TDMS Study 05063-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
PHENYLBUTAZONE
NTP Experiment-Test: 05063-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/08/94
Route: GAVAGE Time: 19:05:34
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: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 14 9 14
Natural Death 5 5 14
Accident 1
Survivors
Terminal Sacrifice 30 35 21
Natural Death 1
Terminal Sacrifice 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (5) (49)
Depletion Lymphoid 1 (2%)
Parasite Metazoan 1 (2%) 1 (20%) 1 (2%)
Intestine Large, Colon (49) (7) (49)
Angiectasis 1 (2%)
Parasite Metazoan 9 (18%) 6 (12%)
Mucosa, Fibrosis 1 (2%)
Intestine Large, Rectum (48) (6) (48)
Metaplasia, Focal, Squamous 1 (2%)
Parasite Metazoan 1 (2%) 1 (2%)
Intestine Small, Duodenum (50) (9) (50)
Abscess, Chronic 1 (2%)
Inflammation, Chronic Active, Necrotizing 2 (4%)
Epithelium, Hyperplasia 1 (2%)
Muscularis, Inflammation, Acute 1 (2%)
Muscularis, Mineralization 1 (2%)
Serosa, Fibrosis 1 (2%)
Serosa, Inflammation, Chronic 1 (2%)
Intestine Small, Ileum (49) (8) (50)
Lymphoid Nodule, Depletion Cellular 1 (2%)
Intestine Small, Jejunum (49) (7) (49)
Hemorrhage 1 (2%)
Inflammation, Chronic Active, Necrotizing 1 (2%)
Ulcer 1 (2%)
Muscularis, Inflammation, Acute 1 (2%)
Muscularis, Mineralization 1 (2%)
Liver (50) (27) (50)
Angiectasis 1 (2%) 2 (7%) 1 (2%)
Basophilic Focus 35 (70%) 14 (52%) 31 (62%)
Clear Cell Focus 4 (8%) 1 (4%) 3 (6%)
Eosinophilic Focus 5 (19%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fatty Change 20 (40%) 11 (41%) 19 (38%)
Focal Cellular Change 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%) 3 (11%) 3 (6%)
Hyperplasia 2 (4%) 1 (4%) 2 (4%)
Inflammation, Chronic Active 17 (34%) 11 (41%) 10 (20%)
Mixed Cell Focus 2 (4%)
Necrosis, Coagulative 6 (12%) 3 (11%) 5 (10%)
Pigmentation 1 (2%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 28 (56%) 8 (30%) 23 (46%)
Centrilobular, Cytomegaly 1 (2%)
Kupffer Cell, Hyperplasia, Focal 1 (2%) 1 (2%)
Periportal, Fibrosis 2 (4%) 1 (4%) 1 (2%)
Serosa, Inflammation, Chronic, Focal 1 (4%)
Serosa, Inflammation, Suppurative 1 (2%)
Subserosa, Necrosis, Coagulative 1 (2%)
Mesentery (2) (5) (10)
Fibrosis 1 (50%) 3 (60%) 2 (20%)
Hemorrhage 1 (20%) 1 (10%)
Inflammation, Chronic Active 1 (50%) 5 (50%)
Mineralization 2 (40%) 4 (40%)
Necrosis, Coagulative 1 (50%) 3 (60%) 5 (50%)
Pancreas (50) (9) (50)
Atrophy 11 (22%) 3 (33%) 11 (22%)
Fibrosis, Focal 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Chronic 12 (24%) 2 (22%) 7 (14%)
Salivary Glands (50) (7) (50)
Inflammation, Chronic, Focal 1 (2%)
Stomach, Forestomach (49) (49) (49)
Acanthosis 4 (8%) 12 (24%)
Edema 1 (2%)
Erosion 1 (2%)
Hyperkeratosis 3 (6%) 12 (24%)
Hyperplasia, Basal Cell 4 (8%) 1 (2%) 12 (24%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Granulomatous 1 (2%)
Ulcer 1 (2%) 1 (2%) 12 (24%)
Ulcer, Multiple 1 (2%)
