Korea Releases Two Guidelines for Animal Testing Alternative Methods

Takehome:

On Aug 31, 2018, Korean MFDS released two guidelines for animal testing alternative methods, which are 1) Guideline of in-Vitro Skin Corrosion for Cosmetics (Transcutaneous Electrical Resistance) 2) Guideline of Skin Sensitization for Cosmetics (Local Lymph Node Assay: Flow Cytometry Method, LLNA: BrdU-FCM).

These two guidelines include principles of the test, considerations and limitations, method of the test, approval requirements, result and report of the test.

In-Vitro Skin Corrosion for Cosmetics (Transcutaneous Electrical Resistance)

This method is used as an alternative method to evaluate the skin corrosion of cosmetic ingredients. It is based on rat skin transcutaneous electrical resistance testing, which utilizes harvested skin discs to identify corrosiveness which corresponds to a loss of normal stratum corneum integrity and barrier function in normal physiological settings. 

Skin Sensitization for Cosmetics (Local Lymph Node Assay: Flow Cytometry Method, LLNA: BrdU-FCM)

The LLNA is a skin sensitization test method used to measure the proliferation of murine local LNCs in response to topical exposure to chemicals. The LLNA: BrdU-FCM can be used to identify skin-sensitizing substances. 

Animal testing was the mainstay to evaluate the sensitizing and corrosive potential of chemical substances in the past. After the European Union imposed a blanket ban on animal testing of cosmetic ingredients in 2013, alternative in vitro tests to assess cosmetic ingredient inducement of skin sensitization has become increasingly popular. Korea is following global best practices and working towards a full phase out of animal testing and the acceptance of these two methods is a major step forward in realizing this goal.