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

Détails

ID Serval
serval:BIB_365F6E8960C5
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Regulatory assessment of in vitro skin corrosion and irritation data within the European framework: Workshop recommendations
Périodique
Regulatory Toxicology and Pharmacology
Auteur⸱e⸱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
Statut éditorial
Publié
Date de publication
2012
Peer-reviewed
Oui
Volume
62
Numéro
2
Pages
393-403
Langue
anglais
Résumé
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
Création de la notice
27/02/2012 16:40
Dernière modification de la notice
20/08/2019 13:24
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