The epiCS® skin irritation test (SIT) method

Abstract

The epiCS® skin irritation test (SIT) method is based on epiCS®, a reconstructed human epidermis, produced with normal human keratinocytes. During production, these cells differentiate in a multilayered epidermis that serves as a model for human in vivo epidermis. For the epiCS® SIT method, the tissues are exposed to test substances for 20 min followed by a 42 h post-incubation period. Subsequently, the relative viability of the tissues is determined by an MTT assay and is used to differentiate between irritants and non-irritants. A me-too validation study of the epiCS® SIT method was conducted involving EURL ECVAM and the independent scientific peer reviewing by the EURL ECVAM Scientific Advisory Committee. With the positive ESAC opinion, the epiCS® SIT method will be proposed for incorporation into the OECD Test Guideline 439.