Peer-Reviewed Publication

Evaluation of a New In Chemico Skin Corrosion Test

Toxicology In Vitro, Vol. 100, September 2024 · Lebrun Labs Research Team

Overview

This paper introduces and evaluates the DermaSafe SCT™, Lebrun Labs' proprietary in chemico skin corrosion test, as a fully nonanimal alternative for classifying chemicals that cause irreversible skin damage. The method uses a chemical reaction between the test substance and a synthetic peptide substrate to detect corrosive potential without any animal tissue or cells. Results demonstrate strong concordance with the established OECD TG 431 (reconstructed human epidermis) reference standard, positioning DermaSafe SCT™ as a practical, shelf-stable option for regulatory submissions under GHS, EU CLP, and EPA classification frameworks.

Abstract

Skin corrosion, defined as irreversible damage to the skin following a single application of a test substance, must be assessed for chemicals and formulations under GHS, EU CLP, and EPA regulatory frameworks. Current OECD-accepted nonanimal methods rely on reconstructed human epidermis (RhE) models that require specialized cell culture infrastructure and have limited shelf life. This study describes the development and performance evaluation of a new in chemico skin corrosion test (DermaSafe SCT™) that uses a synthetic peptide substrate to detect corrosive reactivity. The test was evaluated against a reference set of chemicals with known skin corrosion classifications. Sensitivity, specificity, and overall accuracy were calculated relative to the GHS classification system. The method demonstrated high concordance with the RhE reference standard and correctly classified the majority of corrosives and non-corrosives in the reference set. The DermaSafe SCT™ requires no cell culture, is stable at room temperature, and can be performed in a standard analytical laboratory, making it accessible to a broad range of testing facilities.

Relevance to Lebrun Labs Services

Lebrun Labs offers the DermaSafe SCT™ as a contract testing service for clients who need skin corrosion data for regulatory submissions. This assay is particularly valuable for industrial chemicals, cleaning products, personal care formulations, and any substance subject to GHS or EPA hazard classification. Because the method requires no animal tissue and no specialized cell culture equipment, turnaround times are fast and costs are lower than RhE-based alternatives. If your product development pipeline requires skin corrosion classification, whether for a Safety Data Sheet, a cosmetic dossier, or a pesticide registration, our team can run DermaSafe SCT™ and provide a fully documented study report suitable for regulatory submission.

Research reported in this publication was supported by the National Institute of Environmental Health Sciences of the National Institutes of Health under Award Number R44ES036065. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.