Abstract：
For years, the strive for in vitro methods for toxicological assessment suitable to replace animal studies gained progressive importance. OECD Test Guideline (TG) 431 was implemented in 2004, allowing to circumvent animal testing according to OECD TG 404 while reliably predicting skin corrosion potential of many substances and products. However, non-animal assays often show protocol-dependent limitations, that complicate or even prevent the testing of several groups of substances. In this study, the suitability of the OECD TG 431 for assessment of the skin corrosion potential of known acidic, thus often skin corrosive or irritating acrylic and methacrylic acid-based adhesives and monomers, was investigated. The commercially available Phenion® Open Source Reconstructed Epidermis (OS-REp) model, developed at Henkel & Co. KGaA, was used. The EpiDerm™ prediction model was considered most applicable to the Phenion® OS-REp model. All Proficiency Substances listed in OECD TG 431, amongst them six acids, were correctly classified and subcategorized as Skin Corr. 1 A or 1B/C corrosives. The OS-REp model was shown to be suitable for the assessment of skin corrosion potential in accordance with OECD TG 431. However, our results also indicate that acrylic and methacrylic monomer-based adhesives might fall outside the applicability domain of this guideline.
摘要：
多年来,寻找适合替代动物研究的体外毒理学评估方法的努力变得越来越重要。OECD测试指南（TG）431于2004年实施，允许根据OECDTG404进行动物测试，同时可靠地预测许多物质和产品的皮肤腐蚀潜力。然而,非动物试验通常显示出依赖于方案的局限性，使几组物质的测试复杂化甚至阻止。在这项研究中,OECDTG431评估已知酸性皮肤腐蚀电位的适用性，因此，通常会对皮肤有腐蚀性或刺激性的丙烯酸和甲基丙烯酸基粘合剂和单体，被调查。商用Phenion®开源重建表皮(OS-REp)模型，在汉高公司KGaA开发，被使用。EpiDerm™预测模型被认为最适用于Phenion®OS-REp模型。OECDTG431中列出的所有熟练物质，其中包括六种酸，被正确地分类和分类为SkinCorr。1A或1B/C腐蚀剂。根据OECDTG431，OS-REp模型被证明适用于评估皮肤腐蚀电位。然而,我们的结果还表明，丙烯酸和甲基丙烯酸单体基粘合剂可能落在本指南的适用范围之外。
