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Exposure-based waiving

The NC3Rs commissioned the Health and Safety Laboratory to review the potential for application of 'exposure-based waiving', whereby the conduct of certain toxicity studies can be avoided where there is no significant exposure of humans and/or environment, under REACH. The review, which has a particular emphasis on inhalation toxicity, concludes that the use of exposure-based waiving in intelligent testing strategies for substance registration could advance the goals of REACH and the 3Rs by reducing the usage of animals in toxicity tests, whilst maintaining appropriate protection of human health and the environment. However, greater regulatory evaluation, acceptance and guidance are required for EBW to achieve its full impact.


HSL review of exposure-based waiving: 

Rowbotham A, Gibson RM (2011) Exposure-driven risk assessment: Applying exposure-based waiving of toxicity tests under REACH. Food and Chemical Toxicology 49 (8): 1661-1673

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