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

摘要 目前，Draize活兔眼测试是区分消费产品和材料的基准 是安全的，远离那些危险的，可能会导致轻微、中度或严重眼睛损伤的东西。然而， 新的法律目前正在或计划在加利福尼亚州、美国和 欧盟禁止使用动物进行眼刺激测试。尽管如此，目前还没有 单独的非动物试验或非动物试验的组合，可以准确地对所有水平的眼睛刺激进行分类 和腐蚀剂。尤其令人担忧的是，所有非动物试验通常都高估了危害最小的部分。 眼睛刺激物的类别，并且不能确定(或以低灵敏度确定)最极端的类别 他们的敏感率低至50%。更重要的是，目前验证的替代方案中没有一个 测试可以检测到需要适当安全标签的刺激物(GHS Cat.或那些令人恼火的 持续21天，但随后消失，不会对角膜造成永久性损害。此目标分类 代表未得到满足的关键需求，需要正确地告知消费者和制造商 产品安全。我们最近开发并测试了一种新的方法，即体外损伤眼刺激深度 测试(IVD EIT)，以检测所有类别的刺激物，具有高度的敏感性和特异性。这样做的目的是 应用程序是进一步发展IVD EIT，长期目标是为以下项目提供服务和/或套件 眼刺激物的准确分类，以满足非动物眼刺激试验的这一未得到满足的需求 用于标识产品和化学品，从而确保安全搬运。 1

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