Under the EU REACH regulation (on the Registration, Evaluation, Authorisation and Restriction of Chemicals), certain animal studies can be waived or triggered on the basis of exposure considerations. A report from the Dutch National Institute for Public Health and the Environment (RIVM) discusses the REACH criteria for exposure-based waiving (EBW – where there is minimal exposure) and exposure-based triggering (EBT – where high level exposure is likely to occur), and the qualitative and quantitative justifications for each (with examples). The main section of the report concludes with an assessment of what this all means for the current exposure assessment methodology, while an appendix shows the options for EBW and EBT for human end-points (and for EBW for environmental end-points).

[Vermeire T.G. et al. (2008). Exposure informed testing under REACH. RIVM Report 601017001/2008. Available at http://www.rivm.nl/bibliotheek/rapporten/601017001.pdf on the internet.] {179067}

The above item is taken from the November 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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