TDMS Study 05063-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
PHENYLBUTAZONE
NTP Experiment-Test: 05063-02 Report: PEIRPT03
Study Type: CHRONIC Date: 09/08/94
Route: GAVAGE Time: 21:00:16
Facility: TSI Mason Research
Chemical CAS #: 50-33-9
Lock Date: None
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 20 11 5
Natural Death 8 9 12
Dead 1
Accident 1
Survivors
Terminal Sacrifice 22 29 32
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (47) (14) (44)
Inflammation, Acute 1 (2%)
Necrosis 1 (2%)
Gallbladder (44) (28) (47)
Inflammation, Acute 4 (9%) 3 (6%)
Inflammation, Chronic 7 (16%) 7 (15%)
Inflammation, Chronic Active 2 (5%)
Intestine Large, Cecum (50) (8) (40)
Mesothelium, Hyperplasia 1 (3%)
Serosa, Inflammation, Chronic Active 2 (4%)
Intestine Large, Colon (50) (16) (48)
Inflammation, Acute 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Mesothelium, Hyperplasia 1 (2%) 1 (2%)
Muscularis, Inflammation, Chronic Active 1 (2%)
Serosa, Inflammation, Acute 1 (2%)
Intestine Large, Rectum (48) (11) (43)
Mesothelium, Hyperplasia 1 (2%)
Serosa, Inflammation, Acute 1 (2%)
Intestine Small, Duodenum (48) (15) (46)
Mesothelium, Hyperplasia 1 (2%) 1 (2%)
Serosa, Fibrosis 1 (2%)
Serosa, Inflammation, Chronic Active 2 (4%)
Intestine Small, Ileum (46) (15) (44)
Lymphoid Nodule, Hyperplasia 3 (7%)
Mesothelium, Hyperplasia 2 (4%) 1 (2%)
Mucosa, Vacuolization Cytoplasmic 1 (2%)
Serosa, Inflammation, Acute 2 (13%)
Intestine Small, Jejunum (49) (15) (45)
Hemorrhage 1 (2%)
Mesothelium, Hyperplasia 3 (6%) 1 (2%)
Serosa, Inflammation, Chronic Active 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Liver (50) (49) (50)
Basophilic Focus 1 (2%) 1 (2%)
Clear Cell Focus 1 (2%)
Congestion 2 (4%) 1 (2%)
Degeneration 1 (2%)
Eosinophilic Focus 1 (2%) 1 (2%)
Fatty Change 5 (10%) 6 (12%)
Hematopoietic Cell Proliferation 19 (38%) 3 (6%) 7 (14%)
Hemorrhage 6 (12%) 1 (2%)
Inflammation, Acute 3 (6%)
Inflammation, Chronic 12 (24%) 7 (14%) 3 (6%)
Inflammation, Chronic Active 1 (2%) 7 (14%)
Mixed Cell Focus 3 (6%)
Necrosis, Coagulative 8 (16%) 14 (29%) 12 (24%)
Pigmentation 2 (4%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 2 (4%)
Periportal, Inflammation, Chronic 19 (38%) 16 (33%) 21 (42%)
Serosa, Inflammation, Acute 5 (10%) 1 (2%) 4 (8%)
Mesentery (9) (8) (4)
Abscess 1 (13%)
Fibrosis 1 (25%)
Inflammation, Acute 1 (11%) 3 (38%) 1 (25%)
Inflammation, Chronic 1 (11%)
Inflammation, Chronic Active 5 (56%) 1 (13%) 2 (50%)
Necrosis 1 (11%) 1 (13%) 1 (25%)
Pancreas (50) (19) (49)
Abscess 2 (11%) 1 (2%)
Atrophy 2 (4%) 2 (4%)
Fatty Change 1 (2%)
Fibrosis 1 (2%)
Inflammation, Acute 2 (4%) 1 (5%)
Inflammation, Chronic 17 (34%) 2 (11%) 20 (41%)
Inflammation, Chronic Active 5 (10%)
Duct, Dilatation 1 (2%) 1 (2%)
Serosa, Fibrosis 2 (4%)
Serosa, Inflammation, Acute 5 (10%) 3 (16%) 1 (2%)
