OpenLegislation

Division 3.1 TEST REPORT

United Kingdom

Original text. Later amendments are not shown.

The test report must include the following information:

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

  • description of relevant data available from prior testing;

  • data derived in each step of testing strategy;

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

  • description of in vivo dermal irritation/corrosion study performed, including results obtained;

  • 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, reactivity with water);

  • in case of a mixture, composition and relative percentages of components;

  • if local anaesthetic is used, identification, purity, type, dose, and potential interaction with test substance.

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;

  • age of each animal at start of study;

  • number of animals of each sex in test and control groups (if required);

  • individual animal weights at start and conclusion of test;

  • source, housing conditions, diet, etc.

Results:

  • description of method used to score irritation at each observation time (e.g., hand slitlamp, biomicroscope, fluorescein);

  • tabulation of irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test;

  • narrative description of the degree and nature of irritation or corrosion observed;

  • description of any other lesions observed in the eye (e.g., vascularization, pannus formation, adhesions, staining);

  • description of non-ocular local and systemic adverse effects, and histopathological findings, if any.

Discussion of results.