Author/Authors :
Eskes، نويسنده , , Chantra and Detappe، نويسنده , , Véronique and Koëter، نويسنده , , Herman and Kreysa، نويسنده , , Joachim and Liebsch، نويسنده , , Manfred and Zuang، نويسنده , , Valérie and Amcoff، نويسنده , , Patric and Barroso، نويسنده , , Jo?o and Cotovio، نويسنده , , José and Guest، نويسنده , , Robert and Hermann، نويسنده , , Martina and Hoffmann، نويسنده , , Sebastian and Masson، نويسنده , , Philippe and Alépée، نويسنده , , Nathalie and Arce، نويسنده , , Luis Alfonso and Brüschweiler، نويسنده , , Beat and Catone، نويسنده , , Tiziana and Cihak، نويسنده , , Rostislav and Clouzeau، نويسنده , , Jack and D’Abrosca، نويسنده , , Federica and Delveaux، نويسنده , , Cédric and Derouette، نويسنده , , Jean Paul and Engelking، نويسنده , , Oliver and Facchini، نويسنده , , Davide and Fr?hlicher، نويسنده , , Mirjam and Hofmann، نويسنده , , Markus and Hopf، نويسنده , , Nancy and Molinari، نويسنده , , Jennifer and Oberli، نويسنده , , Aurelia and Ott، نويسنده , , Matthieu and Peter، نويسنده , , Ronald and S?-Rocha، نويسنده , , Vanessa M. and Schenk، نويسنده , , Dominique and Tomicic، نويسنده , , Catherine and Vanparys، نويسنده , , Philippe and Verdon، نويسنده , , Bernadette and Wallenhorst، نويسنده , , Thomas H Winkler، نويسنده , , Gian Christian and Depallens، نويسنده , , Olivier، نويسنده ,
Abstract :
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.
