# 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: REPORTING

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

TEST REPORT
The test report must include the following information:
Test substance:
physical nature (including isomerism, purity and physicochemical properties);
identification data.
Vehicle (if appropriate):
justification for choice of vehicle.
Test animals:
species/strain used;
number, age and sex of animals;
source, housing conditions, acclimatization, diet, etc;
individual weights of animals at the start of the test.
Test conditions:
details of test substance formulation/diet preparation, achieved concentration, stability and homogeneity of the preparation:
specification of the doses administered, including details of the vehicle, volume and physical form of the material administered;
details of the administration of the test substance;
rationale for dose levels selected;
rationale for the route and duration of the exposure;
conversion from diet/drinking water test substance concentration (ppm) to the actual dose (mg/kg body weight/day), if applicable;
details of the food and water quality.
Observation and Test Procedures:
details of the assignment of animals in each group to the perfusion subgroups;
details of scoring systems, including criteria and scoring scales for each measurement in the detailed clinical observations;
details on the functional tests for sensory reactivity to stimuli of different modalities (e.g., auditory, visual and proprioceptive); for assessment of limb grip strength; for motor activity assessment (including
details of automated devices for detecting activity); and other procedures used;
details of ophthalmologic examinations and, if appropriate, haematological examinations and clinical biochemistry tests with relevant base-line values;
details for specific neurobehavioural, neuropathological, neurochemical or electrophysiological procedures.
Results:
body weight/body weight changes including body weight at kill;
food consumption and water consumption, as appropriate;
toxic response data by sex and dose level, including signs of toxicity or mortality;
nature, severity and duration (time of onset and subsequent course) of the detailed clinical observations (whether reversible or not);
a detailed description of all functional test results;
necropsy findings;
a detailed description of all neurobehavioural, neuropathological, and neurochemical or electrophysiological findings, if available;
absorption and metabolism data, if available;
statistical treatment of results, where appropriate.
Discussion of results;
dose response information;
relationship of any other toxic effects to a conclusion about the neurotoxic potential of the test chemical;
no-observed-adverse effect level.
Conclusions:
a specific statement of the overall neurotoxicity of the test chemical is encouraged.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2H/division/B.43/division/3 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.