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

Details

Serval ID
serval:BIB_365F6E8960C5
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Regulatory assessment of in vitro skin corrosion and irritation data within the European framework: Workshop recommendations
Journal
Regulatory Toxicology and Pharmacology
Author(s)
Eskes Chantra, Detappe Véronique, Koëter Herman, Kreysa Joachim, Liebsch Manfred, Zuang Valérie, Amcoff Patric, Barroso Joao, Cotovio José, Guest Robert, Hermann Martina, Hoffmann Sebastian, Masson Philippe, Alépée Nathalie, Arce Luis Alfonso, Brüschweiler Beat, Catone Tiziana, Cihak Rostislav, Clouzeau Jack, D'Abrosca Federica, Delveaux Cédric, Derouette Jean Paul, Engelking Oliver, Facchini Davide, Fröhlicher Mirjam, Hofmann Markus, Hopf Nancy, Molinari Jennifer, Oberli Aurelia, Ott Matthieu, Peter Ronald, Sá-Rocha Vanessa M., Schenk Dominique, Tomicic Catherine, Vanparys Philippe, Verdon Bernadette, Wallenhorst Thomas, Winkler Gian Christian, Depallens Olivier
ISSN
1096-0295 (Electronic)
ISSN-L
0273-2300
Publication state
Published
Issued date
2012
Peer-reviewed
Oui
Volume
62
Number
2
Pages
393-403
Language
english
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.
Pubmed
Web of science
Create date
27/02/2012 16:40
Last modification date
20/08/2019 13:24
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