Testing Status of Androstenedione M990002

CASRN: 63-05-8

Formula: C19-H26-O2

Synonyms/Common Names

• 4-Androstene-3,17-dione
• Androtex

Short-Term Toxicity

• 2 weeks (Gavage)  (C99024)  Completed 
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R&M: 0, 1, 5, 10, 20, OR 50 MG/KG; 5/SEX/SPECIES.
• 2 weeks (Topical Application)  (C99024B)  Completed 
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R&M: 0, 1, 5, 10, 20, OR 50 MG/KG; 5/SEX/SPECIES.
• 13 weeks (Gavage)  (C99024C)  Completed 
  • Rats: F344/N; Mice: B6C3F1/N
  • Dose: R&M: 0, 1, 5, 10, 20, OR 50 MG/KG; 10/SEX/SPECIES; 5X/WEEK.

Long-Term Carcinogenicity

• 2 years (Gavage)  (C99024C)  Completed 
  • TR-560 (NIH Number: 10-5901)  (Peer Review Approval 02/25/2009A )
    Toxicology and Carcinogenesis Studies of Androstenedione (CASRN 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
  • Rats: F344/N; Mice: B6C3F1/N
  • Carcinogenesis Results
    • Male Rats Equivocal Evidence 
    • Female Rats Equivocal Evidence 
    • Male Mice Clear Evidence 
    • Female Mice Clear Evidence 
  • Dose: RATS & MALE MICE: 0, 10, 20, OR 50 MG/KG FEMALE MICE: 0, 2, 10, OR 50 MG/KG; 50/SEX/SPECIES.

Special Studies

• Absorption Distribution Metabolism Excretion (Gavage; in-vitro)  (S0812)  Completed 
  • Male and Female Rats; Male and Female Mice; Male and Female Human (Cell Lines)
• Absorption Distribution Metabolism Excretion (Gavage; Topical Application; in-vitro; Gavage; in-vitro; Gavage; Intravenous; in-vitro)  (S0840)  Completed 
  • Male and Female Rats: F344/N; Male and Female Mice: B6C3F1; Male and Female Dogs: Beagles; Male and Female Human (Cell Lines)
  • Dose: 1, 10, 100 mg/kg. 1, 10, 100 mg/kg [R,M]. 1, 100 mg/kg. 1.1 mg/kg. 10 or 100 uM [R, M, HU].

Genetic Toxicology

• Micronucleus  (A71952)  Completed 
  • Mice: B6C3F1
  • Male Negative 
  • Female Equivocal 
• Micronucleus  (A80598)  Completed 
  • Rats: Fischer 344
  • Male Negative 
• Salmonella  (A21570)  Completed 
  •  Negative 
• Salmonella  (A53831)  Completed 
  •  Negative