TDMS Study 88035-05 Pathology Tables
NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 Facility: Battelle Columbus Laboratory Chemical CAS #: 0000125-33-7 Lock Date: 11/17/94 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Merge 001 001 0 PPM Merge 002 002 0 PPM Merge 003 003 600 PPM Merge 004 004 600 PPM Merge 005 005 1300 PPM Merge 006 006 1300 PPM Merge 007 007 2500 PPM Merge 008 008 2500 PPM a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 21 18 14 19 Natural Death 5 5 5 3 Survivors Terminal Sacrifice 24 27 31 27 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (49) (50) (50) (50) Cyst 1 (2%) Intestine Large, Colon (50) (50) (50) (50) Parasite Metazoan 1 (2%) Intestine Large, Rectum (49) (50) (50) (50) Parasite Metazoan 2 (4%) 2 (4%) 3 (6%) Intestine Small, Ileum (50) (50) (50) (49) Inflammation, Chronic Active 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) 1 (2%) 3 (6%) Basophilic Focus 39 (78%) 35 (70%) 38 (76%) 10 (20%) Clear Cell Focus 6 (12%) 5 (10%) Eosinophilic Focus 2 (4%) 1 (2%) 18 (36%) Hematopoietic Cell Proliferation 1 (2%) Hepatodiaphragmatic Nodule 5 (10%) 13 (26%) 11 (22%) 5 (10%) Inflammation, Chronic 38 (76%) 38 (76%) 44 (88%) 34 (68%) Mixed Cell Focus 5 (10%) 1 (2%) 6 (12%) Pigmentation, Hemosiderin 25 (50%) 14 (28%) 12 (24%) 19 (38%) Bile Duct, Hyperplasia 30 (60%) 23 (46%) 35 (70%) 33 (66%) Hepatocyte, Degeneration 1 (2%) Hepatocyte, Degeneration, Cystic 1 (2%) 1 (2%) Hepatocyte, Necrosis 4 (8%) 1 (2%) 3 (6%) 4 (8%) Hepatocyte, Vacuolization Cytoplasmic 25 (50%) 44 (88%) 46 (92%) 44 (88%) Hepatocyte, Centrilobular, Degeneration 1 (2%) 1 (2%) Hepatocyte, Centrilobular, Hypertrophy 1 (2%) 36 (72%) 38 (76%) 35 (70%) Portal Vein, Thrombosis 1 (2%) Mesentery (9) (10) (7) (7) Accessory Spleen 1 (11%) Fat, Inflammation, Chronic Active 1 (10%) Fat, Necrosis 7 (78%) 5 (50%) 5 (71%) 6 (86%) Pancreas (49) (50) (50) (50) Cyst 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy 8 (16%) 7 (14%) 11 (22%) 11 (22%) Salivary Glands (49) (50) (50) (50) Parotid Gland, Atrophy 1 (2%) Parotid Gland, Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (49) (50) (50) (50) Hyperplasia, Basal Cell 1 (2%) Epithelium, Hyperplasia 4 (8%) 4 (8%) 3 (6%) 4 (8%) Epithelium, Inflammation, Chronic Active 2 (4%) 2 (4%) 2 (4%) 2 (4%) Epithelium, Ulcer 2 (4%) 2 (4%) 2 (4%) 2 (4%) Stomach, Glandular (49) (50) (50) (50) Epithelium, Erosion 2 (4%) 1 (2%) Epithelium, Inflammation, Chronic Active 1 (2%) Epithelium, Ulcer 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (49) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Heart (49) (50) (50) (50) Cardiomyopathy, Chronic 21 (43%) 29 (58%) 27 (54%) 21 (42%) Atrium, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 1 (2%) Angiectasis 1 (2%) Atrophy 1 (2%) Degeneration, Fatty 13 (26%) 11 (22%) 8 (16%) 6 (12%) Hyperplasia 10 (20%) 8 (16%) 10 (20%) 8 (16%) Hypertrophy 1 (2%) 1 (2%) 2 (4%) 3 (6%) Inflammation, Chronic Active 1 (2%) Inflammation, Granulomatous 1 (2%) Necrosis 1 (2%) Adrenal Medulla (50) (50) (49) (50) Hyperplasia 6 (12%) 5 (10%) 9 (18%) 7 (14%) Pituitary Gland (49) (50) (49) (50) Angiectasis 1 (2%) Pars Distalis, Cyst 24 (49%) 24 (48%) 36 (73%) 28 (56%) Pars Distalis, Hyperplasia 26 (53%) 25 (50%) 26 (53%) 21 (42%) Pars Intermedia, Cyst 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (49) (50) (50) (50) C-Cell, Hyperplasia 14 (29%) 15 (30%) 11 (22%) 5 (10%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (49) (50) (50) Cyst 2 (4%) 1 (2%) 2 (4%) Hyperplasia 12 (24%) 5 (10%) 8 (16%) 10 (20%) Inflammation, Chronic Active 4 (8%) 10 (20%) 2 (4%) 3 (6%) Ovary (50) (50) (50) (49) Atrophy 1 (2%) 1 (2%) Cyst 3 (6%) 4 (8%) 2 (4%) 1 (2%) Inflammation, Chronic Active 1 (2%) Uterus (50) (50) (50) (49) Angiectasis 1 (2%) Edema 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hydrometra 2 (4%) Hyperplasia, Cystic 2 (4%) 4 (8%) 3 (6%) Inflammation, Chronic Active 1 (2%) Vagina (1) (1) (2) Cyst 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Atrophy 1 (2%) Hyperplasia 5 (10%) 10 (20%) 7 (14%) 7 (14%) Hyperplasia, Histiocytic 3 (6%) Hyperplasia, Mast Cell 1 (2%) Myelofibrosis 4 (8%) 1 (2%) 1 (2%) 1 (2%) Lymph Node (11) (7) (8) (12) Mediastinal, Hyperplasia, Histiocytic 1 (9%) Mediastinal, Necrosis 1 (9%) Lymph Node, Mandibular (49) (50) (50) (50) Ectasia 1 (2%) Inflammation, Chronic Active 1 (2%) Lymph Node, Mesenteric (50) (50) (50) (49) Ectasia 1 (2%) 3 (6%) Spleen (49) (50) (50) (50) Accessory Spleen 2 (4%) Fibrosis 1 (2%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 3 (6%) 1 (2%) 2 (4%) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Necrosis 2 (4%) 1 (2%) 1 (2%) Thymus (49) (45) (47) (46) Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Cyst 1 (2%) 1 (2%) Hyperplasia, Cystic 37 (74%) 44 (88%) 43 (86%) 37 (74%) Inflammation, Chronic Active 1 (2%) Skin (50) (50) (50) (50) Hyperkeratosis 1 (2%) 1 (2%) Inflammation, Chronic Active 2 (4%) Ulcer 1 (2%) Epidermis, Hyperplasia 1 (2%) 2 (4%) Subcutaneous Tissue, Hemorrhage, Acute 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Osteopetrosis 2 (4%) 5 (10%) 1 (2%) Skeletal Muscle (1) (2) Hemorrhage, Acute 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 1 (2%) 3 (6%) 3 (6%) 1 (2%) Hydrocephalus 1 (2%) 1 (2%) Spinal Cord (1) (2) Hemorrhage 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (50) (50) Inflammation, Chronic Active 1 (2%) 4 (8%) 1 (2%) 3 (6%) Necrosis 1 (2%) Alveolar Epithelium, Hyperplasia 5 (10%) 5 (10%) 6 (12%) 2 (4%) Alveolus, Infiltration Cellular, Histiocyte 36 (73%) 44 (88%) 45 (90%) 46 (92%) Artery, Vein, Mineralization 38 (78%) 39 (78%) 38 (76%) 44 (88%) Interstitium, Inflammation, Chronic Active 1 (2%) Perivascular, Infiltration Cellular, Lymphocyte 4 (8%) 1 (2%) 3 (6%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (50) (49) (50) (50) Inflammation, Chronic