LEBRUN LABS™
Back to Resources
Conference Abstract

Society of Toxicology Annual Meeting: An Improved Version of the OptiSafe™ Test with High Specificity

Society of Toxicology Annual Meeting, 2020

Overview

The Draize rabbit eye test has been the regulatory standard for eye irritation classification for decades, but it is notorious for over-classifying chemicals as irritants, generating false positives that lead to unnecessary hazard labels on safe products. This abstract presents an improved version of OptiSafe™ that directly addresses this problem by achieving high specificity: the ability to correctly identify nonirritants as nonirritants. The improvement means fewer safe ingredients and formulations are incorrectly flagged as eye hazards, reducing the burden of unnecessary hazard communication and opening the door to more accurate, animal-free safety assessments.

Abstract

Most chemical and product safety testing for eye irritation has historically used the Draize live rabbit eye test, which is known to have poor specificity, meaning it frequently classifies nonirritating chemicals as irritants. This high false-positive rate has significant consequences for product labeling, hazard communication, and regulatory compliance. This abstract presents an improved version of the OptiSafe™ nonanimal eye irritation test that achieves substantially higher specificity than the Draize test while maintaining adequate sensitivity for detecting true GHS Category 1 and Category 2 irritants. The improvement was achieved through protocol modifications that better model the chemical environment of the living eye, including the incorporation of biomimetic components that neutralize reactive-but-nonirritating chemicals. The improved protocol was evaluated against a reference chemical set with established in vivo classifications, demonstrating a significant reduction in false-positive rate compared to both the original OptiSafe™ protocol and the Draize test reference data.

Relevance to Lebrun Labs Services

High specificity is one of the most commercially important properties of the OptiSafe™ test for Lebrun Labs' clients. When a formulator receives a "nonirritant" result from OptiSafe™, they can have confidence that the result is not a false negative, and when they receive an "irritant" result, they know it is not a false positive driven by test artifact. This matters enormously for cosmetic and personal care companies that need accurate eye irritation data to support safety assessments, for household product manufacturers managing GHS hazard labels, and for any company that has previously received unexpected positive results from other test methods. Our team can discuss how the current OptiSafe™ protocol compares to your existing test data.

Research reported in this publication was supported by the National Institute of Environmental Health Sciences of the National Institutes of Health under Award Number SB1ES025501. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.