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Risk Assessment of Pulegone in Foods Based on Benchmark Dose-Response Modeling.

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This study re-evaluates pulegone, a possible human carcinogen, using updated methods. A new, lower acceptable daily intake (ADI) was established, indicating current consumption poses a low health risk.

Keywords:
acceptable daily intakebenchmark dosecancer riskgenotoxicitypulegone

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Area of Science:

  • Toxicology
  • Risk Assessment
  • Carcinogenicity Studies

Background:

  • Pulegone is classified as possibly carcinogenic to humans (Group 2B) by the International Agency for Research on Cancer (IARC).
  • Previous risk assessments relied on older data and methods, lacking a definitive no-observed adverse effect level (NOAEL).

Purpose of the Study:

  • To conduct a new risk assessment for pulegone using updated toxicological data and methodologies.
  • To establish a new Acceptable Daily Intake (ADI) for pulegone.
  • To evaluate the current health risks associated with pulegone consumption.

Main Methods:

  • Utilized data from two-year carcinogenicity studies on rats and mice conducted by the National Toxicology Program (NTP) in 2011.
  • Employed the benchmark dose (BMD) approach due to the absence of a NOAEL.
  • Calculated the ADI using the lowest BMD lower confidence level (BMDL) as the point of departure.

Main Results:

  • The new ADI for pulegone was determined to be 48 μg/kg b.w./day, significantly lower than the 1997 tolerable daily intake of 0.1 mg/kg b.w./day.
  • Genotoxicity studies suggest pulegone acts via a nongenotoxic, thresholded mechanism.
  • Estimated pulegone intake levels in the EU and USA are below the newly derived ADI.

Conclusions:

  • The updated risk assessment indicates a lower acceptable daily intake for pulegone.
  • Current estimated consumption levels in the EU and USA suggest a low health risk.
  • The findings support a reassessment of regulatory guidelines for pulegone exposure.