Article Dans Une Revue Journal of Applied Toxicology Année : 2023

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

Takami Akagi
Tomomi Yamada
  • Fonction : Auteur
Hiromi Miyazaki
  • Fonction : Auteur
Hiroyuki Taguchi
  • Fonction : Auteur
Hidefumi Ikeda
  • Fonction : Auteur
Masakazu Katoh
  • Fonction : Auteur
Simona Mura
Paninee Chetprayoon
  • Fonction : Auteur
Rawiwan Maniratanachote
  • Fonction : Auteur
Hiroaki Yoshida
  • Fonction : Auteur
Hiroharu Ajiro
  • Fonction : Auteur
Koji Hashimoto
  • Fonction : Auteur
Takao Ashikaga
  • Fonction : Auteur
Hajime Kojima
  • Fonction : Auteur
Mitsuru Akashi
  • Fonction : Auteur

Résumé

The 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.
Fichier non déposé

Dates et versions

hal-04348366 , version 1 (16-12-2023)

Identifiants

Citer

Takami Akagi, Tomomi Yamada, Hiromi Miyazaki, Hiroyuki Taguchi, Hidefumi Ikeda, et al.. Validation study for in vitro skin irritation test using reconstructed human skin equivalents constructed by layer‐by‐layer cell coating technology. Journal of Applied Toxicology, 2023, 43 (6), pp.874-886. ⟨10.1002/jat.4431⟩. ⟨hal-04348366⟩
14 Consultations
0 Téléchargements

Altmetric

Partager

More