Serosa, Inflammation, Chronic Active 3 (6%) 3 (6%)
Salivary Glands (48) (16) (49)
Parotid Gland, Inflammation, Chronic 2 (4%)
Sublingual Gland, Inflammation, Chronic 3 (6%) 3 (6%)
Submandibular Gland, Atrophy 1 (6%)
Submandibular Gland, Inflammation, Chronic 26 (54%) 4 (25%) 27 (55%)
Stomach, Forestomach (50) (16) (48)
Acanthosis 3 (6%) 4 (8%)
Hyperkeratosis 4 (8%) 4 (8%)
Hyperplasia, Basal Cell 1 (2%)
Inflammation, Chronic 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 1 (2%)
Inflammation, Chronic Active, Necrotizing 1 (2%) 1 (2%)
Stomach, Glandular (49) (16) (48)
Inflammation, Chronic 13 (27%) 13 (27%)
Inflammation, Chronic Active 5 (10%) 3 (6%)
Epithelium, Hyperplasia, Focal 1 (2%)
Tooth (35) (28)
Dysplasia 1 (3%)
Incisor, Abscess 3 (9%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (16) (50)
Abscess 1 (2%)
Bacterium 1 (2%) 1 (2%)
Infiltration Cellular, Mononuclear Cell 1 (2%)
Inflammation, Acute 2 (4%) 1 (2%)
Inflammation, Chronic 5 (10%) 6 (12%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (6%) 1 (2%)
Necrosis, Focal 1 (2%)
Coronary Artery, Perivascular, Inflammation,
Acute 1 (2%)
Coronary Artery, Perivascular, Inflammation,
Chronic Active 1 (2%)
Epicardium, Inflammation, Acute 1 (6%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (48) (15) (49)
Capsule, Inflammation, Chronic Active 6 (13%) 3 (6%)
Adrenal Gland, Cortex (48) (15) (49)
Angiectasis 2 (4%) 1 (2%)
Congestion 1 (7%)
Cyst 2 (4%) 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Adrenal Gland, Medulla (47) (15) (48)
Angiectasis 1 (2%)
Hyperplasia 1 (2%)
Parathyroid Gland (31) (8) (30)
Cyst 1 (3%) 1 (13%)
Pituitary Gland (44) (17) (47)
Pars Distalis, Angiectasis 4 (24%) 2 (4%)
Pars Distalis, Congestion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Cyst 1 (2%) 1 (6%) 1 (2%)
Pars Distalis, Hyperplasia 16 (36%) 3 (18%) 22 (47%)
Thyroid Gland (48) (14) (50)
Inflammation, Chronic 1 (2%) 3 (6%)
Ultimobranchial Cyst 1 (2%) 1 (2%)
C-Cell, Hyperplasia 1 (2%)
Follicle, Cyst 2 (4%) 1 (2%)
Follicular Cell, Hyperplasia 4 (8%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (2)
Cyst 1 (50%)
Ovary (50) (47) (47)
Abscess 19 (38%) 4 (9%) 10 (21%)
Angiectasis 1 (2%) 1 (2%)
Cyst 7 (14%) 9 (19%) 16 (34%)
Hemorrhage 2 (4%)
Mineralization 1 (2%)
Necrosis, Coagulative 1 (2%)
Pigmentation 6 (13%)
Periovarian Tissue, Cyst 4 (8%) 5 (11%) 2 (4%)
Periovarian Tissue, Hemorrhage 1 (2%)
Periovarian Tissue, Inflammation, Acute 1 (2%)
Periovarian Tissue, Inflammation, Chronic 14 (28%) 5 (11%)
Periovarian Tissue, Inflammation, Chronic
Active 1 (2%) 1 (2%) 1 (2%)
Periovarian Tissue, Necrosis 1 (2%)
Periovarian Tissue, Thrombosis 1 (2%)
Serosa, Inflammation, Chronic Active 1 (2%)
Oviduct (8)
Inflammation, Acute 6 (75%)
Inflammation, Acute, Hemorrhagic 1 (13%)
Inflammation, Chronic Active 1 (13%)
