Verification and application of the rat skin transcutaneous electrical resistance test ( TER) as an alternative method to replace the animal skin corrosion test
10.3969/j.issn.1005-4847.2018.03.015
- VernacularTitle:一种体外皮肤腐蚀性试验替代方法的建立
- Author:
Feiya LUO
1
;
Luyong ZHANG
;
Shuxia XING
;
Gangli WANG
Author Information
1. 中国食品药品检定研究院
- Keywords:
transcutaneous electrical resistance;
TER;
skin corrosion;
animal alternative methods;
safety assessment;
ex vivo skin
- From:
Acta Laboratorium Animalis Scientia Sinica
2018;26(3):365-371
- CountryChina
- Language:Chinese
-
Abstract:
Objective In order to verify an alternative method for the skin corrosion test by using transcutaneous electrical resistance ( TER) test, and to optimize the implementation criteria in OECD TG 430 procedure. Methods According to the OECD TG 430 procedure, Wistar rat skin was used to test the TER values of 16 reference chemicals, and selected the most optimal standard via different implementation criteria. The program B was chosen to make inter-laboratory comparison between 5 laboratories by testing 11 chemicals, which were identified as the optimal standard. Results After the TER test, the result of corrosion test of 16 chemicals were accordant with the reference data ( Kappa value=0. 64). The program B was the most optimal implementation criteria, and the specificity was 66. 7% and sensitivity was 100%. There were no significant differences between the corrosion estimations of 5 laboratories, and the concordance rate of the 5 laboratories was 72. 7%. Conclusions Transcutaneous electrical resistance (TER) test is an feasible and efficient tool for skin corrosion testing, and may become a good interim test to replace the in vivo test with this ex vivo test in cosmetics chemical safety assessment, thus, to reduce the animal usage in our country.