ECHA’s report on the use of alternatives to animal testing shows that registrants have used alternatives for at least one endpoint in 89 % of the substances analysed. However, industry needs to improve the quality and robustness of alternative data.
ECHA’s third report on the use of alternative methods under REACH shows that most registrants consider and use alternatives to animal testing. One effective way is data sharing: 98 % of the substances are registered jointly. Registrants also make extensive use of existing information and alternative methods before conducting new studies.
The analysis is based on joint and individual registration dossiers submitted to ECHA between 2008 and 2016 for 6 290 substances. Out of these substances, 89 % have at least one data endpoint where an alternative was used instead of a study on animals. The most common alternative method was using information on similar substances (read-across), used in 63 % of the analysed substances, followed by combining information from different sources (weight of evidence, 43 %) and computer modelling (QSAR prediction, 34 %).
ECHA’s Executive Director Geert Dancet says: “Testing chemicals on animals should be the last resort – when there is no other scientifically reliable way to assess the potential effects of chemicals on humans or the environment. However, registrants need to improve the quality of the alternative data. We will use this report’s findings to promote the proper use of alternative methods and to support their further scientific development. We encourage registrants for the 2018 deadline to use the available in vitro methods, read-across and QSARs.”
Read-across has been particularly used for human health endpoints, for example, developmental and reproductive toxicity. For skin and eye irritation, registrants mostly use existing data, read-across and in vitro studies, using cells, tissues or organs. For environmental endpoints such as bioaccumulation, long-term toxicity to fish and toxicity to birds, data waiving – justification to omit studies – is the most commonly used alternative to testing in animals.
Taking all of the endpoints and substances analysed that can be filled by tests on vertebrate animals, registrants used data from new vertebrate animal studies in 11 % of the cases.
ECHA uses the report’s findings to promote alternative methods through its guidance, web pages, webinars and events. In addition, the Agency gives regulatory input to scientific projects and activities at EU and OECD level that contribute to the development of alternative methods.