{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-n7/division-B.31/division-2/division-2.2",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-n7/division-B.31/division-2/division-2.2.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/n7/division/B.31/division/2/division/2.2",
  "kind": "division",
  "number": "2.2",
  "heading": "EVALUATION OF RESULTS",
  "text": "The findings of the Prenatal Developmental Toxicity Study should be evaluated in terms of the observed effects. The evaluation will include the following information:\nmaternal and embryo/foetal test results, including the evaluation of the relationship, or lack thereof, between the exposure of the animals to the test substance and the incidence and severity of all findings;\ncriteria used for categorising foetal external, soft tissue, and skeletal alterations if categorisation has been done;\nwhen appropriate, historical control data to enhance interpretation of study results;\nthe numbers used in calculating all percentages or indices;\nadequate statistical analysis of the study findings, when appropriate, which should include sufficient information on the method of analysis, so that an independent reviewer/statistician can re-evaluate and reconstruct the analysis;\nIn any study which demonstrates the absence of any toxic effects, further investigations to establish absorption and bioavailability of the test substance should be considered.",
  "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/n7/division/B.31/division/2/division/2.2",
    "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."
}