Skin sensitization testing needs and data uses by US regulatory and research agencies

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.

Keywords: Alternative approaches; Non-animal methods; Regulatory requirements; Skin sensitization testing.

Fig. 1

The adverse outcome pathway for skin sensitization initiated by covalent binding to proteins, with notations indicating accepted OECD test guidelines (TG) for non-animal methods that measure key events in the AOP. Figure reprinted from Strickland et al. (2016).