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
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