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Target Organs and Levels of Evidence for TR-560

Toxicology and Carcinogenesis Studies of Androstenedione (CASRN 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Androstenedione
63-05-8
02/25/2009Dietary supplement being used by body builders and other athletes as a male hormone booster; starting material used in the manufacture of various pharmaceutical steroidsGavage
RATS & MALE MICE: 0, 10, 20, OR 50 MG/KG FEMALE MICE: 0, 2, 10, OR 50 MG/KG; 50/SEX/SPECIES
Southern Research Institute

Levels of Evidence

Male Rats: Equivocal Evidence
TypeOrgan/Tissue (Lesion)
May Have Been Related
  • Lung: Alveolar/bronchiolar adenoma 0/50 0/50 5/50 2/50 alveolar/bronchiolar adenoma or carcinoma (combined) 0/50 0/50 5/50 3/50
Non-Neoplastic Lesions
  • Liver: Basophilic focus; clear cell focus; eosinophilic focus
Decreased Incidences
  • Testis: Interstitial cell adenoma
  • Mononuclear cell leukemia
Female Rats: Equivocal Evidence
TypeOrgan/Tissue (Lesion)
May Have Been Related
  • All Organs: Mononuclear cell leukemia 5/50 11/50 18/50 15/50 (choose all organs until programmer intervention)
Non-Neoplastic Lesions
  • Pancreatic Islets: Hyperplasia
  • Exocrine Pancreas: Atrophy
Decreased Incidences
  • Mammary Gland: Fibroadenoma
Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: Hepatocellular adenoma, multiple 16/50 27/50 23/50 34/50 hepatocellular adenoma (includes multiples) 32/50 38/50 29/50 43/50 hepatocellular carcinoma multiple 7/50 12/50 10/50 17/50 hepatocellular adenoma or hepatocellular carcinoma (combined includes multiples) 41/50 47/50 42/50 48/50 hepatoblastoma 3/50 8/50 7/50 8/50 hepatocellular adenoma, carcinoma, or hepatoblastoma (combined) 41/50 47/50 43/50 48/50
  • Pancreas Islet Cell: Adenoma (includes multiples) 2/50 2/50 2/50 5/49
Non-Neoplastic Lesions
  • Liver: Eosinophilic focus
Female Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: Adenoma 14/50 16/50 18/50 28/50 carcinoma 5/50 13/50 15/50 15/50 adenoma or carcinoma 17/50 23/50 27/50 32/50
  • Pancreas Islet Cell: Adenoma 0/49 2/50 4/49 4/48
Non-Neoplastic Lesions
  • Liver: Mixed cell focus; hepatocyte, cytoplasmic vacuolization
  • Clitoral Gland: Hyperplasia; duct dilatation
  • Kidney: Glomerulus, metaplasia
  • Submandibular salivary gland: Cytoplasmic alteration
Decreased Incidences
  • Malignant Lymphoma