TDMS Study 88035-06 Pathology Tables
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
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 003 003 300 PPM
Merge 004 004 300 PPM
Merge 005 005 600 PPM
Merge 006 006 600 PPM
Merge 007 007 1300 PPM
Merge 008 008 1300 PPM
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 2 7 2 3
Moribund Sacrifice 7 1 3 8
Survivors
Terminal Sacrifice 41 42 44 39
Missing 1
Animals Examined Microscopically 50 50 49 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (50) (49) (49) (50)
Ulcer, Chronic, Focal 1 (2%)
Intestine Small, Jejunum (50) (49) (49) (50)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Serosa, Inflammation, Chronic, Granulomatous 1 (2%)
Liver (50) (50) (49) (50)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%) 1 (2%) 1 (2%)
Clear Cell Focus 1 (2%) 4 (8%) 1 (2%) 4 (8%)
Congestion 1 (2%)
Eosinophilic Focus 8 (16%) 23 (46%) 24 (49%) 17 (34%)
Hematopoietic Cell Proliferation 3 (6%) 2 (4%) 2 (4%)
Inflammation, Chronic 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%)
Necrosis 4 (8%) 2 (4%) 3 (6%)
Thrombosis, Diffuse 1 (2%)
Centrilobular, Hypertrophy 1 (2%) 11 (22%) 11 (22%) 21 (42%)
Centrilobular, Necrosis 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 3 (6%) 35 (70%) 39 (80%) 28 (56%)
Mesentery (5) (5) (6) (2)
Fat, Inflammation, Chronic 4 (80%) 5 (100%) 5 (83%) 2 (100%)
Pancreas (50) (48) (49) (50)
Inflammation, Chronic 1 (2%)
Acinus, Atrophy 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Duct, Cyst 1 (2%)
Salivary Glands (50) (48) (49) (50)
Duct, Cyst 1 (2%)
Stomach, Forestomach (50) (49) (49) (50)
Hyperplasia, Focal, Squamous 4 (8%) 11 (22%) 3 (6%) 7 (14%)
Stomach, Glandular (50) (49) (49) (50)
Necrosis, Focal 1 (2%)
Polyp, Inflammatory 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (49) (49) (50)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (49) (50)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Focal 1 (2%)
Hypertrophy, Focal 2 (4%) 2 (4%) 1 (2%)
Capsule, Hyperplasia 2 (4%) 1 (2%)
Zona Reticularis, Angiectasis, Focal 1 (2%)
Zona Reticularis, Vacuolization Cytoplasmic 1 (2%)
Adrenal Medulla (50) (49) (49) (50)
Hyperplasia 1 (2%)
Islets, Pancreatic (50) (47) (49) (50)
Hyperplasia 15 (30%) 17 (36%) 6 (12%) 5 (10%)
Pituitary Gland (49) (48) (49) (48)
Pars Distalis, Angiectasis 1 (2%) 1 (2%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia 13 (27%) 12 (25%) 19 (39%) 10 (21%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Rathke's Cleft, Cyst 1 (2%)
Thyroid Gland (50) (48) (48) (50)
Inflammation, Chronic 1 (2%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 13 (26%) 12 (25%) 28 (58%) 49 (98%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (45) (48) (48)
Inflammation, Chronic 1 (2%)
Ovary (49) (49) (48) (50)
Angiectasis 1 (2%)
Atrophy 37 (76%) 47 (96%) 39 (81%) 42 (84%)
Hematocyst 5 (10%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Cystic 1 (2%)
Inflammation, Chronic, Granulomatous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Follicle, Cyst 12 (24%) 7 (14%) 9 (19%) 9 (18%)
Periovarian Tissue, Cyst 2 (4%)
Uterus (50) (49) (49) (50)
Angiectasis 1 (2%)
Hydrometra 28 (56%) 23 (47%) 17 (35%) 20 (40%)
Inflammation, Suppurative 2 (4%) 2 (4%)
Endometrium, Hyperplasia, Cystic 36 (72%) 39 (80%) 42 (86%) 42 (84%)
Endometrium, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (49) (50)
Depletion Cellular 1 (2%)
Myelofibrosis, Focal 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (2%) 3 (6%) 2 (4%)
Lymph Node (6) (8) (7) (4)
Lumbar, Infiltration Cellular, Histiocyte 1 (17%) 1 (14%)
Lumbar, Pigmentation 1 (17%)
Mediastinal, Hyperplasia, Lymphoid 1 (14%) 3 (75%)
Renal, Infiltration Cellular, Histiocyte 1 (14%)
Lymph Node, Mandibular (48) (44) (45) (46)
Cyst 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (4%)
Infiltration Cellular, Plasma Cell 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Lymph Node, Mesenteric (48) (48) (47) (47)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Lymphoid 5 (10%) 2 (4%) 4 (9%)
Spleen (50) (48) (49) (50)
Atrophy 1 (2%)
Hematopoietic Cell Proliferation 14 (28%) 13 (27%) 13 (27%) 23 (46%)
Hyperplasia, Lymphoid 5 (10%) 5 (10%) 7 (14%) 4 (8%)
Thrombosis 1 (2%)
Thymus (45) (47) (44) (44)
Angiectasis 1 (2%)
Atrophy 30 (67%) 35 (74%) 37 (84%) 35 (80%)
Hyperplasia, Lymphoid 6 (13%) 5 (11%) 3 (7%) 2 (5%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (49) (50)
Inflammation, Chronic Active 1 (2%)
Ulcer, Chronic Active 1 (2%)
