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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 Disposition Metabolism Elimination (Gavage; in-vitro)  (S0812)  Completed 
    • Male and Female Rats; Male and Female Mice; Male and Female Human (Cell Lines)
  • Absorption Disposition Metabolism Elimination (in-vitro; Gavage; Intravenous; in-vitro)  (S0840)  Completed 
    • Male and Female Rats: F344/N; Male Mice: B6C3F1; Male and Female Dogs: Beagles; Human (Cell Lines)
    • Dose: In vivo experiments: Beagle dogs were administered 14C-androstenedione by intravenous (10 mg/kg) and by oral administration (100 mg/kg). In vitro metabolite profiles: In vitro experiments have been performed with androstenedione at 10 and 100 µM incubated using Fischer 344 rat, B6C3F1 mouse, and human hepatocytes..

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