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

Adriaens, Els; Verstraelen, Sandra; Desprez, Bertrand; Alépée, Nathalie; Abo, Takayuki; Bagley, Daniel M.; Hibatallah, Jalila; Mewes, Karsten; Pfannenbecker, U.; Rompay, An R. Van

doi:10.1016/j.tiv.2020.105044

Cited by 7 publications

(21 citation statements)

References 14 publications

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“…The methods used in DAL-1 and DAL-2 encompass the following validated test methods: the Bovine Corneal Opacity and Permeability (BCOP) using the laser light-based opacitometer (LLBO) 1 according to the OECD TG 437, the Reconstructed human Cornea-like Epithelium (RhCE) according to the OECD TG 492 2 and the Short Time Exposure in vitro (STE) according to the OECD TG 491. Transferability, within-and between-laboratory reproducibility of these individual test methods have been assessed during their respective validation studies (16,17,18,19,20).…”

Section: Das and Use Scenarios Included In The Guidelinementioning

confidence: 99%

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Test No. 467: Defined Approaches for Serious Eye Damage and Eye Irritation

2024

OECD Guidelines for the Testing of Chemicals, Section 4

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Section: Das and Use Scenarios Included In The Guidelinementioning

confidence: 99%

“…2. However, previous data(20) showed that out of 22 in vivo No Cat. liquids, no liquid was mispredicted as Cat.…”

mentioning

confidence: 92%

Test No. 467: Defined Approaches for Serious Eye Damage and Eye Irritation

2024

OECD Guidelines for the Testing of Chemicals, Section 4

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“…1 by the BCOP LLBO. This assumption is based on BCOP LLBO data that were published by Adriaens et al 14 In total, BCOP LLBO data were available for 46 in vivo No Cat. chemicals (22 liquids and 24 solids).…”

Section: Performance Of Dal-1 and Dal-2 By Un Ghsmentioning

confidence: 99%

“…chemicals (22 liquids and 24 solids). 14 Only 1/46 (2.2%) chemicals, a solid, was predicted Cat. 1 based on the BCOP LLBO.…”

Section: Performance Of Dal-1 and Dal-2 By Un Ghsmentioning

confidence: 99%

Performance Statistics of Defined Approaches for Eye Hazard Identification of Non-Surfactant Liquids to Distinguish Between the Three United Nations Globally Harmonized System Categories

Alépée

Abo

Adriaens³

et al. 2021

Applied In Vitro Toxicology

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Introduction: Cosmetics Europe develops two defined approaches (DAs) for eye hazard identification, that is, addressing serious eye damage (Cat. 1), eye irritation (Cat. 2), and the absence thereof (No Cat.), for nonsurfactant liquid test substances. DAL-1 combines four physicochemical properties, the reconstructed human cornea-like epithelium (EpiOcularÔ eye irritation test [EIT]: VRM1 and SkinEthicÔ human corneal epithelium EIT: VRM2) test method (OECD test guideline [TG] 492), and bovine corneal opacity and permeability (BCOP) test method (OECD TG 437). DAL-2 combines the short time exposure test method (OECD TG 491) and the BCOP test method (OECD TG 437). In both DAs, the BCOP with the laser light-based opacitometer is used, however, only opacity is used to identify liquids that cause serious eye damage. Materials and Methods: The performance of the DAs to distinguish between the three United Nations Globally Harmonized System of Classification (UN GHS) categories was compared against the minimum performance values proposed by Cosmetics Europe to the Organisation for Economic Co-operation and Development expert Group on eye/skin irritation/corrosion and phototoxicity and agreed upon by the experts. Furthermore, the classspecific performance metrics are also provided for each DA. Results: The balanced accuracy of DAL-1 with validated reference method-EpiOcular EIT (VRM1), DAL-1 with validated reference method-SkinEthic HCE EIT (VRM2), and DAL-2 was 69.

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“…When test chemicals within certain chemical (i.e., alcohols, ketones) or physical (i.e., solids) classes are excluded from the database, the BCOP OP-KIT test method has an overall accuracy of 85% (n=131), a false positive rate of 20% (n=81), and a false negative rate of 8% (n=50) for the UN GHS classification system (3). The BCOP LLBO test method has an overall accuracy of 78% (n=145), a false positive rate of 21% (n=89), and a false negative rate of 24% (n=56), when compared to in vivo rabbit eye test method data classified according to the UN GHS classification system (12) (see Annex 2, Table 3). When test chemicals within certain chemical (i.e., alcohols, ketones) or physical (i.e., solids) classes are excluded from the database, the BCOP LLBO test method has an overall accuracy of 85% (n=55), a false positive rate of 17% (n=32), and a false negative rate of 13% (n=23) for the UN GHS classification system (12).…”

mentioning

confidence: 99%

Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

2023

OECD Guidelines for the Testing of Chemicals, Section 4

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The closeness of agreement between test method results and accepted reference values. It is a measure of test method performance and one aspect of "relevance." The term is often used interchangeably with "concordance", to mean the proportion of correct outcomes of a test method.Benchmark substance: A substance used as a standard for comparison to a test chemical. A benchmark substance should have the following properties; (i) a consistent and reliable source(s); (ii) structural and functional similarity to the class of substances being tested; (iii) known physical/chemical characteristics; (iv) supporting data on known effects, and (v) known potency in the range of the desired response.Bottom-Up Approach: step-wise approach used for a chemical suspected of not requiring classification for eye irritation or serious eye damage, which starts with the determination of chemicals not requiring classification (negative outcome) from other chemicals (positive outcome). Cornea:The transparent part of the front of the eyeball that covers the iris and pupil and admits light to the interior.Corneal opacity: Measurement of the extent of opaqueness of the cornea following exposure to a test chemical. Increased corneal opacity is indicative of damage to the cornea. Opacity can be evaluated subjectively as done in the Draize rabbit eye test, or objectively with an instrument such as an "opacitometer."Corneal permeability: Quantitative measurement of damage to the corneal epithelium by a determination of the amount of sodium fluorescein dye that passes through all corneal cell layers.Eye irritation: Production of changes in the eye following the application of a test chemical to the anterior surface of the eye, which are fully reversible within 21 days of application. Interchangeable with "Reversible effects on the eye" and with "UN GHS Category 2" (4). False negative rate:The proportion of all positive substances falsely identified by a test method as negative. It is one indicator of test method performance. False positive rate:The proportion of all negative substances that are falsely identified by a test method as positive. It is one indicator of test method performance.Hazard: Inherent property of an agent or situation having the potential to cause adverse effects when an organism, system or (sub) population is exposed to that agent.

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

Cited by 7 publications

References 14 publications

Test No. 467: Defined Approaches for Serious Eye Damage and Eye Irritation

Test No. 467: Defined Approaches for Serious Eye Damage and Eye Irritation

Performance Statistics of Defined Approaches for Eye Hazard Identification of Non-Surfactant Liquids to Distinguish Between the Three United Nations Globally Harmonized System Categories

Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

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