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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