellular,
Histiocyte 1 (2%)
Mediastinal, Pigmentation 1 (2%)
Pancreatic, Angiectasis 2 (4%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%)
Pancreatic, Pigmentation 1 (10%)
Renal, Cyst, Multiple 1 (2%)
Lymph Node, Mandibular (48) (10) (49) (50)
Angiectasis 1 (2%) 2 (4%)
Congestion 1 (2%)
Cyst 1 (2%)
Cyst, Multiple 3 (6%) 2 (4%) 3 (6%)
Hyperplasia, Lymphoid 7 (15%) 2 (4%) 2 (4%)
Lymph Node, Mesenteric (48) (10) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Angiectasis 1 (2%) 3 (6%) 2 (4%)
Edema 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Spleen (50) (10) (50) (10) (50) (10)
Atrophy 1 (2%) 1 (2%)
Congestion 2 (4%)
Fibrosis, Focal 2 (4%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 10 (100%) 5 (10%) 8 (80%)
Inflammation, Granulomatous 2 (4%)
Necrosis 1 (2%)
Pigmentation 3 (6%) 5 (10%) 10 (100%) 2 (4%) 10 (100%)
Capsule, Fibrosis 1 (2%)
Capsule, Hypertrophy 1 (2%) 3 (30%) 3 (30%)
Capsule, Inflammation, Granulomatous 1 (2%)
Thymus (47) (10) (49) (47)
Cyst 3 (6%)
Cyst, Multiple 1 (2%)
Hyperplasia, Lymphoid 1 (10%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (10) (50) (50)
Hyperplasia, Lobular 19 (38%) 26 (52%) 22 (44%)
Duct, Cyst 38 (76%) 1 (10%) 36 (72%) 33 (66%)
Skin (50) (10) (50) (50)
Hyperkeratosis 2 (4%)
Parakeratosis 2 (4%)
Ulcer 2 (4%)
Nipple, Hyperkeratosis 1 (2%)
Nipple, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (10) (50) (50)
Osteopetrosis 2 (4%) 1 (2%) 1 (2%)
Calvarium, Hyperostosis 6 (12%) 1 (10%) 5 (10%) 4 (8%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10) (50) (50)
Compression 10 (20%) 6 (12%) 13 (26%)
Embolus Bacterial, Multiple 1 (2%)
Hemorrhage 2 (4%) 2 (4%)
Hemorrhage, Multiple 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Inflammation, Multiple, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (50) (50) (1)
Atelectasis 1 (2%)
Congestion 1 (2%)
Edema 1 (2%)
Embolus Bacterial, Multiple 1 (2%)
Hemorrhage, Multiple 1 (2%)
Infiltration Cellular, Focal, Histiocyte 1 (2%) 1 (2%) 4 (8%)
Infiltration Cellular, Multiple, Histiocyte 1 (2%) 1 (2%)
Infiltration Cellular, Lymphocyte 2 (4%)
Inflammation, Focal, Granulomatous 3 (6%) 2 (4%)
Inflammation, Multiple, Suppurative 1 (2%)
Mineralization, Focal 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 3 (6%) 1 (2%)
Nose (50) (10) (50) (3) (50) (6)
Metaplasia, Squamous 1 (2%)
Lumen, Foreign Body 1 (2%)
Lumen, Fungus 4 (8%) 2 (4%) 2 (4%)
Lumen, Hyperkeratosis 1 (2%)
Lumen, Inflammation, Suppurative 4 (8%) 3 (6%) 2 (4%)
Nasolacrimal Duct, Hemorrhage 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%)
Submucosa, Hemorrhage 2 (4%)
Submucosa, Pigmentation 46 (92%) 8 (80%) 48 (96%) 3 (100%) 46 (92%) 6 (100%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (4) (1)
Cataract 4 (100%) 1 (100%)
Retina, Degeneration 4 (100%) 1 (100%)
Harderian Gland (1) (2)
Hemorrhage 1 (100%) 2 (100%)
Zymbal's Gland (1) (1)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (50) (10) (50) (10)
Cyst 2 (4%) 1 (10%)
Fibrosis, Focal 1 (2%)
Hydronephrosis 1 (2%)
Infarct 1 (2%)
Infarct, Multiple 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic, Focal 1 (10%)
