{
  "url": "https://openlegislation.uk/eu-directive-2010-63/annex-VIII/section-III/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-2010-63/annex-VIII/section-III/division-2.json",
  "legislation": "eudr/2010/63",
  "legislation_title": "Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2010-63",
  "path": "annex/VIII/section/III/division/2",
  "kind": "division",
  "number": "2",
  "heading": "Moderate:",
  "text": "(a) frequent application of test substances which produce moderate clinical effects, and withdrawal of blood samples (> 10 % of circulating volume) in a conscious animal within a few days without volume replacement;\n(b) acute dose-range finding studies, chronic toxicity/carcinogenicity tests, with non-lethal end-points;\n(c) surgery under general anaesthesia and appropriate analgesia, associated with post surgical pain, suffering or impairment of general condition. Examples include: thoracotomy, craniotomy, laparotomy, orchidectomy, lymphadenectomy, thyroidectomy, orthopaedic surgery with effective stabilisation and wound management, organ transplantation with effective management of rejection, surgical implantation of catheters, or biomedical devices (e.g. telemetry transmitters, minipumps etc.);\n(d) models of induction of tumours, or spontaneous tumours, that are expected to cause moderate pain or distress or moderate interference with normal behaviour;\n(e) irradiation or chemotherapy with a sublethal dose, or with an otherwise lethal dose but with reconstitution of the immune system. Adverse effects would be expected to be mild or moderate and would be short-lived (< 5 days);\n(f) breeding of genetically altered animals which are expected to result in a phenotype with moderate effects;\n(g) creation of genetically altered animals through surgical procedures;\n(h) use of metabolic cages involving moderate restriction of movement over a prolonged period (up to 5 days);\n(i) studies with modified diets that do not meet all of the animals’ nutritional needs and are expected to cause moderate clinical abnormality within the time-scale of the study;\n(j) withdrawal of food for 48 hours in adult rats;\n(k) evoking escape and avoidance reactions where the animal is unable to escape or avoid the stimulus, and are expected to result in moderate distress.",
  "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/2010/63/annex/VIII/section/III/division/2",
    "retrieved_at": "2026-11-01T14:42:06.739931+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."
}