Kalyanaraman V, Naveen Sangeetha Vasudevaraj, Mohana N, Balaje R M, Navaneethakrishnan K R, Brabu B, Murugan S S, Kumaravel T S
GLR Laboratories Private Limited , 444 Gokulam Street , Mathur , Chennai 600068 , India . Email:
Nanoregulatory Platform , Pharma Chemistry , Drug Discovery and Development , Instituto Italiano di Tecnologia (IIT) , Genova 16163 , Italy.
Toxicol Res (Camb). 2018 Oct 18;8(1):25-37. doi: 10.1039/c8tx00248g. eCollection 2019 Jan 1.
An implantation study of cerium oxide nanoparticles (CeO2-NP) combined with 28-day systemic toxicity and genotoxicity studies aligned to current regulatory standards was conducted. The results suggested that local tissue reactions caused by CeO2-NP was minimal (implantation irritation index of less than 3) and was better tolerated than most other implant materials tested in our laboratory. Furthermore, CeO2-NP showed virtually no systemic toxicity or micronucleus induction in bone marrow implantation route. Chemical analysis showed that CeO2-NP migrated from the implant sites (250 mg per site) in low levels and was deposited predominantly in liver (191.8 ± 35.1 ng g of tissue; < 0.01), lungs (263.4 ± 30.9 ng g of tissue; < 0.001), spleen (211.2 ± 6.5 ng g of tissue; < 0.001) and kidneys (272.8 ± 20.4 ng g of tissue; < 0.001). These observations provide a base line biocompatibility and toxicity data on CeO2-NP. The current findings will also be useful in defining standards for nanoparticle containing biomaterials and devices.
开展了一项氧化铈纳米颗粒（CeO2-NP）的植入研究，并结合了符合现行监管标准的28天全身毒性和遗传毒性研究。结果表明，CeO2-NP引起的局部组织反应极小（植入刺激指数小于3），并且比我们实验室测试的大多数其他植入材料耐受性更好。此外，在骨髓植入途径中，CeO2-NP几乎没有显示出全身毒性或微核诱导作用。化学分析表明，CeO2-NP从植入部位（每个部位250毫克）以低水平迁移，主要沉积在肝脏（每克组织191.8±35.1纳克；<0.01）、肺（每克组织263.4±30.9纳克；<0.001）、脾脏（每克组织211.2±6.5纳克；<0.001）和肾脏（每克组织272.8±20.4纳克；<0.001）中。这些观察结果提供了关于CeO2-NP的基线生物相容性和毒性数据。目前的研究结果对于定义含纳米颗粒生物材料和装置的标准也将是有用的。
