TDMS Study 05155-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) P-NITROBENZOIC ACID NTP Experiment-Test: 05155-03 Report: PEIRPT03 Study Type: CHRONIC Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 Facility: Southern Research Institute Chemical CAS #: 62-23-7 Lock Date: 02/15/92 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: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 21 23 27 26 Natural Death 2 4 2 3 Survivors Terminal Sacrifice 27 23 21 21 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (60) (58) (60) (60) Parasite Metazoan 1 (2%) 1 (2%) Intestine Large, Rectum (60) (58) (60) (58) Parasite Metazoan 7 (12%) 2 (3%) 4 (7%) Intestine Large, Cecum (60) (57) (60) (59) Parasite Metazoan 1 (2%) Liver (60) (60) (60) (60) Angiectasis 1 (2%) 2 (3%) 2 (3%) Basophilic Focus 40 (67%) 43 (72%) 50 (83%) 55 (92%) Clear Cell Focus 4 (7%) 7 (12%) 7 (12%) 12 (20%) Eosinophilic Focus 4 (7%) 4 (7%) 1 (2%) Fatty Change 14 (23%) 14 (23%) 7 (12%) 7 (12%) Fibrosis, Focal 1 (2%) 2 (3%) Focal Cellular Change 1 (2%) 1 (2%) 2 (3%) Hematopoietic Cell Proliferation 2 (3%) 2 (3%) 1 (2%) Hepatodiaphragmatic Nodule 8 (13%) 6 (10%) 12 (20%) 16 (27%) Hepatodiaphragmatic Nodule, Multiple 2 (3%) 2 (3%) 3 (5%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Multifocal 9 (15%) 10 (17%) 3 (5%) 2 (3%) Infiltration Cellular, Mixed Cell 1 (2%) 4 (7%) 3 (5%) 1 (2%) Inflammation, Focal 33 (55%) 33 (55%) 41 (68%) 45 (75%) Mixed Cell Focus 5 (8%) 8 (13%) 4 (7%) 7 (12%) Necrosis, Focal 2 (3%) 1 (2%) 1 (2%) Pigmentation 1 (2%) Thrombosis 1 (2%) Bile Duct, Dilatation 1 (2%) Bile Duct, Hyperplasia 27 (45%) 25 (42%) 24 (40%) 33 (55%) Centrilobular, Atrophy 14 (23%) 11 (18%) 4 (7%) 2 (3%) Centrilobular, Congestion 1 (2%) Centrilobular, Hemorrhage 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (11) (9) (10) (6) Accessory Spleen 1 (11%) 1 (17%) Cyst 1 (10%) Inflammation, Chronic 1 (11%) 1 (10%) 1 (17%) Fat, Necrosis 7 (64%) 4 (44%) 7 (70%) 4 (67%) Pancreas (60) (60) (59) (59) Accessory Spleen 1 (2%) 1 (2%) Atrophy, Diffuse 2 (3%) 1 (2%) 1 (2%) 1 (2%) Atrophy, Focal 21 (35%) 18 (30%) 21 (36%) 13 (22%) Cyst 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Acinar Cell, Depletion Secretory 1 (2%) Duct, Dilatation 1 (2%) Stomach, Forestomach (60) (60) (59) (59) Edema 1 (2%) Hemorrhage, Focal 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) 2 (3%) 1 (2%) Ulcer 1 (2%) 2 (3%) Mucosa, Hyperplasia 2 (3%) 1 (2%) 1 (2%) 2 (3%) Stomach, Glandular (60) (60) (59) (59) Bacterium 1 (2%) Erosion 2 (3%) 1 (2%) Inflammation, Chronic 1 (2%) Ulcer 1 (2%) Tongue (1) (1) Hypertrophy, Squamous 1 (100%) Tooth (1) Gingiva, Hyperplasia 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (60) (60) (60) (60) Mesenteric Artery, Inflammation, Chronic 1 (2%) 2 (3%) Mesenteric Artery, Thrombosis 1 (2%) Heart (60) (60) (60) (60) Bacterium 1 (2%) Embolus 1 (2%) Inflammation, Chronic, Focal 2 (3%) 1 (2%) Artery, Inflammation, Chronic 2 (3%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (60) (60) (60) Accessory