{
  "url": "https://openlegislation.uk/eu-regulation-2009-761/annex-III/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2009-761/annex-III/division-3/division-3.1.json",
  "legislation": "eur/2009/761",
  "legislation_title": "Commission Regulation (EC) No 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2009-761",
  "path": "annex/III/division/3/division/3.1",
  "kind": "division",
  "number": "3.1",
  "heading": "TEST REPORT",
  "text": "The test report should include the following information:\nTest and Control Substances:\nchemical name(s) such as IUPAC or CAS name and CAS number, if known,\npurity and composition of the substance (in percentage(s) by weight),\nphysical-chemical properties relevant to the conduct of the study (e.g. physical state, stability and volatility, pH, water solubility if known),\ntreatment of the test/control substances prior to testing, if applicable (e.g. warming, grinding),\nstorage conditions.\nJustification of the skin model and protocol used.\nTest Conditions:\ncell system used,\ncalibration information for measuring device, and bandpass used for measuring cell viability (e.g. spectrophotometer),\ncomplete supporting information for the specific skin model used including its performance. This should include, but is not limited to:\n(i) viability;\n(ii) barrier function;\n(iii) morphology;\n(iv) reproducibility and predictivity;\n(v) quality controls (QC) of the model;\ndetails of the test procedure used,\ntest doses used, duration of exposure and post treatment incubation period,\ndescription of any modifications of the test procedure,\nreference to historical data of the model. This should include, but is not limited to:\n(i) acceptability of the QC data with reference to historical batch data;\n(ii) acceptability of the positive and negative control values with reference to positive and negative control means and ranges,\ndescription of evaluation criteria used including the justification for the selection of the cut-off point(s) for the prediction model.\nResults:\ntabulation of data from individual test samples,\ndescription of other effects observed.\nDiscussion of the results.\nConclusions.",
  "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/eur/2009/761/annex/III/division/3/division/3.1",
    "retrieved_at": "2026-11-01T14:51:19.625001+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."
}