Guidance on dermal absorption

Tabs

Article
dermal absorption, plant protection products, in vitro, in vivo, triple pack, default values
First published in the EFSA Journal
30 June 2017
Approved
24 May 2017
Type
Guidance of EFSA
Abstract

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 active substances in Plant Protection Products (PPPs). It is based on the ‘scientific opinion on the science behind the revision of the guidance document on dermal absorption’ issued in 2011 by the EFSA Panel on Plant Protection Products and their Residues (PPR). The guidance refers to the EFSA PPR opinion in many instances. In addition, the first version of this guidance, issued in 2012 by the EFSA PPR Panel, has been revised in 2017 on the basis of new available data on human in vitro dermal absorption for PPPs and wherever clarifications were needed. Basic details of experimental design, available in the respective test guidelines and accompanying guidance for the conduct of studies, have not been addressed but recommendations specific to performing and interpreting dermal absorption studies with PPPs 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 (regarded to provide the best estimate), 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 assessment reports is also provided. The issue of nanoparticles in PPPs is not addressed. Data from volunteer studies have not been discussed since their use is not allowed in EU for risk assessment of PPPs.

Contact
pesticides.ppr [at] efsa.europa.eu
doi
10.2903/j.efsa.2017.4873
EFSA Journal 2017;15(6):4873 [60 pp.].
Question Number
European Food Safety Authority
On request from
European Commission
Note

This scientific output, approved on 24 May 2017, supersedes the previous output published on 25 April 2012 (EFSA PPR Panel, 2012). The European Commission will decide the implementation time for the mandatory use of this guidance in the regulatory context.

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Number of Pages
60