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 US Consumer Product Safety Commission, the US Environmental Protection Agency, the US Food and Drug Administration, the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health, and the US 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; the 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 US federal agencies.
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The authors thank Drs. B. Alex Merrick and Kristen Ryan for their thoughtful critical review of this manuscript, and Ms. Catherine Sprankle for editorial review. This project was funded in part with federal funds from the National Institute of Environmental Health Sciences, National Institutes of Health under Contract No. HHSN273201500010C to ILS in support of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods.
This article may be the work product of an employee or group of employees of the US CPSC, DoD, EPA, FDA, NIEHS, NIH, NIOSH, OSHA, or other organizations. However, the statements, opinions, or conclusions contained therein do not necessarily represent the statements, opinions, or conclusions of these organizations or the United States government. ILS staff provides technical support for NICEATM, but do not represent NIEHS, NTP, or the official positions of any federal agency.
This manuscript does not contain clinical studies or patient data.
Conflict of interest
The authors declare that they have no conflict of interest.
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Strickland, J., Daniel, A.B., Allen, D. et al. Skin sensitization testing needs and data uses by US regulatory and research agencies. Arch Toxicol 93, 273–291 (2019). https://doi.org/10.1007/s00204-018-2341-6
- Skin sensitization testing
- Alternative approaches
- Non-animal methods
- Regulatory requirements