TSAR : Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals

Eye Irritation
Isolated chicken eye test (ICE)
3 Rs Category :  Replacement
Type of Method :  In vitro
Validation Statement :  Scientific validity of test method (ESAC): 27/04/2007
Comment :  Useful for the identification of ocular corrosives and severe irritants only.
If combined with other validated alternative test methods in the frame of a testing strategy (e.g. Bottom-Up and Top-Down Approach, Scott L. et al. 2009), could eventually lead to the complete replacement of the classical in vivo Draize eye test.
Uses ("ex-vivo") organ from animals slaughtered for food industry.
Already mentioned in REACH Guidance on "Information Requirements and Chemical Safety Assessment" (May 2008) ECHA
Status of adoption in EU :  Positive results already accepted since 2002:
See in Manual of Decisions of the Competent Authorities MoD.
Formal adoption on-going in collaboration with OECD.
Stage 4.
Foreseen for second Adaptation to Technical Progress (ATP) of Regulation 440/2008, by the end of 2009.
Corresponding OECD TG :  TG 438.
Adopted 7 September 2009.
Status of adoption by OECD :  OECD