Federal Office of Public Health, Nutritional and Toxicological Risks Section, Stauffacherstrasse 101, CH-8004 Zurich, Switzerland.
Food Chem Toxicol. 2009 Dec;47(12):2906-25. doi: 10.1016/j.fct.2009.08.002. Epub 2009 Aug 12.
The benchmark dose (BMD) approach is being increasingly used in the area of food risk assessment because it offers several advantages compared to the conventional no-observed-adverse-effect-level approach. The aim of this work was to check the applicability of the BMD approach on toxicity data available from pesticides, mycotoxins and natural toxins. Based on toxicological evaluations, the pivotal study was identified. Detailed data from the original study were retrieved and used for BMD modelling. Twenty-five studies used for BMD modelling were analysed with regard to study design: total number of animals, number of dose levels, and spacing between dose levels. The quality of the modelled endpoints was evaluated according to the following aspects: BMD/BMDL ratio, test for goodness of fit and BMD in the range of dose levels. If one of these aspects was not fulfilled, the BMD derived from this endpoint was considered to be uncertain to some extent and corresponding modelled data sets were examined. The present work demonstrates that the BMD approach is in principle applicable to pesticides, mycotoxins, and natural toxins. Although large differences relating to data availability and data quality were noticed, 69 of 82 modelled endpoints (84%) fulfilled the three quality aspects of BMD modelling.
基准剂量（BMD）方法在食品风险评估领域中得到了越来越多的应用，因为与传统的无观察不良效应水平方法相比，它具有若干优势。本工作旨在检验 BMD 方法在来自农药、霉菌毒素和天然毒素的毒性数据中的适用性。基于毒理学评价，确定了关键研究。从原始研究中检索详细数据，并用于 BMD 建模。对用于 BMD 建模的 25 项研究从以下方面分析了研究设计：动物总数、剂量水平数和剂量水平之间的间隔。根据以下方面评估建模终点的质量：BMD/BMDL 比、拟合优度检验和剂量范围内的 BMD。如果其中一个方面不满足，则认为由此终点得出的 BMD 在某种程度上不确定，并对相应的模型数据集进行了检查。本工作表明，BMD 方法原则上适用于农药、霉菌毒素和天然毒素。尽管在数据可用性和数据质量方面存在很大差异，但在 82 个建模终点中有 69 个（84%）满足 BMD 建模的三个质量方面。
