Regulatory assessment of in vitro skin corrosion and irritation data within the European framework: Workshop recommendations.

Validated in vitro methods for skin corrosion and irritation were adopted by the OECD and by the European Union during the last decade. In the EU, Switzerland and countries adopting the EU legislation, these assays may allow the full replacement of animal testing for identifying and classifying compounds as skin corrosives, skin irritants, and non irritants. In order to develop harmonised recommendations on the use of in vitro data for regulatory assessment purposes within the European framework, a workshop was organized by the Swiss Federal Office of Public Health together with ECVAM and the BfR. It comprised stakeholders from various European countries involved in the process from in vitro testing to the regulatory assessment of in vitro data. Discussions addressed the following questions: (1) the information requirements considered useful for regulatory assessment; (2) the applicability of in vitro skin corrosion data to assign the corrosive subcategories as implemented by the EU Classification, Labelling and Packaging Regulation; (3) the applicability of testing strategies for determining skin corrosion and irritation hazards; and (4) the applicability of the adopted in vitro assays to test mixtures, preparations and dilutions. Overall, a number of agreements and recommendations were achieved in order to clarify and facilitate the assessment and use of in vitro data from regulatory accepted methods, and ultimately help regulators and scientists facing with the new in vitro approaches to evaluate skin irritation and corrosion hazards and risks without animal data.

Dermal penetration of bisphenol A in human skin contributes marginally to total exposure.

Bisphenol A (BPA) is ubiquitous and many exposure scenarios have been described during the last decades. While oral uptake is considered as the major route of exposure, the contribution of skin penetration has been recently discussed. In the present study, the dermal penetration rate of BPA has been determined in human skin in an in vitro test method according to the OECD Test Guideline 428. This analysis resulted in penetration of 8.6% and a total amount of bio-available BPA of 9.3% of the dose applied after 24h incubation under realistic exposure conditions. This confirms that the systemic exposure to BPA via the skin contributes in a negligible way to total systemic BPA exposure.