{
  "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.2.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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",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/5.2",
  "kind": "division",
  "number": "5.2",
  "heading": "Acute toxicity",
  "text": "The studies, data and information to be provided and evaluated must be sufficient to permit the identification of effects following a single exposure to the active substance, and in particular to establish, or indicate:\nthe toxicity of the active substance,\nthe time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem,\nwhere possible mode of toxic action, and\nthe relative hazard associated with the different routes of exposure.\nWhile the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the active substance to be classified in accordance with Regulation (EC) No 1272/2008. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.",
  "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      "text": "Repealed (subject to transitional measures in Arts. 3, 4) by Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active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/5.2",
    "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."
}