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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

8.9.2. Sub-chronic repeated dose toxicity study (90 days), preferred species is rat The sub-chronic toxicity study (90 days) does not need to be conducted if: a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as H372 and H373 (Regulation (EC) No 1272/2008), for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor allows the extrapolation towards the NOAEL-90 days for the same route of exposure, and a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or the substance is unreactive, insoluble, not bioaccumulative and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited human exposure

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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.