IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II

IVD EIT 用于检测眼部刺激物的非动物试剂盒和服务：第二阶段

• 批准号: 10699287
• 负责人: Stewart Lebrun
• 金额: $ 87.8万
• 依托单位: LEBRUN LABS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-10 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699287
• 关键词: Address; Animal Sources; Animal Testing; Animals; Area; Benchmarking; Biological Assay; Biological Markers; California; Categories; Cell Death; Cell Survival; Chemicals; Classification; Code; Cornea; Corrosives; Dangerousness; Data; Detection; Development; Diagnostic Reagent Kits; Dose; Ensure; European Union; Eye; Eye Injuries; Feasibility Studies; Felis catus; Food; Future; Generations; Goals; Grant; Hazardous Chemicals; Hour; In Vitro; Incubated; Industry; Irritants; Label; Laws; Liquid substance; Manufacturer; Measures; Methods; Oryctolagus cuniculus; Performance; Phase; Preparation; Procedures; Process; Product Labeling; Protocols documentation; Refrigeration; Research; Safety; Sampling; Sensitivity and Specificity; Services; Small Business Innovation Research Grant; Solid; Specificity; Standardization; Statutes and Laws; Surface; Testing; United States; commercialization; consumer product; improved; in vitro testing; in vivo; irritation; manufacture; phase 1 study; predictive modeling; prevent; retinal toxicity; safety testing; success; surfactant; timeline; tool; validation studies

Abstract Currently, the Draize live rabbit eye test is the benchmark to distinguish consumer products and materials that are safe from those that are hazardous and can cause mild, moderate, or severe ocular damage. However, new laws are currently being, or are planned to be, implemented in California, the United States, and the European Union to ban the use of animals for ocular irritation testing. Despite this fact, there is currently no single nonanimal test or combination of nonanimal tests that can accurately classify all levels of ocular irritants and corrosives. It is of particular concern that all nonanimal tests generally overpredict the least damaging class of ocular irritants and cannot determine (or determine with low sensitivity) the most extreme class for which they have sensitivity rates as low as 50%. More importantly, none of the currently validated alternative tests can detect irritants that require proper safety labeling (GHS Cat. 2A) or those that cause irritation that lasts up to 21 days but then clears without causing permanent corneal damage. This target classification represents a critical UNMET NEED for correctly informing and advising consumers and manufacturers about product safety. We have recently developed and tested a new method, the in vitro depth of injury eye irritation test (IVD EIT), to detect all classes of irritants with high sensitivity and specificity. The purpose of this application is to further develop the IVD EIT with the long-term goal of providing a service and/or kit for the accurate classification of ocular irritants to meet this UNMET NEED for a nonanimal ocular irritation test to be used to label product and chemicals and hence ensure safe handling practices. 1

抽象的 目前，Draize活兔眼测试是区分消费产品和材料的基准 可以免受危险的危害，并可能造成轻度，中度或严重的眼部损害。然而， 目前正在加利福尼亚州，美国和计划实施新法律 欧盟禁止使用动物进行眼部刺激测试。尽管这一事实，目前没有 单次非反应测试或非动物测试的组合，可以准确地对所有级别的眼部刺激物进行分类 和腐蚀剂。特别令人担忧的是，所有非动物测试通常都过度预测是最小破坏的 眼部刺激物类别，无法确定（或低灵敏度）最极端的类别 他们的灵敏度率低至50％。更重要的是，当前验证的替代方案都没有 测试可以检测需要适当安全标签的刺激物（GHSCAT。2A）或引起刺激的刺激物 持续长达21天，但随后清除而不会造成永久性的角膜损伤。此目标分类 代表了正确告知和建议消费者和制造商有关的关键需求 产品安全。我们最近开发并测试了一种新方法，即损伤眼睛刺激的体外深度 测试（IVD EIT），以检测具有高灵敏度和特异性的所有类别的刺激性。这个目的 应用程序是进一步开发IVD EIT，其长期目标是为该服务提供服务和/或套件 准确地分类眼刺激物，以满足对非动物刺激测试的未满足的需求 用于标记产品和化学物质，从而确保安全处理实践。 1