Oecd Guidelines for the Testing of Chemicals

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 first 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). In the second evaluation, the ICE test method was evaluated for use as a screening test to identify chemicals not classified for eye irritation or serious eye damage as defined by UN GHS (3) (4). The results from the validation study and the peer review panel recommendations maintained the original recommendation for using the ICE for classification of chemicals inducing serious eye damage (UN GHS Category 1), as the available database remained unchanged since the original ICCVAM validation. At that stage, no further recommendations for an expansion of the ICE applicability domain to also include other categories were suggested. A re-evaluation of the in vitro and in vivo dataset used in the validation study was made with the focus of evaluating the usefulness of the ICE to identify chemicals not requiring classification for eye irritation or serious eye damage (5). This re-evaluation concluded that the ICE test method can also be used to identify chemicals not requiring classification for eye irritation and serious eye damage as defined by the UN GHS (4) (5). This Test Guideline (adopted in 2009 and updated in 2013) includes the recommended uses and limitations of the ICE test method based on these evaluations. The main differences between the original 2009 version and the 2013 updated version include, but are not limited to, the use of the ICE test method to identify chemicals not requiring classification according to the UN GHS Classification System, an update to the test report elements, an update of Annex 1 on definitions, and an update to Annex 2 on the proficiency chemicals.