Commission Directive 2004/73/ECShow full title

3 REPORTING U.K.

TEST REPORT U.K.

The test report should contain the following information:

Test substance:

• identification data (e.g., CAS number, if available; source; purity; known impurities; lotnumber);

• physical nature and physicochemical properties (e.g., volatility, stability, solubility);

• if mixture, composition and relative percentages of components.

Vehicle:

• identification data [purity; concentration (where appropriate); volume used]

• justification for choice of vehicle.

Test animals:

• strain of mice used;

• microbiological status of the animals, when known;

• number, age and sex of animals;

• source of animals, housing conditions, diet, etc.

Test conditions:

• details of test substance preparation and application;

• justification for dose selection, including results from range finding study, if conducted; vehicle and test substance concentrations used and the total amount of substance applied

• details of food and water quality (including diet type/source, water source).

Reliability check:

• a summary of the results of the latest reliability check including information on substance, concentration and vehicle used.

• concurrent and/or historical positive and negative control data for testing laboratory

Results:

• individual weights of animals at the start of dosing and at scheduled kill.

• a table of mean (pooled approach) and individual (individual approach) DPM values as well as the range of values for both approaches and the stimulation indices for each dose (including vehicle control) group.

• statistical analysis where appropriate

• time course of onset and signs of toxicity, including dermal irritation at site of administration, if any, for each animal.

Discussion of results:

• A brief commentary on the results, the dose-response analysis, and statistical analyses, where appropriate, with a conclusion as to whether the test substance should be considered a skin sensitiser.