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

> **NIH NIH R44** · LEBRUN LABS, LLC · 2024 · $17,735

## Abstract

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.
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## Key facts

- **NIH application ID:** 11076992
- **Project number:** 3R44ES031881-03S1
- **Recipient organization:** LEBRUN LABS, LLC
- **Principal Investigator:** Stewart Lebrun
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $17,735
- **Award type:** 3
- **Project period:** 2023-05-10 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11076992

## Citation

> US National Institutes of Health, RePORTER application 11076992, IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II (3R44ES031881-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11076992. Licensed CC0.

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