Development of Potential Alternatives to the Draize Eye Test: The CTFA Evaluation of Alternatives Program

Abstract

The CTFA Evaluation of Alternatives Program is a multi-year effort organised by a scientific advisory committee (the CTFA Animal Welfare Task Force), and is designed to evaluate (in Phase I) approximately twenty-five potential alternative methods to the Draize eye irritancy test. Coordination, management of logistics, collection and statistical analysis of data, are being conducted by the Columbus Division of the Battelle Memorial Institute. The US Food and Drug Administration has been aware of the Program since its inception. The intention of the Program is to provide industry with information on the performance of a series of potential alternatives to the Draize test, so as to aid individual companies to identify those methods which seem best suited to their own particular testing needs. The participants are either CTFA member companies who are already using or developing alternative tests, or those independent investigators whose development work is being sponsored by CTFA members. The purpose of the Program is to determine the effectiveness and limitations of a variety of tests for a range of different product types. Specifically, the Program will evaluate the capacity of the tests under investigation to rank and discriminate between the ocular irritation potential of a range of prototype cosmetic and personal care products. The Program is designed as a multi-year effort with a different product type evaluated each year. In Phase I, ten different ethanol-based substances are being tested; oil/water emulsions will be evaluated in Phase II.