title: An integrated testing strategy for in vitro skin corrosion and irritation assessment using SkinEthic™ Reconstructed Human Epidermis.
abstract: The SkinEthic™ Reconstructed Human Epidermis (RHE) method has been formally adopted for the regulatory assessment of skin irritation (OECD TG 439) and corrosion (OECD TG 431). Recently, the OECD adopted an Integrated Approach on Testing and Assessment (IATA) for skin corrosion and skin irritation (OECD GD 203), which provides guidance on the integration of existing and new information in a modular approach for classification and labelling. The present study aimed to evaluate the use of the SkinEthic™ RHE model within the proposed OECD IATA. Data on 86 substances were integrated in a bottom-up and top-down testing strategy to assess their capacity for EU CLP and UN GHS classifications. For EU CLP, strategies showed an accuracy of 84.8% to discriminate non-classified from classified substances, 94.4% to discriminate corrosive from non-corrosive substances, and 68.5% to discriminate the four (sub)-categories. For UN GHS, strategies showed an accuracy of 89.5% to discriminate non-classified from classified substances, 93.4% to discriminate corrosive from non-corrosive substances, and 74.2% to discriminate four GHS (sub)-categories (excluding Category 3). In conclusion, the integration of SkinEthic™ RHE irritation and corrosion data in a bottom-up and top-down testing strategy allows the classification of substances according to EU CLP and UN GHS.
authors.affiliation: L'Oréal Research & Innovation, Aulnay sous-Bois, France. Electronic address: nalepee@rd.loreal.com.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alépée
authors.affiliation: L'Oréal Research & Innovation, Aulnay sous-Bois, France.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Grandidier
authors.affiliation: Episkin SA, Lyon, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Tornier
authors.affiliation: L'Oréal Research & Innovation, Aulnay sous-Bois, France.
authors.forename: José
authors.initials: J
authors.lastname: Cotovio
mesh_terms: D000826:Animal Testing Alternatives; D002424:Caustics / Q000633:toxicity*; D004817:Epidermis / Q000187:drug effects*; D006801:Humans; D066298:In Vitro Techniques; D007509:Irritants / Q000633:toxicity*; D023422:Skin Irritancy Tests
chemical_list: D002424:Caustics; D007509:Irritants
keywords: EU Labelling and Packaging Regulation Classification; Integrated Approach on Testing and Assessment; OECD Test Guideline 431 and 439; Skin corrosion and irritation; SkinEthic™ Reconstructed Human Epidermis; United Nations Globally Harmonized System