Applicability of the SENS-IS assay to assess skin sensitization of medical devices according the technical specification ISO/TS11796

IF 2.6 3区医学 Q3 TOXICOLOGY Toxicology in Vitro Pub Date : 2025-02-19 DOI:10.1016/j.tiv.2025.106032

Françoise Cottrez , Elodie Boitel , Essia Sahli , Christian Pellevoisin , Hervé Groux

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Abstract

Assessing skin sensitization is critical in the development of medical devices, and the SENS-IS assay provides a reliable in vitro alternative to traditional animal models. By utilizing reconstructed human epidermis (RHE), which closely mimics human skin, the assay allows testing with both saline and sesame oil under conditions similar to in vivo models, facilitating a smoother transition to non-animal testing. This study evaluated the efficacy of the SENS-IS assay according to ISO/TS 11796, testing 14 sensitizers and 3 non-sensitizers during the prevalidation phase, as well as the 8 sensitizers and 4 non-sensitizers recommended in an interlaboratory study using MED-2000 silicone extracts spiked with ISO-specified chemicals at LLNA EC3 concentrations.

The assay successfully identified 20 out of 22 sensitizers tested at EC3 concentrations. Two chemicals, poorly soluble in the vehicles used,—TPO (EC3 = 27) and Isopropyl Myristate (EC3 = 44)—were detected at slightly higher concentrations, with TPO detected at 50 % and Isopropyl Myristate at 75 % of their EC3 values. All 7 non-sensitizers were accurately classified. These results confirm the sensitivity of the SENS-IS assay and underscore its potential for medical device development, advancing the use of non-animal testing methods.

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评估皮肤过敏对医疗器械的开发至关重要，而 SENS-IS 分析法为传统动物模型提供了可靠的体外替代方法。通过利用近似人体皮肤的重建人体表皮（RHE），该检测方法可在与体内模型相似的条件下使用生理盐水和芝麻油进行测试，从而更顺利地过渡到非动物测试。这项研究根据 ISO/TS 11796 评估了 SENS-IS 检测法的功效，在预验证阶段测试了 14 种致敏物和 3 种非致敏物，并在实验室间研究中使用添加了 LLNA EC3 浓度 ISO 指定化学物质的 MED-2000 硅胶提取物测试了推荐的 8 种致敏物和 4 种非致敏物。在 EC3 浓度下测试的 22 种致敏剂中，该检测方法成功鉴定出了 20 种。在所用载体中溶解度较低的两种化学物质--TPO（EC3 = 27）和肉豆蔻酸异丙酯（EC3 = 44）--的检测浓度略高，其中 TPO 的检测浓度为其 EC3 值的 50%，肉豆蔻酸异丙酯的检测浓度为其 EC3 值的 75%。所有 7 种非致敏剂都被准确分类。这些结果证实了 SENS-IS 分析法的灵敏度，并强调了它在医疗器械开发方面的潜力，推动了非动物测试方法的使用。

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来源期刊

Toxicology in Vitro 医学-毒理学

CiteScore

6.50

自引率

3.10%

发文量

181

审稿时长

65 days

期刊介绍： Toxicology in Vitro publishes original research papers and reviews on the application and use of in vitro systems for assessing or predicting the toxic effects of chemicals and elucidating their mechanisms of action. These in vitro techniques include utilizing cell or tissue cultures, isolated cells, tissue slices, subcellular fractions, transgenic cell cultures, and cells from transgenic organisms, as well as in silico modelling. The Journal will focus on investigations that involve the development and validation of new in vitro methods, e.g. for prediction of toxic effects based on traditional and in silico modelling; on the use of methods in high-throughput toxicology and pharmacology; elucidation of mechanisms of toxic action; the application of genomics, transcriptomics and proteomics in toxicology, as well as on comparative studies that characterise the relationship between in vitro and in vivo findings. The Journal strongly encourages the submission of manuscripts that focus on the development of in vitro methods, their practical applications and regulatory use (e.g. in the areas of food components cosmetics, pharmaceuticals, pesticides, and industrial chemicals). Toxicology in Vitro discourages papers that record reporting on toxicological effects from materials, such as plant extracts or herbal medicines, that have not been chemically characterized.