# 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 the 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 the 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/n4/division/B.1/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n4/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.

