Validation of human skin models for skin corrosivity tests in Japan

Abstract

As shown in OECD test guidelines 430 and 431, the human skin epidermal assay and Transcutaneous Electrical Resistance Test (TER) were validated and peer reviewed as an alternative method to corrosivity testing; however, these methods have not been used widely in Japan. The problems related to techniques and evaluation are not clear. Therefore, we performed a validation study of EPI-200 (EpiDerm^TM), a 3-dimensional cultured epidermal model and Vitrolife-Skin^TM, a 3-dimensional cultured skin model made in Japan as a catch-up validation trial of alternatives for skin corrosivity testing using 13 chemicals including a positive control: 10% potassium hydroxide solution in Japan. From the obtained data, we identified the potential of utilizing these models to evaluate the corrosivity of a chemical.