Uterus (50) (49) (48)
Abscess 3 (6%) 4 (8%) 2 (4%)
Hydrometra 1 (2%) 1 (2%)
Inflammation, Acute 19 (38%) 5 (10%) 9 (19%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%) 4 (8%)
Necrosis, Coagulative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Pigmentation 1 (2%)
Endometrium, Hyperplasia 50 (100%) 42 (86%) 41 (85%)
Muscularis, Congestion 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (15) (50)
Bacterium 1 (2%)
Congestion 1 (7%) 4 (8%)
Hypoplasia 3 (6%)
Myelofibrosis 42 (84%) 1 (7%) 28 (56%)
Myeloid Cell, Hyperplasia 4 (8%) 2 (13%) 1 (2%)
Lymph Node (47) (24) (48)
Bronchial, Inflammation, Chronic Active 1 (4%)
Lumbar, Bacterium 1 (2%)
Lumbar, Hemorrhage 1 (4%)
Lumbar, Hyperplasia, Lymphoid 1 (4%)
Lumbar, Hyperplasia, Plasma Cell 9 (19%) 1 (4%) 2 (4%)
Lumbar, Inflammation, Acute 1 (2%)
Lumbar, Inflammation, Chronic Active 4 (9%)
Mediastinal, Abscess 1 (4%) 1 (2%)
Mediastinal, Congestion 1 (2%)
Mediastinal, Depletion Lymphoid 2 (4%) 1 (4%)
Mediastinal, Hemorrhage 2 (4%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 1 (4%)
Mediastinal, Hyperplasia, Plasma Cell 6 (13%) 2 (4%)
Mediastinal, Inflammation, Acute 4 (9%) 2 (8%) 2 (4%)
Mediastinal, Inflammation, Chronic Active 1 (2%)
Pancreatic, Angiectasis 1 (2%)
Pancreatic, Hemorrhage 1 (2%) 1 (4%)
Pancreatic, Hyperplasia, Plasma Cell 2 (4%) 2 (4%)
Pancreatic, Inflammation, Acute 2 (4%)
Renal, Bacterium 1 (2%)
Renal, Hemorrhage 1 (2%)
Renal, Hyperplasia, Lymphoid 1 (4%)
Renal, Hyperplasia, Plasma Cell 11 (23%) 3 (13%) 7 (15%)
Renal, Inflammation, Acute 1 (4%) 3 (6%)
Renal, Inflammation, Chronic Active 2 (4%)
Lymph Node, Mandibular (34) (12) (30)
Depletion Lymphoid 1 (3%) 1 (8%) 1 (3%)
Ectasia 1 (3%)
Hyperplasia, Plasma Cell 3 (9%)
Inflammation, Acute 1 (3%)
Lymph Node, Mesenteric (42) (18) (41)
Abscess 1 (6%)
Angiectasis 5 (12%) 1 (6%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Congestion 1 (2%)
Depletion Lymphoid 2 (5%) 1 (6%)
Hemorrhage 2 (5%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 4 (10%) 1 (6%) 2 (5%)
Hyperplasia, Plasma Cell 2 (5%) 1 (2%)
Inflammation, Acute 3 (7%) 1 (6%) 1 (2%)
Inflammation, Acute, Necrotizing 1 (6%)
Inflammation, Chronic 1 (6%)
Inflammation, Chronic Active 2 (5%) 1 (6%)
Necrosis 1 (6%)
Serosa, Congestion 1 (2%)
Serosa, Fibrosis 1 (2%)
Serosa, Inflammation, Chronic Active 1 (2%)
Spleen (50) (29) (49)
Angiectasis 1 (2%) 1 (3%)
Congestion 1 (3%) 1 (2%)
Depletion Lymphoid 4 (8%) 6 (21%) 7 (14%)
Hematopoietic Cell Proliferation 23 (46%) 8 (28%) 8 (16%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 9 (18%) 1 (3%) 8 (16%)
Inflammation, Acute 1 (2%)
Necrosis, Coagulative 1 (2%)
Capsule, Abscess 1 (2%)
Capsule, Fibrosis 1 (2%)
Capsule, Inflammation, Acute 3 (6%) 1 (3%)
Capsule, Inflammation, Chronic Active 1 (3%)
Thymus (37) (11) (39)