Muscularis, Mineralization 1 (2%)
Submucosa, Foreign Body 1 (2%)
Stomach, Glandular (50) (49) (50)
Abscess 1 (2%)
Edema 1 (2%)
Erosion 2 (4%) 1 (2%) 2 (4%)
Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 5 (10%)
Mineralization 1 (2%) 4 (8%)
Ulcer 3 (6%)
Muscularis, Mineralization 2 (4%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (2)
Aorta, Inflammation, Chronic Active 1 (50%)
Heart (50) (7) (50)
Cardiomyopathy 35 (70%) 4 (57%) 43 (86%)
Mineralization 3 (6%)
Necrosis, Focal 1 (2%)
Atrium, Embolus 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50)
Angiectasis 30 (60%) 26 (52%) 17 (34%)
Atrophy 1 (2%) 1 (2%)
Autolysis 1 (2%) 1 (2%)
Congestion 1 (2%)
Degeneration 1 (2%)
Degeneration, Fatty 1 (2%)
Hyperplasia 7 (14%) 12 (24%) 9 (18%)
Mineralization 1 (2%)
Necrosis, Coagulative 1 (2%) 2 (4%) 2 (4%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic 24 (48%) 27 (54%) 31 (62%)
Adrenal Gland, Medulla (50) (50) (50)
Angiectasis 1 (2%)
Autolysis 1 (2%) 1 (2%)
Hyperplasia 3 (6%) 6 (12%) 19 (38%)
Necrosis, Coagulative 2 (4%)
Thrombosis 1 (2%)
Islets, Pancreatic (50) (7) (50)
Angiectasis, Focal 1 (2%)
Hyperplasia 1 (2%)
Parathyroid Gland (31) (34) (14)
Hyperplasia 3 (21%)
Pituitary Gland (48) (49) (50)
Pars Distalis, Angiectasis 36 (75%) 19 (39%) 30 (60%)
Pars Distalis, Cyst 23 (48%) 26 (53%) 23 (46%)
Pars Distalis, Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia 10 (21%) 6 (12%) 15 (30%)
Pars Distalis, Pigmentation 12 (25%) 2 (4%) 6 (12%)
Pars Intermedia, Angiectasis 2 (4%) 2 (4%) 1 (2%)
Pars Intermedia, Cyst 4 (8%)
Pars Intermedia, Pigmentation 2 (4%)
Pars Nervosa, Angiectasis 2 (4%) 1 (2%)
Pars Nervosa, Cyst 1 (2%)
Pars Nervosa, Pigmentation 1 (2%)
Thyroid Gland (50) (49) (50)
Inflammation, Chronic 1 (2%)
C-Cell, Hyperplasia 24 (48%) 26 (53%) 24 (48%)
Follicular Cell, Cyst 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (36) (11) (41)
Inflammation, Acute 1 (9%) 3 (7%)
Inflammation, Chronic 8 (22%) 6 (15%)
Inflammation, Chronic Active 12 (33%) 1 (9%) 17 (41%)
Inflammation, Chronic Active, Necrotizing 4 (36%)
Ovary (50) (14) (50)
Atrophy 1 (7%)
Congestion 1 (2%)
Cyst 3 (6%) 2 (14%) 2 (4%)
Hyperplasia 1 (2%)
Mineralization 2 (4%)
Corpus Luteum, Cyst 1 (2%)
Periovarian Tissue, Cyst 4 (8%) 4 (29%)
Oviduct (1)
Inflammation, Chronic 1 (100%)
Uterus (50) (17) (50)
Hydrometra 6 (12%) 1 (6%) 9 (18%)
Inflammation, Acute 2 (4%) 1 (2%)
Thrombosis 1 (2%)
Endometrium, Hyperplasia 9 (18%) 3 (18%) 7 (14%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (6) (48)
Myelofibrosis 1 (2%) 1 (2%)
Lymph Node (50) (15) (49)
Mediastinal, Depletion Lymphoid 1 (7%) 1 (2%)
Mediastinal, Ectasia 1 (7%)
Mediastinal, Hemorrhage 3 (6%) 3 (20%) 11 (22%)
Mediastinal, Hyperplasia 2 (4%)
Mediastinal, Inflammation, Chronic Active 1 (2%)
Mediastinal, Pigmentation 4 (8%)
Pancreatic, Depletion Lymphoid 1 (2%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (2%)
Pancreatic, Pigmentation 3 (6%)
