{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.42/division-3/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.42/division-3/division-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/2H/division/B.42/division/3/division/1",
  "kind": "division",
  "number": null,
  "heading": "TEST REPORT",
  "text": "The test report should contain the following information:\nTest substance:\nidentification data (e.g., CAS number, if available; source; purity; known impurities; lotnumber);\nphysical nature and physicochemical properties (e.g., volatility, stability, solubility);\nif mixture, composition and relative percentages of components.\nVehicle:\nidentification data [purity; concentration (where appropriate); volume used]\njustification for choice of vehicle.\nTest animals:\nstrain of mice used;\nmicrobiological status of the animals, when known;\nnumber, age and sex of animals;\nsource of animals, housing conditions, diet, etc.\nTest conditions:\ndetails of test substance preparation and application;\njustification for dose selection, including results from range finding study, if conducted; vehicle and test substance concentrations used and the total amount of substance applied\ndetails of food and water quality (including diet type/source, water source).\nReliability check:\na summary of the results of the latest reliability check including information on substance, concentration and vehicle used.\nconcurrent and/or historical positive and negative control data for testing laboratory\nResults:\nindividual weights of animals at the start of dosing and at scheduled kill.\na table of mean (pooled approach) and individual (individual approach) DPM values as well as the range of values for both approaches and the stimulation indices for each dose (including vehicle control) group.\nstatistical analysis where appropriate\ntime course of onset and signs of toxicity, including dermal irritation at site of administration, if any, for each animal.\nDiscussion of results:\nA brief commentary on the results, the dose-response analysis, and statistical analyses, where appropriate, with a conclusion as to whether the test substance should be considered a skin sensitiser.",
  "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.42/division/3/division/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."
}