Test No. 491: Short Time Exposure In Vitro 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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doi:10.1787/9789264242432-en

Cited by 18 publications

(7 citation statements)

References 8 publications

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“… OECD = Organization for Economic Cooperation and Development; BCOP = Bovine Corneal Opacity and Permeability; LLBO = Laser-light based opacitometer; ICE = Isolated Chicken Eye; STE = Short Time Exposure; FNR = False-negative rate; FPR = False-positive rate. 1 = OECD, 2020b ; 2 = OECD, 2020a ; 4 = OECD, 2018 ; 5 = OECD, 2019b . …”

Section: Tablementioning

confidence: 99%

Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™)

Lebrun¹,

Chavez²,

Nguyen³

et al. 2023

Toxicology in Vitro

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Section: Tablementioning

confidence: 99%

Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™)

Lebrun¹,

Chavez²,

Nguyen³

et al. 2023

Toxicology in Vitro

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“…Currently, state-of-the-art tissue cultures are not only safe and reliable, but also consistently outperform animal tests in predicting human safety. Over the past decade, an increasing number of non-animal methods based on tissue engineering approaches have been incorporated into OECD test guidelines to assess skin irritation, eye irritation/burns, and skin sensitization potential, among others [38][39][40][41]. Non-animal methods are increasingly being used by agencies around the world for regulatory decisionmaking because they efficiently provide reliable information while reducing the use of animals.…”

Section: Tissue Engineeringmentioning

confidence: 99%

Track‐Etched Membranes for Drug Pharmaceutical Research

Cuanalo-Contreras,

Hogrebe,

Teichmann

et al. 2023

Chemie Ingenieur Technik

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Over the last decades, the incorporation of membranes into micro physiological systems used for pharmaceutical research and drug development has grown significantly. One example is the use of microporous track‐etched membranes in microfluidic systems like organs‐on‐a‐chip and cell culture inserts for tissue engineering. Tissue‐culture treated track‐etched membranes serve as excellent support for cell growth and efficient nutrient supply, with the added benefit of precise control of pore parameters, a critical pre‐requisite to achieve reproducible results. Here, we provide an overview of track‐etched membrane technology in the context of applications in drug discovery and development.

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“…[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.…”

Section: Introductionmentioning

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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Test No. 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

Cited by 18 publications

References 8 publications

Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™)

Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™)

Track‐Etched Membranes for Drug Pharmaceutical Research

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

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