Cyst 1 (9%)
Depletion Lymphoid 9 (24%) 7 (64%) 6 (15%)
Hemorrhage 3 (8%) 1 (9%) 1 (3%)
Hyperplasia, Lymphoid 2 (5%)
Inflammation, Acute 2 (5%)
Necrosis 3 (27%) 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (31) (5) (23)
Galactocele 1 (3%)
Hyperplasia 2 (6%) 1 (4%)
Infiltration Cellular, Mixed Cell 1 (3%)
Inflammation, Chronic 3 (10%)
Skin (49) (16) (48)
Inflammation, Acute, Necrotizing 2 (4%) 1 (2%)
Subcutaneous Tissue, Fibrosis 2 (4%)
Subcutaneous Tissue, Inflammation, Chronic
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2) (4) (4)
Intercostal, Inflammation, Acute 1 (25%)
Thoracic, Inflammation, Acute 1 (25%) 2 (50%)
Thoracic, Inflammation, Chronic Active 1 (25%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (16) (50)
Bacterium 1 (2%)
Hemorrhage 2 (4%) 1 (2%)
Infarct, Multifocal 1 (2%)
Cerebellum, Inflammation, Chronic 1 (2%)
Thalamus, Mineralization 40 (80%) 4 (25%) 25 (50%)
Spinal Cord (1) (1)
Hemorrhage, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (21) (50)
Bacterium 2 (4%)
Congestion 2 (4%) 2 (10%) 1 (2%)
Hemorrhage 6 (12%) 3 (6%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (5%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%)
Leukocytosis 3 (6%) 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%)
Artery, Hyperplasia 1 (2%)
Artery, Thrombosis 1 (2%)
Mediastinum, Inflammation, Chronic Active 1 (2%)
Peribronchiolar, Inflammation, Chronic 1 (2%) 1 (2%)
Perivascular, Inflammation, Acute 4 (8%) 1 (2%)
Perivascular, Inflammation, Chronic 3 (6%) 2 (10%) 3 (6%)
Perivascular, Inflammation, Chronic Active 1 (2%) 1 (2%)
Pleura, Inflammation, Acute 2 (4%) 1 (5%) 1 (2%)
Pleura, Inflammation, Chronic 1 (2%) 1 (2%)
Pleura, Inflammation, Chronic Active 1 (5%)
Pleura, Inflammation, Chronic Active,
Hemorrhagic 1 (2%)
Nose (50) (12) (41)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Lumen, Inflammation, Acute 4 (8%) 2 (5%)
Mucosa, Glands, Dilatation 1 (2%)
Mucosa, Glands, Inflammation, Acute 18 (36%) 19 (46%)
Mucosa, Glands, Inflammation, Chronic Active 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (8%)
Nasolacrimal Duct, Inflammation, Chronic 3 (25%)
Nasolacrimal Duct, Inflammation, Chronic
Active 5 (10%) 4 (10%)
Trachea (49) (15) (50)
Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (1) (1)
Hyperplasia 1 (100%) 1 (100%)
Inflammation, Acute, Necrotizing 1 (50%)
Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Abscess 1 (2%)
Bacterium 1 (2%) 1 (2%) 1 (2%)
Glomerulosclerosis 15 (30%) 2 (4%) 2 (4%)
Hydronephrosis 1 (2%)
Inflammation, Acute, Necrotizing 1 (2%)
Inflammation, Chronic 44 (88%) 39 (78%) 41 (82%)
Inflammation, Chronic Active 1 (2%)
Metaplasia, Osseous 2 (4%) 1 (2%) 2 (4%)
Necrosis, Coagulative, Focal 1 (2%)
Artery, Thrombosis 1 (2%)
Capsule, Inflammation, Acute 1 (2%)
Papilla, Inflammation, Acute, Necrotizing 1 (2%)
