Skin Sensitization Testing: The Ascendancy of Non-Animal Methods

Abstract

A century ago, toxicology was an empirical science identifying substance hazards in surrogate mammalian models. Over several decades, these models improved, evolved to reduce animal usage, and recently have begun the process of dispensing with animals entirely. However, despite good hazard identification, the translation of hazards into adequately assessed risks to human health often has presented challenges. Unfortunately, many skin sensitizers known to produce contact allergy in humans, despite being readily identified as such in the predictive assays, continue to cause this adverse health effect. Increasing the rigour of hazard identification is inappropriate. Regulatory action has only proven effective via complete bans of individual substances. Since the problem applies to a broad range of substances and industry categories, and since generic banning of skin sensitizers would be an economic catastrophe, the solution is surprisingly simple—they should be subject to rigorous safety assessment, with the risks thereby managed accordingly. The ascendancy of non-animal methods in skin sensitization is giving unparalleled opportunities in which toxicologists, risk assessors, and regulators can work in concert to achieve a better outcome for the protection of human health than has been delivered by the in vivo methods and associated regulations that they are replacing.

Keywords

• skin sensitization
• predictive testing
• non-animal methods
• hazard identification
• risk assessment
• defined approaches