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

This study presents a new risk assessment of pulegone, a substance classified as possibly carcinogenic to humans (Group 2B) by the WHO International Agency for Research on Cancer (IARC). The analysis used data from a two-year carcinogenicity studies in rats and mice conducted by the National Toxicol...

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Bibliographic Details
Published in:Foods 2024-09, Vol.13 (18), p.2906
Main Authors: Voigt, Verena, Franke, Heike, Lachenmeier, Dirk W
Format: Article
Language:English
Subjects:
acceptable daily intake
benchmark dose
Benchmarks
cancer risk
Carcinogenicity
Carcinogens
Confidence intervals
Consumption patterns
Cosmetics
Females
Food
Genotoxicity
Health risks
Oils & fats
Pulegone
Review
Risk assessment
Software
Toxicity
Toxicology
Tumors
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Summary:This study presents a new risk assessment of pulegone, a substance classified as possibly carcinogenic to humans (Group 2B) by the WHO International Agency for Research on Cancer (IARC). The analysis used data from a two-year carcinogenicity studies in rats and mice conducted by the National Toxicology Program (NTP) in 2011. Because of the absence of a no-observed adverse effect level (NOAEL) in these studies, the benchmark dose (BMD) approach was employed as an alternative risk assessment method. The lowest BMD lower confidence level (BMDL) of 4.8 mg/kg b.w./day among the eight endpoints served as the point of departure for calculating an acceptable daily intake (ADI) of 48 μg/kg b.w./day. This new ADI is significantly lower than the previously established tolerable daily intake of 0.1 mg/kg b.w./day set in 1997. The analysis also considered various genotoxicity studies, which indicate that pulegone's effects follow a nongenotoxic, thresholded mechanism. The estimated intake levels of pulegone in the European Union and USA were below the newly calculated ADI, suggesting a low health risk based on current consumption patterns.
ISSN:2304-8158
2304-8158
DOI:10.3390/foods13182906