Inflammation, Suppurative 1 (2%)
Mineralization 2 (4%)
Nephropathy, Chronic 39 (78%) 3 (30%) 46 (92%) 9 (90%) 46 (92%) 5 (50%)
Papilla, Necrosis 1 (2%)
Pelvis, Dilatation 1 (2%)
Renal Tubule, Dilatation 1 (10%) 6 (60%)
Renal Tubule, Mineralization 1 (2%) 1 (10%) 1 (2%) 6 (60%) 3 (6%) 7 (70%)
Renal Tubule, Pigmentation 41 (82%) 47 (94%) 45 (90%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
Urinary Bladder (50) (10) (50) (10) (50) (10)
Calculus Gross Observation 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Suppurative 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10
Scheduled Sacrifice 9
Early Deaths
Moribund Sacrifice 14 1
Natural Death 3
Survivors
Terminal Sacrifice 33
Animals Examined Microscopically 50 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (49) (10)
Parasite Metazoan 1 (2%)
Intestine Large, Colon (49) (10)
Parasite Metazoan 2 (4%) 1 (10%)
Intestine Large, Rectum (49) (10)
Parasite Metazoan 6 (12%)
Intestine Small (50) (10)
Wall, Foreign Body 1 (2%)
Intestine Small, Jejunum (48) (10)
Inflammation, Granulomatous 1 (2%)
Ulcer 1 (2%)
Liver (50) (10)
Angiectasis 1 (2%)
Basophilic Focus 3 (6%) 2 (20%)
Basophilic Focus, Multiple 26 (52%) 1 (10%)
Clear Cell Focus 3 (6%)
Clear Cell Focus, Multiple 2 (4%)
Eosinophilic Focus 9 (18%)
Eosinophilic Focus, Multiple 5 (10%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 8 (16%) 1 (10%)
Hyperplasia, Nodular 14 (28%)
Inflammation, Granulomatous, Multiple 21 (42%) 5 (50%)
Mixed Cell Focus 5 (10%) 1 (10%)
Necrosis 1 (10%)
Vacuolization Cytoplasmic 5 (10%)
Bile Duct, Hyperplasia 43 (86%) 4 (40%)
Centrilobular, Necrosis 1 (2%)
Centrilobular, Vacuolization Cytoplasmic 1 (2%)
Hepatocyte, Kupffer Cell, Pigmentation 1 (10%)
Vein, Thrombosis 1 (2%)
Mesentery (12) (4)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic 1 (8%)
Fat, Inflammation, Focal, Granulomatous 1 (8%) 3 (75%)
Fat, Necrosis, Focal 10 (83%) 2 (50%)
Pancreas (50) (10)
Basophilic Focus, Multiple 2 (4%)
Ectopic Tissue 1 (2%)
Acinar Cell, Atrophy 12 (24%)
Acinar Cell, Hyperplasia 5 (10%)
Salivary Glands (50) (10)
Acinar Cell, Atrophy 1 (2%)
Acinar Cell, Hyperplasia 1 (2%)
Stomach, Forestomach (50) (10)
Edema 5 (10%)
Inflammation, Chronic 6 (12%)
Ulcer 6 (12%)
Ulcer, Multiple 1 (2%)
Epithelium, Hyperplasia 28 (56%) 1 (10%)
Stomach, Glandular (50) (10)
Erosion 2 (4%)
Ulcer 2 (4%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10)
Inflammation, Chronic 39 (78%) 2 (20%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (10)
Accessory Adrenal Cortical Nodule 7 (14%)
Cyst 1 (2%)
Degeneration, Cystic 2 (4%)
Hyperplasia, Focal 6 (12%)
Hypertrophy, Focal 5 (10%)
Vacuolization Cytoplasmic, Focal 11 (22%)
Bilateral, Hyperplasia 1 (2%)
Bilateral, Vacuolization Cytoplasmic 3 (6%)
Bilateral, Vacuolization Cytoplasmic, Focal 1 (2%)
Pituitary Gland (50) (10)
Pars Distalis, Angiectasis 1 (2%)
Pars Distalis, Cyst 5 (10%)
Pars Distalis, Cyst, Multiple 6 (12%) 1 (10%)
Pars Distalis, Hyperplasia 4 (8%) 1 (10%)
Pars Distalis, Hyperplasia, Focal 7 (14%)
Pars Intermedia, Cyst 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (50) (10)
