# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division: Aim of the test

Extent: E+W+S+N.I.

These studies are of value in:
the prediction of genotoxic potential
the early identification of genotoxic carcinogens
the elucidation of the mechanism of action of some carcinogens.
To avoid responses that are artefacts of the test system, excessively toxic doses must not be used in either in vitro or in vivo assays for mutagenicity. This approach shall be regarded as general guidance. It is important that a flexible approach is adopted, with selection of further tests which are dependent upon interpretation of results at each stage.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.4/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.4/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.