It covers the evaluation of medical devices, cosmetic products or drug formulations for their potential for irritation and skin sensitization. This method is based on in vitro tissue culture testing as an alternative method without the use of experimental animals.
In this method, a reconstructed three-dimensional human skin model is used in the laboratory. Sample, Positive Control and Negative control groups are tested simultaneously. Cell viability in tissues after application is measured in spectrophotometer. A ratio of the number of viable cells in the sample to the number of viable cells in the negative control >50% indicates that the sample is not irritant.