National Toxicology Program

CASRN: 76-57-3

Related: CODEINE PHOSPHATE (CAS 52-28-8)

Formula: C18-H21-N-O3

Synonyms/Common Names:

• METHYLMORPHINE
• MORPHINAN-6-0L,7,8-DIDEHYDRO-4,5-EPOXY-3-METHOXY-17-METHYL-, (5ALPHA,6ALPHA)- (9CI)

Known Uses:

ANTITUSSIVE, ANALGESIC, CHEMICAL INTERMEDIATE, NATURALLY OCCURRING.

Short-Term Toxicity

• 14-Day (Dosed-Feed)  (C61541A) Completed 
  • NTIS No. PB97-116743
    Citation: Toxicology and Carcinogenesis Studies of Codeine (CAS No. 76-57-3) in F344 Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
• 13-Week (Dosed-Feed)  (C61541A) Completed 
  • NTIS No. PB97-116743
    Citation: Toxicology and Carcinogenesis Studies of Codeine (CAS No. 76-57-3) in F344 Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: 0,390,6250 PPM/10 PER GROUP

Long-Term Carcinogenicity

• 2-YEAR (Dosed-Feed)  (C61541C) Report Complete 
  • TR-455 (NTIS No. PB97-116743)  (Peer Review 06/20/1995)
    Toxicology and Carcinogenesis Studies of Codeine (CAS No. 76-57-3) in F344 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

Organ Systems Toxicity

• GD 6-15 Conventional Teratology (Gavage)  (TER90057) Completed 
  • NTIS No. PB87-209524
    Citation: Teratologic Evaluation of Codeine Administered to CD-1 Mice on Gestation Days 6 through 15
  • F Mice: Swiss
  • Mice Maternal Positive 
  • Mice Fetal Positive 
  • Dose: 0, 37.5, 75, 150, 300 MG/KG/DAY
• GD 5-13 Conventional Teratology (Gavage)  (TER90058) Completed 
  • NTIS No. PB88-131040
    Citation: Teratologic Evaluation of Codeine Administered to LVG Hamsters on Gestational Days 5 through 13
  • F Hamsters: LVG (SYR)
  • Hamsters Maternal Positive 
  • Hamsters Fetal Positive 
  • Dose: 0, 10, 50, 150 MG/KG/DAY