{
  "url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-3/part-2/chapter-1",
  "json_url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-3/part-2/chapter-1.json",
  "legislation": "uksi/1993/3050",
  "legislation_title": "The Notification of New Substances Regulations 1993",
  "legislation_url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993",
  "path": "schedule/3/part/2/chapter/1",
  "kind": "chapter",
  "number": null,
  "heading": "Toxicological studies",
  "text": "The test programme shall cover the following aspects unless there are strong reasons to the contrary, supported by evidence, that it should not be followed:\nChronic toxicity study.\nCarcinogenicity study.\nFertility study (e. g. three-generation study): only if an effect on fertility has been established at level 1.\nDevelopmental toxicity study on perinatal and postnatal effects.\nTeratology study (species not employed in the respective level 1).\nAdditional toxicokinetic studies which cover biotransformation, pharmokinetics.\nAdditional tests to investigate organ or system toxicity.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "subst",
      "affecting": "uksi/2002/2176",
      "affecting_title": "The Notification of New Substances (Amendment) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1993/3050/schedule/3/part/2/chapter/1",
    "retrieved_at": "2026-10-29T13:45:27.938319+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."
}