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Testing Status of Codeine 11119-T

 

CASRN: 76-57-3

Formula: C18-H21-N-O3

Synonyms/Common Names

  • Methylmorphine
  • Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5alpha,6alpha)-

Short-Term Toxicity

  • 14-Day (Dosed-Feed)  (C61541A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C61541A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: 0, 390, 6250 PPM/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C61541C)  Completed 
    • TR-455 (NIH Number: 96-3360)  (Peer Review Approval 06/20/1995A )
      Toxicology and Carcinogenesis Studies of Codeine in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: R: 0, 400, 800, OR 1600 M: 0, 750, 1500, OR 3000 PPM; 60/GROUP.

Special Studies

  • 10 days Toxicokinetic Study (Dosed-Feed)  (K61541B)  Completed 
    • 10-day dosed-feed
    • Male Rats: Fischer 344
    • Dose: 0, 400, 800, or 1600 ppm.
  • Toxicokinetic Study (Gavage)  (K61541B)  Completed 
    • Mice: B6C3F1
  • 90 days Toxicokinetic Study (Dosed-Feed)  (K61541C)  Completed 
    • 90-day dosed-feed
    • Male and Female Rats: Fischer 344
    • Dose: 400, 800, or 1600 ppm.
  • 2 years Toxicokinetic Study (Dosed-Feed)  (K61541D)  Completed 
    • 2-year dosed-feed
    • Male and Female Rats: Fischer 344
    • Dose: 0, 400, 800, or 1600 ppm.
  • 90 days Toxicokinetic Study (Dosed-Feed)  (K61541E)  Completed 
    • 90-day dosed-feed
    • Male and Female Mice: B6C3F1
    • Dose: 0, 750, 3000, or 6000 ppm.
  • 2 years Toxicokinetic Study (Dosed-Feed)  (K61541F)  Completed 
    • Male and Female Mice: B6C3F1
    • Dose: 750, 3000, or 6000 ppm/day.

Organ Systems Toxicity

  • 6 to 15 GD Conventional Teratology (Gavage)  (TER90057)  Completed 
    • Female Mice: Swiss
    • Mice Maternal Positive 
    • Mice Fetal Positive 
    • Dose: 0, 37.5, 75, 150, 300 MG/KG/DAY.
  • 5 to 13 GD Conventional Teratology (Gavage)  (TER90058)  Completed 
    • Female Hamsters: LVG (SYR)
    • Hamsters Maternal Positive 
    • Hamsters Fetal Positive 
    • Dose: 0, 10, 50, 150 MG/KG/DAY.