Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8553885 | Toxicology in Vitro | 2018 | 35 Pages |
Abstract
Assessment of ocular irritancy is an international regulatory requirement in the safety evaluation of industrial and consumer products. Although many in vitro ocular irritation assays exist, alone they are incapable of fully categorizing chemicals. The objective of CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for eye irritation assessment that can lead to complete replacement of the in vivo Draize rabbit eye test (OECD TG 405). A set of 80 reference chemicals was tested with seven test methods, one method was the Slug Mucosal Irritation (SMI) test method. The method measures the amount of mucus produced (MP) during a single 1-hour contact with a 1% and 10% dilution of the chemical. Based on the total MP, a classification (Cat 1, Cat 2, or No Cat) is predicted. The SMI test method correctly identified 65.8% of the Cat 1 chemicals with a specificity of 90.5% (low over-prediction rate for in vivo Cat 2 and No Cat chemicals). Mispredictions were predominantly unidirectional towards lower classifications with 26.7% of the liquids and 40% of the solids being underpredicted. In general, the performance was better for liquids than for solids with respectively 76.5% vs 57.1% (Cat 1), 61.5% vs 50% (Cat 2), and 87.5% vs 85.7% (No Cat) being identified correctly.
Keywords
UN GHS classification for chemicals causing irreversible effects on the eye/serious damage to the eyeCONsortium for in vitro Eye Irritation testing strategyOECDDRDSlug Mucosal IrritationFPRContact periodFNRCON4EISMIUN GHSBACBenzalkonium chlorideMucus productiontest guidelineUnited Nations Globally Harmonized System of Classification and Labelling of ChemicalsOrganization for Economic Co-operation and DevelopmentPersPersistenceFalse positive rateFalse negative rateiritiscorneal opacityPositive controlnegative controlCONJCat 1Cat 2
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Authors
E. Adriaens, R. Guest, J.A. Sr., P. Fochtman, H. Kandarova, S. Verstraelen, A.R. Van Rompay,