Voigt Verena, Franke Heike, Lachenmeier Dirk W
Postgraduate Study of Toxicology and Environmental Protection, Rudolf-Boehm-Institut für Pharmakologie und Toxikologie, Universität Leipzig, Härtelstrasse 16-18, 04107 Leipzig, Germany.
Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Strasse 3, 76187 Karlsruhe, Germany.
Foods. 2024 Sep 13;13(18):2906. doi: 10.3390/foods13182906.
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.
本研究对胡薄荷酮进行了新的风险评估。胡薄荷酮是世界卫生组织国际癌症研究机构（IARC）分类为对人类可能致癌（2B组）的一种物质。该分析使用了美国国家毒理学计划（NTP）2011年在大鼠和小鼠中进行的为期两年的致癌性研究数据。由于这些研究中没有未观察到不良作用水平（NOAEL），因此采用基准剂量（BMD）方法作为替代风险评估方法。八个终点中最低的BMD较低置信水平（BMDL）为4.8毫克/千克体重/天，作为计算每日可接受摄入量（ADI）48微克/千克体重/天的起始点。这个新的ADI显著低于1997年设定的先前确定的每日耐受摄入量0.1毫克/千克体重/天。该分析还考虑了各种遗传毒性研究，这些研究表明胡薄荷酮的作用遵循非遗传毒性、有阈值的机制。欧盟和美国胡薄荷酮的估计摄入量低于新计算的ADI，这表明基于当前消费模式，健康风险较低。
