Conference Abstract

Society of Toxicology Annual Meeting: Repeatability of a Depth of Injury Test Method for the Classification of Eye Irritants

Society of Toxicology Annual Meeting, 2021

Overview

For a nonanimal test method to be accepted by regulators, it must not only be accurate, it must also be repeatable. This abstract evaluates the within-laboratory and between-run variability of the in vitro depth of injury (DoI) test method for classifying ocular irritants under the GHS system. The data demonstrate that the DoI method produces consistent, reproducible results across multiple independent test runs, a critical requirement for regulatory validation and eventual OECD test guideline adoption. This work is part of the broader validation package supporting the IVD EIT as a standalone Draize test replacement.

Abstract

The in vitro depth of injury (DoI) test method classifies eye irritants by measuring the penetration depth of a test substance into a surrogate corneal substrate, generating a classification that maps onto GHS Category 1, Category 2, and No Category endpoints. For regulatory acceptance, test methods must demonstrate adequate repeatability, defined as the ability to produce consistent results across independent test runs within the same laboratory. This abstract evaluates the within-laboratory repeatability of the DoI method using a panel of reference chemicals spanning the full range of GHS eye irritation categories. Coefficient of variation (CV) and classification concordance were calculated across multiple independent test runs. Results demonstrated low variability in DoI measurements and high classification concordance across runs, supporting the method's suitability for regulatory use. The data contribute to the prevalidation package for the IVD EIT and support its development toward OECD test guideline status.

Relevance to Lebrun Labs Services

Repeatability data like those presented in this abstract are essential for clients who need to submit eye irritation test results to regulatory agencies. When Lebrun Labs provides an IVD EIT study report, the underlying method has been demonstrated to produce consistent, reproducible results, meaning your data will withstand regulatory scrutiny. This is particularly important for EPA pesticide registrations, EU cosmetic safety assessments, and GHS SDS classifications where method reliability is a prerequisite for data acceptance. Our quality system ensures that every study is conducted under conditions that meet or exceed the repeatability standards described in this abstract.

Research reported in this publication was supported by the National Institute of Environmental Health Sciences of the National Institutes of Health under Award Number SB1ES038803. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.