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Testing Status of 2,3-Butanedione M940009

 

CASRN: 431-03-8

Formula: C4-H6-O2

Synonyms/Common Names

  • Biacetyl
  • 2,3-Butadione
  • DIACETYL
  • 2,3-Diketobutane
  • Dimethyl diketone
  • Dimethyl glyoxal
  • Dimethylglyoxal
  • Dioxobutane

Short-Term Toxicity

  • 90 days (Inhalation)  (C20725)  Completed 
    • Citation: Morgan DL, Jokinen MP, Johnson CL, Price HC, Gwinn WM, Bousquet RW, Flake GP. Chemical reactivity and respiratory toxicity of the alpha-diketone flavoring agents: 2,3-butanedione, 2,3-pentanedione, and 2,3-hexanedione. Toxicol Pathol. 2016 Jul;44(5):763-783
    • Rats: Wistar Han; Mice: B6C3F1
    • Dose: 0, 6.25, 12.5, 25, 50, or 100; R: 20/sex/conc; M: 10/sex/conc.

Long-Term Carcinogenicity

  • 2 years (Inhalation)  (C20725)  Completed 
    •   (Peer Review Approval 07/13/2017A ) Citation: Morgan DL, Jokinen MP, Johnson CL, Price HC, Gwinn WM, Bousquet RW, Flake GP. Chemical reactivity and respiratory toxicity of the alpha-diketone flavoring agents: 2,3-butanedione, 2,3-pentanedione, and 2,3-hexanedione. Toxicol Pathol. 2016 Jul;44(5):763-783
    • TR-593   (Peer Review Approval 07/13/2017A )
      Toxicology and Carcinogenesis Studies of 2,3-Butanedione (CASRN 431-03-8) in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies)
    • Rats: Wistar Han; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats Some Evidence 
      • Male Mice No Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 0, 12.5, 25, or 50 ppm; R&M: 50/sex/species/exp conc.

Special Studies

  • Absorption Disposition Metabolism Elimination (Intratracheal; Oropharyngeal)  (K94009)  Completed 
    • Citation: Fennell TR, Morgan DL, Watson SL, Dhungana S, Waidyanatha S. Systemic uptake, albumin and hemoglobin binding of [(14)C]2,3-butanedione administered by intratracheal instillation in male Harlan Sprague Dawley rats and oropharyngeal aspiration in male B6C3F1/N mice. Chem Biol Interact. 2015 Feb 5;227:112-9. doi: 10.1016/j.cbi.2014.12.029. Epub 2015 Jan 2.Pubmed Abstract
    • Male Rats: Harlan Sprague-Dawley; Male Mice: B6C3F1
    • Dose: Mice, 200 mg/kg. Rats, 100 and 125 mg/kg.
  • Absorption Disposition Metabolism Elimination (Gavage)  (S0653)  Completed 
    • Male Rats: F344/N
    • Dose: 1.58 (low) 15.8 (mid), 158 (high) mg/kg.
  • Absorption Disposition Metabolism Elimination (in-vitro)  (S0900)  Completed 
    • Citation: Mathews JM, Watson SL, Snyder RW, Burgess JP, Morgan DL. Reaction of the butter flavorant diacetyl (2,3-butanedione) with N-alpha-acetylarginine: a model for epitope formation with pulmonary proteins in the etiology of obliterative bronchiolitis. J Agric Food Chem. 2010 Dec 22;58(24):12761-8. doi: 10.1021/jf103251w. Epub 2010 Nov 15.Pubmed Abstract
    • Mice: AM3 (C57BL/6)

Genetic Toxicology

  • Micronucleus  (A44706)  Completed 
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (G94009B)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Micronucleus  (G94009)  Completed 
    • Rats: Wistar Han
    • Male Negative 
    • Female Negative 
  • Salmonella  (A04292)  Completed 
    •  Weakly Positive 
  • Salmonella  (G94009C)  On Test 

    Organ Systems Toxicity

    • varies Immunotoxicity (Topical Application)  (IMM20602)  Completed 
      • Female Mice: BALB/c
      • Dose: 0, 1, 2.5, 5, 10, or 25%.
    • 28 days Immunotoxicity (Inhalation)  (IMM20606)  Data in Review 
      • Female Mice: BALB/c
      • Dose: 0, 25, 50, or 100 ppm.