{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-3",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-3.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/3",
  "kind": "division",
  "number": "3",
  "heading": "REPORTING",
  "text": "TEST REPORT\nThe test report must include the following information:\nTest substance:\nphysical nature (including isomerism, purity and physicochemical properties);\nidentification data.\nVehicle (if appropriate):\njustification for choice of vehicle.\nTest animals:\nspecies/strain used;\nnumber, age and sex of animals;\nsource, housing conditions, acclimatization, diet, etc;\nindividual weights of animals at the start of the test.\nTest conditions:\ndetails of test substance formulation/diet preparation, achieved concentration, stability and homogeneity of the preparation:\nspecification of the doses administered, including details of the vehicle, volume and physical form of the material administered;\ndetails of the administration of the test substance;\nrationale for dose levels selected;\nrationale for the route and duration of the exposure;\nconversion from diet/drinking water test substance concentration (ppm) to the actual dose (mg/kg body weight/day), if applicable;\ndetails of the food and water quality.\nObservation and Test Procedures:\ndetails of the assignment of animals in each group to the perfusion subgroups;\ndetails of scoring systems, including criteria and scoring scales for each measurement in the detailed clinical observations;\ndetails on the functional tests for sensory reactivity to stimuli of different modalities (e.g., auditory, visual and proprioceptive); for assessment of limb grip strength; for motor activity assessment (including\ndetails of automated devices for detecting activity); and other procedures used;\ndetails of ophthalmologic examinations and, if appropriate, haematological examinations and clinical biochemistry tests with relevant base-line values;\ndetails for specific neurobehavioural, neuropathological, neurochemical or electrophysiological procedures.\nResults:\nbody weight/body weight changes including body weight at kill;\nfood consumption and water consumption, as appropriate;\ntoxic response data by sex and dose level, including signs of toxicity or mortality;\nnature, severity and duration (time of onset and subsequent course) of the detailed clinical observations (whether reversible or not);\na detailed description of all functional test results;\nnecropsy findings;\na detailed description of all neurobehavioural, neuropathological, and neurochemical or electrophysiological findings, if available;\nabsorption and metabolism data, if available;\nstatistical treatment of results, where appropriate.\nDiscussion of results;\ndose response information;\nrelationship of any other toxic effects to a conclusion about the neurotoxic potential of the test chemical;\nno-observed-adverse effect level.\nConclusions:\na specific statement of the overall neurotoxicity of the test chemical is encouraged.",
  "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/3",
    "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."
}