Validation of human skin models for skin corrosivity tests in Japan

Hajime Kojima1,6, Tomoko Ando2, Katsuhiro Inagaki3, Mahito Ohhira4, Tadashi Kosaka5, Yosuke Nakamura7, Hisashi Torishima8, Noriyuki Morikawa9, Jun Kanno2, Mami Kuboki4, Michiru Genno8, Masaru Nokata3, Takanori Harada5, Takashi Morimoto7, Isao Yoshimura10and Yasuo Ohno11

1Japanese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences (NIHS), 2Div. Cellular and Molecular Toxicol. NIHS, 3Res. & Develop., Div., Product Safety & Pharmaceutical Research Unit, Nihon Nohyaku Co., Ltd., 4 Toxicol. Res. Dep.,ODAWARA Res. Center, Nippon Soda Co.,Ltd., 5Toxicol. Div. The Inst. Environ. Toxicol., 6Res.Lab., Nippon Menard Cosmetic Co., Ltd., 7Environ. Health Sci. Lab., Sumitomo Chemical Co., Ltd., 8Bio-Medical Dep., Kurabo Industries Ltd., 9Div. R&D, Gunze Ltd., 10Fac. Eng. Tokyo Univ.Science, 11NIHS

AATEX 13(1):36-44, 2008

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 (EpiDermTM), a 3-dimensional cultured epidermal model and Vitrolife-SkinTM, 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.

Key words: Skin corrosivity, cultured epidermal model, cultured skin model, validation


(AATEX: Altern. Animal Test. EXperiment.: Alternatives to Animal Testing and EXperimentation)