Peer-Reviewed PublicationApril 2021

Same-chemical comparison of nonanimal eye irritation test methods: BCOP, EpiOcular™, ICE, Ocular Irritection®, OptiSafe™, and STE

Toxicology In Vitro, Vol. 72, April 2021 · Lebrun Labs Research Team

Overview

How does OptiSafe™ stack up against every other accepted nonanimal eye irritation test? This landmark head-to-head study tested the same panel of chemicals across six different methods, bovine corneal opacity and permeability (BCOP), EpiOcular™ reconstructed tissue, isolated chicken eye (ICE), Ocular Irritection®, OptiSafe™, and short time exposure (STE), and directly compared their accuracy, sensitivity, and specificity. The study provides regulators, formulators, and testing laboratories with an objective, data-driven basis for selecting the most appropriate method for a given chemical class or regulatory purpose, and demonstrates where OptiSafe™ performs best relative to its alternatives.

Abstract

Multiple nonanimal eye irritation test methods have been accepted by regulatory agencies as alternatives to the Draize rabbit eye test, but direct performance comparisons using the same chemical set are rare. This study evaluated six methods, bovine corneal opacity and permeability (BCOP, OECD TG 437), EpiOcular™ eye irritation test (OECD TG 492), isolated chicken eye (ICE, OECD TG 438), Ocular Irritection® assay, OptiSafe™ eye irritation test, and short time exposure (STE, OECD TG 491), using an identical reference chemical set with established GHS classifications. Sensitivity, specificity, and overall accuracy were calculated for each method relative to GHS Category 1, Category 2, and No Category endpoints. Results revealed method-specific strengths and limitations across chemical classes, with OptiSafe™ demonstrating competitive performance particularly for aqueous formulations and surfactant-containing mixtures. The data support a tiered or weight-of-evidence testing strategy in which method selection is guided by chemical class and regulatory context.

Relevance to Lebrun Labs Services

This study is directly relevant to clients who need to choose the right eye irritation test for their product. Lebrun Labs offers OptiSafe™ EIT as its primary nonanimal eye irritation service, and this publication provides the scientific basis for understanding when OptiSafe™ is the optimal choice versus when a complementary method might be warranted. Our scientific team uses this comparative data to guide test method selection during project scoping, helping clients avoid unnecessary testing, reduce costs, and select the method most likely to produce accurate, regulatorily-acceptable results for their specific formulation type. We can also design tiered testing strategies that combine multiple methods for complex or borderline chemicals.

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.