KocVAM

KoCVAM-developed Alternative Method for Skin Irritation Tests
Approved as OECD Test Guideline

KeraSkin™ Skin Irritation Test (SIT), an alternative method to animal testing developed in Korea, was approved as an OECD Test Guideline (TG)

in the 33rd Working Group of National Coordinators of the Test Guidelines Programme (WNT)*, which was held from April 20 to 23, 2021.
 

KeraSkin™ SIT is a test method for evaluating skin irritation potential of chemicals based on KeraSkinTM model (Biosolution Co., Ltd.). KeraSkin™

is a 3D-reconstructed human skin epidermis model that is manufactured with keratinocytes originating from the human foreskin,

which is biochemically and morphologically similar to the human epidermis. KeraSkin™ SIT was proposed as an OECD work plan

following its validation study (project leader, Prof. Lim Kyung-Min) between 2018 and 2019 organized by KoCVAM. The method was proven to be scientifically valid

by the international peer review conducted between February and July in 2020.
 

The test guidelines approved by the WNT will be officially endorsed at the joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology,

which is scheduled for June. They are expected to be utilized in toxicity tests submitted to regulatory authorities of different countries. 
 

Thanks to the recent approval, the local GLP facilities and companies will be able to reduce the cost of skin irritation testing as they will be able to use the skin models

that are domestically developed and manufactured, instead of relying on imported ones. 
 

KoCVAM will organize workshops and training sessions regularly to help the domestic industry to widely utilize internationally approved alternative test methods.

We will continue to work hard to facilitate local development of alternative test methods and promote their use.
 

* Working Group of National Coordinators of the Test Guidelines Programme (WNT), represented by regulatory authorities of OECD member countries that adhere to Mutual Acceptance of Data (MAD),

 holds annual meetings to make decisions on TGs (i.e. approve and update TGs) and to decide on whether to include project proposals in the work plan.