{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-1/division-1.6/division-1.6.1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-1/division-1.6/division-1.6.1.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/2H/division/B.43/division/1/division/1.6/division/1.6.1",
  "kind": "division",
  "number": "1.6.1",
  "heading": "Frequency of observations and tests",
  "text": "In repeated dose studies, the observation period should cover the dosage period. In acute studies, 14-day post-treatment period should be observed. For animals in satellite groups which are kept without exposure during a post-treatment period, observations should cover this period as well.\nObservations should be made with sufficient frequency to maximize the probability of detection of any behavioural and/or neurological abnormalities. Observations should be made preferably at the same times each day with consideration given to the peak period of anticipated effects after dosing. The frequency of clinical observations and functional tests is summarized in Table 2. If kinetic or other data generated from previous studies indicates the need to use different time points for observations, tests or post-observation periods, an alternative schedule should be adopted in order to achieve maximum information. The rationale for changes to the schedule should be provided.",
  "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/2H/division/B.43/division/1/division/1.6/division/1.6.1",
    "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."
}