In Vitro Skin Irritation Assay with the LabCyte EPI-MODEL
LabCyte EPI-MODEL24 is a commercially available reconstructed human cultured epidermal model produced by Japan Tissue Engineering Co. Ltd., Japan. It consists of normal human epidermal keratinocytes whose biological origin is neonatal foreskin. The several validation studies of the in vitro skin irritation test method using LabCyte EPI-MODEL24 (LabCyte EPI-MODEL24 SIT) were conducted at three laboratories to assess both intra- and interlaboratory reproducibility as well as predictive capacity of this test method using set of coded test chemicals.
The results showed that the revised SOP of LabCyte EPI-MODEL24 SIT conformed more accurately to the classifications for skin irritation under UN GHS (United Nations, Globally harmonised system of classification and labelling of chemicals (GHS). Part 3: health and environmental hazards. New York/Geneva: United Nations Organisation, 2015), thereby highlighting the importance of an optimized rinsing operation for the removal of exposed chemicals in obtaining consistent results from in vitro skin irritation assays. The LabCyte EPI-MODEL24 is included in OECD TG 439 in vitro skin irritation: reconstructed human epidermis test method, which also provides information on the type of validation study used to validate the respective test methods (OECD, In vitro skin irritation-reconstructed human epidermis test method, test guideline, No. 439, 2015).
KeywordsReconstructed human cultured epidermal model Skin irritation In vitro OECD TG
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