{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-1/division-1.5/division-1.5.5",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-1/division-1.5/division-1.5.5.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/2H/division/B.43/division/1/division/1.5/division/1.5.5",
  "kind": "division",
  "number": "1.5.5",
  "heading": "Limit test",
  "text": "If a study at one dose level of at least 1000 mg/kg body weight/day, using the procedures described, produces no observable neurotoxic effects and if toxicity would not be expected based upon data from structurally related compounds, then a full study using three dose levels may not be considered necessary. Expected human exposure may indicate the need for a higher oral dose level to be used in the limit test. For other types of administration, such as inhalation or dermal application, the physical chemical properties of the test substance often may dictate the maximum attainable level of exposure. For the conduct of an oral acute study, the dose for a limit test should be at least 2000 mg/kg.",
  "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/2H/division/B.43/division/1/division/1.5/division/1.5.5",
    "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."
}