Decision framework to evaluate new chemicals for eye and skin irritation and corrosion hazards
EPA, in collaboration with NICEATM and nongovernmental organizations, is developing a new framework for identifying eye irritation and corrosion hazards for new chemicals reviewed under TSCA. With this new framework, EPA will prioritize data from non-animal test methods that are more reproducible and provide results more relevant to humans than the corresponding in vivo animal model test. Under the framework, information is collected and evaluated in the following order: (1) data from human cell/tissue-based test methods that have been demonstrated to be reproducible and relevant to eye irritation; (2) data from in chemico or non-human in vitro and/or ex vivo test methods that have been demonstrated to be reproducible and provide information on the mechanisms of toxicity relevant to eye irritation in humans; and (3) data from in vivo animal studies. If no acceptable information on eye irritation is available, the framework allows for consideration of skin irritation data that predict irritating or corrosive properties to make inferences about eye irritation hazard of the new chemical substance. Evaluation of skin irritation and corrosion data follows the same prioritization order as presented above for eye irritation information. This framework will streamline the decision-making process and increase efficiency through a standard process for EPA to use each time it evaluates eye irritation or corrosion hazards test data. The new framework supports EPA’s mandate under TSCA to promote the development and implementation of alternative test methods and strategies that can provide information on chemical hazards without vertebrate animal testing. This framework also supports EPA’s ongoing efforts to reduce the use of animal testing and make the Agency’s review of new chemicals more efficient, helping to bring new chemicals to market more quickly while protecting human health.