News release

The In Vitro Skin Sensitization Test Method EpiSensA Using the Human 3-Dimensional Cultured Tissue Model LabCyte EPI-MODEL24 Becomes an International Standard

Japan Tissue Engineering Co., Ltd. (Headquarters: Gamagori, Aichi Prefecture; President and CEO: Ken-ichiro Hata) is pleased to announce that the in vitro skin sensitization test method EpiSensA, which Kao Corporation has developed by using Japan Tissue Engineering's human 3-dimensional cultured tissue model LabCyte EPI-MODEL24, has been listed (standardized) in the Organization for Economic Cooperation and Development Test Guidelines (OECD TG442D)^*1.

In vitro skin sensitization tests assess the risk of chemicals inducing skin allergies when they come into contact with the skin. In recent years, moves have been accelerating worldwide to use alternatives to animal testing in the research and development of cosmetics, chemicals, drugs, medical devices, agricultural chemicals, etc. Particularly, there is an immense need for sensitization tests to assess allergic reactions, and the market for these tests is expected to expand. EpiSensA, which uses LabCyte EPI-MODEL24, is an in vitro skin sensitization test method developed by Kao Corporation. It is a test method for evaluating skin sensitization potential of chemicals that has been recognized to meet the OECD TG442D criteria. It was the first time in the world for an in vitro skin sensitization test method using human 3-dimensional cultured tissue model to be standardized.

We develop, manufacture, and market regenerative medical products, such as autologous cultured epidermis and autologous cultured cartilage for medical use. Leveraging the technologies and know-how concerning cell culture and other applications that we have amassed through these activities, we provide the cultured human tissue for research use LabCyte (epidermal model and corneal model). The LabCyte series products are widely used because they reproduce a structure closely similar to the human tissue and can be utilized as alternatives to animal testing in safety tests during the development of cosmetics and other daily commodities. The in vitro skin irritation test and in vitro skin corrosion test methods using EPI-MODEL24 and the in vitro eye irritation test method using CORNEA-MODEL24 are listed in the OECD Test Guidelines^*2.

We will continue to promote the use of alternatives to animal testing by providing the LabCyte series products and to support the development efforts of domestic and overseas manufacturers of daily commodities, drugs, cosmetics, chemicals, etc. that deal with a wide variety of chemical substances. We also aim to contribute to the further development of regenerative medicine and the improvement of the quality of life (QOL) of patients.

*1 The Organization for Economic Cooperation and Development Test Guidelines are intended for the Organization for Economic Cooperation and Development (OECD) to internationally standardize test methods to assess the properties and safety of chemicals. OECD TG442D describes a test method to assess the sensitization of chemicals by using a human skin model designed to closely resemble the biochemical and physiological characteristics of the human skin. For details, visit the website of the OECD.
*2 The in vitro skin irritation test using EPI-MODEL24 is listed in OECD TG439, and the in vitro skin corrosion test in OECD TG431. The in vitro eye irritation test using CORNEA-MODEL24 is listed in OECD TG492.

News Release on EpiSensA (PDF)

LabCyte: Human 3-Dimensional Cultured Tissue Model
https://www.jpte.co.jp/en/business/LabCyte/