Subcutaneous Tissue, Cyst, Chronic Active 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (49) (50)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Retina, Atrophy 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (49) (50)
Cyst 1 (2%)
Hydronephrosis 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 2 (4%)
Nephropathy 7 (14%) 3 (6%) 6 (12%) 3 (6%)
Renal Tubule, Pigmentation, Hemosiderin 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 6 7 6 17
Natural Death 9 9 13 14
Survivors
Terminal Sacrifice 35 33 31 19
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (44) (48) (48) (45)
Necrosis, Focal 1 (2%)
Ulcer 1 (2%) 1 (2%)
Intestine Small, Jejunum (46) (49) (50) (47)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Ileum (42) (47) (49) (48)
Congestion 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 2 (4%) 1 (2%)
Basophilic Focus 2 (4%) 1 (2%)
Clear Cell Focus 11 (22%) 7 (14%) 8 (16%) 1 (2%)
Clear Cell Focus, Multiple 6 (12%) 4 (8%) 2 (4%)
Eosinophilic Focus 7 (14%) 4 (8%) 8 (16%) 5 (10%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic 2 (4%) 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%) 1 (2%)
Necrosis 6 (12%) 7 (14%) 6 (12%) 6 (12%)
Thrombosis, Acute 1 (2%)
Centrilobular, Hypertrophy 3 (6%) 30 (60%) 21 (42%) 18 (36%)
Hepatocyte, Vacuolization Cytoplasmic 1 (2%) 8 (16%) 3 (6%) 2 (4%)
Mesentery (1) (2) (1) (1)
Fat, Inflammation, Chronic 1 (100%) 1 (50%) 1 (100%) 1 (100%)
Pancreas (46) (48) (50) (47)
Duct, Cyst 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Stomach, Forestomach (50) (49) (50) (49)
Hyperplasia, Diffuse, Squamous 2 (4%)
Hyperplasia, Focal, Squamous 6 (12%) 9 (18%) 9 (18%) 3 (6%)
Stomach, Glandular (50) (49) (50) (49)
Epithelium, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization, Diffuse 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (50)
Hyperplasia, Focal 2 (4%)
Hypertrophy, Focal 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Necrosis 1 (2%)
Capsule, Accessory Adrenal Cortical Nodule 1 (2%)
Capsule, Hyperplasia 3 (6%) 4 (8%) 2 (4%)
Islets, Pancreatic (45) (48) (49) (47)
Hyperplasia 32 (71%) 34 (71%) 18 (37%) 4 (9%)
Pituitary Gland (45) (46) (48) (47)
Pars Distalis, Cyst 2 (4%) 1 (2%)
Thyroid Gland (49) (48) (50) (50)
Follicle, Cyst 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 8 (16%) 20 (42%) 31 (62%) 42 (84%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm, Focal 1 (2%)
Spermatocele, Focal 1 (2%)
Preputial Gland (50) (50) (48) (50)
Inflammation, Chronic Active 1 (2%)
Duct, Cyst 23 (46%) 32 (64%) 26 (54%) 30 (60%)
Prostate (49) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Testes (50) (50) (50) (50)
Germinal Epithelium, Atrophy 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Myeloid Cell, Hyperplasia 2 (4%) 1 (2%) 1 (2%)
Lymph Node (1) (4) (1) (3)
Hyperplasia, Lymphoid 1 (33%)
Inflammation, Chronic 1 (33%)
Mediastinal, Hyperplasia, Lymphoid 1 (25%)
Renal, Hematopoietic Cell Proliferation 1 (33%)
Renal, Hyperplasia, Lymphoid 1 (100%)
Lymph Node, Mandibular (39) (43) (46) (46)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (48) (48) (49) (42)
Angiectasis 1 (2%)
Congestion 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (5%)
Hyperplasia, Lymphoid 1 (2%)
Spleen (48) (49) (50) (49)
Atrophy 2 (4%) 3 (6%) 4 (8%)
Hematopoietic Cell Proliferation 14 (29%) 15 (31%) 26 (52%) 37 (76%)
Infiltration Cellular, Plasma Cell 1 (2%)
Capsule, Fibrosis 1 (2%)
Thymus (42) (40) (42) (34)
Atrophy 39 (93%) 36 (90%) 35 (83%) 29 (85%)
Hyperplasia, Lymphoid 1 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Hyperplasia, Squamous 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Ulcer 1 (2%) 1 (2%) 2 (4%)
Subcutaneous Tissue, Edema 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 88035-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PRIMACLONE Date: 12/30/96
Route: DOSED FEED Time: 16:42:44
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 300 PPM 600 PPM 1300 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Infiltration Cellular, Focal, Mast Cell 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 4 (8%) 6 (12%) 3 (6%) 3 (6%)
Perivascular, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Hydronephrosis 1 (2%) 1 (2%)
Infiltration Cellular, Focal, Mast Cell 1 (2%)
Inflammation, Acute 1 (2%)
Nephropathy 34 (68%) 30 (61%) 25 (50%) 20 (40%)
Cortex, Cyst 1 (2%) 1 (2%)
Cortex, Infarct, Focal 1 (2%)
Renal Tubule, Pigmentation, Hemosiderin 7 (14%) 8 (16%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
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