Skin Sensitization Testing Needs and Data Uses by U.S. Regulatory and Research Agencies

Autor: Naomi Hudson, Abigail Jacobs, Surender Ahir, Amber B. Daniel, Emily N. Reinke, Cecilia Aguila, Joanna Matheson, Judy Strickland, Simona Bancos, David M. Lehmann, Stanislav Vukmanovic, Evisabel Craig, David Allen, Dori R. Germolec, Chandramallika Ghosh, Nakissa Sadrieh, Nicole Kleinstreuer
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Popis: 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.
Databáze: OpenAIRE