Test No. 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants

This Test Guideline describes an in vitro assay that may be used for identifying water soluble ocular corrosives and severe irritants as defined by the UN Globally Harmonized System of Classification and Labelling, Category 1. The assay is performed in a well where a confluent monolayer of Madin-Dar...

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Detalles Bibliográficos
Autor principal: Organisation for Economic Co-operation and Development.
Autor Corporativo: Organisation for Economic Co-operation and Development (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Paris : OECD Publishing 2017.
Colección:OECD Guidelines for the Testing of Chemicals, Section 4,
Materias:
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009705931906719
Descripción
Sumario:This Test Guideline describes an in vitro assay that may be used for identifying water soluble ocular corrosives and severe irritants as defined by the UN Globally Harmonized System of Classification and Labelling, Category 1. The assay is performed in a well where a confluent monolayer of Madin-Darby Canine Kidney (MDCK) is used as a separation between two chambers. It uses a fluorescein dye as marqueur. The test substance has the potential to impair the junctions of the MDCK cells and thus to increase the monolayer¡¯s permeability. Consequently the fluorescein passes through the monolayer and the fluorescein leakage (FL) increases. The FL is calculated as a percentage of leakage relative to both a blank control and a maximum leakage control. The concentration of test substance that causes 20% FL (FL20, in mg/mL) is calculated and used in the prediction model for identification of ocular corrosive and severe irritants. The cut-off value of FL20 to identify water soluble chemicals as ocular corrosives/severe irritants is ¡Ü 100mg/mL. The FL test method should be part of a tiered testing strategy.
Notas:Bibliographic Level Mode of Issuance: Monograph
Descripción Física:1 online resource (16 pages)
ISBN:9789264185401