Journal of Clinical & Experimental Dermatology Research
Open Access

Abstract

Risk Assessment of Cosmetics: KoCVAM's New Alternative Test Methods for Phototoxicity and Established Reference Chemical Database System for Skin Irritation

Nam-Hee Kang*

Background: The Korean Center for the Validation of Alternative Methods (KoCVAM) was established within Ministry of Food and Drug Safety (MFDS) in 2009. Since then, KoCVAM has been the leading validation center of alternative test methods in Korea and actively promoting the Three Rs principles and the utilization of alternative test methods. Additionally, the MFDS is the first government body in Korea to begin researching alternative methods to animal testing.

Method: Both skin irritation and phototoxicity test methods using KeraSkin^TM evaluate each toxicity by measuring cell viability as an endpoint of tissue death caused by test chemicals. Cell viability is determined using the MTT [3- (4,5-Dimethyl thiazol-2-yl)-2,5-diphenyltetrazolium bromide] assay by calculating the OD value of the tissues exposed to a test chemical compared to those exposed to the corresponding vehicle/negative control, which is set to 100 %.

Results: We have established RCDS-Skin Irritation and we evaluated 59 test chemicals across three RhE models and incorporated 95 test results into the Reference Chemical Database System (RCDS)-Skin Irritation. Additionally, we have established RCDS-Skin sensitization and RCDS-Eye irritation containg information on 396 and 514 test chemicals, respectively. The KeraSkin^TM Phototoxicity Assay demonstrated predictive performance with 100 % accuracy, 100 % sensitivity, and 100 % specificity.

Conclusion: KoCVAM has developed RCDS for Skin Irritation, Skin sensitization and Eye irritation. The‘KeraSkin^TM Phototoxicity Assay’ fulfills the requirements to be included in OECD TG498.

Published Date: 2024-11-27; Received Date: 2024-10-28