Adrenal Cortical Nodule 2 (3%) 1 (2%) 3 (5%) Angiectasis 1 (2%) 2 (3%) Congestion 4 (7%) 1 (2%) 2 (3%) Degeneration, Cystic 2 (3%) Depletion Cellular 1 (2%) Focal Cellular Change 13 (22%) 9 (15%) 10 (17%) 13 (22%) Hyperplasia, Focal 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Vacuolization Cytoplasmic 1 (2%) Capsule, Extra Adrenal Tissue, Fibrosis 1 (2%) Adrenal Medulla (59) (60) (60) (60) Hyperplasia 2 (3%) 1 (2%) 2 (3%) 2 (3%) Pituitary Gland (60) (60) (59) (59) Angiectasis 19 (32%) 13 (22%) 12 (20%) 11 (19%) Cyst 4 (7%) 6 (10%) 2 (3%) 4 (7%) Granuloma 1 (2%) Hemorrhage 1 (2%) Pars Distalis, Cyst 1 (2%) 1 (2%) Pars Distalis, Focal Cellular Change 6 (10%) 4 (7%) 2 (3%) 3 (5%) Pars Distalis, Hyperplasia, Focal 16 (27%) 11 (18%) 14 (24%) 9 (15%) Rathke's Cleft, Hyperplasia, Cystic 1 (2%) Thyroid Gland (60) (59) (60) (60) Degeneration, Cystic 1 (2%) Inflammation, Focal 1 (2%) Ultimobranchial Cyst 2 (3%) 3 (5%) C-Cell, Hyperplasia 10 (17%) 8 (14%) 11 (18%) 14 (23%) Follicle, Dilatation 1 (2%) Follicular Cell, Hyperplasia 2 (3%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (60) (59) (59) (60) Atrophy 1 (2%) Cyst 1 (2%) 1 (2%) 1 (2%) 2 (3%) Degeneration, Cystic 42 (70%) 43 (73%) 47 (80%) 39 (65%) Hyperplasia 10 (17%) 6 (10%) 6 (10%) 7 (12%) Inflammation, Chronic 1 (2%) 1 (2%) Duct, Hyperplasia, Squamous 1 (2%) Ovary (60) (60) (60) (59) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Angiectasis 1 (2%) 1 (2%) Atrophy 1 (2%) Cyst 5 (8%) 10 (17%) 10 (17%) 9 (15%) Hemorrhage 1 (2%) Bilateral, Cyst 1 (2%) Corpus Luteum, Hyperplasia, Lymphoid 2 (3%) 1 (2%) Corpus Luteum, Thecal Cell, Hyperplasia 2 (3%) 1 (2%) Uterus (60) (60) (60) (59) Hydrometra 1 (2%) 6 (10%) 5 (8%) 3 (5%) Endometrium, Cyst 1 (2%) 1 (2%) 1 (2%) Endometrium, Hyperplasia, Cystic 3 (5%) 10 (17%) 4 (7%) 6 (10%) Endometrium, Infarct 2 (3%) Vagina (3) (2) (3) Cyst 2 (67%) 2 (100%) 1 (33%) Cyst, Multiple 1 (33%) Inflammation, Chronic 1 (33%) Mucosa, Hyperplasia 1 (33%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hypercellularity 2 (3%) 4 (7%) 2 (3%) 3 (5%) Hyperplasia, Focal, Histiocytic 3 (5%) 4 (7%) 4 (7%) 4 (7%) Metaplasia, Osseous 1 (2%) Myelofibrosis 1 (2%) Lymph Node (14) (14) (11) (10) Deep Cervical, Angiectasis 1 (9%) Inguinal, Depletion Lymphoid 1 (7%) Inguinal, Hyperplasia 2 (20%) Mediastinal, Angiectasis 1 (9%) Mediastinal, Congestion 1 (7%) 3 (21%) 7 (64%) 1 (10%) Mediastinal, Depletion Lymphoid 1 (7%) Mediastinal, Hyperplasia 3 (30%) Mediastinal, Hyperplasia, Lymphoid 1 (7%) Mediastinal, Hyperplasia, Macrophage 1 (9%) Mediastinal, Pigmentation 2 (18%) 2 (20%) Pancreatic, Congestion 2 (14%) Pancreatic, Depletion Lymphoid 1 (7%) Pancreatic, Edema 1 (10%) Pancreatic, Hyperplasia, Lymphoid 1 (10%) Pancreatic, Inflammation, Chronic 1 (10%) Pancreatic, Pigmentation 1 (10%) Renal, Hyperplasia, Macrophage 1 (10%) Renal, Pigmentation 1 (10%) Lymph Node, Mandibular (60) (60) (60) (60) Congestion 1 (2%) 1 (2%) 2 (3%) 4 