United States regulatory requirements for skin and eye irritation testing

Abstract

Purpose: Eye and skin irritation test data are required or considered by chemical regulation authorities in the United States to develop product hazard labelling and/or to assess risks for exposure to skin- and eye-irritating chemicals. The combination of animal welfare concerns and interest in implementing methods with greater human relevance has led to the development of non-animal skin- and eye-irritation test methods. To identify opportunities for regulatory uses of non-animal replacements for skin and eye irritation tests, the needs and uses for these types of test data at U.S. regulatory and research agencies must first be clarified.

Methods: We surveyed regulatory and non-regulatory testing needs of U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) agencies for skin and eye irritation testing data. Information reviewed includes the type of skin and eye irritation data required by each agency and the associated decision context: hazard classification, potency classification, or risk assessment; the preferred tests; and whether alternative or non-animal tests are acceptable. Information on the specific information needed from non-animal test methods also was collected.

Results: A common theme across U.S. agencies is the willingness to consider non-animal or alternative test methods. Sponsors are encouraged to consult with the relevant agency in designing their testing program to discuss the use and acceptance of alternative methods for local skin and eye irritation testing.

Conclusions: To advance the implementation of alternative testing methods, a dialog on the confidence of these methods to protect public health and the environment must be undertaken at all levels.

Keywords:

• Eye irritation testing
• skin irritation testing
• alternative approaches
• non-animal methods
• regulatory requirements
• corrosive

Acknowledgements

The authors thank Drs. Michael DeVito and Alex Merrick for their thoughtful critical review of this manuscript, Ms. Amber Daniel for review and document preparation, and Ms. Catherine Sprankle for editorial review. The authors also wish to thank Mr. Yadvinder Bhuller, from Health Canada’s Pest Management Regulatory Agency, for his input.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by the National Institute of Environmental Health Sciences, National Institutes of Health under Contract No. HHSN273201500010C to ILS in support of NICEATM