SkinEthic RHE method categorises chemicals between corrosive subcategories and non-corrosive as stated in OECD TG431

SkinEthic Reconstructed Human Epidermis (RHE) method has been recently adopted in the Test Guideline OECD TG 431 (2014) in terms of sub-categorisation predictions leading to a significant impact on the sub-group transport package labeling. Tthe present study displays the results supporting this statement. In total 85 substances were tested in three independent runs. The results obtained were reproducible, as shown by the 92.5% concordance of classification between runs for discriminating corrosives versus non-corrosives, and the 87.5% concordance for discriminating the GHS subcategories versus non-corrosives. Moreover results confirmed a high sensitivity of the SkinEthic™ RHE method to predict corrosives (94.6%) and good specificity (= 73.7%).

Regarding the identification of UN GHS corrosive subcategories, when considering the 30 reference chemicals as recommended in OECD TG 431, an accuracy of 83.3% was achieved.

In conclusion, the SkinEthic RHE method is highly reproducible, sensitive for discriminating corrosives from non-corrosives and allows reliable identification of GHS subcategory 1B-and-1C substances. The test method is used as a stand-alone method for the detection or exclusion of corrosive effects of test chemicals. A negative result will require an additional in vitro skin irritation test, if not performed upfront, to determine if the chemical should be classified irritant.