TDMS Study 88032-05 Pathology Tables
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
79 WEEK SSAC
Facility: Battelle Columbus Laboratory
Chemical CAS #: 434-07-01
Lock Date: 01/02/96
Cage Range: All
Reasons For Removal: 25017 Scheduled Sacrifice
Removal Date Range: 10/20/94 - 10/21/94
Treatment Groups: Include 002 0 MG/KG
Include 004 3 MG/KG
Include 006 30 MG/KG
Include 008 100 MG/KG
Include 001 0 MG/KG
Include 003 3 MG/KG
Include 005 30 MG/KG
Include 007 150 MG/KG
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 90 90 90 90
Scheduled Sacrifice 10 10 10 10
Early Deaths
Survivors
Animals Examined Microscopically 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (10) (10) (10) (10)
Parasite Metazoan 1 (10%)
Intestine Large, Rectum (10) (10) (10) (10)
Parasite Metazoan 4 (40%) 4 (40%) 4 (40%)
Liver (10) (10) (10) (10)
Basophilic Focus 7 (70%) 10 (100%) 10 (100%) 9 (90%)
Clear Cell Focus 1 (10%) 3 (30%)
Hepatodiaphragmatic Nodule 2 (20%) 1 (10%) 2 (20%) 1 (10%)
Inflammation, Chronic Active 7 (70%) 6 (60%) 7 (70%) 1 (10%)
Mixed Cell Focus 2 (20%)
Bile Duct, Hyperplasia 1 (10%)
Centrilobular, Vacuolization Cytoplasmic 9 (90%) 1 (10%)
Mesentery (4) (3) (2) (1)
Fat, Inflammation, Chronic Active 4 (100%) 3 (100%) 2 (100%) 1 (100%)
Fat, Mineralization 1 (25%)
Pancreas (10) (10) (10) (10)
Acinus, Atrophy 1 (10%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (10) (10) (10) (10)
Myocardium, Degeneration, Chronic 6 (60%) 7 (70%) 8 (80%) 9 (90%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (10) (10) (10) (10)
Angiectasis 3 (30%)
Vacuolization Cytoplasmic 1 (10%) 9 (90%)
Adrenal Medulla (10) (10) (10) (10)
Hyperplasia 1 (10%)
Pituitary Gland (10) (9) (10) (10)
Cyst 2 (20%) 1 (11%) 2 (20%) 1 (10%)
Hyperplasia 1 (10%) 1 (11%) 2 (20%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Thyroid Gland (10) (10) (10) (10)
C-Cell, Hyperplasia 1 (10%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (9) (10) (8) (10)
Cyst 3 (30%)
Inflammation, Chronic Active 5 (56%) 3 (30%) 2 (25%) 4 (40%)
Ovary (10) (10) (10) (10)
DYSGENESIS 8 (80%) 10 (100%)
Periovarian Tissue, Cyst 3 (30%) 1 (10%) 1 (10%) 1 (10%)
Uterus (10) (10) (10) (10)
Hydrometra 3 (30%) 2 (20%)
Endometrium, Cyst 1 (10%)
Endometrium, Hyperplasia 1 (10%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (10) (10) (10) (10)
Ectasia 1 (10%)
Lymph Node, Mesenteric (10) (10) (10) (10)
Ectasia 1 (10%)
Spleen (10) (10) (10) (10)
Hematopoietic Cell Proliferation 1 (10%)
Pigmentation, Hemosiderin 1 (10%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (10) (10) (10) (10)
Dilatation 4 (40%) 1 (10%) 1 (10%)
Galactocele 1 (10%) 1 (10%)
Lobular, Hyperplasia 1 (10%) 9 (90%) 9 (90%)
Skin (10) (10) (10) (10)
Epidermis, Cyst 1 (10%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10) (10)
Inflammation, Chronic Active 1 (10%) 4 (40%) 4 (40%) 3 (30%)
Mineralization 2 (20%) 1 (10%) 5 (50%) 3 (30%)
Nose (10) (10) (10) (10)
Inflammation, Suppurative 1 (10%)
Glands, Hyperplasia 1 (10%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10)
Mineralization 8 (80%) 9 (90%) 10 (100%) 9 (90%)
Nephropathy 8 (80%) 4 (40%) 9 (90%) 10 (100%)
Renal Tubule, Hyperplasia 1 (10%)
Urinary Bladder (10) (10) (10) (10)
Inflammation, Chronic Active 1 (10%) 2 (20%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 90 90 90 90
Scheduled Sacrifice 10 10 10 10
Early Deaths
Survivors
