Target Organs and Levels of Evidence for TR-485
Toxicology and Carcinogenesis Studies of Oxymetholone (CASRN 434-07-1) in F344/N Rats and Toxicology Studies of Oxymetholone in B6C3F1 Mice (Gavage Studies)
Chemical (Study Title) CASRN |
Peer Review Date |
Route/Exposure Levels |
Study Laboratory |
Oxymetholone 434-07-1 |
10/30/1998 |
Gavage MR: 0, 3, 30, OR 150 MG/KG; FR: 0, 3, 30, OR 100 MG/KG |
Battelle Columbus Laboratory |
Levels of Evidence
Male Rats: Equivocal Evidence
Type |
Organ/Tissue (Lesion) |
May Have Been Related |
- Skin: FIBROMA 0/51 5/50 2/49 2/50 COMBINED 0/51 7/50 2/49 2/50
- Adrenal Gland Medulla: PHEOCHROMOCYTOMA 19/51 21/50 21/50 29/49 COMBINED 19/51 25/50 21/50 29/49
- Kidney Tubular Cell: ADENOMA (STANDARD) 0/51 1/50 0/50 2/49 (EXTENDED) 4/51 12/50 1/50 5/49 COMBINED 4/51 13/50 1/50 6/49
|
Non-Neoplastic Lesions |
- LIVER: BASOPHILIC FOCUS; CLEAR CELL FOCUS
- LUNG: MINERALIZATION
- ADRENAL GLAND: CORTEX; CYTOPLASMIC VACUOLIZATION
- KIDNEY: MINERALIZATION; INCREASED SEVERITY OF NEPHROPATHY
- MAMMARY GLAND: LOBULAR HYPERPLASIA
- TESTES: DEGENERATION; MINERALIZATION
|
Other Considerations |
- TESTES: ADENOMA 33/51 20/50 0/50 0/49
- MONONUCLEAR CELL LEUKEMIA: 21/51 15/50 7/50 4/50
|
Female Rats: Clear Evidence
Type |
Organ/Tissue (Lesion) |
Neoplastic Lesions |
- Liver: ADENOMA 1/50 1/50 1/50 8/49 COMBINED 1/50 1/50 1/50 10/49
- Lung: ADEMONA 0/50 0/50 6/50 1/49 COMBINED 0/50 0/50 7/50 1/49
- Skin: COMBINED 0/50 0/50 4/50 5/50
|
Non-Neoplastic Lesions |
- LIVER: BASOPHILIC FOCUS; CLEAR CELL FOCUS
- LUNG: MINERALIZATION
- ADRENAL GLAND: CORTEX, CYTOPLASMIC VACUOLIZATION
- KIDNEY: INCREASED SEVERITY OF NEPHROPATHY
- OVARY: DYSGENESIS, SEVERITY OF DYSGENESIS
- HEART: MYOCARDIUM; CHRONIC DEGENERATION, SEVERITY OF DEGENERATION
|
Other Considerations |
- UTERUS: STROMAL SARCOMA: 5/50 9/50 2/50 0/50
- MAMMARY GLAND: FIBROADEMONA 21/50 11/50 1/50 4/50 COMBINED 23/50 11/50 1/50 4/50
- PITUITARY GLAND: ADEMONA 27/50 26/50 18/49 14/50
- MONONUCLEAR CELL LEUKEMIA: 12/50 11/50 11/50 5/50
|