Islas-Robles Argel, Ramani Meera, Phillips Jakeb, Costin Gertrude-Emilia
Department of Skin Sensitization, Institute for In Vitro Sciences, Inc. (IIVS), Gaithersburg, MD 20878, USA.
Toxics. 2025 Aug 20;13(8):693. doi: 10.3390/toxics13080693.
Skin sensitization is a complex biological process induced by a wide range of chemicals, from single molecules to complex mixtures and finished products. While single chemical entities were used to design and validate sophisticated safety assessment assays, complex chemistries have proven challenging to test in practice using these methods. These assays range from in silico and in chemico methods to cell-based and reconstructed tissues-based approaches and target the key events now grouped within the Adverse Outcome Pathway. We focused our analysis on the use of New Approach Methodologies for skin sensitization assessments of complex mixtures, botanicals, medical and wearable devices, agrochemicals, and pollutants. We present the defined approaches that integrate these technologies, aligning with the principles of the replacement, reduction, and refinement of animal testing. We also detail the known challenges posed by these product classes in terms of testing and data interpretation. Our analysis indicates that validated and non-validated NAMs have shown some success in predicting skin sensitization potential across the product categories reviewed.
皮肤致敏是一个复杂的生物学过程，由多种化学物质引发，从单一分子到复杂混合物及成品。虽然单一化学实体被用于设计和验证复杂的安全性评估试验，但实践证明，使用这些方法对复杂化学物质进行测试具有挑战性。这些试验涵盖从计算机模拟和化学方法到基于细胞和基于重建组织的方法，针对目前归类于不良结局途径中的关键事件。我们将分析重点放在使用新方法学对复杂混合物、植物药、医疗和可穿戴设备、农用化学品及污染物进行皮肤致敏评估上。我们介绍了整合这些技术的既定方法，这些方法符合替代、减少和优化动物试验的原则。我们还详细阐述了这些产品类别在测试和数据解读方面带来的已知挑战。我们的分析表明，经过验证和未经验证的新方法学在预测所审查产品类别的皮肤致敏潜力方面已取得了一些成功。