Animals Examined Microscopically 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (10) (10) (10) (10)
Parasite Metazoan 1 (10%) 1 (10%)
Intestine Large, Rectum (10) (10) (10) (10)
Parasite Metazoan 2 (20%) 4 (40%) 1 (10%) 1 (10%)
Intestine Small, Ileum (10) (10) (10) (10)
Fibrosis 1 (10%)
Liver (10) (10) (10) (10)
Basophilic Focus 4 (40%) 8 (80%) 9 (90%) 8 (80%)
Clear Cell Focus 2 (20%) 2 (20%) 2 (20%)
Degeneration, Cystic 1 (10%)
Eosinophilic Focus 1 (10%) 1 (10%) 1 (10%)
Hepatodiaphragmatic Nodule 2 (20%) 1 (10%) 1 (10%)
Inflammation, Chronic Active 8 (80%) 5 (50%) 1 (10%)
Mixed Cell Focus 1 (10%) 3 (30%)
Necrosis 1 (10%)
Bile Duct, Hyperplasia 10 (100%) 6 (60%) 6 (60%)
Centrilobular, Vacuolization Cytoplasmic 3 (30%) 5 (50%) 2 (20%) 1 (10%)
Mesentery (3) (1) (3)
Fat, Congestion 1 (33%)
Fat, Inflammation, Chronic Active 2 (67%) 1 (100%) 3 (100%)
Fat, Mineralization 1 (33%)
Pancreas (10) (10) (10) (10)
Acinus, Atrophy 1 (10%) 2 (20%) 2 (20%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (10) (10) (10) (10)
Myocardium, Degeneration, Chronic 10 (100%) 10 (100%) 10 (100%) 10 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (10) (10) (10) (10)
Vacuolization Cytoplasmic 4 (40%) 8 (80%) 10 (100%) 10 (100%)
Adrenal Medulla (10) (10) (10) (10)
Hyperplasia 3 (30%) 1 (10%) 2 (20%)
Islets, Pancreatic (10) (10) (10) (10)
Pigmentation, Hemosiderin 1 (10%)
Pituitary Gland (10) (10) (10) (9)
Atrophy 1 (10%)
Cyst 2 (20%)
Hyperplasia 2 (20%) 3 (30%) 2 (20%) 1 (11%)
Thyroid Gland (10) (10) (10) (10)
C-Cell, Hyperplasia 1 (10%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (10) (10) (10) (10)
Degeneration 1 (10%)
Preputial Gland (10) (10) (10) (10)
Inflammation, Chronic Active 10 (100%) 8 (80%) 9 (90%) 8 (80%)
Prostate (10) (10) (10) (10)
Inflammation, Chronic Active 2 (20%) 2 (20%)
Seminal Vesicle (10) (10) (10) (10)
Cyst 1 (10%)
Testes (10) (10) (10) (10)
Degeneration 2 (20%) 1 (10%) 2 (20%) 3 (30%)
Mineralization 3 (30%) 1 (10%) 7 (70%) 4 (40%)
Interstitial Cell, Hyperplasia 3 (30%) 4 (40%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (10) (10) (10) (10)
Myelofibrosis 1 (10%) 1 (10%)
Lymph Node, Mandibular (10) (10) (10) (10)
Ectasia 1 (10%)
Spleen (10) (10) (10) (10)
Hematopoietic Cell Proliferation 1 (10%)
Thymus (10) (10) (9) (10)
Atrophy 2 (20%) 1 (10%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (10) (10) (10) (10)
Dilatation 2 (20%) 3 (30%) 1 (10%) 7 (70%)
Galactocele 2 (20%) 1 (10%)
Lobular, Hyperplasia 6 (60%)
Skin (10) (10) (10) (10)
Parakeratosis 1 (10%)
Ulcer 1 (10%)
Epidermis, Cyst 1 (10%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (9) (10)
Inflammation, Chronic Active 4 (40%) 3 (33%)
Mineralization 1 (10%) 4 (40%) 6 (67%) 3 (30%)
Vacuolization Cytoplasmic 1 (10%) 3 (30%) 1 (11%) 2 (20%)
Alveolar Epithelium, Hyperplasia 1 (10%)
Nose (10) (10) (10) (10)
Inflammation, Chronic Active 1 (10%)
Inflammation, Suppurative 1 (10%) 2 (20%) 1 (10%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10)
Mineralization 4 (40%)
Nephropathy 10 (100%) 10 (100%) 9 (90%) 10 (100%)
Pigmentation, Hemosiderin 1 (10%)
Urinary Bladder (10) (10) (10) (10)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97
Route: GAVAGE Time: 11:06:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Inflammation, Chronic Active 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
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