Conventional Test Method:

Acute dermal irritation/corrosion (Draize rabbit skin irritation test) (OECD TG 404)

Alternative Test Method:

Name & Description:


A three-dimensional human skin model composed of a human collagen matrix and human keratinocytes. Once EPISKINTM is exposed to the test substance, irritability is identified as a decrease in cell viability (as determined by a dye-binding assay such as the MTT reduction assay) below defined threshold levels. Measuring production of inflammatory cytokines such as IL-1α using ELISA may also be used as a complementary endpoint to evaluate keratinocyte stress response.

Validation Status:

EU: Endorsed as valid by ECVAM for the prediction of both irritant and non-irritant substances (April 2007)

Regulatory Status:

OECD: TG 439 (2013)

EU: Test method B.46 in COM regulation 440/2008/EC (2008)

Effect or Potential Effect on Animal Use:



(When part of a tiered testing strategy that results in use of  fewer animals)

Information Last Reviewed:
June 2014