Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method
The test described in this Test Guideline allows the identification of corrosive chemical
substances and mixtures and it enables the identification of non-corrosive substances
and mixtures when supported by a weight of evidence determination using other existing
information. The test protocol may also provide an indication of the distinction between
severe and less severe skin corrosives. This Test Guideline does not require the use
of live animals or animal tissue for the assessment of skin corrosivity.
The test material (solid or liquid) is applied uniformly and topically to a three-dimensional
human skin model, comprising at least a reconstructed epidermis with a functional
stratum corneum. Two tissue replicates are used for each treatment (exposure time),
and for controls. Corrosive materials are identified by their ability to produce a
decrease in cell viability below defined threshold levels at specified exposure periods.
Coloured chemicals can also be tested by used of an HPLC procedure. The principle
of the human skin model assay is based on the hypothesis that corrosive chemicals
are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic
to the underlying cell layers.
Published on July 28, 2015Also available in: French