Division 3.1 TEST REPORT

The test report must include the following information:

Rationale for in vivo testing: weight-of-evidence analysis of pre-existing test data, including results from sequential testing strategy:

• description of relevant data available from prior testing;

• data derived at each stage of testing strategy;

• description of in vitro tests performed, including details of procedures, results obtained with test/reference substances;

• weight-of-the-evidence analysis for performing in vivo study.

Test substance:

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

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

• if mixture, composition and relative percentages of components.

Vehicle:

• identification, concentration (where appropriate), volume used;

• justification for choice of vehicle.

Test animals:

• species/strain used, rationale for using animals other than albino rabbit;

• number of animals of each sex;

• individual animal weights at start and conclusion of test;

• age at start of study;

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

Test conditions:

• technique of patch site preparation;

• details of patch materials used and patching technique;

• details of test substance preparation, application, and removal.

Results:

• tabulation of irritation/corrosion response scores for each animal at all time points measured;

• descriptions of all lesions observed;

• narrative description of nature and degree of irritation or corrosion observed, and any histopathological findings;

• description of other adverse local (e.g., defatting of skin) and systemic effects in addition to dermal irritation or corrosion.

Discussion of results