Safety evaluation of nanomaterials by a 13-week repeated dose intratracheal toxicity study in rats
作者单位：National Institute of Health SciencesDivision of Medical Devices
会议名称：《中国生物医学工程学会成立30周年纪念大会暨2010中国生物医学工程学会学术大会》
会议日期：2010年
学科分类：08[工学] 080501[工学-材料物理与化学] 0805[工学-材料科学与工程（可授工学、理学学位）] 080502[工学-材料学]
关 键 词：Biomaterials silica,silver,zinc oxide intratracheal administration a 13-week repeated dose test
摘 要：Recently,nanomaterials(NMs) have been used in industry,consequently arriving just around us as many kinds of *** are being used in medical devices as *** the amount of NMs contained in those products may be a little,we may need to pay attention to their safety because it may be different from that of their bulky *** present,not only OECD and ISO but also many other cooperative study groups are trying to establish test methods for NMs’ safety evaluation heading for the international cooperation on development and harmonization of the test *** this presentation,first I will talk about the particle size-dependent toxicity of polystyrene(PS) particles in vitro,and then introduce an in vivo test method performed with colloidal silica,silver and zinc *** particles were tested assuming them to be the aggregates of *** and genotoxicity of eleven size-different PS spheres with defined diameters ranging from 0.1 to 9.2 μm were tested in a Chinese hamster cell line,CHL[1].The 4.45-μm PS particles were most cytotoxic and smaller or larger particles showed less *** was a big toxicity difference between the 4.45-and 5.26-μm particles,although both precipitated and covered cells to the same extent in the *** analysis of particles and chemical analysis of dispersion vehicles did not show any difference between *** particles induced polyploidy in the chromosome aberration test and the intensity was correlated well with their *** images clearly showed the uptake of the 4.45-μm PS particles into CHL *** cytometric analysis seemed to measure the uptake of PS particles *** findings suggest that polyploidy may be induced by cytokinesis block due to particles *** are considering that such a size specific toxicity may be induced in the test with NM *** may need to provide information about aggregate sizes or some parameters indicating dispersion cond