کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5562686 | 1562704 | 2017 | 9 صفحه PDF | دانلود رایگان |
- The China EpiSkin⢠Skin Irritation Test was established with 45 chemicals.
- This test method showed good within-laboratory reproducibility.
- The predictive performance on 45 chemicals met the OECD TG 439 acceptance criteria.
- This work provided a solid scientific foundation for future validation in China.
- The validity of this method supports the promotion of alternative methods in China.
The in vitro EpiSkin⢠test method was validated in 2007 by the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) as a full replacement method for the Draize acute skin irritation test and adopted in the OECD Test Guideline 439 in 2009. Based on the EpiSkin⢠technology, the production of a reconstructed epidermis model has been established and standardized in China. The evaluation of the in vitro skin irritation test method using this EpiSkin⢠model produced in China was performed on a set of 45 chemicals. Good predictive capacity was obtained with 94% (n = 17) for sensitivity, 75% (n = 28) for specificity and 82% for accuracy. The accuracy of the included 20 OECD reference chemicals also met the OECD acceptance criteria, indicating that this testing method based on the EpiSkin⢠model produced in China can be used as a stand-alone test method to predict skin irritation. The availability and validity of in vitro epidermis model and testing method are of great significance for extending the applications of non-animal alternative testing methods in China.
Journal: Toxicology in Vitro - Volume 41, June 2017, Pages 159-167