| European CommissionJRCIHCPTSAR |
| Eye Irritation |
| Bovine Cornea Opacity Test (BCOP) |
| 3 Rs Category | : | Replacement |
| Type of Method | : | In vitro |
| Validation Statement | : | Scientific validity of test method: 27/04/2007 (ESAC); 2009 (ICCVAM) |
| Comment | : | Useful for the identification of ocular corrosives and severe irritants (ESAC, 27/04/2007) as well as non classified chemicals (non-irritants) (ICCVAM, 2009), but not of mild/moderate irritants (ICCVAM, 2009). 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 437. Adopted 7 September 2009. |
| Status of adoption by OECD | : | OECD |