{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-2B/division-B.1/division-1/division-1.2",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-2B/division-B.1/division-1/division-1.2.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/2B/division/B.1/division/1/division/1.2",
  "kind": "division",
  "number": "1.2",
  "heading": "DEFINITIONS",
  "text": "Acute oral toxicity: refers to those adverse effects occurring following oral administration of a single dose of a substance or multiple doses given within 24 hours.\nDelayed death: means that an animal does not die or appear moribund within 48 hours but dies later during the 14-day observation period.\nDose: is the amount of test substance administered. Dose is expressed as weight of test substance per unit weight of test animal (e.g. mg/kg).\nEvident toxicity: is a general term describing clear signs of toxicity following the administration of test substance (see (3) for examples) such that at the next highest fixed dose either severe pain and enduring signs of severe distress, moribund status (criteria are presented in the Humane Endpoints Guidance Document (8)), or probable mortality in most animals can be expected.\nGHS: Globally Harmonised Classification System for Chemical Substances and Mixtures. A joint activity of OECD (human health and the environment), UN Committee of Experts on Transport of Dangerous Goods (physical-chemical properties) and ILO (hazard communication) and co-ordinated by the Interorganisation Programme for the Sound Management of Chemicals (IOMC).\nImpending death: when moribund state or death is expected prior to the next planned time of observation. Signs indicative of this state in rodents could include convulsions, lateral position, recumbence, and tremor. (See the Humane Endpoint Guidance Document (8) for more details).\nLD50 (median lethal dose): is a statistically derived single dose of a substance that can be expected to cause death in 50 per cent of animals when administered by the oral route. The LD50 value is expressed in terms of weight of test substance per unit weight of test animal (mg/kg).\nLimit dose: refers to a dose at an upper limitation on testing (2000 or 5000 mg/kg).\nMoribund status: being in a state of dying or inability to survive, even if treated. (See the Humane Endpoint Guidance Document (8) for more details).\nPredictable death: presence of clinical signs indicative of death at a known time in the future before the planned end of the experiment, for example: inability to reach water or food. (See the Humane Endpoint Guidance Document (8) for more details).",
  "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/2B/division/B.1/division/1/division/1.2",
    "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."
}