C-Cell, Hyperplasia 2 (4%)
C-Cell, Hyperplasia, Focal 5 (10%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (10)
Cyst 15 (31%) 1 (10%)
Hyperplasia 6 (13%) 2 (20%)
Inflammation, Suppurative 2 (4%)
Bilateral, Cyst 11 (23%)
Ovary (50) (10)
Cyst 5 (10%)
Cyst, Multiple 1 (2%)
Uterus (50) (10)
Dilatation 4 (8%) 1 (10%)
Fibrosis, Focal 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Glandular 5 (10%)
Cervix, Hemorrhage 1 (2%)
Cervix, Myometrium, Hyperplasia 3 (6%)
Endometrium, Hyperplasia, Cystic 12 (24%)
Vein, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (50) (10)
Mediastinal, Angiectasis 6 (12%)
Mediastinal, Congestion 1 (2%)
Mediastinal, Hemorrhage 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 2 (4%)
Mediastinal, Pigmentation 2 (4%)
Pancreatic, Angiectasis 6 (12%)
Lymph Node, Mandibular (50) (10)
Hyperplasia, Lymphoid 1 (2%)
Pigmentation 2 (4%)
Lymph Node, Mesenteric (47) (10)
Angiectasis 1 (2%)
Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic 1 (2%)
Spleen (50) (10)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 3 (6%)
Inflammation, Granulomatous 1 (2%)
Pigmentation 1 (2%) 1 (10%)
Thymus (48) (10)
Congestion 1 (2%)
Cyst 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Mediastinum, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (10)
Hyperplasia, Lobular 21 (42%)
Duct, Cyst 34 (68%)
Skin (50) (10)
Hyperkeratosis 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (10)
Osteopetrosis 1 (2%)
Calvarium, Hyperostosis 5 (10%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10)
Compression 6 (12%)
Hemorrhage, Multiple 2 (4%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Infiltration Cellular, Focal, Histiocyte 2 (4%)
Infiltration Cellular, Multiple, Histiocyte 2 (4%)
Inflammation, Focal, Granulomatous 4 (8%)
Inflammation, Granulomatous, Multiple 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Alveolar Epithelium, Hyperplasia 2 (4%)
Alveolus, Pigmentation 2 (4%)
Nose (50) (10)
Lumen, Fungus 1 (2%)
Lumen, Inflammation, Suppurative 1 (2%)
Submucosa, Pigmentation 50 (100%) 10 (100%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (5)
Cataract 4 (80%)
Inflammation, Suppurative 1 (20%)
Retina, Degeneration 4 (80%)
Harderian Gland (2)
Hemorrhage 1 (50%)
Zymbal's Gland (1)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10)
Nephropathy, Chronic 44 (88%) 4 (40%)
Renal Tubule, Dilatation 1 (2%) 8 (80%)
Renal Tubule, Mineralization 2 (4%) 6 (60%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 46 (92%)
Urinary Bladder (50) (10)
Hemorrhage, Focal 1 (2%)
Inflammation, Chronic 2 (4%)
Transitional Epithelium, Hyperplasia 6 (12%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10 50 10 50 10
Scheduled Sacrifice 10 10 10
Early Deaths
Natural Death 2 3 2
Moribund Sacrifice 16 13 24
Survivors
Terminal Sacrifice 32 34 24
Animals Examined Microscopically 50 10 50 10 50 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (10) (48) (49)
Dilatation 1 (2%)
Parasite Metazoan 1 (2%) 3 (6%)
Intestine Large, Colon (48) (10) (48) (50)
Dilatation 1 (2%)
Parasite Metazoan 5 (10%) 4 (40%) 4 (8%) 2 (4%)
