{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2.json",
  "legislation": "eur/2013/283",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-283",
  "path": "annex/section/5/division/5.2",
  "kind": "division",
  "number": "5.2",
  "heading": "Acute toxicity",
  "text": "The studies, data and information to be provided and evaluated shall be sufficient to permit the identification of effects following a single exposure to the active substance, and in particular to establish, or indicate:\n(a)the toxicity of the active substance;\n(b)the time course and characteristics of the effects with full details of behavioural changes, clinical signs, where evident, and possible gross pathological findings at post-mortem;\n(c)the possible need to consider establishing acute reference doses (such as ARfD, aAOEL);\n(d)where possible mode of toxic action;\n(e)the relative hazard associated with the different routes of exposure.\nWhile the emphasis shall be on estimating the toxicity ranges involved, the information generated shall 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": "footnote",
      "label": "f1",
      "text": "aAOEL, abbreviation for ‘Acute AOEL’."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.2",
    "retrieved_at": "2026-11-01T14:48:46.014078+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."
}