Development of potential alternatives to the Draize eye test: the CTFA evaluation of alternatives program. Phase II. Review of materials and methods

By Gettings, S.D. - Bagley, D.M. - Chudkowski, M. - Demetrullas, J.L. - Dipasquale, L.C. - Galli, C.L. - Gay, R. - Hintze, K.L. - Janus, J. - Marenus, K.D.

The CTFA Evaluation of Alternatives Program is a multi-year effort, organised by the CTFA Animal Welfare Task Force, designed to evaluate the performance of currently promising in vitro (alternative) methods to the Draize eye irritancy test. The sole criterion for inclusion of a particular test is that it shows some initial promise as an alternative to the Draize eye test, and that it is under evaluation or development by a participating CTFA member company. Tests are evaluated for their ability to rank and discriminate the ocular irritation potential of prototype cosmetic and personal care formulations compared to the Draize eye test. Test materials and in vitro methods currently under evaluation in Phase Il of the CTFA Program are described. Additional tests may be included in subsequent phases of the Program, should it be determined that they show particular promise as replacements for specific types of formulation. Conversely (at the discretion of sponsors), tests may be removed from the Program should initial promise be unfulfilled.