Intestine Large, Rectum (46) (10) (49) (50)
Dilatation 1 (2%)
Parasite Metazoan 9 (20%) 4 (8%) 13 (26%)
Intestine Small, Duodenum (49) (10) (47) (50)
Ectopic Tissue 1 (2%)
Intestine Small, Ileum (48) (10) (47) (48)
Hyperplasia, Lymphoid 1 (2%) 2 (4%) 4 (8%)
Liver (50) (10) (50) (10) (50) (10)
Angiectasis 1 (2%)
Basophilic Focus 3 (6%) 5 (50%) 2 (4%) 1 (10%) 2 (4%)
Basophilic Focus, Multiple 29 (58%) 27 (54%) 11 (22%)
Clear Cell Focus 6 (12%) 3 (30%) 4 (8%) 1 (2%) 1 (10%)
Clear Cell Focus, Multiple 7 (14%) 2 (20%) 6 (12%) 1 (10%) 4 (8%)
Degeneration, Cystic 10 (20%) 1 (10%) 10 (20%) 14 (28%)
Eosinophilic Focus 6 (12%) 10 (20%) 1 (10%) 15 (30%) 3 (30%)
Eosinophilic Focus, Multiple 2 (4%) 8 (16%) 1 (10%) 6 (12%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 4 (8%) 3 (6%) 2 (4%) 1 (10%)
Hepatodiaphragmatic Nodule, Multiple 1 (10%)
Hyperplasia, Nodular 7 (14%) 2 (4%) 18 (36%)
Inflammation, Granulomatous, Multiple 2 (4%) 5 (50%) 2 (4%) 4 (40%) 2 (4%) 6 (60%)
Mixed Cell Focus 4 (8%) 2 (20%) 2 (4%)
Mixed Cell Focus, Multiple 2 (4%) 2 (4%) 1 (2%)
Necrosis 1 (2%)
Thrombosis, Multiple 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Vacuolization Cytoplasmic 5 (10%) 8 (80%) 4 (8%) 10 (100%) 4 (8%) 8 (80%)
Bile Duct, Hyperplasia 46 (92%) 10 (100%) 44 (88%) 10 (100%) 46 (92%) 7 (70%)
Centrilobular, Degeneration 2 (4%) 2 (4%) 2 (4%)
Mesentery (10) (2) (11) (2) (5) (2)
Accessory Spleen 1 (50%)
Fat, Hemorrhage, Focal 2 (20%) 1 (50%)
Fat, Inflammation, Focal, Granulomatous 1 (10%) 1 (50%) 4 (36%) 1 (50%)
Fat, Necrosis, Focal 7 (70%) 9 (82%) 1 (50%) 3 (60%)
Pancreas (49) (10) (49) (50) (1)
Basophilic Focus 2 (4%)
Ectopic Tissue 1 (2%)
Edema 1 (2%) 1 (2%)
Polyarteritis 1 (2%) 1 (2%)
Acinar Cell, Atrophy 18 (37%) 21 (43%) 18 (36%)
Acinar Cell, Basophilic Focus 2 (4%)
Acinar Cell, Hyperplasia 6 (12%) 10 (20%) 4 (8%)
Acinar Cell, Hyperplasia, Focal 1 (2%)
Acinar Cell, Vacuolization Cytoplasmic 1 (2%)
Salivary Glands (50) (10) (50) (50)
Cytomegaly 1 (2%) 8 (16%) 4 (8%)
Fibrosis, Focal 1 (2%)
Infiltration Cellular, Lipocyte 39 (78%) 6 (12%)
Inflammation, Suppurative 1 (2%)
Acinar Cell, Atrophy 1 (2%) 1 (2%)
Stomach, Forestomach (50) (10) (50) (50) (1)
Edema 3 (6%) 3 (6%) 5 (10%)
Inflammation, Chronic 2 (4%) 2 (4%) 1 (2%)
Mineralization 1 (2%)
Perforation 1 (2%)
Ulcer 3 (6%) 3 (6%) 6 (12%)
Ulcer, Multiple 2 (4%)
Epithelium, Hyperplasia 3 (6%) 16 (32%) 25 (50%) 1 (100%)
Stomach, Glandular (50) (10) (49) (50) (1)
Edema 4 (8%)
Erosion, Multiple 1 (2%)
Mineralization 1 (2%) 1 (2%)
Ulcer 1 (2%)
Ulcer, Multiple 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10) (50) (1) (50)
Inflammation, Chronic 43 (86%) 6 (60%) 46 (92%) 42 (84%)
Atrium, Congestion 2 (4%) 1 (2%)
Atrium, Thrombosis 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (10) (50) (50)
Accessory Adrenal Cortical Nodule 8 (17%) 1 (10%) 5 (10%) 5 (10%)
Degeneration, Cystic 1 (2%)
Hyperplasia, Focal 3 (6%) 1 (10%) 7 (14%) 4 (8%)
Hypertrophy, Focal 5 (10%) 2 (4%) 1 (2%)
Vacuolization Cytoplasmic 2 (4%)
Vacuolization Cytoplasmic, Focal 9 (19%) 1 (10%) 10 (20%) 11 (22%)
Vacuolization Cytoplasmic, Focal, Multiple 2 (4%)
