Title: Alternative methods for regulatory toxicology – a state-of-the-art review
Authors: WORTH AndrewVIEGAS BARROSO JOAO FILIPEBREMER SusanneBURTON JULIENCASATI SilviaCOECKE SandraCORVI RaffaellaDESPREZ BERTRANDDUMONT CORALIEGOULIARMOU VARVARAGOUMENOU MARINA - PARASKEVIGRAEPEL RABEAGRIESINGER ClaudiusHALDER MARIA ELISABETHJANUSCH ROI AnnettKIENZLER AUDEMADIA FEDERICAMUNN SHARONNEPELSKA MALGORZATAPAINI ALICIAPRICE AnnaPRIETO PERAITA Maria Del PilarROLAKI ALEXANDRASCHAEFFER MICHAEL WILHELMTRIEBE JuttaWHELAN MauriceWITTWEHR ClemensZUANG Valerie
Publisher: Publications Office of the European Union
Publication Year: 2014
JRC N°: JRC91361
ISBN: 978-92-79-39651-9
ISSN: 1831-9424
Other Identifiers: EUR 26797
OP LB-NA-26797-EN-N
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC91361
DOI: 10.2788/11111
Type: EUR - Scientific and Technical Research Reports
Abstract: This state-of-the art review is based on the final report of a project carried out by the European Commission’s Joint Research Centre (JRC) for the European Chemicals Agency (ECHA). The aim of the project was to review the state of the science of non-standard methods that are available for assessing the toxicological and ecotoxicological properties of chemicals. Non-standard methods refer to alternatives to animal experiments, such as in vitro tests and computational models, as well as animal methods that are not covered by current regulatory guidelines. This report therefore reviews the current scientific status of non-standard methods for a range of human health and ecotoxicological endpoints, and provides a commentary on the mechanistic basis and regulatory applicability of these methods. For completeness, and to provide context, currently accepted (standard) methods are also summarised. In particular, the following human health endpoints are covered: a) skin irritation and corrosion; b) serious eye damage and eye irritation; c) skin sensitisation; d) acute systemic toxicity; e) repeat dose toxicity; f) genotoxicity and mutagenicity; g) carcinogenicity; h) reproductive toxicity (including effects on development and fertility); i) endocrine disruption relevant to human health; and j) toxicokinetics. In relation to ecotoxicological endpoints, the report focuses on non-standard methods for acute and chronic fish toxicity. While specific reference is made to the information needs of REACH, the Biocidal Products Regulation and the Classification, Labelling and Packaging Regulation, this review is also expected to be informative in relation to the possible use of alternative and non-standard methods in other sectors, such as cosmetics and plant protection products.
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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