On January 8, 2024, EPA issued a new framework for identifying eye irritation or corrosion hazards for new chemicals reviewed under the Toxic Substances Control Act (TSCA). In their framework, EPA states that the New Chemicals Program “does not encourage the prospective use of the in vivo eye irritation test using live rabbits (e.g., the Draize test).” Thus, the 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 animal testing. By establishing this framework, EPA expects to simplify and streamline the decision-making process for identifying potential eye irritation and corrosion hazard concerns for new chemicals. Transitioning to new-approach methods (NAMs) can also decrease time and costs for stakeholders by eliminating the need for animal studies.
The framework is based on prioritizing reproducible and human-relevant data and on existing peer-reviewed literature, accepted Organization for Economic Cooperation and Development (OECD) test guidelines, and other accepted risk assessments. In the framework, data are prioritized in the following order: (1) data from human cell or tissue test methods; (2) data from in chemico, in vitro, or ex vivo test methods; and (3) data from in vivo test methods.
ToxStrategies has overseen in vitro human cell line (OECD 492) testing to evaluate the potential eye irritation of chemical ingredients and consumer products, including household cleaning products, and incorporated findings into safety assessments. Using EPA’s framework, these test data can support classification of materials as to their eye irritation and corrosion designations. EPA’s framework also suggests that, in the absence of eye irritation data, certain skin irritation data can be relied upon to support eye irritation and corrosion classification.
The Center of Excellence for 21st Century Toxicology (21CT) assists clients with the transition from traditional toxicology testing strategies to 21CT tools and technologies.
Framework to Assess Eye Irritation or Corrosion in New Chemicals | US EPA