Validation study for in vitro skin irritation test using reconstructed human skin equivalents constructed by layer‐by‐layer cell coating technology

Author:

Akagi Takami1ORCID,Yamada Tomomi2,Miyazaki Hiromi3,Taguchi Hiroyuki4,Ikeda Hidefumi5,Katoh Masakazu6,Mura Simona7ORCID,Couvreur Patrick7,Chetprayoon Paninee8,Maniratanachote Rawiwan8,Yoshida Hiroaki9,Ajiro Hiroharu9,Hashimoto Koji10,Ashikaga Takao11,Kojima Hajime11,Akashi Mitsuru1

Affiliation:

1. Graduate School of Frontier Bioscience Osaka University Suita Japan

2. Department of Medical Innovation Osaka University Hospital Suita Japan

3. National Defense Medical College Research Institute Tokorozawa Japan

4. Kao Corporation Tokyo Japan

5. Mandom Corporation Osaka Japan

6. Japan Tissue Engineering Co., Ltd Gamagori Japan

7. Institut Galien Paris‐Sud Paris France

8. National Science and Technology Development Agency Pathum Thani Thailand

9. Nara Institute of Science and Technology Nara Japan

10. Ehime Prefectural University Of Health Sciences Tobe Ehime Japan

11. National Institute of Health Sciences Kawasaki Japan

Abstract

AbstractThe aim of this study is to validate an in vitro skin irritation test (SIT) using three‐dimensional reconstructed human epidermal (RhE) skin equivalents prepared by layer‐by‐layer (LbL) method (LbL‐3D Skin) in a series of interlaboratory studies. The goal of these validation studies is to evaluate the ability of this in vitro test to reliably discriminate skin irritant from nonirritant chemicals, as defined by OECD and UN GHS. This me‐too validation study is to assess the within‐ and between‐laboratory reproducibility, as well as the predictive capacity, of the LbL‐3D Skin SIT in accordance with performance standards for OECD TG 439. The developed skin model, LbL‐3D Skin had a highly differentiated epidermis and dermis, similar to the validated reference methods (VRM) and native human skin. The quality parameters (cell survival in controls, tissue integrity, and barrier function) were similar to VRM and in accordance with OECD TG 439. The LbL‐3D Skin SIT validation study was performed by three participating laboratories and consisted of three independent tests using 20 reference chemicals. The results obtained with the LbL‐3D Skin demonstrated high within‐laboratory and between‐laboratory reproducibility, as well as high accuracy for use as a stand‐alone assay to distinguish skin irritants from nonirritants. The predictive potency of LbL‐3D Skin SIT using total 54 test chemicals were comparable to those in other RhE models in OECD TG 439. The validation study demonstrated that LbL‐3D Skin has proven to be a robust and reliable method for predicting skin irritation.

Publisher

Wiley

Subject

Toxicology

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