Validation study for in vitro skin irritation test using reconstructed human skin equivalents constructed by layer‐by‐layer cell coating technology
Validation study for in vitro skin irritation test using reconstructed human skin equivalents constructed by layer‐by‐layer cell coating technology
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利用层层细胞涂层技术构建的重建人体皮肤等效物进行体外皮肤刺激试验的验证研究
DOI：
10.1002/jat.4431
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发表时间：
2023
影响因子：
3.3
通讯作者：
Akashi Mitsuru
中科院分区：
文献类型：
--
作者：
Akagi Takami;Yamada Tomomi;Miyazaki Hiromi;Taguchi Hiroyuki;Ikeda Hidefumi;Katoh Masakazu;Mura Simona;Couvreur Patrick;Chetprayoon Paninee;Maniratanachote Rawiwan;Yoshida Hiroaki;Ajiro Hiroharu;Hashimoto Koji;Ashikaga Takao;Kojima Hajime;Akashi Mitsuru
本研究的目的是在一系列实验室间研究中使用通过逐层（LbL）方法（LbL‐3D Skin）制备的三维重建人表皮（RhE）皮肤等同物验证体外皮肤刺激试验（SIT）。这些验证研究的目的是评价该体外试验可靠区分皮肤刺激性和非刺激性化学品的能力，如OECD和UN GHS所定义。该替代确认研究旨在根据OECD TG 439的性能标准评估LbL‐3D皮肤SIT的实验室内和实验室间重现性以及预测能力。开发的皮肤模型LbL‐3D皮肤具有高度分化的表皮和真皮，与经验证的参考方法（VRM）和天然人类皮肤相似。质量参数（对照品中的细胞存活率、组织完整性和屏障功能）与VRM相似，符合OECD TG 439。LbL‐3D皮肤SIT确认研究由三个参与实验室进行，包括使用20种参比化学品进行的三项独立测试。使用LbL‐3D Skin获得的结果证明了实验室内和实验室间的高重现性，以及作为独立测定区分皮肤刺激物和非刺激物的高准确度。使用总共54种试验化学品的LbL‐3D皮肤SIT的预测效力与OECD TG 439中其他RhE模型的预测效力相当。验证研究表明，LbL‐3D Skin已被证明是预测皮肤刺激的稳健可靠方法。
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.
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逐层细胞涂层技术构建的 3D 成纤维细胞真皮对全层皮肤等效物紧密连接形成和功能的影响。
影响因子：
5.8
作者：
Masato Murakami;T. Akagi;Yumi Sasano;M. Akashi
通讯作者：
M. Akashi
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DOI：
--
发表时间：
2001
期刊：
Bioscience, biotechnology and biochemistry
影响因子：
--
作者：
Jae;Jun;Jae;H. Chang;Chan‐Wha Kim
通讯作者：
Chan‐Wha Kim
影响因子：
2.7
作者：
Kojima, Hajime;Ando, Yoko;Omori, Takashi
通讯作者：
Omori, Takashi
影响因子：
3.4
作者：
Han, Juhee;Kim, Seolyeong;Lim, Kyung-Min
通讯作者：
Lim, Kyung-Min
ECVAM 关于急性皮肤刺激体外测试的国际验证研究：EPISKIN 和 EpiDerm 测定以及皮肤完整性功能测试的有效性报告
DOI：
--
发表时间：
2007
期刊：
Alternatives to laboratory animals : ATLA
影响因子：
--
作者：
H. Spielmann;S. Hoffmann;M. Liebsch;P. Botham;J. Fentem;C. Eskes;R. Roguet;J. Cotovio;Thomas Cole;Andrew Paul Worth;J. Heylings;Penny Jones;C. Robles;Helena Kandarova;A. Gamer;M. Remmele;R. Curren;H. Raabe;A. Cockshott;I. Gerner;V. Zuang
通讯作者：
V. Zuang