{
  "url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.7/division-3.7.2/division-3.7.2.4/division-3.7.2.4.4",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.7/division-3.7.2/division-3.7.2.4/division-3.7.2.4.4.json",
  "legislation": "eur/2008/1272",
  "legislation_title": "Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-1272",
  "path": "annex/I/division/3/division/3.7/division/3.7.2/division/3.7.2.4/division/3.7.2.4.4",
  "kind": "division",
  "number": "3.7.2.4.4",
  "heading": "Some of the end points used to assess maternal effects are provided below. Data on these end points, if available, need to be evaluated in light of their statistical or biological significance and dose response relationship.",
  "text": "Maternal mortality:\nan increased incidence of mortality among the treated dams over the controls shall be considered evidence of maternal toxicity if the increase occurs in a dose-related manner and can be attributed to the systemic toxicity of the test material. Maternal mortality greater than 10 % is considered excessive and the data for that dose level shall not normally be considered for further evaluation.\nMating index\n(no. animals with seminal plugs or sperm/no. mated × 100)\nFertility index\n(no. animals with implants/no. of matings × 100)\nGestation length\n(if allowed to deliver)\nBody weight and body weight change:\nConsideration of the maternal body weight change and/or adjusted (corrected) maternal body weight shall be included in the evaluation of maternal toxicity whenever such data are available. The calculation of an adjusted (corrected) mean maternal body weight change, which is the difference between the initial and terminal body weight minus the gravid uterine weight (or alternatively, the sum of the weights of the foetuses), may indicate whether the effect is maternal or intrauterine. In rabbits, the body weight gain may not be useful indicators of maternal toxicity because of normal fluctuations in body weight during pregnancy.\nFood and water consumption (if relevant):\nThe observation of a significant decrease in the average food or water consumption in treated dams compared to the control group is useful in evaluating maternal toxicity, particularly when the test material is administered in the diet or drinking water. Changes in food or water consumption need to be evaluated in conjunction with maternal body weights when determining if the effects noted are reflective of maternal toxicity or more simply, unpalatability of the test material in feed or water.\nClinical evaluations (including clinical signs, markers, haematology and clinical chemistry studies):\nThe observation of increased incidence of significant clinical signs of toxicity in treated dams relative to the control group is useful in evaluating maternal toxicity. If this is to be used as the basis for the assessment of maternal toxicity, the types, incidence, degree and duration of clinical signs shall be reported in the study. Clinical signs of maternal intoxication include: coma, prostration, hyperactivity, loss of righting reflex, ataxia, or laboured breathing.\nPost-mortem data:\nIncreased incidence and/or severity of post-mortem findings may be indicative of maternal toxicity. This can include gross or microscopic pathological findings or organ weight data, including absolute organ weight, organ-to-body weight ratio, or organ-to-brain weight ratio. When supported by findings of adverse histopathological effects in the affected organ(s), the observation of a significant change in the average weight of suspected target organ(s) of treated dams, compared to those in the control group, may be considered evidence of maternal toxicity.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "It is recognised that the Mating index and the Fertility index can also be affected by the male."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/1272/annex/I/division/3/division/3.7/division/3.7.2/division/3.7.2.4/division/3.7.2.4.4",
    "retrieved_at": "2026-11-01T14:51:47.470832+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."
}