Proximal Convoluted Renal Tubule, Atrophy 1 (2%) 2 (4%)
Proximal Convoluted Renal Tubule,
Regeneration 7 (14%) 1 (2%) 9 (18%)
Urinary Bladder (50) (16) (48)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 38 (76%) 6 (38%) 36 (75%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Serosa, Inflammation, Acute 2 (4%)
Serosa, Inflammation, Chronic Active 2 (4%)
Submucosa, Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 12 6 11
Natural Death 2 2 3
Accident 2
Survivors
Terminal Sacrifice 35 40 36
Natural Death 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (46) (4) (43)
Necrosis 1 (25%)
Adventitia, Inflammation, Acute 1 (25%)
Gallbladder (45) (20) (39)
Calculus Micro Observation Only 1 (5%)
Fibrosis 1 (5%)
Inflammation, Chronic 5 (11%) 6 (15%)
Inflammation, Chronic Active 1 (5%)
Epithelium, Hyperplasia 1 (3%)
Intestine Large, Cecum (48) (3) (46)
Hyperplasia, Lymphoid 5 (10%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Intestine Large, Colon (49) (5) (50)
Hyperplasia, Lymphoid 1 (2%)
Intestine Large, Rectum (48) (3) (50)
Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Duodenum (49) (5) (50)
Epithelium, Hyperplasia 2 (40%)
Intestine Small, Ileum (49) (9) (50)
Hyperplasia, Lymphoid 4 (8%) 1 (11%) 1 (2%)
Lymphoid Tissue, Necrosis 1 (2%)
Intestine Small, Jejunum (49) (3) (49)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Peyer's Patch, Inflammation, Chronic Active 1 (2%)
Liver (50) (50) (50)
Abscess 1 (2%)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%) 1 (2%) 2 (4%)
Clear Cell Focus 5 (10%)
Cyst 1 (2%)
Degeneration 22 (44%) 38 (76%)
Eosinophilic Focus 2 (4%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fatty Change 11 (22%) 7 (14%) 20 (40%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 4 (8%)
Hemorrhage 1 (2%) 16 (32%) 27 (54%)
Infarct 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 8 (16%) 6 (12%) 8 (16%)
Inflammation, Chronic Active 2 (4%) 5 (10%) 8 (16%)
Karyomegaly 1 (2%)
Mineralization 1 (2%) 1 (2%)
Mixed Cell Focus 2 (4%) 2 (4%)
Necrosis, Coagulative 4 (8%) 11 (22%) 36 (72%)
Pigmentation 1 (2%) 1 (2%) 26 (52%)
Regeneration 1 (2%)
Centrilobular, Cytomegaly 34 (68%) 45 (90%)
Centrilobular, Karyomegaly 34 (68%) 44 (88%)
Periportal, Inflammation, Chronic 16 (32%) 2 (4%) 2 (4%)
Mesentery (4) (2) (2)
Fibrosis 4 (100%) 1 (50%) 1 (50%)
Inflammation, Chronic 1 (25%) 1 (50%) 1 (50%)
Inflammation, Chronic Active 1 (50%) 1 (50%)
Mineralization 3 (75%)
Necrosis, Coagulative 3 (75%) 2 (100%)
Pigmentation 1 (50%)
Artery, Thrombosis 1 (25%)
Pancreas (49) (8) (49)
Atrophy 1 (2%) 1 (2%)
Ectopic Tissue 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic 17 (35%) 11 (22%)
Inflammation, Chronic Active 2 (25%) 1 (2%)
Necrosis, Coagulative 1 (2%) 1 (13%)
Vacuolization Cytoplasmic 1 (2%)