Renal, Angiectasis 1 (2%)
Renal, Ectasia 1 (2%)
Renal, Hemorrhage 1 (2%)
Renal, Hyperplasia 1 (7%)
Renal, Infiltration Cellular, Histiocyte 1 (2%)
Renal, Pigmentation 1 (2%)
Lymph Node, Mandibular (42) (5) (37)
Angiectasis 1 (2%)
Depletion Lymphoid 1 (3%)
Ectasia 4 (10%) 1 (3%)
Hemorrhage 6 (14%) 2 (40%) 7 (19%)
Hyperplasia 1 (2%) 5 (14%)
Infiltration Cellular, Histiocyte 1 (3%)
Pigmentation 1 (2%) 1 (3%)
Lymph Node, Mesenteric (50) (13) (46)
Depletion Lymphoid 1 (8%) 2 (4%)
Ectasia 5 (11%)
Hemorrhage 2 (4%) 4 (9%)
Hyperplasia 1 (2%)
Infiltration Cellular, Histiocyte 35 (70%) 5 (38%) 28 (61%)
Pigmentation 34 (68%) 7 (54%) 29 (63%)
Spleen (50) (50) (50)
Congestion 2 (4%) 1 (2%)
Depletion Lymphoid 14 (28%) 14 (28%) 19 (38%)
Hematopoietic Cell Proliferation 1 (2%) 4 (8%)
Pigmentation 4 (8%) 5 (10%) 1 (2%)
Capsule, Fibrosis, Focal 1 (2%)
Subcapsular, Necrosis, Coagulative 1 (2%)
Thymus (42) (8) (38)
Congestion 1 (13%) 2 (5%)
Cyst 2 (5%)
Depletion Lymphoid 28 (67%) 6 (75%) 32 (84%)
Hemorrhage 2 (5%) 2 (25%)
Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (18) (40)
Degeneration 1 (3%)
Galactocele 4 (9%) 1 (6%) 1 (3%)
Hyperplasia 41 (89%) 5 (28%) 32 (80%)
Inflammation, Chronic Active 1 (2%)
Skin (50) (12) (49)
Subcutaneous Tissue, Inflammation, Chronic
Active, Granulomatous 1 (8%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (7) (50)
Fibrous Osteodystrophy 1 (2%)
Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10) (50)
Congestion 1 (2%)
Hemorrhage 2 (4%)
Hydrocephalus 1 (2%)
Cerebellum, Infarct 2 (4%)
Medulla, Infarct 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (20) (50)
Congestion 1 (2%) 3 (15%) 2 (4%)
Edema 2 (4%)
Foreign Body 4 (8%)
Granuloma 1 (2%)
Hemorrhage 4 (8%) 1 (5%)
Infiltration Cellular, Histiocyte 9 (18%) 6 (30%) 22 (44%)
Inflammation, Acute 3 (6%)
Inflammation, Acute, Necrotizing 1 (2%) 1 (2%)
Inflammation, Chronic 11 (22%) 8 (16%)
Inflammation, Chronic Active 9 (18%) 4 (20%) 6 (12%)
Thrombosis, Multiple 1 (2%)
Alveolar Epithelium, Hyperplasia 9 (18%) 1 (5%) 2 (4%)
Artery, Hyperplasia 1 (2%)
Artery, Mineralization 18 (36%) 4 (20%) 19 (38%)
Bronchus, Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Nose (48) (6) (49)
Inflammation, Acute 4 (8%) 3 (6%)
Inflammation, Acute, Necrotizing 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 5 (10%) 1 (2%)
Inflammation, Chronic Active, Necrotizing 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic 1 (2%) 1 (17%) 3 (6%)
Nasolacrimal Duct, Inflammation, Chronic
Active 1 (2%) 1 (2%)
Nasolacrimal Duct, Metaplasia, Squamous 1 (17%) 1 (2%)
Trachea (50) (48) (50)
Inflammation, Acute, Necrotizing 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3)
Cataract 1 (33%)
Retina, Degeneration 1 (33%)
Sclera, Metaplasia, Osseous 1 (33%)
Harderian Gland (2)
Hyperplasia 1 (50%)
Inflammation, Chronic 1 (50%)
Lacrimal Gland (1)
Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Atrophy 1 (2%)
