Conventional Test Method:

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

Alternative Test Method:

Name & Description:

EpiDerm^TM (SIT)

In vitro skin model made up of human epidermal keratinocytes which have been cultured in chemically defined medium to produce a stratified, highly differentiated, organotypic tissue model of the human epidermis. Once EpiDerm^TM 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. (Modification of the previously validated EpiDerm method, with a prolongation of the exposure time to the test substance from 15 to 60 minutes.)

Validation Status:

EU: Endorsed as valid by ECVAM for prediction of R38 skin irritating and no-label (non-skin irritating) test substances (2008)

Regulatory Status:

OECD: TG 439 (2010)

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

Effect or Potential Effect on Animal Use:

Replacement

OR

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

References:

• ECVAM (2008) ESAC statement on the scientific validity of in vitro tests for skin irritation testing.
• OECD (2010) TG 439 In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Information Last Reviewed:

May 2012