Conference AbstractFebruary 2019

Society of Toxicology Annual Meeting: Prevalidation of the OptiSafe™ Ocular Irritation Assay for the Detection of Ocular Corrosives

Society of Toxicology Annual Meeting, 2019

Overview

Before a nonanimal test method can be formally validated and submitted for OECD test guideline adoption, it must pass a prevalidation phase, a structured assessment of the method's performance, reproducibility, and transferability to independent laboratories. This abstract presents the prevalidation data for OptiSafe™ specifically for its ability to detect ocular corrosives: chemicals so hazardous that they cause irreversible damage to the eye. The prevalidation results demonstrate that OptiSafe™ can reliably discriminate ocular corrosives from irritants and nonirritants using a simple, shelf-stable, test tube format, without any animal tissue or cells.

Abstract

OptiSafe™ is a novel, shelf-stable, test tube-based assay that can discriminate ocular irritants and corrosives from nonirritants without animal tissues or cells. The assay uses a macromolecular substrate to detect the irritation potential of test substances through a colorimetric endpoint that correlates with ocular hazard classification under GHS and EPA frameworks. This abstract presents prevalidation data for the OptiSafe™ assay with a focus on its performance for detecting ocular corrosives, GHS Category 1 substances that cause irreversible eye damage. The prevalidation study evaluated the assay against a reference chemical set that included confirmed corrosives, irritants, and nonirritants with established in vivo classifications. Results demonstrated high sensitivity for ocular corrosives and adequate overall accuracy across the full classification range. The shelf-stable format and simple protocol were confirmed to be transferable to standard analytical laboratories without specialized equipment. The prevalidation data support advancement of OptiSafe™ toward formal validation and regulatory submission.

Relevance to Lebrun Labs Services

The prevalidation work described in this abstract was a critical milestone in establishing OptiSafe™ as a credible regulatory tool. For Lebrun Labs' clients, this history of rigorous scientific validation means that OptiSafe™ results are defensible in regulatory submissions, not just a screening tool, but a method with a documented validation pedigree. Clients who need to classify highly hazardous chemicals, industrial cleaning agents, or concentrated actives under GHS Category 1 (ocular corrosive) criteria can rely on OptiSafe™ to provide accurate, well-documented results. Our team can provide the full method validation documentation as part of any study report.

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.