CON4EI: Development of testing strategies for hazard identification and labelling for serious eye damage and eye irritation of chemicals. (June 2018)

• Record Type: Journal Article
• Authors: Adriaens, E.; Verstraelen, S.; Alépée, N.; Kandarova, H.; Drzewiecka, A.; Gruszka, K.; Guest, R.; Willoughby, J.A.; Van Rompay, A.R.
• Is Part Of: Toxicology in vitro. Volume 49(2018)
• Page Start: 99
• Page End: 115
• Publication Date: 2018-06
• Subjects: BCOP bovine corneal opacity and permeability -- BCOP LLBO bovine corneal opacity and permeability laser light-based opacitometer -- CAS RN chemical abstracts service registry number -- Cat 1 UN GHS classification for chemicals causing irreversible effects on the eye/serious damage to the eye -- Cat 2 UN GHS classification for chemicals causing reversible effects on the eye/eye irritation, sub-catagorised in 2A (irritant to eyes, eye effects are not fully reversible within 7 days of observation) and 2B (mild irritant to eyes, eye effects fully reversible within 7 days of observation) -- CO corneal opacity -- CON4EI CONsortium for in vitro eye irritation testing strategy -- DRD Draize eye test reference database -- EIT Eye irritation test -- EU CLP EU classification, labeling and packaging regulation -- EpiOcular ET-50 EpiOcular time to toxicity test -- EpiOcular EIT EpiOcular eye irritation test -- EURL ECVAM European Union reference laboratory for alternatives to animal testing -- GD guidance document -- HCE Human Corneal Epithelium -- ICE Isolated Chicken Eye -- NC negative control -- No Cat chemicals not classified for serious eye damage/eye irritation under GHS/EU CLP -- No Pred no prediction can be made -- OECD Organisation for Economic Co-operation and Development -- pers persistence -- RhCE Reconstructed human Cornea-like Epithelium -- SkinEthic™ HCE EIT SkinEthic™ Human Corneal Epithelium Eye irritation Test -- SMI Slug Mucosal Irritation -- STE Short Time Exposure -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals -- WNT Working Group of the National Coordinators; CON4EI -- Ocular irritation -- Reference chemicals -- Draize rabbit eye test -- Testing strategies -- UN GHS categories; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2017.09.008
• Languages: English
• ISSNs: 0887-2333

Abstract

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 ≥ 80% No Cat chemicals were correctly identified. Also, similar results were obtained for the Top-Down and Bottom-Up approach. Highlights: CON4EI: CONsortium for in vitro Eye Irritation testing strategy (TS) develop TS for assessment of serious eye damage/eye irritation 80 reference chemicals balanced by driver of classification and physical state Seven test methods were evaluated. Proposed TS's: a standalone, a two-tiered and three-tiered strategy