{
  "url": "https://openlegislation.uk/eu-regulation-2006-1907/annex-VII/division-8",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-1907/annex-VII/division-8.json",
  "legislation": "eur/2006/1907",
  "legislation_title": "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2006-1907",
  "path": "annex/VII/division/8",
  "kind": "division",
  "number": "8",
  "heading": "TOXICOLOGICAL INFORMATION",
  "text": "COLUMN 1 STANDARD INFORMATION REQUIRED\nCOLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1\n8.1.\nSkin corrosion/irritation\n8.1.\nThe study/ies do(es) not need to be conducted if:\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as skin corrosion (Category 1), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or\nthe substance is classified as acute toxicity by the dermal route (Category 1), or\nan acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level ( 2 000 mg/kg body weight).\nIf results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted.\n8.1.1.\nSkin corrosion, in vitro\n8.1.2.\nSkin irritation, in vitro\n8.2.\nSerious eye damage/eye irritation\n8.2.\nThe study/ies do(es) not need to be conducted if:\nthe substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1), or\nthe substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2), or\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature.\n8.2.1.\nSerious eye damage/eye irritation, in vitro\n8.2.1.\nIf results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered.\n8.3.\nSkin sensitisation\nInformation allowing:\na conclusion whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Cat. 1A), and\nrisk assessment, where required.\nThe study(ies) under point 8.3.1 and 8.3.2 do not need to be conducted if:\nthe substance is classified as skin corrosion (Category 1), or\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature.\n8.3.1.\nSkin sensitisation, in vitro/in chemico\nInformation from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation:\n(a) molecular interaction with skin proteins;\n(b) inflammatory response in keratinocytes;\n(c) activation of dendritic cells.\nThe(se) test(s) do not need to be conducted if:\nan in vivo study according to point 8.3.2 is available, or\nthe available in vitro/in chemico test methods are not applicable for the substance or are not adequate for classification and risk assessment according to point 8.3.\nIf information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted.\n8.3.2.\nSkin sensitisation, in vivo\nAn in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3.\nThe murine local lymph node assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test shall be provided.\nIn vivo skin sensitisation studies that were carried out or initiated before 10 May 2017 , and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement.\n8.4.\nMutagenicity\n8.4.\nFurther mutagenicity studies shall be considered in case of a positive result.\n8.4.1.\nIn vitro gene mutation study in bacteria\n8.4.1.\nThe study does not need to be conducted for nanoforms where it is not appropriate. In this case other studies involving one or more in vitro mutagenicity study(ies) in mammalian cells (Annex VIII, sections 8.4.2. and 8.4.3 or other internationally recognised in vitro methods) shall be provided.\n8.5.\nAcute toxicity\n8.5.\nThe study/ies do(es) not generally need to be conducted if:\nthe substance is classified as corrosive to the skin.\n8.5.1.\nBy oral route\n8.5.1.\nThe study need not be conducted if\na study on acute toxicity by the inhalation route (8.5.2) is available.\nFor nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Inserted by Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV 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)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Substituted by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance)."
    },
    {
      "type": "X",
      "label": "X1",
      "text": "Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006)."
    },
    {
      "type": "X",
      "label": "X2",
      "text": "Substituted by Corrigendum to Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Official Journal of the European Union L 44 of 18 February 2011)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2006/1907/annex/VII/division/8",
    "retrieved_at": "2026-11-01T14:53:13.283023+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."
}