{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-n5/division-B/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-n5/division-B/division-3/division-3.1.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/n5/division/B/division/3/division/3.1",
  "kind": "division",
  "number": "3.1",
  "heading": "TEST REPORT",
  "text": "The test report must include the following information:\nRationale for in vivo testing: weight-of-evidence analysis of pre-existing test data, including results from sequential testing strategy:\ndescription of relevant data available from prior testing;\ndata derived at each stage of testing strategy;\ndescription of in vitro tests performed, including details of procedures, results obtained with test/reference substances;\nweight-of-the-evidence analysis for performing in vivo study.\nTest substance:\nidentification data (e.g., CAS number; source; purity; known impurities; lot number);\nphysical nature and physicochemical properties (e.g. pH, volatility, solubility, stability);\nif mixture, composition and relative percentages of components.\nVehicle:\nidentification, concentration (where appropriate), volume used;\njustification for choice of vehicle.\nTest animals:\nspecies/strain used, rationale for using animals other than albino rabbit;\nnumber of animals of each sex;\nindividual animal weights at start and conclusion of test;\nage at start of study;\nsource of animals, housing conditions, diet, etc.\nTest conditions:\ntechnique of patch site preparation;\ndetails of patch materials used and patching technique;\ndetails of test substance preparation, application, and removal.\nResults:\ntabulation of irritation/corrosion response scores for each animal at all time points measured;\ndescriptions of all lesions observed;\nnarrative description of nature and degree of irritation or corrosion observed, and any histopathological findings;\ndescription of other adverse local (e.g., defatting of skin) and systemic effects in addition to dermal irritation or corrosion.\nDiscussion of results",
  "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/n5/division/B/division/3/division/3.1",
    "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."
}