Artery, Mineralization 5 (10%) 2 (4%)
Duct, Dilatation 1 (2%)
Salivary Glands (50) (4) (50)
Parotid Gland, Inflammation, Chronic 1 (2%) 1 (2%)
Parotid Gland, Mineralization 2 (4%)
Sublingual Gland, Inflammation, Chronic 1 (2%)
Submandibular Gland, Inflammation, Chronic 42 (84%) 1 (25%) 40 (80%)
Stomach, Forestomach (48) (5) (50)
Acanthosis 4 (8%) 4 (8%)
Hyperkeratosis 5 (10%) 6 (12%)
Hyperplasia, Basal Cell 4 (8%) 3 (6%)
Inflammation, Acute 1 (2%)
Inflammation, Acute, Necrotizing 1 (2%)
Inflammation, Chronic 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 3 (6%) 4 (8%)
Inflammation, Chronic Active, Necrotizing 1 (2%)
Karyomegaly, Chronic Active 1 (2%)
Ulcer 1 (2%)
Epithelium, Mineralization 1 (2%)
Muscularis, Mineralization 1 (2%)
Stomach, Glandular (48) (5) (50)
Cyst 2 (4%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 12 (25%) 1 (20%) 8 (16%)
Inflammation, Chronic Active 2 (4%) 5 (10%)
Pigmentation 1 (2%)
Muscularis, Mineralization 1 (2%)
Tooth (17) (5)
Incisor, Abscess 8 (47%) 4 (80%)
Incisor, Bacterium 1 (20%)
Incisor, Dysplasia 9 (53%) 2 (40%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (5) (50)
Fibrosis 1 (2%)
Inflammation, Chronic 10 (20%) 3 (6%)
Inflammation, Chronic Active 1 (2%)
Coronary Artery, Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (49) (8) (48)
Capsule, Inflammation, Chronic 1 (2%)
Adrenal Gland, Cortex (49) (8) (48)
Cyst 1 (2%)
Hyperplasia 5 (10%) 2 (4%)
Pigmentation 1 (2%) 2 (4%)
Adrenal Gland, Medulla (48) (8) (48)
Angiectasis 1 (2%)
Hyperplasia 3 (6%)
Islets, Pancreatic (49) (5) (50)
Hyperplasia 1 (2%)
Parathyroid Gland (27) (3) (34)
Vacuolization Cytoplasmic 1 (3%)
Pituitary Gland (47) (5) (45)
Pars Distalis, Cyst 7 (15%) 1 (20%) 1 (2%)
Pars Distalis, Hyperplasia 3 (6%) 1 (20%) 6 (13%)
Thyroid Gland (48) (5) (49)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Follicle, Cyst 1 (2%) 2 (4%)
Follicular Cell, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (1) (11)
Inflammation, Chronic 1 (9%)
Perivascular, Inflammation, Chronic 1 (9%)
Epididymis (49) (4) (50)
Inflammation, Chronic 20 (41%) 20 (40%)
Inflammation, Chronic Active 1 (2%)
Preputial Gland (10) (14) (8)
Abscess 6 (60%) 4 (29%)
Cyst 1 (7%)
Hemorrhage 1 (13%)
Inflammation, Chronic 2 (20%) 2 (14%) 1 (13%)
Inflammation, Chronic Active 2 (20%) 4 (29%) 5 (63%)
Inflammation, Chronic Active, Necrotizing 2 (14%)
Duct, Dilatation 2 (20%) 1 (7%)
Prostate (49) (5) (50)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Acute, Necrotizing 1 (2%)
Inflammation, Chronic 36 (73%) 1 (20%) 33 (66%)
Epithelium, Hyperplasia 1 (2%)
Seminal Vesicle (50) (6) (50)
Atrophy 1 (17%)
Fibrosis 1 (2%) 1 (2%)
Inflammation, Chronic 22 (44%) 8 (16%)
Inflammation, Chronic Active 1 (2%)
Testes (50) (7) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%) 2 (4%)
Inflammation, Chronic Active 1 (14%)
