To predict dermal irritation potential of test articles in the context of identification and classification of skin irritation hazard according to the European Union (EU) classification (R38 or no label), United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification system (Category 2 and non-irritants), and OECD Guideline for the Testing of Chemicals No. 439 -- In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method. This study is designed based on MatTek protocol in vitro EpiDermTM Skin Irritation Test.
Since the EU and GHS systems were harmonized in 2008, the procedure described in this protocol also allows for hazard identification of irritant substances in accordance with United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The Modified EpiDerm SIT allows discrimination between irritants of Category 2 and non-irritants. The test does not discriminate between non-mandatory subcategories of the UN GHS, i.e., it does not distinguish between GHS Category 2 and Category 3 irritants.