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Test No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

2015; Organization for Economic Cooperation and Development; Linguagem: Inglês

10.1787/9789264242548-en

2074-5788

Animal testing and alternatives

© OECD, (2024)2 GHS (1), and the test methods were recommended as scientifically valid for that purpose.Annexes II-VII provide a synopsis of the important elements of the test methods, as well as flowcharts providing guidance for specific situations. 5.The test method(s) described in this Test Guideline cannot be used on their own to replace the in vivo Draize eye test to predict across the full range of serious eye damage/eye irritation responses for different chemical classes.It is therefore recommended to make use of alternative testing strategies such as those described in TG 467 and 492B to address the required ranges of irritation potential.Strategic combinations of several alternative test methods within (tiered) testing strategies such as the Bottom-Up/Top-Down approach may be able to fully replace the Draize eye test (19).The Bottom-Up approach is designed to be used when, based on existing information, a chemical is expected not to cause sufficient eye irritation to require a classification, while the Top-Down approach is designed to be used when, based on existing information, a chemical is expected to cause serious eye damage.The EpiOcular™ EIT, SkinEthic™ HCE EIT, LabCyte CORNEA-MODEL24 EIT, and MCTT HCE TM EIT are recommended to identify chemicals that do not require classification for eye irritation or serious eye damage according to UN GHS (UN GHS No Category) (1) without further testing, within a testing strategy such as the Bottom-Up/Top-Down approach suggested by Scott et al. e.g., as an initial step in a Bottom-Up approach or as one of the last steps in a Top-Down approach.However, the EpiOcular™ EIT, SkinEthic™ HCE EIT, LabCyte CORNEA-MODEL24 EIT, and MCTT HCE TM EIT are not intended to differentiate between UN GHS Category 1 (serious eye damage) and UN GHS Category 2 (eye irritation).This differentiation will need to be addressed by another tier of a test strategy (3).A test chemical that is identified as requiring classification for eye irritation/serious eye damage with EpiOcular™ EIT, SkinEthic™ HCE EIT, LabCyte CORNEA-MODEL24 EIT or MCTT HCE TM EIT will thus require additional testing (in vitro and/or in vivo) to reach a definitive conclusion (UN GHS No Category, Category 2 or Category 1), using e.g., TG 437, 438, 460, 491, or as a last option TG 405. 6.The purpose of this Test Guideline is to describe the procedure used to evaluate the eye hazard potential of a test chemical based on its ability to induce cytotoxicity in a RhCE tissue construct, as measured by the tetrazolium dye {TD; e.g., ,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide; Thiazolyl blue tetrazolium bromide; CAS RN 298-93-1] for VRM1 and VRM2, WST-8 [2-(2methoxy-4-nitrophenyl)-3-(4-nitrophenyl)-5-(2,4-disulfophenyl)-2H-tetrazolium, monosodium salt; CAS RN 193149-74-5] for LabCyte CORNEA-MODEL24 EIT, or WST-1 [4-[3-(4-Iodophenyl)-2-(4-nitrophenyl)-2H-5-tetrazolio]-1,3-benzene disulfonate; CAS RN 150849-52-8] for MCTT HCE™ EIT} assay (20)(21)(22) (see paragraph 23).The viability of the RhCE tissue following exposure to a test chemical is determined in comparison to tissues treated with the negative control substance (%viability), and is then used to predict the eye hazard potential of the test chemical. 7.Performance Standards ( 23) are available to facilitate the validation of new or modified in vitro RhCE-based test methods similar to EpiOcular™ EIT, SkinEthic™ HCE EIT, LabCyte CORNEA-MODEL24 EIT, and MCTT HCE™ EIT, in accordance with the principles of Guidance Document No. 34 (24), and allow for timely amendment of this Test Guideline for their inclusion.Mutual Acceptance of Data (MAD) will only be guaranteed for test methods validated according to the Performance Standards, if these test methods have been reviewed and included in this Test Guideline by the OECD. 8.Definitions are provided in Annex I.ULOQ: Upper Limit of Quantification.United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS): A system proposing the classification of chemicals (substances and mixtures) according to standardised types and levels of physical, health and environmental hazards, and addressing corresponding communication elements, such as pictograms, signal words, hazard statements, precautionary statements and safety data sheets, so that to convey information on their adverse effects with a view to protect people (including employers, workers, transporters, consumers and emergency responders) and the environment (1).UN GHS Category 1: See "Serious eye damage".UN GHS Category 2: See "Eye irritation".UN GHS No Category: Chemicals that do not meet the requirements for classification as UN GHS Category 1 or 2 (2A or 2B).Interchangeable with "Not Classified".UPLC: Ultra-