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Testing Status of Pulegone M980045

 

CASRN: 89-82-7

Formula: C10-H16-O

Synonyms/Common Names

  • Cyclohexanone, 5-methyl-2-(1-methylethylidene)-,R-(9CI)
  • p-Menth-4(8)-en-3-one, R-(+)- (8CI)
  • (+)-R-Pulegone

Short-Term Toxicity

  • 5 days (Gavage)  (C98045)  Completed 
    • 5-Day Transcriptomic Dose-Response Studies
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 2.4, 4.7, 9.4, 18.75, 37.5, 75, 150, or 300 mg/kg; N=4.
  • 2 weeks (Gavage)  (C99020)  Completed 
    • Rats: F344/N; Mice: B6C3F1/N
    • Dose: R: 0, 37.5, 75, 150, 300, OR 600 MG/KG; 5/SEX/DOSE M: 0, 18.75, 37.5, 75, 150, OR 300 MG/KG; 5/SEX/DOSE.
  • 13 weeks (Gavage)  (C99020)  Completed 
    • Rats: F344/N; Mice: B6C3F1/N
    • Dose: R&M: 0, 9.375, 18.75, 37.5, 75, OR 150 MG/KG; 10/SEX/DOSE.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C99020)  Completed 
    • TR-563 (NIH Number: 10-5905)  (Peer Review Approval 11/19/2009A )
      Toxicology and Carcinogenesis Studies of Pulegone (CASRN 89-82-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
    • Rats: F344/N; Mice: B6C3F1/N
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats Some Evidence 
      • Male Mice Clear Evidence 
      • Female Mice Clear Evidence 
    • Dose: MALE RATS: 0, 18.75, 37.5, OR 75 MG/KG; FEMALE RATS AND MALE & FEMALE MICE: 0, 37.5, 75, OR 150 MG/KG.

Special Studies

  • Absorption Distribution Metabolism Excretion (Gavage; Intravenous; Gavage)  (S0668)  Completed 
    • Citation: Chen LJ, Lebetkin EH, Burka LT. Metabolism of (R)-(+)-pulegone in F344 rats. Drug Metab Dispos. 2001 Dec;29(12):1567-77.Pubmed Abstract
    • Male and Female Rats: F344/N; Rats: F344/N; Male and Female Mice: B6C3F1
    • Dose: 0.8, 8, 80, 160 mg/kg.

Genetic Toxicology

  • Micronucleus  (A36729)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Salmonella  (A17590)  Completed 
    •  Negative 
  • Salmonella  (A65321)  Completed 
    •  Negative 
  • Salmonella  (G98045)  Completed 
    •  Positive 

Toxicogenomics

  • 5 days Transcriptome Sequencing (Gavage)  (T98045)  Completed 
    • 5-Day Transcriptomic Dose-Response Studies
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley