NiPERA, Inc., 2525 Meridian Parkway, Suite 240, Durham, NC 27713, USA.
Regul Toxicol Pharmacol. 2012 Apr;62(3):425-32. doi: 10.1016/j.yrtph.2012.02.002. Epub 2012 Feb 8.
Acute oral toxicity studies were conducted on samples of nine unique nickel compounds and two complex materials to comply with the data and classification requirements of the new Registration, Evaluation, and Authorization of Chemicals Regulation (REACH) in Europe. The samples tested in this study confirmed the overall low oral toxicity of nickel substances and demonstrated a wide range of LD(50) values extending from 310 to >11,000 mg/kg. This variation highlights the differences in toxicological properties between various forms of nickel and underscores the importance of Ni(II) ion bioavailability in determining toxicity. The relative acute oral toxicity of the various nickel substances was found to be: nickel fluoride, nickel sulfate, nickel chloride, nickel acetate > nickel sulfamate > nickel hydroxycarbonate > nickel dihydroxide >> nickel subsulfide, nickel oxides, nickel ash, nickel mattes. Based on these data, four nickel compounds would receive a Category 4 acute toxicity classification according to the European Regulation on Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP), while the rest of the nickel substances tested fit the criterion for no classification. These data also provided the in vivo verification needed to perform read-across for additional oral toxicity endpoints and nickel substances.
进行了九种独特的镍化合物和两种复合材料的急性经口毒性研究，以符合欧洲新的化学品注册、评估、授权和限制法规（REACH）的数据和分类要求。本研究测试的样品证实了镍物质的总体低经口毒性，并显示出从 310 到 >11000mg/kg 不等的 LD(50)值范围很广。这种差异突出了各种形式的镍之间毒理学特性的差异，并强调了 Ni(II)离子生物利用度在确定毒性方面的重要性。各种镍物质的相对急性经口毒性为：氟化镍、硫酸镍、氯化镍、醋酸镍>氨基磺酸镍>羟基碳酸镍>氢氧化镍>次硫化镍、氧化镍、镍灰、镍冰铜。根据这些数据，根据欧洲关于化学品和混合物分类、标签和包装的法规（CLP），有四种镍化合物将被归类为 4 类急性毒性，而其余测试的镍物质则符合无需分类的标准。这些数据还为进行额外的经口毒性终点和镍物质的同类物质推断提供了体内验证。
