{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.3.json",
  "legislation": "eur/2008/429",
  "legislation_title": "Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-429",
  "path": "annex/II/division/3/division/3.2/division/3.2.2/division/3.2.2.3",
  "kind": "division",
  "number": "3.2.2.3",
  "heading": "Sub-chronic repeated dose oral toxicity studies",
  "text": "To investigate the sub-chronic toxic potential of the active substance, at least one study on a rodent species must be submitted with duration of at least 90 days. If deemed necessary, a second study must be performed with a non-rodent species. The test item must be administered orally with at least three levels in addition to a control group to obtain a dose response. The maximum dose used should normally be expected to reveal evidence of adverse effects. The lowest dose level should not be expected to produce any evidence of toxicity.\nProtocols for these studies should be in line with the OECD Guidelines 408 (rodents) or 409 (non-rodents).",
  "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/2008/429/annex/II/division/3/division/3.2/division/3.2.2/division/3.2.2.3",
    "retrieved_at": "2026-11-01T14:52:17.021143+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."
}