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.

WORTH Andrew;  VIEGAS BARROSO Joao Filipe;  BREMER Susanne;  BURTON Julien;  CASATI Silvia;  COECKE Sandra;  CORVI Raffaella;  DESPREZ Bertrand;  DUMONT Coralie;  GOULIARMOU Varvara;  GOUMENOU Marina - Paraskevi;  GRAEPEL Rabea;  GRIESINGER Claudius;  HALDER Maria Elisabeth;  JANUSCH ROI Annett;  KIENZLER Aude;  MADIA Federica;  MUNN Sharon;  NEPELSKA Malgorzata;  PAINI Alicia;  PRICE Anna;  PRIETO PERAITA Maria Del Pilar;  ROLAKI Alexandra;  SCHAEFFER Michael Wilhelm;  TRIEBE Jutta;  WHELAN Maurice;  WITTWEHR Clemens;  ZUANG Valerie; 

2014-09-11

Publications Office of the European Union

JRC91361

978-92-79-39651-9,   

1831-9424,   

EUR 26797,    OP LB-NA-26797-EN-N,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC91361,   

10.2788/11111,