Guidance on Dermal Absorption EFSA Panel on Plant Protection Products and their Residues (PPR)
Guidance on Dermal Absorption EFSA Panel on Plant Protection Products and their Residues (PPR)
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DOI：
10.2903/j.efsa.2012.2665
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发表时间：
2012-04-01
期刊：
影响因子：
3.3
通讯作者：
Vleminckx, Christiane
中科院分区：
文献类型：
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作者：
Boesten, Jos;Bolognesi, Claudia;Vleminckx, Christiane
制定本皮肤吸收评估指南是为了协助通知者、测试设施的使用者和成员国当局了解与设定用于化学植物保护产品风险评估的皮肤吸收值有关的关键方面。它是基于对皮肤吸收指导文件（欧洲食品安全局，2011年）修订背后的科学的意见，该指导文件在许多情况下都提到了这一点。实验设计的基本细节（可在其他地方找到）尚未讨论，但给出了对植物保护产品进行和解释皮肤吸收研究的具体建议。讨论的问题包括对皮肤及其影响真皮吸收的特性的简要描述。为方便使用指引，指引内附有流程图。还提供指导，例如，当没有评估产品的皮肤吸收数据时。介绍了分层方法的要素，包括默认值的使用、密切相关产品的数据、人体皮肤的体外研究、体外和体内实验动物（大鼠）的数据以及所谓的“三包”方法。研究设计和报告的各种要素，减少实验变化和帮助一致的解释，提出。还提供了关于报告评估报告草案和注册报告的数据的建议。植物保护产品中纳米颗粒的问题没有得到解决。志愿者研究的数据没有被讨论，因为它们在欧盟不允许用于植物保护产品的风险评估。(C)欧洲食品安全局，2012
This guidance on the assessment of dermal absorption has been developed to assist notifiers, users of test facilities and Member State authorities on critical aspects related to the setting of dermal absorption values to be used in risk assessments of chemical plant protection products. It is based on the opinion on the science behind the revision of the guidance document on dermal absorption (EFSA, 2011) to which the guidance refers to in many instances. Basic details of experimental design, available elsewhere, have not been addressed but recommendations specific to performing and interpreting dermal absorption studies with plant protection products are given. Issues discussed include a brief description of the skin and its properties affecting dermal absorption. To facilitate use of the guidance, flow charts are included. Guidance is also provided, for example, when there are no data on dermal absorption for the product under evaluation. Elements for a tiered approach are presented including use of default values, data on closely related products, in vitro studies with human skin, data from experimental animals (rats) in vitro and in vivo and the so called "Triple pack" approach. Various elements of study design and reporting, that reduce experimental variation and aid consistent interpretation, are presented. A proposal for reporting data for Draft Assessment Reports and Registration Reports is also provided. The issue of nanoparticles in plant protection products is not addressed. Data from volunteer studies have not been discussed since their use is not allowed in EU for risk assessment of plant protection products. (C) European Food Safety Authority, 2012