Overall performance of Bovine Corneal Opacity and Permeability (BCOP) Laser Light-Based Opacitometer (LLBO) test method with regard to solid and liquid chemicals testing. (February 2021)

• Record Type: Journal Article
• Authors: Adriaens, E.; Verstraelen, S.; Desprez, B.; Alépée, N.; Abo, T.; Bagley, D.; Hibatallah, J.; Mewes, K.R.; Pfannenbecker, U.; Van Rompay, A.R.
• Is Part Of: Toxicology in vitro. Volume 70(2021)
• Publication Date: 2021-02
• Subjects: ALT4EI ALTernatives for Eye Irritation -- BCOP Bovine Corneal Opacity and Permeability -- CAS RN Chemical Abstracts Service Registry Number -- Cat. 1 UN GHS/EU CLP classification for chemicals causing irreversible effects on the eye/serious damage to the eye -- Cat. 2 UN GHS/EU CLP classification for chemicals causing reversible effects on the eye/eye irritation, sub-categorised in 2A (irritant to eyes, eye effects are not fully reversible within 7 days of observation) and 2B (mildly irritant to eyes, eye effects fully reversible within 7 days of observation) -- CEFIC European Chemical Industry Council -- CC Conjunctival Chemosis -- CO Corneal Opacity -- CR Conjunctival Redness -- CON4EI CONsortium for in vitro Eye Irritation testing strategy -- DRD Draize eye test Reference Database -- EU CLP European Union Regulation on Classification, Labelling and Packaging of chemicals implementing UN GHS in the EU -- FNR False Negative Rate -- FPR False Positive Rate -- IATA Integrated Approach on Testing and Assessment -- IR iritis -- IRE Isolated Rabbit Eye -- IVIS In Vitro Irritation Score -- LIS LLBO Irritation Score -- LLBO Laser Light-Based Opacitometer -- NC Negative Control -- No Cat Chemicals not classified for serious eye damage or eye irritation under UN GHS/EU CLP -- NPCM No Stand-alone Prediction can be made -- OD Optical density -- OECD Organisation for Economic Co-operation and Development -- PC Positive Control -- pers. Persistence -- RhCE Reconstructed human Cornea-like Epithelium -- STE Short Time Exposure -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals -- VITO Flemish Institute for Technological Research; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2020.105044
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: A prospective study of the Bovine Corneal Opacity and Permeability (BCOP) Laser Light-Based Opacitometer (LLBO) test method was conducted to evaluate its usefulness to identify chemicals as inducing serious eye damage (Cat. 1) or chemicals not requiring classification for eye irritation (No Cat.) applying United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). The aim was to demonstrate the reproducibility of the BCOP LLBO protocol for liquids and solids and define its predictive capacity. Briefly, 145 chemicals were simultaneously tested with BCOP LLBO and OP-KIT (OECD TG 437), one to two times in one laboratory. When used to identify Cat. 1, the BCOP LLBO has a false negative rate (FNR) of 24.1% ( N = 56) compared to 34.8% (N = 56) for the BCOP OP-KIT, with a comparable false positive rate (FPR, N = 89) of 18.5% and 20.8%, respectively. When used to identify chemicals not requiring classification (No Cat.) the BCOP LLBO and BCOP OP-KIT had a FNR ( N = 104) of 6.2% and 7.2% and a FPR ( N = 41) of 45.1% and 42.7%, respectively. The OP-KIT and LLBO devices are interchangeable at no cost to data quality and reliability. The OP-KIT and LLBO devices are interchangeable at no cost to data quality and reliability. The performance of the LLBO is at least as good as the OP-KIT, both methods can be used to identify UN GHS Cat. 1 and UN GHS No Cat. chemicals. Highlights: Performance of the BCOP Laser Light-Based Opacitometer (LLBO) test method Test Method for Identifying Chemicals Inducing Serious Eye Damage Test Method for Identifying Chemicals Not Requiring Classification for Eye Irritation/Serious Eye Damage