Title: EURL ECVAM strategy to avoid and reduce animal use in genotoxicity testing
Authors: CORVI RaffaellaMADIA FEDERICAWORTH AndrewWHELAN Maurice
Publisher: Publications Office of the European Union
Publication Year: 2013
JRC N°: JRC86616
ISBN: 978-92-79-34845-7 (paper); 978-92-79-34844-0 (pdf)
ISSN: 1018-5593 (paper); 1831-9424 (online)
Other Identifiers: EUR 26375
OPOCE LB-NA-26375-EN-C (paper); LB-NA-26375-EN-N (online)
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC86616
DOI: 10.2788/44623
10.2788/43865
Type: EUR - Scientific and Technical Research Reports
Abstract: The assessment of genotoxicity represents an important component of the safety assessment of all types of substances. Although several in vitro tests are available at different stages of development and acceptance, they cannot at present be considered to fully replace animal tests needed to evaluate the safety of substances. Based on an analysis of regulatory requirements for this endpoint within different pieces of EU legislation, EURL ECVAM proposes a pragmatic approach to improve the traditional genotoxicity testing paradigm that offers solutions in both the short- and medium-term and that draws on the considerable experience of 40 years of regulatory toxicology testing in this area. EURL ECVAM considers that efforts should be directed towards the overall improvement of the current testing strategy for better hazard and risk assessment approaches, which either avoids or minimises the use of animals, whilst satisfying regulatory information requirements, irrespective of regulatory context. Several opportunities for the improvement of the testing strategy have been identified which aim to i) enhance the performance of the in vitro testing battery so that fewer in vivo follow-up tests are necessary and ii) guide more intelligent in vivo follow-up testing to reduce unnecessary use of animals. The implementation of this strategic plan will rely on the cooperation of EURL ECVAM with other existing initiatives and the coordinated contribution from various stakeholders.
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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