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Depletion Lymphoid 1 (2%) Hyperplasia 2 (3%) 2 (3%) 1 (2%) Hyperplasia, Lymphoid 2 (3%) Pigmentation 2 (3%) Lymph Node, Mesenteric (59) (60) (60) (59) Congestion 1 (2%) Depletion Lymphoid 1 (2%) Hyperplasia 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Spleen (60) (60) (60) (59) Cyst 1 (2%) Fibrosis 1 (2%) 6 (10%) 1 (2%) Hematopoietic Cell Proliferation 2 (3%) 14 (23%) 9 (15%) 8 (14%) Necrosis, Focal 2 (3%) 1 (2%) Pigmentation 60 (100%) 60 (100%) 60 (100%) 59 (100%) Thymus (59) (58) (60) (60) Congestion 1 (2%) Cyst 1 (2%) 1 (2%) Fibrosis 1 (2%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (60) Dilatation 44 (73%) 40 (67%) 42 (70%) 37 (62%) Hyperplasia 9 (15%) 15 (25%) 13 (22%) 16 (27%) Skin (60) (60) (60) (60) Cyst Epithelial Inclusion 1 (2%) Hemorrhage, Focal 1 (2%) Inflammation, Chronic, Focal 1 (2%) Ulcer 1 (2%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Fracture Healed 1 (2%) Hyperostosis 18 (30%) 11 (18%) 9 (15%) 9 (15%) Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Compression 8 (13%) 16 (27%) 11 (18%) 14 (23%) Demyelination, Focal 1 (2%) Hemorrhage 4 (7%) 1 (2%) 1 (2%) 1 (2%) Spinal Cord (1) (2) (2) Hemorrhage, Focal 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Bacterium 1 (2%) Congestion 1 (2%) 2 (3%) Fibrosis, Focal 1 (2%) 1 (2%) Hemorrhage, Focal 2 (3%) Hyperplasia, Focal, Macrophage 1 (2%) 2 (3%) Infiltration Cellular, Mixed Cell 1 (2%) 1 (2%) 1 (2%) Metaplasia, Focal, Osseous 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 3 (5%) 3 (5%) 4 (7%) 4 (7%) Mediastinum, Infiltration Cellular, Lymphocyte 1 (2%) Nose (60) (60) (60) (59) Fungus 1 (2%) Inflammation, Suppurative 2 (3%) 4 (7%) 5 (8%) 2 (3%) Nasolacrimal Duct, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (4) (2) (2) (1) Atrophy 1 (50%) Cataract 3 (75%) 1 (50%) 2 (100%) 1 (100%) Fibrosis 1 (25%) Hemorrhage 1 (25%) 1 (50%) 1 (50%) Inflammation, Chronic 1 (25%) 1 (50%) 1 (50%) Necrosis, Focal 1 (50%) Retina, Degeneration 3 (75%) 1 (50%) 2 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Atrophy, Focal 1 (2%) Bacterium 1 (2%) Congestion 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Cyst 1 (2%) 1 (2%) Fibrosis, Focal 1 (2%) Nephropathy 60 (100%) 59 (98%) 58 (97%) 58 (97%) Cortex, Renal Tubule, Autolysis 1 (2%) Glomerulus, Autolysis 1 (2%) Interstitium, Infarct 1 (2%) Papilla, Epithelium, Hyperplasia, Focal 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Hyperplasia, Oncocytic 1 (2%) 5 (8%) Renal Tubule, Pigmentation 60 (100%) 60 (100%) 60 (100%) 60 (100%) Urinary Bladder (60) (60) (60) (60) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 32 34 34 25 Natural Death 6 3 3 4 Survivors Terminal Sacrifice 12 13 13 21 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (59) (60) (59) (59) Parasite Metazoan 2 (3%) 1 (2%) 2 (3%) Intestine Large, Rectum (59) (60) (59) (60) Parasite Metazoan 3 (5%) 4 (7%) 5 (8%) 1 (2%) Intestine Large, Cecum (59) (60) (59) (60) Inflammation, Chronic 