神戸大学附属図書館デジタルアーカイブ
https://hdl.handle.net/20.500.14094/90005643

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メタデータID
90005643
アクセス権
open access
出版タイプ
Version of Record
タイトル
Comparative assessment of 24-hr primary skin irritation test and human patch test data with in vitro skin irritation tests according to OECD Test Guideline 439 (for quasi-drugs in Japan)
著者
Sugiyama, Mariko ; Akita, Masaharu ; Alepee, Nathalie ; Fujishiro, Miyuki ; Hagino, Shigenobu ; Handa, Yuki ; Ikeda, Hidefumi ; Imai, Noriyasu ; Jitsukawa, Setsuko ; Katoh, Masakazu ; Kurihara, Koji ; Kyotani, Daiki ; Nomura, Shigeyuki ; Okamoto, Yuko ; Okumura, Hidenobu ; Omori, Takashi ; Sugibayashi, Kenji ; Todo, Hiroaki ; Toyoda, Akemi ; Ohno, Yasuo
著者名
Sugiyama, Mariko
著者名
Akita, Masaharu
著者名
Alepee, Nathalie
著者名
Fujishiro, Miyuki
著者名
Hagino, Shigenobu
著者名
Handa, Yuki
著者名
Ikeda, Hidefumi
著者名
Imai, Noriyasu
著者名
Jitsukawa, Setsuko
著者名
Katoh, Masakazu
著者名
Kurihara, Koji
著者名
Kyotani, Daiki
著者名
Nomura, Shigeyuki
著者名
Okamoto, Yuko
著者名
Okumura, Hidenobu
著者ID
A0396
研究者ID
1000050318218
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=3e41a5a210f2b078520e17560c007669
著者名
Omori, Takashi
大森, 崇
オオモリ, タカシ
所属機関名
医学部附属病院
著者名
Sugibayashi, Kenji
著者名
Todo, Hiroaki
著者名
Toyoda, Akemi
著者名
Ohno, Yasuo
言語
English (英語)
収録物名
Journal of Toxicological Sciences
巻(号)
43(12)
ページ
751-768
出版者
The Japanese Society of Toxicology
刊行日
2018
公開日
2019-03-07
抄録
The Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) 439 is an in vitro test method of reconstructed human epidermis (RhE), which was developed for hazard identification of irritating chemicals in accordance with a primary skin irritation test using rabbits with 4-hr exposure. A regulation for quasi-drugs in Japan requires data from primary skin irritation tests using rabbits to undergo 24-hr exposure, and this is used as an evidence for 24-hr closed patch tests in humans. In this study with the same chemicals, primary skin irritation test data using rabbits undergoing 24-hr exposure and a 24-hr occlusive human patch test data were analyzed by comparing the results obtained with four test methods adopted in OECD TG 439. The performances of in vitro test methods showed a positive predictive value of 72.7-85.7% to predict the results of 24-hr primary rabbit skin irritation test knowing that its positive predictive value was 57.1% against humans only. The prediction factors of in vitro test methods were higher for the human patch test data with a sensitivity reaching 60 to 80%. Three surfactants gave false negatives in some of the RhE methods evaluated with the human patch test, but in each case, they were correctly classified as positive when evaluated at double concentration. Therefore, the approach of setting the margin to 2 was effective in eliminating false negatives. This suggests that in vitro test methods are useful for assessing skin irritation potential without animal testing for the application of quasi-drugs in Japan.
キーワード
Skin irritation
24-hr Human patch test
Reconstructed human epidermis
OECD TG 439
In vitro
Quasi-drugs
カテゴリ
医学部附属病院
学術雑誌論文
権利
© 2018 The Japanese Society of Toxicology
関連情報
DOI
https://doi.org/10.2131/jts.43.751