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Strategy to replace, reduce and refine the use of animals in the assessment of acute mammalian systemic toxicity

Released in December 2014

Based on an assessment of regulatory needs across sectors and the scientific state-of-the art in the area, the strategy sets out strategic aims and associated objectives that are expected to deliver a significant 3Rs impact.

Information on acute systemic toxicity is a standard requirement within several pieces of chemicals legislation in the EU. Currently, only data derived from animal tests are accepted by regulatory bodies. Most of the standard tests use lethality as endpoint, even though this has been widely criticised both on animal welfare and scientific grounds. The development of mechanistically-based alternative methods and strategies for acute systemic toxicity is hampered by the limited understanding of the key acute toxicity pathways in humans.

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) considers that efforts should be directed to collecting and organising mechanistic knowledge related to this health effect in order to improve the design and validation of predictive models and approaches. EURL ECVAM also highlights the need to explore scientific options to support the waiving of acute systemic toxicity testing, including the better use of existing alternative methods such as mechanistically relevant in vitro assays, as well as existing information on repeated dose toxicity. Efforts should also be directed towards the refinement of in vivo studies.

The strategy underwent consultation with EURL ECVAM's advisory and stakeholder bodies and aims to satisfy regulatory requirements within various pieces of EU legislation. One clear target is to minimise the use of animals in the assessment of acute systemic toxicity for chemicals subject to the 2018 REACH registration deadline. The strategy will also provide a framework for prioritisation of alternative methods submitted to EURL ECVAM for validation.

The implementation of this strategy will rely on the efforts of EURL ECVAM and on the collective and coordinated contribution of a wide range of stakeholders.

The document "EURL ECVAM strategy to replace, reduce and refine the use of animals in the assessment of acute mammalian systemic toxicity" is downloadable below.