Title: Skin sensitisation – Moving forward with non-animal testing strategies for regulatory purposes in the EU
Authors: BASKETTER DavidALEPEE NathalieCASATI SilviaCROZIER JonathanEIGLER DorotheaGRIEM PeterHUBESH BrunoDE KNECHT JoopLANDSIEDEL RobertLOUEKARI KimmoMANOU IreneMAXWELL GavinMEHLING AnnetteNETZEVA TatianaPETRY ThomasROSSI Laura
Citation: REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 67 no. 3 p. 531-535
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Publication Year: 2013
JRC N°: JRC85030
ISSN: 0273-2300
URI: http://www.sciencedirect.com/science/article/pii/S0273230013001785
http://publications.jrc.ec.europa.eu/repository/handle/JRC85030
DOI: 10.1016/j.yrtph.2013.10.002
Type: Articles in periodicals and books
Abstract: Report of a EPAA/CEFIC LRI cross sector workshop, 4th February 2013 In a previous EPAA-Cefic LRI workshop in 2011, issues surrounding the use and interpretation of results from the local lymph node assay were addressed. At the beginning of 2013 a second joint workshop focused greater attention on the opportunities to make use of non-animal test data, not least since a number of in vitro assays have progressed to an advanced position in terms of their formal validation. It is already recognised that information produced from non-animal assays can be used in regulatory decision-making, notably in terms of classifying a substance as a skin sensitiser. The evolution into a full replacement for hazard identification, where the decision is not to classify, requires the generation of confidence in the in vitro alternative, e.g. via formal validation, the existence of peer reviewed publications and the knowledge that the assay(s) are founded on key elements of the Adverse Outcome Pathway for skin sensitisation. It is foreseen that the validated in vitro assays and relevant QSAR models can be organised into formal testing strategies to be applied for regulatory purposes by the industry. To facilitate progress, the European Partnership for Alternative Approaches to animal testing (EPAA) provided the platform for cross-industry and regulatory dialogue, enabling an essential and open debate on the acceptability of an in vitro based integrated strategy. Based on these considerations, a follow up activity was agreed upon to explore an example of an Integrated Testing Strategy for skin sensitisation hazard identification purposes in the context of REACH submissions
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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