Recently, the EU has accepted the in vitro skin irritation test using reconstituted human skin as stand alone test to determine the skin irritancy potential of a substance within a testing and evaluation strategy.

Substances will be applied to, and interact with three-dimensional multilayered in vitro tissues that closely approximate the biochemical and physiological properties of the upper parts of the human skin. Substances that are able to penetrate the stratum corneum by diffusion are possible cytotoxic to the cells in the underlying layers, which can be measured.

Validated methods for the in vitro skin irritation test, like EpiSkinTM are therefore now recommended as stand-alone replacement test method for the rabbit in vivo test for classifying GHS category 2 irritant substances.

Within the EU the acceptance of the in vitro skin irritation test is of high importance for REACH but also for the 7th Amendment of the European Cosmetics Directive in which alternative, non-animal tests must be used as soon as they have been validated.

The acceptance of in vitro alternatives by the EU is considered as a major step forward in toxicology in the replacement of animal testing.

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EU accepts in vitro alternative for the Draize test

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