{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-2E/division-B/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-2E/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/2E/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-the-evidence analysis of pre-existing test data, including results from sequential testing strategy\ndescription of relevant data available from prior testing;\ndata derived in each step of testing strategy;\ndescription of in vitro tests performed, including details of procedures, results obtained with test/reference substances;\ndescription of in vivo dermal irritation/corrosion study performed, including results obtained;\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, reactivity with water);\nin case of a mixture, composition and relative percentages of components;\nif local anaesthetic is used, identification, purity, type, dose, and potential interaction with test substance.\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;\nage of each animal at start of study;\nnumber of animals of each sex in test and control groups (if required);\nindividual animal weights at start and conclusion of test;\nsource, housing conditions, diet, etc.\nResults:\ndescription of method used to score irritation at each observation time (e.g., hand slitlamp, biomicroscope, fluorescein);\ntabulation of irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test;\nnarrative description of the degree and nature of irritation or corrosion observed;\ndescription of any other lesions observed in the eye (e.g., vascularization, pannus formation, adhesions, staining);\ndescription of non-ocular local and systemic adverse effects, and histopathological findings, if any.\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/2E/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."
}