Assessment of new scientific studies on human in vitro dermal absorption

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EFSA Panel on EFSA Panel on Plant Protection Products and their Residues (PPR)

This EFSA scientific report describes the results from the evaluation of new human in vitro studies on dermal absorption made available by European Crop Protection Association (ECPA) and the German public organisation Bundesinstitut für Risikobewertung (BfR) and their possible impact on the guidance on dermal absorption (EFSA, 2012). A quality check was performed in order to verify if new studies were conducted according to the current regulatory standards and to identify potential deviations from EFSA guidance on dermal absorption. In addition, a plausibility check to validate the correctness of data entry in the datasets from sources (study reports) was undertaken applying a two tiers (I and II) validation protocol. Although a number of deviations from the EFSA guidance on dermal absorption have been identified, the outcome of the evaluation indicates that the new studies comply with the current regulatory standards. EFSA recommendations to address the variability within studies and to improve the consistency of interpretation have not been applied routinely. In addition the datasets as provided to EFSA are not completed, lacking individual data or other information addressing variability. However, the overall conclusion regarding the scientific quality of the provided datasets is that they are consistent and solid and include a relevant number of in vitro dermal adsorption studies with human skin. The new data provide sufficient information for the revision of the current guidance or the development a new guidance on dermal absorption. For the exploitation of the new datasets, in the revision of the current guidance or the development of a new guidance on dermal absorption, it is recommended to add the missing information, to compile a comprehensive dataset and to analyse dermal absorption data applying a model-based statistical protocol.