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Abstract
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.
Details
; Daniel, Amber B 1 ; Allen, David 1 ; Aguila, Cecilia 2 ; Ahir, Surender 3
; Bancos, Simona 4 ; Evisabel Craig 5 ; Germolec, Dori 6 ; Ghosh, Chandramallika 4 ; Hudson, Naomi L 7 ; Jacobs, Abigail 8 ; Lehmann, David M 9
; Matheson, Joanna 10 ; Reinke, Emily N 11 ; Sadrieh, Nakissa 12 ; Vukmanovic, Stanislav 12 ; Kleinstreuer, Nicole 13
1 ILS, Research Triangle Park, NC, USA
2 Center for Veterinary Medicine, US Food and Drug Administration (FDA), Rockville, MD, USA
3 US Occupational Safety and Health Administration, Washington, DC, USA
4 Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA
5 Office of Pesticide Programs, US Environmental Protection Agency, Washington, DC, USA
6 Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA
7 National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Cincinnati, OH, USA
8 Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
9 Office of Research and Development, US Environmental Protection Agency, Research Triangle Park, NC, USA
10 US Consumer Product Safety Commission, Rockville, MD, USA
11 US Army Public Health Center, Aberdeen Proving Ground, MD, USA
12 Center for Food Safety and Applied Nutrition, FDA, College Park, MD, USA
13 National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA