# 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), Division 3.1: Test report

Extent: E+W+S+N.I.

The test report must include the following information, as appropriate:
Test substance:
physical nature, purity, and, where relevant, physico-chemical properties (including isomerisation);
identification data, including CAS number.
Vehicle (if appropriate):
justification for choice of vehicle, if other than water.
Test animals:
species/strain used;
microbiological status of the animals, when known;
number, age and sex of animals (including, where appropriate, a rationale for use of males instead of females);
source, housing conditions, diet etc.;
Test conditions:
details of test substance formulation, including details of the physical form of the material administered;
details of the administration of the test substance including dosing volumes and time of dosing;
details of food and water quality (including diet type/source, water source);
the rationale for the selection of the starting dose.
Results:
tabulation of response data and dose level for each animal (i.e. animals showing signs of toxicity including mortality, nature, severity and duration of effects);
tabulation of body weight and body weight changes;
individual weights of animals at the day of dosing, in weekly intervals thereafter, and at time of death or sacrifice;
date and time of death if prior to scheduled sacrifice.
time course of onset of signs of toxicity and whether these were reversible for each animal;
necropsy findings and histopathological findings for each animal; if available.
Discussion and interpretation of results.
Conclusions.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2B/division/B.1/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2B/division-B.1/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

