{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-n4/division-7/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-n4/division-7/division-1.json",
  "legislation": "eudr/2004/73",
  "legislation_title": "Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-73",
  "path": "annex/n4/division/7/division/1",
  "kind": "division",
  "number": null,
  "heading": "CRITERIA FOR CLASSIFICATION OF TEST SUBSTANCES WITH EXPECTED LD50 VALUES EXCEEDING 2000 MG/KG WITHOUT THE NEED FOR TESTING",
  "text": "Criteria for hazard Category 5 are intended to enable the identification of test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral or dermal LD50 in the range of 2000-5000 mg/kg or equivalent doses for other routes. The test substance should be classified in the hazard category defined by: 2000mg/kg < LD50 < 5000mg/kg (Category 5 in the GHS) in the following cases:\na)) If directed to this category by any of the testing schemes of Annex 1a-1d, based on mortality incidences;\nb)) if reliable evidence is already available that indicates the LD50 to be in the range of Category 5 values; or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature.\nc)) through extrapolation, estimation or measurement of data if assignment to a more hazardous class is not warranted, and\nreliable information is available indicating significant toxic effects in humans, or\nany mortality is observed when tested up to Category 4 values by the oral route, or\nwhere expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance, or\nwhere expert judgement confirms reliable information indicating the potential for significant acute effects from the other animal studies.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2004/73/annex/n4/division/7/division/1",
    "retrieved_at": "2026-11-01T15:22:47.605967+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."
}