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

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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