Shiseido and the Kao Group’s human Cell Line Activation Test (h-CLAT) has been adopted as a globally recognised official test method for skin sensitisation by the Organisation for Economic Co-operation and Development (OECD), providing an alternative to animal testing.
The h-CLAT test is said to be a world-first alternative method for skin sensitisation tests focusing on the in vitro replication of functions in immune cells. The method is said to give equally or more accurate results than current animal tests. In vitro tests also take around two weeks in total to analyse, less than the four weeks for an animal trial.
The test is also said to be cheaper than animal testing methods.
Human skin sensitisation tests are important to determine the safety of cosmetics, but difficult to replicate and measure due to the need for an immune response. The h-CLAT test measures the levels of two proteins on the surface of human acute leukaemia cell lines, which increase during an allergic response.
Offering a cost effective alternative, the h-CLAT method is expected to have a significant impact in the cosmetics industry. The test was validated with support from the European Commission and has been adopted as the OECD Test Guideline 442E.
The h-CLAT method is now being considered for testing quasi-drugs in Japan under the Ministry of Health, Labour and Welfare research grant. Alternative testing methods are also being considered for REACH in Europe.
Kao has been working to find alternatives to animal testing since the 1980s and its Short Time Exposure test method was adopted by the OECD as an alternative to the eye irritation test in 2015.