- Name & Description:
-
Human Skin Model Test (EPISKINTM, EpiDermTM and SkinEthicTM)
The substance is applied topically to a three-dimensional human skin model (such as EPISKINTM, EpiDermTM and SkinEthicTM) comprising at least a reconstructed epidermis with a functional stratum corneum. Corrosivity 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 at certain time points. The principle is that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers. Distinguishes between corrosive and non-corrosive substances, and may also provide an indication of how potent a corrosive substance is.
- Validation Status:
-
EU: EPISKINTM, EpiDermTM and SkinEthicTM endorsed as valid by ECVAM (1998, 2000, 2006)
US: EPISKINTM and EpiDermTM endorsed as valid by ICCVAM (2002)
- Regulatory Status:
-
OECD: TG 431 (EPISKINTM and EpiDermTM 2004; SkinEthicTM included retroactively in 2006; revised in 2013)
EU: EPISKINTM and EpiDermTM accepted for corrosivity testing (Method B.40 bis. in Annex of Commission Regulation 440/2008/EC) (2000, 2008)
US: Accepted for corrosivity testing as part of the integrated testing strategy for corrosivity/irritation
- Effect or Potential Effect on Animal Use:
-
Replacement (EU)
OR
Reduction (US)
(Substances identified as corrosive will not progress to animal test)
