OpenLegislation

Division 3.1 Test report

United Kingdom

Original text. Later amendments are not shown.

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.