Seminiferous Tubule, Atrophy 2 (4%) 1 (14%) 3 (6%)
Seminiferous Tubule, Giant Cell 1 (2%)
Seminiferous Tubule, Mineralization 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (5) (50)
Congestion 1 (20%) 2 (4%)
Infarct 1 (20%)
Myeloid Cell, Hyperplasia 1 (2%) 1 (20%)
Lymph Node (50) (27) (50)
Axillary, Hyperplasia, Lymphoid 1 (4%)
Axillary, Hyperplasia, Plasma Cell 1 (2%)
Bronchial, Hyperplasia, Lymphoid 1 (2%)
Inguinal, Angiectasis 1 (2%)
Inguinal, Ectasia 1 (2%)
Inguinal, Hyperplasia, Plasma Cell 1 (2%)
Inguinal, Inflammation, Acute 1 (2%)
Inguinal, Pigmentation 2 (4%)
Lumbar, Hyperplasia, Lymphoid 2 (4%) 1 (4%)
Lumbar, Hyperplasia, Plasma Cell 1 (2%) 1 (4%)
Lumbar, Pigmentation 1 (2%)
Mediastinal, Angiectasis 1 (2%)
Mediastinal, Depletion Lymphoid 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Pigmentation 1 (2%)
Pancreatic, Angiectasis 1 (2%)
Pancreatic, Depletion Lymphoid 1 (2%)
Pancreatic, Ectasia 1 (2%)
Pancreatic, Hematopoietic Cell Proliferation 1 (2%)
Pancreatic, Hemorrhage 1 (4%)
Renal, Hemorrhage 1 (4%)
Renal, Hyperplasia, Lymphoid 2 (4%) 1 (4%)
Lymph Node, Mandibular (27) (1) (23)
Depletion Lymphoid 1 (4%)
Hyperplasia, Lymphoid 1 (4%)
Hyperplasia, Plasma Cell 2 (7%)
Pigmentation 2 (9%)
Lymph Node, Mesenteric (45) (20) (47)
Angiectasis 28 (62%) 3 (15%) 30 (64%)
Depletion Lymphoid 1 (2%) 2 (4%)
Ectasia 2 (4%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (5%)
Hemorrhage 3 (7%) 14 (70%) 3 (6%)
Hyperplasia, Lymphoid 3 (7%) 1 (5%) 5 (11%)
Infiltration Cellular, Histiocyte 1 (5%) 1 (2%)
Inflammation, Acute 2 (4%)
Pigmentation 1 (5%)
Thrombosis 2 (4%)
Spleen (50) (20) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Depletion Lymphoid 1 (2%) 5 (10%)
Hematopoietic Cell Proliferation 7 (14%) 5 (25%) 7 (14%)
Hyperplasia, Lymphoid 4 (8%) 3 (15%) 6 (12%)
Necrosis, Coagulative 1 (2%)
Artery, Endothelium, Hyperplasia 1 (2%)
Thymus (41) (4) (34)
Cyst 12 (29%) 7 (21%)
Depletion Lymphoid 4 (10%) 4 (100%) 4 (12%)
Hemorrhage 4 (10%) 2 (6%)
Necrosis 1 (2%) 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (11) (49)
Acanthosis 1 (2%)
Cyst 1 (2%)
Hemorrhage 3 (6%)
Inflammation, Acute 2 (4%) 6 (12%)
Inflammation, Acute, Hemorrhagic 1 (2%)
Inflammation, Acute, Necrotizing 2 (4%) 1 (9%) 4 (8%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (2%)
Inflammation, Chronic Active, Necrotizing 2 (18%)
Epidermis, Inflammation, Acute 1 (9%)
Subcutaneous Tissue, Abscess 1 (2%) 1 (9%)
Subcutaneous Tissue, Fibrosis 2 (4%) 1 (2%)
Subcutaneous Tissue, Granuloma 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic 1 (9%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (33) (50)
Joint, Tarsal, Hyperostosis 33 (66%) 28 (85%) 35 (70%)
Skeletal Muscle (2)
Abdominal, Regeneration 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (5) (50)
