July 15, 2022
Japan Tissue Engineering Co., Ltd.

Toward creation of a database for results of skin irritation tests
using an alternative to animal testing– With a grant from JSAAE, 6 corporations continue contributing jointly to the cosmetics industry –Japan Tissue Engineering Co., Ltd. (“J-TEC”, headquarters in Gamagori, Aichi, Japan; President &CEO, Ken-ichiro Hata) manufactures and markets the reconstructed three-dimensional human skinmodels for a skin irritation test. With a focus on the skin irritation that is one of the safety evaluation
items, a total of 6 companies – J-TEC together with Mandom Corp., Kobayashi Pharmaceutical Co.,
Ltd., Nihon Kolmar Co., Ltd., ROHTO Pharmaceutical Co., Ltd., etc. – have been striving to expand
data on alternatives to animal testing and enrich testing conditions. The results of this research werepresented in a poster presentation at the 49th Annual Meeting of the Japanese Society of Toxicology
held from June 30, 2022 (Thursday) to July 2, 2022 (Saturday) at Sapporo Convention Center.
Having been awarded the “8th Research Grant on the Evaluation of Testing Methods for Ensuring theSafety of Cosmetics, etc.”, the 6-company group is proceeding with the further expansion of data andthe creation of a database of the test results and findings obtained, to continue contributing to thecosmetics industry.
1. Background, results, and future development of the 6-company joint enterpriseUse of safety testing through alternatives to animal testing is now advancing in the cosmetics
industry, but information published in scientific journals or by public institutions is limited. Moreover,there is little information on the ingredients of quasi-drugs and cosmetics, and individual companies
tend to keep the results they have obtained independently confidential.
Similarly, in OECD TG439*, which is listed in “Guidance on the System for Evaluating Skin Irritationin the Evaluation of the Safety of Quasi-Drugs and Cosmetics (PSEHB/PED Notification No. 04223)” issued by the Ministry of Health, Labour and Welfare on April 22 of last year, there is still little
usable information on the raw ingredients of cosmetics, and expansion of test data and enrichmentof testing conditions, etc., will be needed in order to promote its utilization in safety testing.
This is why the 6 companies have jointly tested 16 ingredients commonly used in cosmetics, using
reconstructed three-dimensional human skin model EPI-MODEL24 (Fig. 1, left), a J-TEC product.
Through testing and verification by multiple companies, it has been possible to obtain reliable datathat will be instructive to companies in the cosmetics industry when they use this testing method insafety testing. (Fig. 1, blue circle)
Moreover, it was found that even with ingredients and concentrations that are judged to be nonirritant by EPI-MODEL24 (a reconstructed three-dimensional human skin model assuming normalskin), there are cases in which they would be found irritant in a reconstructed three-dimensional
human skin model of skin with a thin stratum corneum (Fig., 1, right), such as in sensitive skin. (Fig.
2, red circle) This suggests that by using a reconstructed three-dimensional human skin model
assuming sensitive skin, it would be possible to evaluate the risk associated with cosmetic
ingredients (probability and degree of irritation).
Findings that could be used to improve the dilution concentration of ingredients, solvents, and othertesting conditions, as well as the sensitivity of irritant detection, were also obtained.
These activities will be continued with the “8th Research Grant on the Evaluation of Testing
Methods for Ensuring the Safety of Cosmetics, etc.” sponsored by the Japanese Society for
Alternatives to Animal Experiments. With this grant, the 6 companies plan to proceed with thefurther expansion of effective data and the creation of a database that can also be used by othercompanies that were not involved in the joint research for the development of the cosmetics industry.
The 6 companies aim to connect further expansion of findings to the continued provision of safe
Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan. URL: https://www.jpte.co.jp

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products that consumers can use with peace of mind.
Fig. 1. Reconstructed three-dimensional human skin model
Product name
Listed in OECD TG439

Figure of tissue
sectionTransepidermal water loss

Low

High

Barrier function

HighLow

Skin condition

Assuming ordinary skin condition

Assuming sensitive skin condition

Fig. 2. Example results of skin irritation test of preservative ingredient
Normal skin condition
Sensitive skin condition

Cell survival rate (%)

Non-irritant

IrritationlevelIrritant

Ethyl hexyl glycerin

Propyl paraben

Phenoxy ethanol

Methyl paraben

2. J-TEC’s efforts to promote the spread of alternatives to animal testing
J-TEC has applied the advanced culturing technology accumulated through the regenerative
medical products of cultured epidermis and cultured cartilage to develop, manufacture, and market
cultured human tissue for research use. This is a reconstructed tissue model using human cells
cultured outside the body. It can be applied to various experiments as an alternative to animals andsimple cultured cells as it can replicate a structure that is extremely close to human tissue.
Reconstructed three-dimensional human skin model EPI-MODEL24 is a product that is listed inOECD TG431 (Skin Corrosion Test) and OECD TG439 (Skin Irritation Test). J-TEC will go on
contributing to the spread of alternatives to animal testing by making efforts to expand the marketfor this product.
* OECD TG439: The Organisation for Economic Co-operation and Development (OECD) adopted in vitro method forskin irritation “Test method using Reconstructed human Epidermis (RhE)” as OECD Test Guideline (TG) 439.

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

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(Reference: About J-TEC)
J-TEC is a maker of regenerative medical products whose corporate vision is “creating a futurefor regenerative medicine,” and has been a member of the Teijin Group since March 2021. As
Japan’s top runner in regenerative medicine, J-TEC obtained marketing approval for autologous
cultured epidermis “JACE”, Japan’s first regenerative medical product, in October of 2007, andbegan marketing the product in January of 2009. J-TEC then went on to obtain marketing approvalfor Autologous Cultured Cartilage “JACC” in July of 2012, for Autologous Cultured Corneal
Epithelium “Nepic” in March of 2020, and for Autologous Cultured Oral Mucosal Epithelium “Ocural”
in June 2021. “JACC” was Japan’s first regenerative medical product for use in orthopedic surgery,and “Nepic” was the first for use in ophthalmology. Of the 16 regenerative medical products thathave been approved in Japan, four are J-TEC products.

[Contact information for inquiries about this announcement]
Japan Tissue Engineering Co., Ltd.
TEL0533-66-2020
E-mail jtec-info@jpte.co.jp

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

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