Non-animal eye irritation pilot study Initiated

EPA’s Office of Pesticide Programs (OPP) is proceeding in its efforts to reduce animal testing in cases where other methods can be used. The Agency is implementing a new voluntary pilot program to evaluate the use of a non-animal testing approach for eye irritation labeling for certain antimicrobial products with cleaning claims. The pilot’s goal is to evaluate the effectiveness of a non-animal testing method to replace the current Draize rabbit eye test. This approximately 18-month project encompasses the use of three new assays: the Bovine Corneal Opacity and Permeability test (the use of eyes from recently slaughtered cows, the EpiOcular model (the use of an In Vitro model of the human corneal epithelium), and the Cytosensor Microphysiometer assay (the electronic measurement of the metabolic rate of cell populations to evaluate potential cell toxicity). Along with the three alternative assays, OPP is asking participating registrants to submit available consumer incident data and any existing Draize rabbit test results on similar or structurally related chemicals or products as further support for the testing approach.

During this pilot phase, labeling decisions will be made using data acquired from these non-animal tests, as long as the testing methods and testing results are deemed by EPA to be adequate and appropriate to support labeling decisions. To ensure accuracy, the pilot will be conducted by a knowledgeable OPP team, experienced in the evaluation of these non-animal studies.

At the close of this project, there will be a comprehensive assessment of the data in order to evaluate the testing strategy. The pilot’s success will be based on whether the approach is deemed to be adequately protective of toxicity to the eye.