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

Abstract

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.

An in vitro depth of injury prediction model for a histopathologic classification of EPA and GHS eye irritants

“…Surfactants are typically water soluble and may be diluted by tearing. Most nonanimal tests dilute surfactants as a class prior to testing, including BCOP (OECD, 2017) and OptiSafe (Vij et al, 2019). For this assay, it may be that additional work as well as dilution are required to optimize the dosing procedures for surfactants.…”

In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

“…The Draize test evaluates changes to the cornea, conjunctiva, and iris and identifies irreversible and reversible effects. The test is accepted by the Organisation for Economic Cooperation and Development (OECD) as test guidance 405 (TG 405), is capable of separating all categories of ocular irritancy, and functions as a basis for the standardized GHS classification of ocular hazard assessment (OECD 2017a;Silk 2003). At present, the Draize eye irritation test has the largest database of ocular responses to various materials (Barroso et al 2017), although it is also one of the most criticized because of poor reproducibility, subjectivity, and cruelty to animals (Wilson et al 2015;Luechtefeld et al 2016).…”

“…The bovine corneal opacity and permeability (BCOP) assay and the isolated chicken eye (ICE) test are OECDaccepted eye irritation test methods included in test guidelines (TG), OECD TG 437 and OECD TG 438 (OECD 2017b;OECD 2018b). These models preserve normal physiological and biochemical functions for a short time (for up to a few days), but the assessment of toxicity with animal tissues has been criticized as not representative of the human eye and for its low-throughput nature (Barile 2010;Wilson et al 2015;Lee et al 2017)…”

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

“…[1][2][3] These DAs are DAL-1 for non-surfactant liquids combining physicochemical properties, reconstructed human cornea-like epithelium (RhCE) test method (OECD test guideline [TG] 492), and bovine corneal opacity and permeability (BCOP) test method (OECD TG 437); and DAL-2 for non-surfactant liquids combining short time exposure (STE) test method (OECD TG 491) and BCOP test method (OECD TG 437). [4][5][6] In both DAs, the BCOP laser lightbased opacitometer (LLBO) is used, as described within the OECD TG 437. 5 Both DAs have been shown to be useful for making predictions across the whole range of UN GHS categories, that is, category 1 (Cat.…”

“…[4][5][6] In both DAs, the BCOP laser lightbased opacitometer (LLBO) is used, as described within the OECD TG 437. 5 Both DAs have been shown to be useful for making predictions across the whole range of UN GHS categories, that is, category 1 (Cat. 1) on ''serious eye damage''; category 2 (Cat.…”