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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Summaries of U.S. and International Testing Needs in Skin Sensitization

U.S. regulatory and research agencies often rely upon skin sensitization test data to assess the sensitization hazards associated with dermal exposure to chemicals and products and ensure that such substances will not cause unreasonable adverse effects to human health when used appropriately. The ICCVAM Skin Sensitization Workgroup conducted a review of U.S. agencies (Strickland et al. 2019) to identify 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 agencies.

NICEATM scientists and International Cooperation on Alternative Test Methods (ICATM) participants also reviewed skin sensitization testing requirements for ICATM participating countries or regions (Daniel et al. 2018). The survey considered the type of skin sensitization data required for each chemical sector and whether these data were used in a hazard classification, potency classification, or risk assessment context; the preferred tests; and whether alternative non-animal tests were acceptable. An understanding of national and regional regulatory requirements for skin sensitization testing will inform the development of ICATM's international strategy for the acceptance and implementation of non-animal alternatives to assess the health hazards and risks associated with potential skin sensitizers.