Testing Status of Acetaminophen (4-hydroxyacetanilide) 10127-H

CASRN: 103-90-2

Formula: C8-H9-N-O2

Synonyms/Common Names

• APAP
• 4'-Hydroxyacetanilide
• N(4-Hydroxyphenyl)-Acetamide

Short-Term Toxicity

• 14-Day (Dosed-Feed)  (C55801)  Completed 
  • Rats: F344/N; Mice: B6C3F1
• 2 days (Gavage)  (C55801E)  Completed 
  • Rats: F344/N
  • Dose: RATS ONLY: 0, 50, 150, 1000, OR 2000 MG/KG; 6/GROUP.
• 90 days (Gavage)  (C10127)  On Test 
  • Rats: Harlan Sprague-Dawley
  • Dose: 0, 100, 200,400 mg/kg/day.
• 13-Week (Dosed-Feed)  (C55801)  Completed 
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R&M:0, 0.08, 2.50%/10 PER GROUP.

Long-Term Carcinogenicity

• 2 years (Dosed-Feed)  (C55801)  Completed 
  • TR-394 (NIH Number: 90-2849)  (Peer Review Approval 11/19/1990A )
    Toxicology and Carcinogenesis Studies of Acetaminophen in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Carcinogenesis Results
    • Male Rats No Evidence 
    • Female Rats Equivocal Evidence 
    • Male Mice No Evidence 
    • Female Mice No Evidence 
  • Dose: R&M:0, .06, .3, .6%/60 PER GROUP.

Special Studies

• C. elegans  (S0943)  Completed 
  • C. elegans

Genetic Toxicology

• In Vitro Cytogenetics (CA/SCE)  (034886)  Completed 
  • Sister Chromatid Exchange Positive 
  • Chromosome Aberrations Positive 
• Salmonella  (413793)  Completed 
  • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
  •  Negative 

Organ Systems Toxicity

• 120 day minimum Continuous Breeding (Legacy) (Dosed-Feed)  (RACB83079)  Completed 
  • Male and Female Mice: Swiss
  • Dose: 0, .31, .62, 1.25, 2.5, 5.0%; 0, .25, .5, 1%; N/A; 0, 1%.