Bacterium 3 (6%)
Cyst 1 (2%) 2 (4%) 16 (32%)
Inflammation, Acute, Necrotizing 1 (2%) 2 (4%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Chronic Active, Necrotizing 2 (4%)
Nephropathy 38 (76%) 46 (92%) 47 (94%)
Pigmentation 2 (4%) 1 (2%)
Collecting Tubule, Mineralization 3 (6%) 31 (62%) 46 (92%)
Distal Convoluted Renal Tubule,
Mineralization 1 (2%)
Papilla, Angiectasis 4 (8%)
Papilla, Inflammation, Acute 2 (4%)
Papilla, Mineralization 1 (2%)
Papilla, Necrosis 18 (36%) 35 (70%)
Papilla, Necrosis, Coagulative 6 (12%)
Pelvis, Calculus Gross Observation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Pelvis, Dilatation 1 (2%) 22 (44%)
Pelvis, Epithelium, Hyperplasia 7 (14%) 20 (40%) 37 (74%)
Pelvis, Epithelium, Mineralization 13 (26%) 11 (22%) 6 (12%)
Proximal Convoluted Renal Tubule, Hyperplasia 1 (2%)
Proximal Convoluted Renal Tubule,
Inflammation, Acute 2 (4%) 4 (8%) 26 (52%)
Proximal Convoluted Renal Tubule,
Mineralization 1 (2%) 4 (8%)
Proximal Convoluted Renal Tubule,
Pigmentation 4 (8%) 1 (2%) 1 (2%)
Renal Tubule, Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Ureter (1)
Dilatation 1 (100%)
Urinary Bladder (50) (49) (49)
Calculus Gross Observation 1 (2%)
Inflammation, Acute, Focal, Necrotizing 1 (2%)
Inflammation, Acute, Necrotizing 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Metaplasia, Squamous 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund Sacrifice 11 13 16
Natural Death 6 16 7
Accident 1
Survivors
Terminal Sacrifice 32 20 27
Terminal Sacrifice 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (44) (17) (32)
Inflammation, Acute, Necrotizing 1 (3%)
Submucosa, Hemorrhage 1 (2%)
Intestine Large, Cecum (47) (14) (50)
Inflammation, Acute, Necrotizing 1 (2%)
Parasite Metazoan 1 (2%) 2 (4%)
Intestine Large, Colon (50) (21) (49)
Angiectasis 1 (2%)
Parasite Metazoan 13 (26%) 3 (14%) 12 (24%)
Intestine Large, Rectum (49) (18) (49)
Parasite Metazoan 2 (4%) 2 (4%)
Intestine Small, Duodenum (50) (23) (49)
Inflammation, Acute, Necrotizing 1 (2%)
Inflammation, Chronic Active 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Liver (50) (50) (50)
Angiectasis 2 (4%) 2 (4%)
Basophilic Focus 37 (74%) 27 (54%) 25 (50%)
Clear Cell Focus 15 (30%) 11 (22%) 19 (38%)
Congestion 1 (2%)
Degeneration, Cystic 4 (8%) 1 (2%) 4 (8%)
Eosinophilic Focus 7 (14%) 9 (18%) 10 (20%)
Fatty Change 41 (82%) 39 (78%) 49 (98%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 2 (4%) 1 (2%)
Hyperplasia 3 (6%)
Infarct 1 (2%)
Inflammation, Chronic Active 28 (56%) 23 (46%) 17 (34%)
Mixed Cell Focus 3 (6%) 4 (8%) 7 (14%)
Necrosis, Coagulative 6 (12%) 6 (12%) 5 (10%)
Bile Duct, Hyperplasia 35 (70%) 43 (86%) 32 (64%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Centrilobular, Cytomegaly 1 (2%)
Kupffer Cell, Hyperplasia 2 (4%)
Mesentery (4) (5) (3)
Inflammation, Chronic Active 1 (25%) 2 (40%)
Necrosis, Coagulative 1 (25%) 2 (40%) 1 (33%)
