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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance · European Union

8.8.1. Further toxicokinetic and metabolism studies in mammals Additional studies might be required based on the outcome of the toxicokinetic and metabolism study conducted in rat. These further studies shall be required if: there is evidence that metabolism in the rat is not relevant for human exposure route-to-route extrapolation from oral to dermal/inhalation exposure is not feasible Where it is considered appropriate to obtain information on dermal absorption, the assessment of this endpoint shall proceed using a tiered approach for assessment of dermal absorption ADS

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.