KeraSkin™-VM: A novel reconstructed human epidermis model for skin irritation tests

- A new reconstructed human epidermis model, KearSkin™-VM was developed for in vitro SIT.
- The integrity and the barrier function of the KeraSkin™-VM models were examined similar to VRM.
- KearSkin™-VM was 95% (within lab reproducibility) which satisfies with OECD TG439 PS.
- KearSkin™-VM is proposed for a novel model in vitro SIT according to OECD TG439 PS.

Several alternative in vitro methods to evaluate skin irritants have been developed recently. In July 2010, OECD officially endorsed the validated reference method (VRM) that uses reconstituted human epidermis (RhE) models as replacements for the in vivo skin irritation test. This study evaluated the KeraSkin™-VM model, a novel human epidermis model that was reconstructed with Asian skin tissue using 20 reference chemicals according to the OECD TG 439 performance standard. The test chemicals were applied to the epidermal surface side for 45 min and then rinsed, and then incubated for 42 h post-treatment. An overall accuracy of 80%, sensitivity of 90% and specificity of 70% were obtained when the results from KeraSkin™-VM were compared with UN GHS categories, which was comparable to the EpiDerm™ Skin irritation test (SIT) rates. Furthermore, KeraSkin™-VM demonstrated good performance in terms of within-laboratory reproducibility and predictive capacity to screen skin irritants.