1 (2%) Parasite Metazoan 1 (2%) Intestine Small, Duodenum (58) (58) (59) (60) Mucosa, Hyperplasia 1 (2%) Intestine Small, Jejunum (59) (59) (59) (60) Necrosis 1 (2%) Ulcer 1 (2%) Intestine Small, Ileum (58) (59) (59) (60) Diverticulum 1 (2%) Fibrosis 1 (2%) Inflammation, Chronic, Focal 1 (2%) Ulcer 1 (2%) Liver (59) (60) (60) (60) Angiectasis 4 (7%) 6 (10%) 6 (10%) 1 (2%) Atrophy, Focal 1 (2%) Autolysis 1 (2%) Basophilic Focus 18 (31%) 19 (32%) 30 (50%) 35 (58%) Clear Cell Focus 8 (14%) 8 (13%) 9 (15%) 12 (20%) Congestion, Focal 3 (5%) 1 (2%) Degeneration, Cystic 7 (12%) 11 (18%) 11 (18%) 12 (20%) Developmental Malformation 1 (2%) Eosinophilic Focus 5 (8%) 5 (8%) 7 (12%) 5 (8%) Fatty Change 25 (42%) 21 (35%) 21 (35%) 16 (27%) Fibrosis, Focal 1 (2%) Focal Cellular Change 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 2 (3%) Hemorrhage, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatodiaphragmatic Nodule 7 (12%) 2 (3%) 12 (20%) 9 (15%) Hepatodiaphragmatic Nodule, Multiple 2 (3%) 1 (2%) 1 (2%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Multifocal 13 (22%) 12 (20%) 13 (22%) 4 (7%) Infiltration Cellular, Mixed Cell 7 (12%) 5 (8%) 4 (7%) 3 (5%) Inflammation, Focal 18 (31%) 16 (27%) 22 (37%) 32 (53%) Mixed Cell Focus 2 (3%) 3 (5%) 1 (2%) 2 (3%) Necrosis, Focal 6 (10%) 3 (5%) 1 (2%) Pigmentation 1 (2%) Thrombosis 2 (3%) Bile Duct, Hyperplasia 58 (98%) 58 (97%) 59 (98%) 58 (97%) Centrilobular, Atrophy 22 (37%) 27 (45%) 23 (38%) 5 (8%) Centrilobular, Congestion 1 (2%) Centrilobular, Necrosis 2 (3%) 1 (2%) 1 (2%) Mesentery (18) (14) (15) (20) Accessory Spleen 1 (6%) 2 (14%) 1 (7%) 1 (5%) Angiectasis 1 (7%) Fibrosis 1 (6%) 1 (7%) 1 (5%) Hemorrhage 1 (6%) Inflammation, Chronic 1 (7%) 1 (5%) Fat, Necrosis 12 (67%) 5 (36%) 4 (27%) 16 (80%) Pancreas (59) (60) (59) (60) Accessory Spleen 1 (2%) 1 (2%) Atrophy, Diffuse 1 (2%) Atrophy, Focal 30 (51%) 32 (53%) 29 (49%) 27 (45%) Edema 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Necrosis 1 (2%) Acinar Cell, Focal Cellular Change 1 (2%) Acinar Cell, Hyperplasia 1 (2%) 2 (3%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) Duct, Dilatation 2 (3%) Salivary Glands (59) (59) (60) (60) Atrophy, Focal 1 (2%) Stomach, Forestomach (60) (60) (60) (60) Edema 1 (2%) 1 (2%) 1 (2%) Erosion 1 (2%) 1 (2%) Inflammation, Chronic 2 (3%) 2 (3%) 3 (5%) Mineralization, Focal 1 (2%) Ulcer 1 (2%) 2 (3%) 4 (7%) Mucosa, Hyperplasia 4 (7%) 3 (5%) 5 (8%) Stomach, Glandular (60) (59) (59) (60) Erosion 4 (7%) 2 (3%) 1 (2%) Hyperplasia, Focal, Lymphoid 1 (2%) Pigmentation, Focal 2 (3%) 1 (2%) 1 (2%) Mucosa, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Tongue (2) Hyperplasia, Squamous 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (59) (60) (60) (60) Mesenteric Artery, Inflammation, Chronic 1 (2%) 1 (2%) 2 (3%) Heart (60) (60) (60) (60) Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%) Thrombosis 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Accessory Adrenal Cortical Nodule 2 (3%) 1 (2%) 