Active 2 (4%) 4 (8%) 5 (10%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 3 (6%) 3 (6%) 4 (8%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (2) (2) Inflammation, Chronic Active 1 (50%) Anterior Chamber, Inflammation, Suppurative 1 (50%) Lens, Cataract 1 (100%) 1 (100%) 1 (50%) 1 (50%) Retina, Degeneration 1 (100%) 1 (100%) 2 (100%) 1 (50%) Harderian Gland (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 1 (2%) 1 (2%) Hydronephrosis 1 (2%) Mineralization 12 (24%) 10 (20%) 5 (10%) 8 (16%) Nephropathy, Chronic 43 (86%) 43 (86%) 44 (88%) 43 (86%) Urinary Bladder (50) (50) (50) (49) Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 33 33 39 36 Natural Death 4 10 7 14 Survivors Terminal Sacrifice 13 7 4 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (49) Inflammation, Chronic Active 1 (2%) Ulcer 1 (2%) Intestine Large, Colon (50) (50) (49) (46) Mineralization 1 (2%) 2 (4%) Parasite Metazoan 2 (4%) 1 (2%) Muscularis, Mineralization 1 (2%) Intestine Large, Rectum (50) (50) (49) (47) Mineralization 1 (2%) Parasite Metazoan 3 (6%) 3 (6%) 1 (2%) 2 (4%) Intestine Small, Duodenum (50) (50) (50) (47) Erosion 2 (4%) Inflammation, Suppurative 2 (4%) Mineralization 1 (2%) Intestine Small, Jejunum (50) (50) (49) (45) Ulcer 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 14 (28%) 9 (18%) 8 (16%) 6 (12%) Clear Cell Focus 2 (4%) 1 (2%) Eosinophilic Focus 1 (2%) 6 (12%) 5 (10%) 2 (4%) Hepatodiaphragmatic Nodule 3 (6%) 2 (4%) 5 (10%) 3 (6%) Inflammation, Chronic 18 (36%) 19 (38%) 22 (44%) 24 (48%) Mixed Cell Focus 2 (4%) 1 (2%) Pigmentation, Hemosiderin 19 (38%) 18 (36%) 15 (30%) 19 (38%) Bile Duct, Hyperplasia 47 (94%) 50 (100%) 50 (100%) 44 (88%) Hepatocyte, Degeneration, Cystic 16 (32%) 27 (54%) 27 (54%) 18 (36%) Hepatocyte, Necrosis 10 (20%) 12 (24%) 6 (12%) 10 (20%) Hepatocyte, Vacuolization Cytoplasmic 26 (52%) 28 (56%) 33 (66%) 43 (86%) Hepatocyte, Centrilobular, Degeneration 1 (2%) Hepatocyte, Centrilobular, Hypertrophy 14 (28%) 33 (66%) 40 (80%) Portal Vein, Thrombosis 1 (2%) Mesentery (11) (6) (9) (3) Angiectasis 1 (33%) Hemorrhage 1 (11%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic Active 1 (11%) 1 (33%) Artery, Inflammation, Chronic Active 1 (33%) Artery, Mineralization 1 (33%) Artery, Necrosis, Fibrinoid 1 (33%) Fat, Inflammation, Chronic Active 1 (11%) Fat, Mineralization 1 (11%) Fat, Necrosis 6 (55%) 3 (50%) 4 (44%) Fat, Pigmentation, Hematoidin 1 (11%) Fat, Pigmentation, Hemosiderin 1 (9%) 1 (11%) Pancreas (50) (50) (50) (49) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 25 (50%) 14 (28%) 12 (24%) 8 (16%) Acinus, Hypertrophy 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (50) (50) (50) (49) Hyperplasia 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 3 (6%) 3 (6%) 12 (24%) Perforation 2 (4%) 1 (2%) Epithelium, Hyperplasia 4 (8%) 11 (22%) 19 (38%) 10 (20%) Epithelium, Inflammation, Chronic Active 2 (4%) 10 (20%) 14 (28%) 9 (18%) Epithelium, Ulcer 2 (4%) 7 (14%) 13 (26%) 8 (16%) Stomach, Glandular (50) (50) (50) (49) Mineralization 6 (12%) 15 (30%) 36 (73%) Epithelium, Erosion 2 (4%) 1 (2%) Epithelium, Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) Epithelium, Necrosis 1 (2%) 2 (4%) 1 (2%) Epithelium, Ulcer 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) Necrosis, Fibrinoid 1 (2%) Aorta, Mineralization 5 (10%) 9 (18%) 31 (62%) Heart (50) (50) (50) (50) Cardiomyopathy, Chronic 42 (84%) 45 (90%) 43 (86%) 48 (96%) Mineralization 4 (8%) 8 (16%) 15 (30%) Pigmentation, Hemosiderin 1 (2%) Atrium, Thrombosis 2 (4%) 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 2 (4%) 1 (2%) Atrophy 1 (2%) Degeneration, Fatty 26 (52%) 18 (36%) 19 (38%) 12 (24%) Hyperplasia 17 (34%) 4 (8%) 9 (18%) 6 (12%) Hypertrophy 3 (6%) 2 (4%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Thrombosis 1 (2%) Adrenal Medulla (50) (50) (50) (49) Hemorrhage 1 (2%) Hyperplasia 19 (38%) 22 (44%) 30 (60%) 29 (59%) Necrosis 1 (2%) Parathyroid Gland (45) (41) (46) (49) Hyperplasia 2 (4%) 16 (39%) 26 (57%) 40 (82%) Pituitary Gland (49) (50) (48) (49) Craniopharyngeal Duct, Cyst 1 (2%) Pars Distalis, Cyst 1 (2%) 7 (14%) 2 (4%) 4 (8%) Pars Distalis, Hyperplasia 17 (35%) 18 (36%) 16 (33%) 7 (14%) Pars Intermedia, Cyst 1 (2%) 2 (4%) 1 (2%) 1 (2%) Thyroid Gland (50) (50) (49) (49) C-Cell, Hyperplasia 11 (22%) 11 (22%) 5 (10%) 3 (6%) Follicle, Cyst 1 (2%) 3 (6%) 1 (2%) 6 (12%) Follicle, Hyperplasia, Cystic 1 (2%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) Follicular Cell, Hyperplasia, Cystic 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (2) (1) (1) Inflammation, Chronic Active 1 (50%) 1 (100%) 1 (100%) Epididymis (50) (50) (50) (48) Granuloma Sperm 3 (6%) 3 (6%) 1 (2%) Mineralization 4 (8%) Necrosis 1 (2%) Preputial Gland (50) (50) (50) (49) Cyst 2 (4%) 1 (2%) 3 (6%) Hyperplasia 5 (10%) 7 (14%) 3 (6%) 4 (8%) Inflammation, Chronic Active 47 (94%) 47 (94%) 40 (80%) 45 (92%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Prostate (50) (50) (50) (48) Cyst 1 (2%) Inflammation, Chronic Active 37 (74%) 34 (68%) 34 (68%) 30 (63%) Mineralization 2 (4%) Seminal Vesicle (50) (50) (50) (48) Atrophy 2 (4%) Mineralization 1 (2%) 2 (4%) 8 (17%) Testes (50) (50) (50) (48) Necrosis 1 (2%) Germinal Epithelium, Degeneration 2 (4%) 2 (4%) 2 (4%) 3 (6%) Interstitial Cell, Hyperplasia 11 (22%) 11 (22%) 8 (16%) 11 (23%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Atrophy 1 (2%) 1 (2%) 1 (2%) Hyperplasia 38 (76%) 35 (70%) 28 (56%) 12 (24%) Inflammation, Suppurative 1 (2%) Myelofibrosis 2 (4%) 1 (2%) 1 (2%) Lymph Node (24) (23) (16) (10) Lumbar, Hyperplasia, Lymphoid 1 (6%) Mediastinal, Hyperplasia, Plasma Cell 1 (6%) Renal, Ectasia 1 (6%) 3 (30%) Renal, Erythrophagocytosis 1 (10%) Renal, Pigmentation, Hemosiderin 2 (20%) Lymph Node, Mandibular (50) (50) (48) (49) Ectasia 3 (6%) Lymph Node, Mesenteric (50) (50) (50) (48) Ectasia 2 (4%) 2 (4%) 4 (8%) 2 (4%) Fibrosis 1 (2%) Spleen (50) (50) (50) (49) Accessory Spleen 1 (2%) Congestion 1 (2%) 1 (2%) Fibrosis 9 (18%) 19 (38%) 9 (18%) 12 (24%) Hematopoietic Cell Proliferation 2 (4%) 6 (12%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Metaplasia, Lipocyte 1 (2%) Necrosis 1 (2%) 1 (2%) Thymus (49) (47) (44) (46) Cyst 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (49) (50) (47) Cyst 1 (2%) 1 (2%) 2 (4%) Hyperplasia, Cystic 28 (58%) 25 (51%) 16 (32%) 6 (13%) Mineralization 1 (2%) Skin (50) (50) (50) (50) Hyperkeratosis 1 (2%) Hyperplasia, Basal Cell 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Epidermis, Hyperplasia 1 (2%) 1 (2%) Pinna, Ulcer 1 (2%) Sebaceous Gland, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 10 (20%) 26 (52%) 37 (74%) Necrosis 1 (2%) Osteopetrosis 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) (49) Hemorrhage 4 (8%) 2 (4%) 4 (8%) 1 (2%) Inflammation, Chronic Active 1 (2%) Spinal Cord (1) (1) Demyelination 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Inflammation, Chronic Active 2 (4%) 3 (6%) 3 (6%) Metaplasia, Osseous 1 (2%) 1 (2%) 2 (4%) Alveolar Epithelium, Hyperplasia 6 (12%) 1 (2%) 2 (4%) 4 (8%) Alveolus, Hemorrhage 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 18 (36%) 18 (36%) 19 (38%) 15 (30%) Alveolus, Inflammation, Suppurative 1 (2%) 4 (8%) Artery, Thrombosis 1 (2%) Artery, Vein, Mineralization 46 (92%) 42 (84%) 43 (86%) 45 (90%) Interstitium, Inflammation, Chronic Active 2 (4%) Interstitium, Mineralization 3 (6%) 7 (14%) 25 (50%) Interstitium, Alveolus, Inflammation, Suppurative 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 88035-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC PRIMACLONE Date: 12/27/96 Route: DOSED FEED Time: 09:32:01 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 600 PPM 1300 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Perivascular, Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 1 (2%) 1 (2%) Nose (50) (50) (50) (50) Inflammation, Chronic Active 8 (16%) 12 (24%) 10 (20%) 9 (18%) Inflammation, Suppurative 6 (12%) 7 (14%) 3 (6%) 9 (18%) Arteriole, Venule, Thrombosis 1 (2%) 2 (4%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 2 (4%) 2 (4%) Respiratory Epithelium, Metaplasia, Squamous 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Anterior Chamber, Inflammation, Suppurative 1 (50%) Lens, Cataract 1 (50%) Retina, Degeneration 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 2 (4%) 2 (4%) 12 (24%) 9 (18%) Infarct 1 (2%) Inflammation, Suppurative 1 (2%) Nephropathy, Chronic 49 (98%) 48 (96%) 50 (100%) 50 (100%) Papilla, Hyperplasia, Atypical 1 (2%) Renal Tubule, Hyperplasia 1 (2%) 2 (4%) 4 (8%) 10 (20%) Urinary Bladder (50) (50) (50) (48) Hemorrhage 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------