So Jaehwan, Ahn Junyoung, Lee Tae-Hee, Park Kyung-Hun, Paik Min-Kyoung, Jeong Mihye, Cho Myung-Haing, Jeong Sang-Hee
Department of Applied Biotoxicology, Hoseo University, Asan, Korea.
National Institute of Agricultural Science, RDA, Jeonju, Korea.
Toxicol Res. 2014 Dec;30(4):251-60. doi: 10.5487/TR.2014.30.4.251.
The number of farmers who have suffered from non-fatal acute pesticide poisoning has been reported to vary from 5.7% to 86.7% in South Korea since 1975. Absorption through the skin is the main route of exposure to pesticides for farmers who operate with them. Several in vitro tests using the skins of humans or animal and in vivo tests using laboratory animals are introduced for the assessment of human dermal absorption level of pesticides. The objective of this study is to evaluate and compare international guidelines and strategies of dermal absorption assessments and to propose unique approaches for applications into pesticide registration process in our situation. Until present in our situation, pesticide exposure level to operator is determined just using default value of 10 as for skin absorption ratio because of data shortage. Dermal absorption tests are requested to get exposure level of pesticides and to ultimately know the safety of pesticides for operators through the comparison with the value of AOEL. When the exposure level is higher than AOEL, the pesticide cannot be approved. We reviewed the skin absorption test guidelines recommended by OECD, EFSA and EPA. The EPA recommends assessment of skin absorption of pesticides for humans through the TPA which includes all the results of in vitro human and animal and animal in vivo skin absorption studies. OECD and EFSA, employ a tiered approach, which the requirement of further study depends on the results of the former stage study. OECD guidelines accept the analysis of pesticide level absorbed through skin without radioisotope when the recovery using the non-labeled method is within 80~120%. Various factors are reviewed in this study, including the origin of skin (gender, animal species and sites of skin), thickness, temperature and, etc., which can influence the integrity of results.
据报道,自1975年以来,韩国遭受非致命性急性农药中毒的农民数量在5.7%至86.7%之间波动。对于接触农药的农民来说,经皮肤吸收是接触农药的主要途径。本文介绍了几种使用人类或动物皮肤进行的体外试验以及使用实验动物进行的体内试验,用于评估农药的人体皮肤吸收水平。本研究的目的是评估和比较国际上关于皮肤吸收评估的指南和策略,并提出适用于我国农药登记过程的独特方法。在我国目前的情况下,由于数据短缺,仅使用默认值10作为皮肤吸收比率来确定操作人员的农药接触水平。需要进行皮肤吸收试验以获取农药的接触水平,并通过与允许日暴露量(AOEL)值进行比较,最终了解农药对操作人员的安全性。当接触水平高于AOEL时,该农药将无法获批。我们回顾了经合组织(OECD)、欧洲食品安全局(EFSA)和美国环境保护局(EPA)推荐的皮肤吸收试验指南。EPA建议通过经皮吸收评估(TPA)来评估农药对人体的皮肤吸收,TPA包括体外人体和动物以及动物体内皮肤吸收研究的所有结果。OECD和EFSA采用分级方法,进一步研究的要求取决于前一阶段研究的结果。当使用非标记方法的回收率在80%至120%之间时,OECD指南接受不使用放射性同位素的皮肤吸收农药水平分析。本研究审查了各种因素,包括皮肤来源(性别、动物种类和皮肤部位)、厚度、温度等,这些因素可能会影响结果的完整性。