Adrenal Gland, Medulla (49) (10) (50) (50)
Hyperplasia 1 (2%)
Hyperplasia, Focal 4 (8%) 9 (18%) 11 (22%)
Bilateral, Hyperplasia, Focal 1 (2%)
Islets, Pancreatic (49) (10) (49) (50)
Hyperplasia 1 (2%) 2 (4%) 2 (4%)
Parathyroid Gland (47) (10) (46) (47)
Hyperplasia 2 (4%) 1 (2%) 3 (6%)
Pituitary Gland (50) (10) (50) (1) (49)
Pars Distalis, Cyst 2 (4%) 1 (2%) 6 (12%)
Pars Distalis, Cyst, Multiple 1 (2%)
Pars Distalis, Hemorrhage 4 (8%)
Pars Distalis, Hyperplasia, Focal 3 (6%) 3 (30%) 9 (18%) 11 (22%)
Pars Intermedia, Cyst 2 (4%)
Thyroid Gland (49) (10) (50) (50)
Ultimobranchial Cyst 1 (2%)
Bilateral, C-Cell, Hyperplasia 1 (2%)
C-Cell, Hyperplasia 3 (6%)
C-Cell, Hyperplasia, Focal 7 (14%) 3 (6%) 3 (6%)
Follicle, Cyst 4 (8%) 5 (10%) 6 (12%)
Follicular Cell, Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1)
Inflammation, Suppurative 1 (100%)
Epididymis (50) (10) (50) (10) (50) (10)
Granuloma Sperm 1 (2%)
Preputial Gland (50) (10) (50) (10) (50) (9)
Abscess 1 (2%)
Atrophy 6 (12%) 13 (26%) 16 (32%) 2 (22%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Atrophy, Multiple 3 (6%) 1 (2%)
Autolysis 1 (2%)
Cyst 7 (14%) 3 (30%) 18 (36%) 2 (20%) 24 (48%) 2 (22%)
Cyst, Multiple 2 (4%) 4 (8%) 7 (14%)
Hyperplasia 2 (4%) 1 (10%) 5 (10%)
Hyperplasia, Focal 1 (2%) 3 (6%)
Inflammation, Chronic 2 (4%) 1 (2%) 1 (2%)
Inflammation, Suppurative 3 (6%) 5 (10%) 3 (6%)
Prostate (50) (10) (50) (50)
Cyst 1 (2%)
Inflammation, Chronic 4 (8%) 6 (12%) 2 (4%)
Inflammation, Suppurative 24 (48%) 3 (30%) 15 (30%) 17 (34%)
Epithelium, Hyperplasia 1 (2%)
Seminal Vesicle (50) (10) (50) (50) (1)
Atrophy 12 (24%) 12 (24%) 7 (14%) 1 (100%)
Hyperplasia, Glandular 1 (2%)
Testes (50) (10) (50) (10) (50) (10)
Atrophy 16 (32%) 13 (26%) 15 (30%) 1 (10%)
Bilateral, Atrophy 1 (2%) 2 (4%)
Bilateral, Interstitial Cell, Hyperplasia 3 (6%) 6 (60%) 5 (10%) 3 (30%) 3 (6%) 5 (50%)
Interstitial Cell, Atrophy 2 (4%)
Interstitial Cell, Hyperplasia 16 (32%) 1 (10%) 6 (12%) 4 (40%) 15 (30%) 4 (40%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (10) (50) (50)
Myelofibrosis 1 (2%) 2 (4%)
Myeloid Cell, Hyperplasia 1 (2%)
Lymph Node (50) (10) (50) (50) (1)
Inguinal, Hyperplasia, Lymphoid 3 (6%) 1 (2%)
Mediastinal, Angiectasis 9 (18%) 5 (10%) 2 (4%)
Mediastinal, Cyst, Multiple 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 2 (4%) 1 (10%) 2 (4%) 1 (2%)
Mediastinal, Pigmentation 2 (4%) 1 (2%)
Pancreatic, Angiectasis 2 (4%) 2 (4%) 2 (4%)
Pancreatic, Cyst, Multiple 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (100%)
Pancreatic, Pigmentation 2 (4%)
Renal, Hyperplasia, Lymphoid 1 (2%)
Renal, Pigmentation 1 (2%)
Lymph Node, Mandibular (50) (10) (48) (50)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Cyst, Multiple 3 (6%) 6 (13%) 3 (6%)
Fibrosis 1 (2%)
Hyperplasia, Lymphoid 4 (8%) 3 (6%) 3 (6%)
Lymph Node, Mesenteric (49) (10) (48) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Angiectasis 1 (2%) 2 (4%) 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 6 (13%) 1 (2%)
Spleen (50) (10) (49) (10) (50) (10)
Congestion 1 (10%) 7 (14%) 1 (10%)
Fibrosis, Focal 7 (14%) 5 (10%) 8 (16%)
Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 1 (2%)
Hyperplasia, Histiocytic, Lymphoid 1 (2%)
Inflammation, Granulomatous, Multiple 1 (2%)
Necrosis 2 (4%)
Capsule, Fibrosis, Focal 1 (10%)
Capsule, Hypertrophy 1 (2%) 5 (50%) 6 (60%)
Thymus (45) (9) (48) (42)
Fibrosis 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (10) (49) (47)
Hyperplasia, Lobular 10 (21%) 21 (43%) 13 (28%)
Duct, Cyst 7 (15%) 17 (35%) 16 (34%)
Duct, Hemorrhage 1 (2%) 3 (6%)
Skin (50) (10) (50) (1) (50)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 1 (2%)
Dermis, Fibrosis 1 (2%)
Epidermis, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (10) (50) (50)
Fibrous Osteodystrophy 1 (2%) 1 (2%)
Osteoporosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10) (50) (50)
Compression 6 (12%) 3 (6%) 4 (8%)
Hemorrhage 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 18
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (50) (1) (50)
Atelectasis, Focal 1 (2%)
Erythrophagocytosis 1 (2%)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Focal, Histiocyte 4 (8%)
Infiltration Cellular, Multiple, Histiocyte 2 (4%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Focal, Granulomatous 2 (4%) 1 (2%)
Inflammation, Granulomatous, Multiple 3 (6%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 1 (10%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%)
Nose (50) (10) (50) (50)
Lumen, Foreign Body 1 (2%) 3 (6%) 5 (10%)
Lumen, Fungus 10 (20%) 9 (18%) 9 (18%)
Lumen, Inflammation, Suppurative 9 (18%) 12 (24%) 13 (26%)
Respiratory Epithelium, Hyperkeratosis 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%)
Septum, Inflammation, Chronic 1 (2%)
Submucosa, Inflammation, Suppurative 1 (2%)
Submucosa, Pigmentation 45 (90%) 37 (74%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (2) (1)
Cataract 1 (100%) 1 (100%) 1 (100%)
Retina, Degeneration 1 (100%) 1 (100%) 1 (50%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (10) (50) (10) (50) (10)
Cyst 1 (2%) 2 (4%) 2 (4%)
Cyst, Multiple 1 (2%)
Fibrosis, Focal 1 (10%)
Nephropathy, Chronic 49 (100%) 10 (100%) 50 (100%) 10 (100%) 50 (100%) 10 (100%)
Pelvis, Dilatation 1 (10%)
Renal Tubule, Hyperplasia 3 (6%)
Renal Tubule, Mineralization 2 (4%)
Renal Tubule, Pigmentation 45 (92%) 41 (82%) 48 (96%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 19
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.0% 0.0% 0.0222% 0.0222% 0.0666% 0.0666%
15 SSAC 15 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 7 (14%) 9 (18%) 9 (18%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 20
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10
Scheduled Sacrifice 9
Early Deaths
Moribund Sacrifice 35 1
Natural Death 6
Survivors
Natural Death 1
Terminal Sacrifice 8
Animals Examined Microscopically 50 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (47) (10)
Parasite Metazoan 1 (2%)
Intestine Large, Colon (48) (10)
Mineralization 1 (2%)
Parasite Metazoan 9 (19%) 4 (40%)
Intestine Large, Rectum (49) (10)
Dilatation 1 (2%)
Edema 1 (2%)
Parasite Metazoan 8 (16%)
Intestine Small, Jejunum (48) (10)
Parasite Metazoan 1 (10%)
Artery, Thrombosis 1 (2%)
Wall, Inflammation, Chronic 1 (2%)
Liver (50) (10)
Angiectasis 1 (2%)
Basophilic Focus 4 (8%) 1 (10%)
Basophilic Focus, Multiple 3 (6%)
Clear Cell Focus 2 (4%) 1 (10%)
Clear Cell Focus, Multiple 3 (6%)
Degeneration, Cystic 24 (48%)
Eosinophilic Focus 13 (26%)
Eosinophilic Focus, Multiple 14 (28%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage, Focal 1 (10%)
Hepatodiaphragmatic Nodule 4 (8%) 2 (20%)
Hyperplasia, Nodular 14 (28%)
Inflammation, Granulomatous, Multiple 7 (70%)
Mixed Cell Focus 2 (4%)
Necrosis 2 (4%) 1 (10%)
Vacuolization Cytoplasmic 1 (2%) 8 (80%)
Bile Duct, Hyperplasia 40 (80%) 9 (90%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 21
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Centrilobular, Degeneration 2 (4%)
Centrilobular, Necrosis 1 (2%)
Vein, Thrombosis 1 (2%)
Mesentery (9)
Polyarteritis 2 (22%)
Thrombosis, Multiple 1 (11%)
Fat, Hemorrhage, Focal 2 (22%)
Fat, Necrosis, Focal 3 (33%)
Pancreas (48) (10)
Ectopic Tissue 2 (4%)
Fibrosis, Focal 1 (2%)
Inflammation, Chronic 1 (2%)
Polyarteritis 2 (4%)
Acinar Cell, Atrophy 13 (27%)
Acinar Cell, Hyperplasia 6 (13%)
Acinus, Atrophy 1 (10%)
Stomach, Forestomach (50) (10)
Edema 11 (22%)
Inflammation, Chronic 12 (24%)
Mineralization 1 (2%)
Ulcer 15 (30%)
Ulcer, Multiple 1 (2%)
Epithelium, Hyperplasia 32 (64%) 2 (20%)
Stomach, Glandular (50) (10)
Edema 1 (2%)
Erosion 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 6 (12%)
Polyarteritis 1 (2%)
Ulcer 1 (2%)
Artery, Thrombosis 1 (2%)
Mucosa, Pigmentation, Focal 1 (2%)
Serosa, Fibrosis, Focal 1 (10%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Aorta, Mineralization 1 (100%)
Mesenteric Artery, Mineralization 1 (100%)
Heart (50) (10)
Inflammation, Chronic 40 (80%) 5 (50%)
Mineralization 1 (2%)
Atrium, Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 22
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (10)
Accessory Adrenal Cortical Nodule 2 (4%) 1 (10%)
Degeneration, Cystic 1 (2%)
Hyperplasia, Focal 2 (4%)
Hypertrophy, Focal 1 (2%)
Hypertrophy, Multiple 1 (2%)
Vacuolization Cytoplasmic 11 (22%)
Vacuolization Cytoplasmic, Focal 8 (16%)
Vacuolization Cytoplasmic, Focal, Multiple 1 (2%)
Spindle Cell, Hyperplasia, Focal 1 (2%)
Adrenal Gland, Medulla (49) (10)
Hemorrhage 1 (2%)
Hyperplasia, Focal 10 (20%)
Parathyroid Gland (48) (10)
Hyperplasia 14 (29%)
Pituitary Gland (49) (10)
Pars Distalis, Cyst 2 (4%)
Pars Distalis, Hyperplasia, Focal 5 (10%) 2 (20%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (50) (10)
Ultimobranchial Cyst 1 (2%)
Artery, Polyarteritis 1 (2%)
C-Cell, Hyperplasia 1 (2%) 1 (10%)
C-Cell, Hyperplasia, Focal 3 (6%)
Follicle, Cyst 5 (10%) 1 (10%)
Follicle, Degeneration 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (10)
Depletion Cellular 1 (10%)
Preputial Gland (49) (10)
Abscess 1 (2%)
Atrophy 13 (27%)
Cyst 16 (33%) 1 (10%)
Cyst, Multiple 1 (2%)
Hyperplasia 2 (4%)
Inflammation, Suppurative 2 (4%)
Bilateral, Atrophy 4 (8%)
Prostate (50) (10)
a Number of animals examined microscopically at site and number of animals with lesion
Page 23
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 3 (6%)
