Purpose: Eye and skin irritation test data are required or considered by chemical regulation authorities in the United States to develop product hazard labeling and/or to assess risks for exposure to skin-and eye-irritating chemicals. The combination of animal welfare concerns and interest in implementing methods with greater human relevance has led to development of nonanimal skin-and eye-irritation test methods. To identify opportunities for regulatory uses of nonanimal replacements for skin and eye irritation tests, the needs and uses for these types of test data at U.S. regulatory and research agencies must first be clarified.
Methods:We surveyed regulatory and non-regulatory testing needs of U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) agencies for skin and eye irritation testing data. Information reviewed includes the type of skin and eye irritation data required by each agency and the associated decision context: hazard classification, potency classification, or risk assessment; the preferred tests; and whether alternative or non-animal tests are acceptable. Information on the specific information needed from non-animal test methods also was collected.Results: A common theme across U.S. agencies is the willingness to consider non-animal or alternative test methods. Sponsors are encouraged to consult with the relevant agency in designing Choksi et al.
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