2 (3%) 3 (5%) Angiectasis 1 (2%) 1 (2%) Atrophy 1 (2%) Congestion 2 (3%) Focal Cellular Change 4 (7%) 7 (12%) 11 (18%) 9 (15%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Vacuolization Cytoplasmic 1 (2%) Adrenal Medulla (60) (60) (60) (60) Angiectasis 1 (2%) Hyperplasia 11 (18%) 8 (13%) 15 (25%) 9 (15%) Pituitary Gland (59) (60) (59) (59) Angiectasis 1 (2%) 3 (5%) 3 (5%) 4 (7%) Cyst 3 (5%) 4 (7%) 3 (5%) 4 (7%) Hemorrhage 1 (2%) 1 (2%) Pars Distalis, Focal Cellular Change 11 (19%) 6 (10%) 6 (10%) 12 (20%) Pars Distalis, Hyperplasia, Focal 3 (5%) 7 (12%) 4 (7%) 1 (2%) Pars Nervosa, Focal Cellular Change 1 (2%) Thyroid Gland (59) (59) (59) (60) Degeneration, Cystic 1 (2%) 1 (2%) 2 (3%) 2 (3%) Ultimobranchial Cyst 2 (3%) 2 (3%) C-Cell, Hyperplasia 6 (10%) 13 (22%) 5 (8%) 9 (15%) Follicle, Dilatation 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 2 (3%) 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) (2) (2) Anterior, Fibrosis 1 (50%) Anterior, Inflammation, Chronic 1 (50%) Oral, Inflammation, Chronic 1 (50%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (59) (60) Inflammation, Chronic 1 (2%) 2 (3%) Epithelium, Degeneration 1 (2%) Preputial Gland (60) (60) (59) (60) Degeneration, Cystic 57 (95%) 57 (95%) 58 (98%) 58 (97%) Hyperplasia 4 (7%) 1 (2%) 3 (5%) Inflammation, Chronic 2 (3%) 3 (5%) Prostate (60) (60) (60) (60) Hemorrhage 1 (2%) Inflammation, Suppurative 45 (75%) 37 (62%) 43 (72%) 44 (73%) Epithelium, Hyperplasia, Focal 1 (2%) 7 (12%) 2 (3%) Seminal Vesicle (60) (60) (59) (60) Dilatation 2 (3%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Testes (60) (60) (59) (60) Congestion 1 (2%) Mineralization, Focal 1 (2%) Artery, Inflammation, Chronic 1 (2%) Bilateral, Interstitial Cell, Hyperplasia 2 (3%) 3 (5%) 10 (17%) Germinal Epithelium, Degeneration 7 (12%) 12 (20%) 13 (22%) 14 (23%) Interstitial Cell, Hyperplasia 15 (25%) 15 (25%) 9 (15%) 17 (28%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hemorrhage 2 (3%) Hypercellularity 5 (8%) 3 (5%) 6 (10%) 5 (8%) Hyperplasia, Focal, Histiocytic 1 (2%) 1 (2%) 3 (5%) Metaplasia, Osseous 1 (2%) Myelofibrosis 2 (3%) 1 (2%) 1 (2%) Lymph Node (26) (26) (32) (15) Inguinal, Hyperplasia 1 (3%) 4 (27%) Lumbar, Hyperplasia 1 (7%) Mediastinal, Angiectasis 3 (12%) 1 (7%) Mediastinal, Congestion 3 (12%) 2 (8%) 6 (19%) 5 (33%) Mediastinal, Hyperplasia 1 (4%) 1 (4%) 1 (3%) 4 (27%) Mediastinal, Pigmentation 3 (9%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pancreatic, Angiectasis 1 (4%) 1 (3%) 1 (7%) Pancreatic, Edema 2 (8%) 1 (3%) 1 (7%) Pancreatic, Hyperplasia 2 (8%) 1 (7%) Pancreatic, Hyperplasia, Lymphoid 1 (7%) Pancreatic, Hyperplasia, Macrophage 1 (7%) Lymph Node, Mandibular (59) (59) (59) (60) Angiectasis 1 (2%) Congestion 1 (2%) 1 (2%) 2 (3%) 2 (3%) Ectasia 1 (2%) Edema 1 (2%) Hemorrhage 1 (2%) Hyperplasia 7 (12%) 8 (14%) 7 (12%) 16 (27%) Lymph Node, Mesenteric (59) (60) (59) (60) Congestion 1 (2%) Edema 1 (2%) 1 (2%) 2 (3%) 1 (2%) Hyperplasia 5 (8%) 3 (5%) 1 (2%) 7 (12%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 3 (5%) Spleen (60) (60) (60) (60) Angiectasis 1 (2%) Congestion 1 (2%) Cyst 1 (2%) Degeneration, Fatty 1 (2%) Fibrosis 12 (20%) 14 (23%) 12 (20%) 7 (12%) Hematopoietic Cell Proliferation 1 (2%) 2 (3%) 7 (12%) 9 (15%) Necrosis, Focal 1 (2%) 4 (7%) 1 (2%) Pigmentation 60 (100%) 60 (100%) 60 (100%) 60 (100%) Red Pulp, Hyperplasia, Focal, Histiocytic 1 (2%) Thymus (57) (59) (58) (56) Congestion 1 (2%) Cyst 2 (4%) Hemorrhage 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (57) (58) (54) Dilatation 19 (32%) 11 (19%) 18 (31%) 9 (17%) Hemorrhage 2 (4%) Hyperplasia 6 (10%) 3 (5%) 2 (3%) 2 (4%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) Skin (60) (60) (60) (60) Cyst Epithelial Inclusion 1 (2%) Exudate 1 (2%) Hemorrhage, Focal 1 (2%) 2 (3%) 1 (2%) Hyperkeratosis, Focal 2 (3%) 4 (7%) 2 (3%) Hyperplasia, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Inflammation, Chronic, Focal 1 (2%) 3 (5%) 2 (3%) Ulcer 1 (2%) 1 (2%) 1 (2%) Epidermis, Hyperplasia, Focal 2 (3%) 4 (7%) 2 (3%) Subcutaneous Tissue, Angiectasis 1 (2%) Subcutaneous Tissue, Congestion 1 (2%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Fracture 1 (2%) 2 (3%) Hyperostosis 1 (2%) 1 (2%) Trabecula, Proliferation 1 (2%) Skeletal Muscle (1) (1) (1) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Compression 8 (13%) 5 (8%) 5 (8%) 2 (3%) Hemorrhage 2 (3%) 4 (7%) Meninges, Fibrosis, Focal 1 (2%) Spinal Cord (2) (4) (2) Demyelination 1 (25%) Hemorrhage, Focal 1 (50%) 1 (25%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Congestion 2 (3%) 2 (3%) 2 (3%) Edema 1 (2%) Fibrosis, Focal 1 (2%) 1 (2%) Hemorrhage, Focal 1 (2%) 3 (5%) 3 (5%) Hyperplasia, Diffuse, Macrophage 1 (2%) Hyperplasia, Focal, Macrophage 2 (3%) 2 (3%) 2 (3%) Infiltration Cellular, Mixed Cell 1 (2%) 2 (3%) Necrosis, Focal 1 (2%) Alveolar Epithelium, Hyperplasia 6 (10%) 6 (10%) 7 (12%) 4 (7%) Nose (60) (60) (60) (60) Fungus 6 (10%) 9 (15%) 8 (13%) 8 (13%) Inflammation, Suppurative 8 (13%) 11 (18%) 12 (20%) 9 (15%) Respiratory Epithelium, Hyperplasia, Focal 1 (2%) Respiratory Epithelium, Ulcer 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 16:48:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) (1) Atrophy 1 (50%) 1 (100%) Cataract 1 (100%) 2 (100%) 1 (100%) Retina, Degeneration 1 (100%) 2 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Autolysis 1 (2%) Congestion 1 (2%) Cyst 1 (2%) 1 (2%) Infarct 1 (2%) Nephropathy 60 (100%) 60 (100%) 60 (100%) 60 (100%) Thrombosis 1 (2%) Pelvis, Dilatation 1 (2%) 1 (2%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) 2 (3%) Renal Tubule, Hyperplasia 3 (5%) 2 (3%) 1 (2%) Renal Tubule, Hyperplasia, Oncocytic 1 (2%) 1 (2%) 5 (8%) Renal Tubule, Pigmentation 60 (100%) 60 (100%) 60 (100%) 60 (100%) Renal Tubule, Vacuolization Cytoplasmic 1 (2%) Urinary Bladder (60) (60) (59) (60) Dilatation 1 (2%) Hemorrhage 2 (3%) 1 (2%) Inflammation, Chronic 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------