Granuloma 1 (10%)
Inflammation, Chronic 3 (6%)
Inflammation, Suppurative 17 (34%) 2 (20%)
Seminal Vesicle (50) (10)
Atrophy 2 (4%)
Testes (50) (10)
Atrophy 17 (34%) 3 (30%)
Degeneration 2 (20%)
Necrosis 1 (2%) 1 (10%)
Arteriole, Inflammation, Chronic 1 (2%)
Bilateral, Atrophy 1 (2%)
Bilateral, Interstitial Cell, Hyperplasia 5 (10%) 1 (10%)
Interstitial Cell, Hyperplasia 10 (20%) 5 (50%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (10)
Myelofibrosis 2 (4%)
Lymph Node (50) (10)
Iliac, Cyst 1 (2%)
Inguinal, Hyperplasia, Lymphoid 3 (6%)
Mediastinal, Angiectasis 2 (4%)
Mediastinal, Pigmentation 4 (8%)
Pancreatic, Angiectasis 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 3 (6%)
Renal, Angiectasis 4 (8%)
Renal, Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mandibular (50) (10)
Angiectasis 1 (2%)
Cyst 1 (2%)
Hyperplasia, Lymphoid 2 (4%)
Lymph Node, Mesenteric (48) (10)
Angiectasis 1 (2%)
Edema 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (50) (10)
Congestion 3 (30%)
Fibrosis, Focal 9 (18%)
Hematopoietic Cell Proliferation 1 (2%)
Necrosis 1 (2%)
Pigmentation 1 (2%)
Capsule, Hypertrophy 8 (80%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 24
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (10)
Hyperplasia, Lobular 23 (46%)
Duct, Cyst 7 (14%)
Skin (50) (10)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Subcutaneous Tissue, Cyst Epithelial
Inclusion 1 (10%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (10)
Calvarium, Hyperostosis 1 (2%)
Femur, Fibrous Osteodystrophy 4 (8%)
Maxilla, Fibrous Osteodystrophy 3 (6%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10)
Compression 2 (4%)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10)
Hemorrhage, Multiple 1 (2%)
Inflammation, Focal, Granulomatous 2 (20%)
Inflammation, Granulomatous, Multiple 1 (2%)
Mineralization 1 (2%)
Alveolus, Pigmentation 1 (2%)
Mediastinum, Polyarteritis, Multiple 1 (2%)
Mediastinum, Thrombosis, Multiple 1 (2%)
Nose (50) (10)
Metaplasia, Squamous 2 (4%)
Lumen, Foreign Body 2 (4%)
Lumen, Fungus 14 (28%) 1 (10%)
Lumen, Inflammation, Suppurative 14 (28%) 1 (10%)
Submucosa, Pigmentation 45 (90%) 7 (70%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 25
NTP Experiment-Test: 05092-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC O-NITROANISOLE Date: 09/12/94
Route: DOSED FEED Time: 15:57:55
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0.200% 0.200%
15 SSAC
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2)
Cataract 1 (50%)
Retina, Degeneration 1 (50%)
Harderian Gland (2)
Hemorrhage 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (10)
Cyst 6 (12%)
Cyst, Multiple 7 (14%)
Hydronephrosis 1 (2%)
Nephropathy, Chronic 49 (100%) 10 (100%)
Renal Tubule, Hyperplasia 2 (4%)
Renal Tubule, Pigmentation 46 (94%)
Transitional Epithelium, Hyperplasia 30 (61%)
Ureter (1)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (50) (10)
Inflammation, Chronic 1 (2%)
Transitional Epithelium, Hyperplasia 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 26
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