Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8553893 | Toxicology in Vitro | 2018 | 50 Pages |
Abstract
Assessment of acute eye irritation potential is part of the international regulatory requirements for safety testing of chemicals. In the last decades, many efforts have been made in the search for alternative methods to replace the regulatory in vivo Draize rabbit eye test (OECD TG 405). Success in terms of complete replacement of the regulatory in vivo Draize rabbit eye test has not yet been achieved. The main objective of the CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for serious eye damage and eye irritation assessment that can lead to complete replacement of OECD TG 405. A set of 80 reference chemicals (e.g. balanced by important driver of classification and physical state), was tested with seven test methods. Based on the results of this project, three different strategies were suggested. We have provided a standalone (EpiOcular ET-50), a two-tiered and three-tiered strategy, that can be used to distinguish between Cat 1 and Cat 2 chemicals and chemicals that do not require classification (No Cat). The two-tiered and three-tiered strategies use an RhCE test method (EpiOcular EIT or SkinEthic⢠EIT) at the bottom (identification No Cat) in combination with the BCOP LLBO (two-tiered strategy) or BCOP OP-KIT and SMI (three-tiered strategy) at the top (identification Cat 1). For our proposed strategies, 71.1% - 82.9% Cat 1, 64.2% - 68.5% Cat 2 and â¥Â 80% No Cat chemicals were correctly identified. Also, similar results were obtained for the Top-Down and Bottom-Up approach.
Keywords
EU CLPRhCEreconstructed human cornea-like epitheliumCON4EIReference chemicalsSlug Mucosal IrritationCAS RNBCOPSTESMIHCEguidance documentEITEURLWntCONsortium for in vitro Eye Irritation testing strategyDRDOECDUN GHS classification for chemicals causing irreversible effects on the eye/serious damage to the eyeUN GHSEye irritation testTesting strategiesHuman corneal epitheliumNo CatOcular irritationBovine Corneal Opacity and Permeabilitytest guidelineChemical Abstracts Service Registry NumberUnited Nations Globally Harmonized System of Classification and Labelling of ChemicalsOrganisation for Economic Co-operation and DevelopmentPersPersistenceisolated chicken eyecorneal opacitynegative controlCat 1Cat 2Ice
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Authors
E. Adriaens, S. Verstraelen, N. Alépée, H. Kandarova, A. Drzewiecka, K. Gruszka, R. Guest, J.A. Sr., A.R. Van Rompay,