Pancreas (50) (27) (50)
Atrophy 9 (18%) 2 (7%) 15 (30%)
Ectopic Tissue 1 (2%)
Hyperplasia 8 (16%) 3 (11%) 6 (12%)
Inflammation, Chronic 8 (16%) 1 (4%) 6 (12%)
Inflammation, Chronic Active 1 (4%)
Pigmentation 2 (4%)
Acinus, Hyperplasia 1 (2%)
Duct, Hyperplasia 1 (2%)
Salivary Glands (49) (23) (49)
Atrophy 1 (2%)
Hemorrhage 2 (4%)
Inflammation, Chronic 2 (4%) 1 (4%) 1 (2%)
Parotid Gland, Atrophy 1 (2%)
Submandibular Gland, Atrophy 1 (2%)
Stomach, Forestomach (50) (50) (50)
Acanthosis 4 (8%) 8 (16%) 7 (14%)
Hyperkeratosis 3 (6%) 8 (16%) 7 (14%)
Hyperplasia, Basal Cell 4 (8%) 9 (18%) 2 (4%)
Hyperplasia, Pseudoepitheliomatous 1 (2%)
Inflammation, Chronic Active 3 (6%) 2 (4%)
Ulcer 5 (10%) 6 (12%)
Muscularis, Mineralization 1 (2%)
Stomach, Glandular (50) (50) (49)
Erosion 1 (2%) 2 (4%)
Fibrosis 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 6 (12%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Ulcer 1 (2%) 1 (2%)
Arteriole, Mineralization 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Mucosa, Mineralization 1 (2%)
Mucosa, Necrosis 1 (2%)
Muscularis, Mineralization 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (20) (50)
Cardiomyopathy 48 (96%) 18 (90%) 48 (96%)
Atrioventricular Valve, Mineralization, Focal 1 (2%)
Atrium, Congestion 1 (2%)
Atrium, Thrombosis 1 (2%) 1 (5%) 3 (6%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (49) (50)
Angiectasis 29 (58%) 19 (39%) 18 (36%)
Atrophy 1 (2%)
Congestion 1 (2%)
Hyperplasia 7 (14%) 6 (12%) 9 (18%)
Vacuolization Cytoplasmic 32 (64%) 26 (53%) 32 (64%)
Adrenal Gland, Medulla (50) (48) (49)
Angiectasis 34 (68%) 23 (48%) 23 (47%)
Fibrosis 1 (2%)
Hyperplasia 11 (22%) 15 (31%) 12 (24%)
Mineralization 1 (2%)
Necrosis 1 (2%)
Thrombosis 2 (4%)
Islets, Pancreatic (50) (22) (50)
Hyperplasia 2 (4%) 2 (4%)
Pituitary Gland (48) (26) (47)
Pars Distalis, Angiectasis 4 (8%) 1 (4%) 1 (2%)
Pars Distalis, Cyst 2 (4%) 1 (4%) 2 (4%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia 22 (46%) 8 (31%) 26 (55%)
Pars Distalis, Necrosis, Coagulative 1 (2%)
Pars Distalis, Pigmentation 2 (8%)
Pars Intermedia, Angiectasis 2 (4%) 1 (2%)
Pars Intermedia, Cyst 1 (2%) 1 (2%)
Pars Intermedia, Hyperplasia 1 (2%)
Pars Intermedia, Pigmentation 1 (4%)
Thyroid Gland (49) (21) (49)
C-Cell, Hyperplasia 22 (45%) 3 (14%) 17 (35%)
Follicle, Cyst 1 (2%) 1 (2%)
Follicle, Mineralization 1 (2%)
Follicular Cell, Hyperplasia 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (49) (50)
Hyperplasia 1 (2%)
Inflammation, Chronic Active 1 (2%)
Epithelium, Hyperplasia 16 (32%) 26 (53%) 26 (52%)
Preputial Gland (43) (25) (47)
Abscess 1 (4%)
Fibrosis 1 (2%)
Hyperplasia 1 (2%)
Inflammation, Acute 1 (2%) 2 (4%)
Inflammation, Chronic 16 (37%) 7 (28%) 7 (15%)
Inflammation, Chronic Active 22 (51%) 12 (48%) 36 (77%)
Prostate (50) (21) (46)
Atrophy 1 (2%)
Cyst 1 (2%)
Inflammation, Acute 5 (10%) 3 (14%) 9 (20%)
Inflammation, Chronic 4 (9%)
Inflammation, Chronic Active 19 (38%) 5 (24%) 10 (22%)
