{
  "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.4/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.4/division-1.json",
  "legislation": "eur/2011/544",
  "legislation_title": "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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-544",
  "path": "annex/part/A/division/5/division/5.4/division/1",
  "kind": "division",
  "number": null,
  "heading": "Aim of the test",
  "text": "These studies are of value in:\nthe prediction of genotoxic potential\nthe early identification of genotoxic carcinogens\nthe elucidation of the mechanism of action of some carcinogens.\nTo 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.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Repealed (subject to transitional measures in Arts. 3, 4) by Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.4/division/1",
    "retrieved_at": "2026-11-01T14:50:06.051752+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}