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- Title
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).
- Authors
Mariko Sugiyama; Masaharu Akita; Nathalie Alépée; Miyuki Fujishiro; Shigenobu Hagino; Yuki Handa; Hidefumi Ikeda; Noriyasu Imai; Setsuko Jitsukawa; Masakazu Katoh; Koji Kurihara; Daiki Kyotani; Shigeyuki Nomura; Yuko Okamoto; Hidenobu Okumura; Takashi Omori; Kenji Sugibayashi; Hiroaki Todo; Akemi Toyoda; Yasuo Ohno
- Abstract
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.
- Subjects
SKIN tests; PROVOCATION tests (Medicine); DRUG efficacy; IRRITATION (Pathology); PHYSIOLOGICAL effects of chemicals
- Publication
Journal of Toxicological Sciences, 2018, Vol 43, Issue 12, p751
- ISSN
0388-1350
- Publication type
Article
- DOI
10.2131/jts.43.751