Current Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Isolated Chicken Eye Test Method. Background Review Document

摘要

This Background Review Document (BRD) reviews available data and information regarding the validation status of the Isolated Chicken Eye (ICE) test method for identifying ocular corrosives and severe irritants. The test method was reviewed for its ability to predict ocular corrosives and severe/irreversible effects as defined by the U.S. Environmental Protection Agency (EPA) (EPA 1996), the European Union (EU) (EU 2001), and the United Nations (UN) Globally Harmonized System (GHS) of Classification and Labeling of Chemicals (UN 2003). The objective of this BRD is to describe the current validation status of the ICE test method, including what is known about its accuracy and reliability, the scope of the substances tested, and the availability of a standardized test method protocol.