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Skin Sensitization Testing Needs and Data Uses by U.S. Regulatory and Research Agencies
Citation:
Strickland, J., A. Daniel, D. Allen, S. Ahir, S. Bancos, E. Craig, D. Germolec, C. Ghosh, N. Hudson, A. Jacobs, D. Lehmann, J. Matheson, E. Reinke, N. Sadrieh, S. Vukmanovic, AND N. Kleinstreuer. Skin Sensitization Testing Needs and Data Uses by U.S. Regulatory and Research Agencies. Archives of Toxicology. Springer, New York, NY, 93(2):273-291, (2019). https://doi.org/10.1007/s00204-018-2341-6
Impact/Purpose:
Regulatory agencies in the United States require the use of skin sensitization test data to assess the skin sensitization hazards that may be associated with chemicals and products. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is composed of representatives from 16 U.S. Federal regulatory and research agencies that use or generate toxicological and safety testing information. The group’s main activity is to evaluate and promote the use of alternative test methods for regulatory use in skin sensitization hazard assessments. ICCVAM reviewed the standards, test guidelines, or guidance documents that are applicable to satisfy each agency’s requirements related to skin sensitization and applied this information to identify opportunities for the use of non-animal replacements to satisfy these testing requirements. This effort will help increase confidence in alternative methods and improve their relevance to human health.
Description:
United States regulatory and research agencies may rely upon skin sensitization test data to assess the sensitization hazards associated with dermal exposure to chemicals and products. These data are evaluated to ensure that such substances will not cause unreasonable adverse effects to human health when used appropriately. The U.S. Consumer Product Safety Commission, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health, and the U.S. Department of Defense are member agencies of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM seeks to identify opportunities for the use of non-animal replacements to satisfy these testing needs and requirements. This review identifies the standards, test guidelines, or guidance documents that are applicable to satisfy each of these agency’s needs; current use of animal testing and flexibility for using alternative methodologies; information needed from alternative tests to fulfill the needs for skin sensitization data; and whether data from non-animal alternative approaches are accepted by these U.S. federal agencies.
URLs/Downloads:
DOI: Skin Sensitization Testing Needs and Data Uses by U.S. Regulatory and Research Agencies