Framework to Assess Eye Irritation or Corrosion in New Chemicals

EPA’s decision framework for identifying eye irritation or corrosion hazards for new chemicals reviewed under the Toxic Substances Control Act (TSCA) provides a standard approach for the Agency to use when evaluating new chemicals for potential eye irritation or corrosion hazards leading to improved consistency across final risk assessments as well as improved transparency.

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 animal testing. These alternatives, also known as New Approach Methodologies (NAMs), reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment. By establishing this framework, EPA expects the decision-making process for identifying potential eye irritation and corrosion hazard concerns for new chemicals to be simplified and streamlined. Transitioning to NAMs can also decrease time and costs for stakeholders by eliminating the need for animal studies.
 
The framework is based on the prioritization of reproducible and human-relevant data and upon existing peer-reviewed literature, accepted Organization for Economic Cooperation and Development test guidelines, and other existing accepted risk assessments. 

A brief overview of the decision framework steps is provided below. Full details of how existing data are prioritized are provided in the framework document.

• Available data on chemical substance evaluated for quality and applicability.
  • Data is prioritized in the following order:
    • Data from human cell or tissue test methods.
    • Data from in chemico, in vitro or ex vivo test methods.
    • Data from in vivo test methods.
  • Where data from eye irritation or corrosion tests are not available, test methods that assess skin irritation or corrosion potential may be considered. 
• If eye and skin irritation or corrosion data are not available, other information may be considered. Where no data exists, a hazard determination may not be possible.
• Any relevant human data will be evaluated and incorporated on a case-by-case basis. 

TSCA New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion (pdf) (464.68 KB) .

Read the public inspection version of the Federal Register notice.