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Test No. 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

1. The Isolated Chicken Eye (ICE) test method was evaluated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), in conjunction with the European Centre for the Validation of Alternative Methods (ECVAM) and the Japanese Centre for the Validation of Alternative Methods (JaCVAM), in 2006 and 2010 (1) (2) (3). In the original evaluation, the ICE was endorsed as a scientifically valid test method for use as a screening test to identify chemicals (substances and mixtures) inducing serious eye damage (Category 1) as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (1) (2) (4). A re-evaluation of the in vitro and in vivo dataset used in the validation study concluded that the ICE test method could also be used to identify chemicals not requiring classification for eye irritation and serious eye damage as defined by the UN GHS (4) (5). Since then, histopathology has been shown to be a useful additional endpoint to identify UN GHS Cat. 1 non-extreme pH (2 < pH < 11.5) detergents (6). Furthermore, the Decision Criteria used to identify chemicals not requiring classification according to the UN GHS Classification System, has been revised based on the latest acceptance standards (5) (7) (8) (9). This Test Guideline (adopted in 2009 and updated in 2013 and in XXX) includes the recommended uses and limitations of the ICE test method based on these evaluations. The main differences between the 2013 version and the present (XXX)version comprise use of histopathology as an additional endpoint for identification of UN GHS Cat. 1 non-extreme pH detergents and revision of the ICE Decision Criteria to identify chemicals not requiring classification according to the UN GHS Classification System.