Hemorrhage 1 (20%)
Thalamus, Mineralization 39 (78%) 1 (20%) 40 (80%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (14) (50)
Congestion 3 (21%)
Embolus Tumor 1 (2%)
Hemorrhage 5 (10%) 4 (29%) 5 (10%)
Infiltration Cellular, Histiocyte 3 (6%) 5 (10%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (2%) 4 (8%)
Alveolar Epithelium, Hyperplasia 3 (6%) 3 (6%)
Bronchiole, Epithelium, Hyperplasia 1 (2%)
Fat, Mediastinum, Necrosis, Liquifactive 1 (7%)
Mediastinum, Inflammation, Chronic Active 1 (2%)
Peribronchial, Inflammation, Chronic 1 (2%)
Peribronchiolar, Inflammation, Chronic 1 (7%)
Perivascular, Inflammation, Chronic 2 (4%) 1 (7%) 1 (2%)
Pleura, Inflammation, Acute 1 (2%)
Nose (50) (3) (47)
Glands, Inflammation, Acute 1 (33%)
Lumen, Inflammation, Acute 2 (4%) 2 (4%)
Mucosa, Inflammation, Acute 26 (52%) 18 (38%)
Mucosa, Inflammation, Chronic 1 (2%)
Mucosa, Inflammation, Chronic Active 2 (4%) 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic
Active 1 (2%) 3 (6%)
Nasolacrimal Duct, Metaplasia, Squamous 1 (2%) 1 (2%)
Nasopharyngeal Duct, Inflammation, Chronic
Active 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1)
Inflammation, Chronic Active 1 (100%)
Eye (2)
Cornea, Inflammation, Chronic Active,
Necrotizing 1 (50%)
Lids, Inflammation, Chronic Active,
Necrotizing 1 (50%)
Harderian Gland (3) (2) (3)
Hyperplasia 1 (50%) 1 (33%)
Inflammation, Chronic 1 (33%) 1 (33%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
NTP Experiment-Test: 05063-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 21:00:16
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 0.15G/KG 0.3 G/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (50)
Abscess 1 (2%)
Bacterium 1 (2%)
Cyst 1 (2%)
Glomerulosclerosis 4 (8%) 6 (12%) 6 (12%)
Hydronephrosis 1 (2%)
Infarct 1 (2%)
Inflammation, Chronic 44 (90%) 42 (84%) 47 (94%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Metaplasia, Osseous 2 (4%)
Medulla, Mineralization 1 (2%)
Papilla, Necrosis, Coagulative 1 (2%)
Proximal Convoluted Renal Tubule, Atrophy 2 (4%)
Proximal Convoluted Renal Tubule,
Degeneration 1 (2%)
Proximal Convoluted Renal Tubule,
Mineralization 1 (2%)
Proximal Convoluted Renal Tubule,
Regeneration 36 (73%) 3 (6%) 36 (72%)
Proximal Convoluted Renal Tubule,
Vacuolization Cytoplasmic 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
Ureter (1)
Inflammation, Chronic 1 (100%)
Urethra (4) (7)
Calculus Micro Observation Only 4 (100%) 6 (86%)
Inflammation, Chronic 1 (14%)
Urinary Bladder (50) (6) (48)
Calculus Gross Observation 1 (2%) 1 (2%)
Calculus Micro Observation Only 3 (6%) 3 (6%)
Inflammation, Chronic 35 (70%) 2 (33%) 30 (63%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Mineralization 1 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 18
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