{
  "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.3.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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",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/5.3",
  "kind": "division",
  "number": "5.3",
  "heading": "Short-term toxicity",
  "text": "Short-term toxicity studies must be designed to provide information as to the amount of the active substance that can be tolerated without toxic effects under the conditions of the study. Such studies provide useful data on the risks for those handling and using preparations containing the active substance. In particular, short-term studies provide an essential insight into possible cumulative actions of the active substance and the risks to workers who may be intensively exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies.\nThe studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following repeated exposure to the active substance, and in particular to further establish, or indicate:\nthe relationship between dose and adverse effects,\ntoxicity of the active substance including where possible the Noael,\ntarget organs, where relevant,\nthe time course and characteristics of poisoning with full details of behavioural changes and possible pathological findings at post-mortem,\nspecific toxic effects and pathological changes produced,\nwhere relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing,\nwhere possible, the mode of toxic action, and\nthe relative hazard associated with the different routes of exposure.",
  "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      "text": "Repealed (subject to transitional measures in Arts. 3, 4) by Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active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/5.3",
    "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."
}