Epithelium, Hyperplasia 4 (8%)
Seminal Vesicle (49) (36) (47)
Atrophy 17 (35%) 14 (39%) 23 (49%)
Inflammation, Acute 1 (3%)
Testes (50) (49) (50)
Hemorrhage 1 (2%)
Arteriole, Inflammation, Chronic Active 2 (4%)
Arteriole, Necrosis, Fibrinoid 1 (2%)
Interstitial Cell, Hyperplasia 35 (70%) 14 (29%) 29 (58%)
Seminiferous Tubule, Atrophy 44 (88%) 41 (84%) 45 (90%)
Seminiferous Tubule, Mineralization 5 (10%) 26 (53%) 14 (28%)
Seminiferous Tubule, Necrosis, Coagulative 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (50) (26) (50)
Mediastinal, Angiectasis 2 (4%)
Mediastinal, Depletion Lymphoid 1 (4%) 1 (2%)
Mediastinal, Ectasia 1 (2%) 1 (4%)
Mediastinal, Hemorrhage 8 (16%) 1 (4%) 7 (14%)
Mediastinal, Hyperplasia 1 (2%)
Mediastinal, Inflammation, Chronic Active 1 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Pigmentation 3 (6%) 2 (8%) 3 (6%)
Pancreatic, Angiectasis 1 (2%)
Pancreatic, Fibrosis 1 (2%)
Pancreatic, Hemorrhage 1 (4%)
Pancreatic, Infiltration Cellular, Histiocyte 1 (4%)
Pancreatic, Pigmentation 1 (2%)
Renal, Hemorrhage 1 (4%)
Renal, Pigmentation 1 (2%) 1 (4%)
Lymph Node, Mandibular (44) (18) (41)
Angiectasis 1 (2%)
Congestion 1 (2%) 1 (2%)
Ectasia 10 (23%) 1 (6%) 2 (5%)
Hematocyst 1 (2%)
Hemorrhage 5 (11%) 3 (17%) 5 (12%)
Hyperplasia 7 (16%) 1 (6%) 2 (5%)
Infiltration Cellular, Histiocyte 3 (7%)
Pigmentation 2 (5%)
Lymph Node, Mesenteric (47) (19) (49)
Angiectasis 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (5%) 5 (10%)
Infiltration Cellular, Histiocyte 30 (64%) 3 (16%) 35 (71%)
Pigmentation 34 (72%) 4 (21%) 32 (65%)
Spleen (50) (32) (50)
Congestion 2 (4%) 1 (3%) 1 (2%)
Depletion Lymphoid 6 (12%) 13 (41%) 9 (18%)
Fibrosis 2 (4%) 2 (6%)
Hematopoietic Cell Proliferation 1 (2%) 1 (3%) 3 (6%)
Hyperplasia, Reticulum Cell 4 (8%)
Necrosis, Coagulative, Focal 1 (2%)
Pigmentation 1 (3%)
Capsule, Inflammation, Chronic Active,
Necrotizing 1 (3%)
Thymus (42) (18) (42)
Congestion 1 (6%)
Cyst 2 (5%) 1 (2%)
Depletion Lymphoid 37 (88%) 13 (72%) 38 (90%)
Hemorrhage 1 (2%) 2 (11%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (21) (8) (24)
Galactocele 1 (13%)
Hyperplasia 10 (48%) 3 (38%) 19 (79%)
Pigmentation 1 (5%)
Skin (50) (27) (49)
Acanthosis 1 (2%) 2 (7%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Atrophy 1 (2%)
Cyst Epithelial Inclusion 2 (4%) 1 (2%)
Hyperkeratosis 1 (2%) 1 (4%) 2 (4%)
Hyperplasia, Basal Cell 1 (2%) 2 (4%)
Hyperplasia, Pseudoepitheliomatous 1 (4%)
Inflammation, Acute, Hemorrhagic 1 (4%)
Inflammation, Acute, Necrotizing 1 (4%)
Inflammation, Chronic Active 1 (4%) 1 (2%)
Inflammation, Chronic Active, Necrotizing 2 (4%)
Ulcer 1 (2%)
Subcutaneous Tissue, Fibrosis 2 (4%) 1 (4%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (21) (50)
Autolysis 1 (5%)
Skeletal Muscle (1) (3) (1)
Hemorrhage 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (20) (50)
Mineralization, Multifocal 1 (2%)
