OpenLegislation

Division 3 REPORTING

United Kingdom

Original text. Later amendments are not shown.

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.