Skin Irritation Test according to ISO 10993-10, REACH (EU Regulation) and OECD Guideline TG 431

The skin irritation test procedure detects possible skin irritating and skin damaging effects of medical devices, cosmetics, textiles and many other products. In the past skin irritation testing was performed using animal experiments (in vivo testing). A growing number of these in vivo tests have to be replaced by in vitro tests (animal-free testing) because of legal requirements of animal welfare. In the case of cosmetics all of these in vivo tests have to be replaced by in vitro test systems. These new in vitro test systems use epidermal 3D-skin cell culture models composed of recultivated human skin. The results of in vitro skin irritation testing provide quantitative data which allows for quantitative comparison of the skin irritating potential of different products or substances.

CYTOX only performs in vitro skin irritation testing procedures.

In the EU biological safety testing of chemicals has to be performed according to the REACH regulation (REACH = registration, evaluation and authorization of chemicals). The OECD guideline TG 431 describes in vitro skin corrosion testing procedures as appropriate test procedures to perform this biological safety testing for REACH.
Apart from complying with present regulations, the skin irritation and skin corrosion tests are also used to promote the product quality of medical devices or cosmetics. In the case of successful testing the products can be advertised as “animal-free tested for skin-tolerance”.

Please request an offer for skin irritation testing at info[at]