To protect human health, acute reference values have been established for pesticides which have the potential to cause a toxic effect after acute human exposure. These values are used to identify exposure levels below which there is no appreciable risk. Comprehensive reference documents, including OECD criteria, are available to aid identification of relevant toxicological endpoints. Within Europe, there is a concern that the identification process is inconsistent and unnecessarily conservative such that safe products with no established human health risk are being restricted. For this reason, the basis for the setting of an acute reference dose (ARfD) has been investigated for 130 pesticides to better understand how the toxicological endpoints are selected. The investigation has shown that most ARfDs are derived from repeat dose studies and that there is an over-representation of prenatal developmental toxicity studies. There is clear evidence that ARfDs derived from rabbit developmental toxicity studies are set over conservatively with regard to acute maternal effects and often inappropriately. To facilitate an improved system, refinements to the existing process are recommended, the use of maternal data in the rabbit as the basis for deriving an ARfD is critically evaluated and a new, more pragmatic approach to ARfD derivation is proposed.

中文翻译：

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欧洲农药急性参考剂量（ARfD）设置的分析。

为了保护人类健康，已经建立了农药的急性参考值，这些农药在急性人类暴露后可能引起毒性作用。这些值用于确定暴露水平，低于此水平则没有明显的风险。包括OECD标准在内的综合参考文件可帮助识别相关的毒理学终点。在欧洲，人们担心鉴定过程会不一致且不必要地保守，从而限制了没有确定的人类健康风险的安全产品。因此，已经对130种农药的急性参考剂量（ARfD）的设定基础进行了研究，以更好地了解如何选择毒理学终点。调查表明，大多数ARfD来源于重复剂量研究，并且对产前发育毒性研究的研究过多。有明显的证据表明，从兔子发育毒性研究得出的ARfDs在急性母体作用方面被保守地设置，并且常常是不合适的。为了促进系统的改进，建议对现有工艺进行改进，严格评估使用兔子的母体数据作为得出ARfD的基础，并提出一种新的，更实用的ARfD派生方法。