Conventional Test Method:

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

Alternative Test Method:

Name & Description:

SkinEthic^TM RHE (Reconstituted Human Epidermal) model

This model consists of normal, human epidermal keratinocytes cultured to form a multi-layer, well differentiated model of the human epidermis in vitro. Features a functional permeability barrier which is a main function of human skin. Once SkinEthic^TM is exposed to the test substance, irritability is identified as a decrease in cell viability (as determined by a dye-binding MTT assay) below defined threshold levels.

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