[Press Release, May 22, 2020 / unofficial translation] Toxicity Test Method Developed by Ministry of Food and Drug Safety Adopted as OECD Work Plan - Skin irritation test method that replaces animal test is officially adopted as “OECD Test Guidelines Development Project” - □ The Ministry of Food and Drug Safety (MFDS; Minister Lee, Eui-kyung) announced that KeraSkinTM SIT (Skin Irritation Test), which was developed domestically as a new alternative test method replacing animal tests, has been adopted as a work plan for the test guideline development program for toxicity testing by the Organization for Economic Cooperation and Development (OECD) and is scheduled to be reviewed by the OECD expert group for approval as an official OECD test guideline. ※ OECD: A policy coordination and cooperation organization consisting of 35 countries, including the Republic of Korea, the United States, Japan, and Germany ○ The Working Group of National Coordinators of the Test Guidelines program (WNT) held a meeting on April 21 to review 15 new or revised test methods proposed by the member countries, and the KeraSkinTM SIT proposed by the Korean Ministry of Food and Drug Safety was adopted as an OECD Test Guideline Development Project. ※ The Working Group of National Co-ordinators of the Test Guidelines Program (WNT) is in charge of operating the Test Guidelines Program and holds regular meetings every year to approve and manage the enactment and revision of test guidelines, and to authorize and manage new projects. ○ The KeraSkinTM SIT was developed to assess skin irritation potentials following exposure to a chemical using a reconstructed human epidermis model, KeraSkinTM*. * The KeraSkinTM model is a 3D-reconstructed human epidermis (RhE) model, which was developed with primary cultured human keratinocytes from residual foreskin after circumcision, and is similar to human skin epidermis in terms of morphological microstructure and biomarker expression. ○ The OECD has been working on standardization of the toxicity test methods for Mutual Accpetance of Data (MAD) of the test results that are produced in the process of the development of medicines and cosmetics, etc. As for now, 70 OECD test guidelines have been developed and are available in the OECD website. □ Minister Lee Eui-kyung said, "The adoption of the toxicity test method using a new RhE model developed domestically with our own technology as a work plan for OECD test guideline development program demonstrates that the international community has recognized Korea‘s outstanding expertise and competence in the field of toxicity. We will continue to make an effort to enhance the nation‘s profile internationally and to contribute to advance in standardization of test methods.