02086nas a2200337 4500000000100000000000100001008004100002260001100043653003800054653003200092653001500124653001300139653001500152653001400167653001300181653002000194653001300214653001500227653002300242653001400265100002300279700001700302700001900319700002700338245013800365856004400503300000800547490000700555520117200562022001401734 2025 d c2025/810aNew Approach Methodologies (NAMs)10aallergic contact dermatitis10abotanicals10aextracts10aIn chemico10ain silico10ain vitro10amedical devices10amixtures10apollutants10aSkin sensitization10awearables1 aArgel Islas-Robles1 aMeera Ramani1 aJakeb Phillips1 aGertrude-Emilia Costin00aNew Horizons in Skin Sensitization Assessment of Complex Mixtures: The Use of New Approach Methodologies Beyond Regulatory Approaches uhttps://www.mdpi.com/2305-6304/13/8/693 a6930 v133 aSkin 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. a2305-6304