September 5, 2024
Japan Tissue Engineering Co., Ltd.

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 andCEO: 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 comeinto 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 assessallergic 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 tomeet 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 knowhow concerning cell culture and other applications that we have amassed through these activities, weprovide 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 thehuman tissue and can be utilized as alternatives to animal testing in safety tests during thedevelopment of cosmetics and other daily commodities. The in vitro skin irritation test and in vitro skincorrosion test methods using EPI-MODEL24 and the in vitro eye irritation test method using CORNEAMODEL24 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 improvementof 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 ahuman 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 inOECD TG431. The in vitro eye irritation test using CORNEA-MODEL24 is listed in OECD TG492.

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022 Japan. https://www.jpte.co.jp/en

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(Reference: About J-TEC)
J-TEC is a maker of regenerative medical products. Our vision is “Creating a Future forRegenerative Medicine”, and we have been a member of the Teijin Group since March 2021.
As the top runner in Japan’s regenerative medicine industry, we provide a stable supply ofregenerative medical products, and of the regenerative medical products that have been approvedin Japan, the following five are J-TEC products.
ü Approved Oct. 2007: Autologous Cultured Epidermis JACE®
– Japan’s first regenerative medical productü Approved July 2012: Autologous Cultured Cartilage JACC®
– Japan’s first regenerative medical product in the orthopedics fieldü Approved March 2020: Autologous Cultured Corneal Epithelium NEPIC®
– Japan’s first regenerative medical product in the ophthalmology fieldü Approved June 2021: Autologous Cultured Oral Mucosal Epithelium OCURAL®
– The world's first regenerative medical product using oral mucosal epithelial cells
ü Approved March 2023: Autologous Cultured Epidermis Maintaining Melanocytes
JACEMIN.
– Second regenerative medical product in Japan in the skin field
Please visit www.jpte.co.jp/en/[Contact information for inquiries about this announcement]
Japan Tissue Engineering Co., Ltd.
E-mail. jtec-info@jpte.co.jp

Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022 Japan. https://www.jpte.co.jp/en2/2