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The European Centre for the Validation of Alternative Methods' (ECVAM) Scientific Advisory Committee (ESAC) endorsed the scientific validity of two in vitro skin irritation tests at its 29th meeting held in November 2008. Both models, SkinEthic RHE and EpiDerm SIT, are based on reconstructed human epiderms and measure or predict the same biological or toxic effect as the fully validated and accepted reference method.
The SkinEthic RHE model, a similar/me-too method, has been submitted to ECVAM as a non-ECVAM coordinated catch-up study. The test was confirmed by ECVAM as sufficiently similar with regard to its structural and functional characteristics, in reference to the Performance Standards, and the test method was admitted as a non-ECVAM coordinated catch-up validation study.
The EpiDerm SIT model, a modification of the previously validated EpiDerm method, has been submitted to ECVAM as a non-ECVAM coordinated update validation study. The main modification performed is the prolongation of the exposure time to the test substances from 15 to 60 min, while all other essential model parameters remained unchanged. The test method was admitted as a non-ECVAM coordinated update validation study.
Detailed information can be found on ECVAM's Web site. The agency notes that test methods submitted to, or validated by, ECVAM must be reviewed and endorsed by the group's advisory committee before they can be used within the regulatory framework.