Pigmentation 1 (2%)
Meninges, Hemorrhage 1 (2%) 1 (2%)
Thalamus, Mineralization 1 (2%)
Third Ventricle, Hemorrhage 1 (5%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (34) (50)
Congestion 2 (4%) 10 (29%) 4 (8%)
Crystals 1 (3%) 1 (2%)
Edema 2 (6%) 1 (2%)
Fibrosis 2 (4%) 1 (3%)
Foreign Body 1 (2%)
Granuloma 1 (2%) 1 (3%) 2 (4%)
Hemorrhage 2 (4%) 2 (6%) 1 (2%)
Infiltration Cellular, Histiocyte 13 (26%) 13 (38%) 12 (24%)
Inflammation, Chronic 11 (22%) 4 (12%) 2 (4%)
Inflammation, Chronic Active 7 (14%) 3 (9%) 6 (12%)
Metaplasia, Focal, Osseous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Pigmentation 1 (2%)
Alveolar Epithelium, Hyperplasia 7 (14%) 3 (9%) 5 (10%)
Artery, Hyperplasia 2 (4%) 1 (3%) 1 (2%)
Artery, Mineralization 21 (42%) 16 (47%) 24 (48%)
Bronchiole, Epithelium, Hyperplasia 1 (2%) 1 (2%)
Bronchus, Bronchiectasis 1 (3%)
Nose (49) (19) (49)
Edema 2 (11%)
Hemorrhage 2 (4%) 1 (5%) 2 (4%)
Inflammation, Acute 11 (22%) 5 (10%)
Inflammation, Chronic 2 (4%) 1 (2%)
Inflammation, Chronic Active 4 (8%) 1 (5%) 2 (4%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%) 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic 1 (2%) 3 (16%) 2 (4%)
Nasolacrimal Duct, Inflammation, Chronic
Active 1 (5%)
Nasolacrimal Duct, Metaplasia, Squamous 2 (11%) 4 (8%)
Nasopharyngeal Duct, Inflammation, Chronic
Active 1 (2%)
Trachea (50) (21) (50)
Inflammation, Acute, Necrotizing 1 (2%)
Peritracheal Tissue, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3) (1)
Inflammation, Chronic Active 1 (33%) 1 (100%)
Eye (1) (3)
Cataract 1 (33%)
Retina, Degeneration 1 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50)
Congestion 3 (6%) 8 (16%)
Cyst 2 (4%) 2 (4%)
Metaplasia, Osseous 1 (2%)
Nephropathy 49 (98%) 49 (100%) 50 (100%)
Collecting Tubule, Mineralization 5 (10%) 10 (20%) 35 (70%)
Papilla, Necrosis 1 (2%) 10 (20%) 24 (48%)
Papilla, Necrosis, Coagulative 1 (2%)
Pelvis, Dilatation 1 (2%) 1 (2%) 1 (2%)
Pelvis, Mineralization 1 (2%)
Pelvis, Epithelium, Hyperplasia 14 (28%) 7 (14%) 12 (24%)
Proximal Convoluted Renal Tubule,
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 05063-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENYLBUTAZONE Date: 09/08/94
Route: GAVAGE Time: 19:05:34
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 0.05G/KG 0.1 G/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Inflammation, Acute 6 (12%) 13 (27%) 27 (54%)
Proximal Convoluted Renal Tubule,
Mineralization 1 (2%) 1 (2%)
Proximal Convoluted Renal Tubule,
Pigmentation 2 (4%) 1 (2%) 1 (2%)
Renal Tubule, Hyperplasia 3 (6%) 1 (2%) 3 (6%)
Renal Tubule, Hyperplasia, Focal 1 (2%)
Urethra (1) (1) (1)
Calculus Micro Observation Only 1 (100%) 1 (100%) 1 (100%)
Urinary Bladder (45) (22) (48)
Calculus Micro Observation Only 1 (5%)
Hemorrhage 1 (2%)
Inflammation, Chronic 2 (4%) 1 (5%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
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