Guidance on Dermal Absorption

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Acknowledgements

EFSA wishes to thank the members of the Working Group on Toxicology of Pesticides Claudia Bolognesi, Karen Ildico Hirsch-Ernst, Susanne Hougaard Bennekou, Angelo Moretto (until January 2011), Yolanda Pico, Maria Tasheva and Christiane Vleminckx, the hearing experts Ingrid Becks-Vermeer and Ian Dewhurst and the EFSA staff Juan Parra Morte, Judith Ricketts, István Sebestyén, Hans Steinkellner and Manuela Tiramani for the support provided to this scientific output.

Panel on Plant Protection Products and their Residues
EFSA Journal
EFSA Journal 2012;10(4):2665
doi
10.2903/j.efsa.2012.2665
Panel members at the time of adoption
Jos Boesten, Claudia Bolognesi, Theo Brock, Ettore Capri, Anthony Hardy, Andrew Hart, Karen Ildico Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Robert Luttik, Kyriaki Machera, Angelo Moretto (until January 2011), Bernadette Ossendorp, Annette Petersen, Yolanda Pico, Andreas Schäffer, Paulo Sousa, Walter Steurbaut, Anita Strömberg, Maria Tasheva, Ton van der Linden, Christiane Vleminckx
Type
Guidance of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2010-01324
Adopted
18 April 2012
Published
25 April 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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 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.