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Testing Status of 4-Methylimidazole M920025

 

CASRN: 822-36-6

Formula: C4-H6-N2

Synonyms/Common Names

  • 1H-Imidazole, 4-methyl (9CI)
  • 4-MeI
  • 4-MI

Short-Term Toxicity

  • 2 weeks (Dosed-Feed)  (C92013)  Completed 
    • TOX-67 (NIH Number: 04-4409)  (Peer Review Approval 04/22/2003A )
      Toxicity Studies of 2- and 4-Methylimidazole Administered in Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 18, 54, OR 161 MG/KG M: 0, 41, 125, OR 375 MG/KG (0, 300, 800, OR 2500 PPM IN FEED) 5/SEX/SPECIES/GROUP.
  • 13 weeks (Dosed-Feed)  (C92013)  Completed 
    • TOX-67 (NIH Number: 04-4409)  (Tox Peer Review 06/15/2002A )
      Toxicity Studies of 2- and 4-Methylimidazole Administered in Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 625, 1250, 2500, 5000, OR 10000 PPM IN FEED; 10/SEX/DOSE.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C92013B)  Completed 
    • TR-535 (NIH Number: 07-4471)  (Peer Review Approval 09/28/2005A )
      Toxicology and Carcinogenesis Studies of 4-Methylimidazole (CASRN 822-36-6) 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 Clear Evidence 
      • Female Mice Clear Evidence 
    • Dose: MR: 0, 625, 1250, OR 2500 PPM; FR: 0, 1250, 2500, OR 5000 PPM; M: 0, 312, 625, OR 1250 PPM; 50/SEX/SPECIES/GROUP.

Special Studies

  • Toxicokinetic Study (Gavage; Intravenous; Gavage; Intravenous)  (K02922)  Completed 
    • Rats: Fischer 344; Rats; Mice: B6C3F1
  • Toxicokinetic Study (Gavage; Intravenous)  (S0332)  Completed 
    • Citation: Yuan JH, Burka LT. Toxicokinetics of 4-methylimidazole in the male F344 rat. Xenobiotica. 1995 Aug;25(8):885-94.Pubmed Abstract
    • Male Rats: F344/N
    • Dose: 5 mg/kg. 5, 50, 150 mg/kg.

Genetic Toxicology

  • Micronucleus  (A12637)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Micronucleus  (A38684)  Completed 
    • Rats: Fischer 344
    • Male Negative 
  • Micronucleus  (A49564)  Completed 
    • Mice: B6C3F1
    • Male Negative 
  • Salmonella  (A41578)  Completed 
    •  Negative 
  • Salmonella  (A53668)  Completed 
    •  Negative 

Organ Systems Toxicity

  • M: 10 weeks prior to cohabitation; F: 2 weeks prior to cohabitation; M&F: during cohabitation; F: during gestation, delivery and up to PND4 Continuous Breeding (Dosed-Feed)  (R92025)  Completed 
    • Citation: Behl M, Willson CJ, Cunny H, Foster PMD, McIntyre B, Shackelford C, Shockley KR, McBride S, Turner K, Waidyanatha S, Blystone CR. Multigenerational reproductive assessment of 4-methylimidazole administered in the diet to Hsd:Sprague Dawley SD rats. Reprod Toxicol. 2020 Dec;98:13-28. doi: https://doi.org/10.1016/j.reprotox.2020.03.005. Epub 2020 Mar 27.
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 625, 1250, 2500, 5000, or 10, 000 ppm.
  • Continuous Continuous Breeding (Dosed-Feed)  (R92025B)  Completed 
    • Main study
    • Citation: Behl M, Willson CJ, Cunny H, Foster PMD, McIntyre B, Shackelford C, Shockley KR, McBride S, Turner K, Waidyanatha S, Blystone CR. Multigenerational reproductive assessment of 4-methylimidazole administered in the diet to Hsd:Sprague Dawley SD rats. Reprod Toxicol. 2020 Dec;98:13-28. doi: https://doi.org/10.1016/j.reprotox.2020.03.005. Epub 2020 Mar 27.
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 750, 2500, or 5000 ppm.