{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-n8/division-B.35/division-3/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-n8/division-B.35/division-3/division-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/n8/division/B.35/division/3/division/1",
  "kind": "division",
  "number": null,
  "heading": "TEST REPORT",
  "text": "The test report must include the following information:\nTest substance:\nphysical nature and, where relevant, physicochemical properties;\nidentification data;\npurity.\nVehicle (if appropriate):\njustification for choice of vehicle if other than water.\nTest animals:\nspecies/strain used;\nnumber, age and sex of animals;\nsource, housing conditions, diet, nesting materials, etc.;\nindividual weights of animals at the start of the test.\nTest conditions:\nrationale for dose level selection;\ndetails of test substance formulation/diet preparation, achieved concentrations;\nstability and homogeneity of the preparation;\ndetails of the administration of the test substance;\nconversion from diet/drinking water test substance concentration (ppm) to the achieved dose (mg/kg body weight/day), if applicable;\ndetails of food and water quality.\nResults:\nfood consumption, and water consumption if available, food efficiency (body weight gain per gram of food consumed), and test material consumption for P and F1 animals, except for the period of cohabitation and for at least the last third of lactation;\nabsorption data (if available);\nbody weight data for P and F1 animals selected for mating;\nlitter and pup weight data;\nbody weight at sacrifice and absolute and relative organ weight data for the parental animals;\nnature, severity and duration of clinical observations (whether reversible or not);\ntime of death during the study or whether animals survived to termination;\ntoxic response data by sex and dose, including indices of mating, fertility, gestation, birth, viability, and lactation; the report should indicate the numbers used in calculating these indices;\ntoxic or other effects on reproduction, offspring, post-natal growth, etc.;\nnecropsy findings;\ndetailed description of all histopathological findings;\nnumber of P and F1 females cycling normally and cycle length;\ntotal cauda epididymal sperm number, percent progressively motile sperm, percent morphologically normal sperm, and percent of sperm with each identified abnormality;\ntime-to-mating, including the number of days until mating;\ngestation length;\nnumber of implantations, corpora lutea, litter size;\nnumber of live births and post-implantation loss;\nnumber of pups with grossly visible abnormalities, if determined the number of runts should be reported;\ndata on physical landmarks in pups and other post natal developmental data; physical landmarks evaluated should be justified;\ndata on functional observations in pups and adults, as applicable;\ntatistical treatment of results, where appropriate.\nDiscussion of results.\nConclusions, including NOAEL values for maternal and offspring effects.",
  "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/n8/division/B.35/division/3/division/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."
}