Cazelle Elodie, Eskes Chantra, Hermann Martina, Jones Penny, McNamee Pauline, Prinsen Menk, Taylor Hannah, Wijnands Marcel V W
A.I.S.E., Brussels, Belgium.
SeCAM, Magliaso, Switzerland.
Toxicol In Vitro. 2015 Apr;29(3):609-16. doi: 10.1016/j.tiv.2014.12.020. Epub 2015 Jan 19.
A.I.S.E. investigated the suitability of the regulatory adopted ICE in vitro test method (OECD TG 438) with or without histopathology to identify detergent and cleaning formulations having extreme pH that require classification as EU CLP/UN GHS Category 1. To this aim, 18 extreme pH detergent and cleaning formulations were tested covering both alkaline and acidic extreme pHs. The ICE standard test method following OECD Test Guideline 438 showed good concordance with in vivo classification (83%) and good and balanced specificity and sensitivity values (83%) which are in line with the performances of currently adopted in vitro test guidelines, confirming its suitability to identify Category 1 extreme pH detergent and cleaning products. In contrast to previous findings obtained with non-extreme pH formulations, the use of histopathology did not improve the sensitivity of the assay whilst it strongly decreased its specificity for the extreme pH formulations. Furthermore, use of non-testing prediction rules for classification showed poor concordance values (33% for the extreme pH rule and 61% for the EU CLP additivity approach) with high rates of over-prediction (100% for the extreme pH rule and 50% for the additivity approach), indicating that these non-testing prediction rules are not suitable to predict Category 1 hazards of extreme pH detergent and cleaning formulations.
国际肥皂和洗涤剂协会（A.I.S.E.）研究了采用的体外冻融（ICE）试验方法（经合组织测试指南438）在有无组织病理学检查的情况下，用于识别pH值极端、需分类为欧盟《化学品分类、标签和包装法规》（CLP）/联合国《全球化学品统一分类和标签制度》（GHS）第1类的洗涤剂和清洁配方的适用性。为此，对18种pH值极端的洗涤剂和清洁配方进行了测试，涵盖了碱性和酸性极端pH值情况。遵循经合组织测试指南438的ICE标准测试方法与体内分类结果具有良好的一致性（83%），特异性和灵敏度值良好且平衡（83%），这与目前采用的体外测试指南的性能相符，证实了其适用于识别第1类pH值极端的洗涤剂和清洁产品。与之前对非极端pH值配方的研究结果不同，组织病理学检查的使用并未提高该试验的灵敏度，反而大大降低了其对极端pH值配方的特异性。此外，使用非测试预测规则进行分类时，一致性值较差（极端pH值规则为33%，欧盟CLP相加法为61%），且过度预测率较高（极端pH值规则为100%，相加法为50%），这表明这些非测试预测规则不适用于预测pH值极端的洗涤剂和清洁配方的第1类危害。
