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Toxicity of colloidal silica nanoparticles administered orally for 90 days in rats

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TLDR
The results of this study indicate that the NOAEL forSiO2EN20(−) and SiO2 EN100(−), administered by gavage in Sprague-Dawley rats, would most likely be 2,000 mg/kg, and no target organ was identified in rats of either sex.
Abstract
This study was undertaken to investigate the potential toxicity and establish the no observed adverse effect level (NOAEL) and target organ(s) of negatively charged colloidal silica particles of different sizes, ie, SiO2 (EN20(-)) (20 nm) or SiO2 (EN100(-)) 2(100 nm), administered by gavage in Sprague-Dawley rats. After verification of the physicochemical properties of the SiO2 particles to be tested, a preliminary dose range-finding study and 90-day repeated dose study were conducted according to the Organisation for Economic Cooperation and Development test guideline. Based on the results of the 14-day dose range-finding study, a high dose was determined to be 2,000 mg/kg, and middle and low doses were set at 1,000 and 500 mg/kg, respectively. In the 90-day toxicity study, there were no animal deaths in relation to administration of SiO2 particles of either size. In addition, no treatment-related clinical changes or histopathological findings were observed in any of the experimental groups. Moreover, no difference in toxic effects from chronic exposure to SiO2 (EN20(-))(20 nm) or SiO2 (EN100(-)) (100 nm) was observed. The results of this study indicate that the NOAEL for SiO2 (EN20(-)) and SiO2 (EN100(-)) would most likely be 2,000 mg/kg, and no target organ was identified in rats of either sex.

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Silica-based systems for oral delivery of drugs, macromolecules and cells.

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References
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Journal ArticleDOI

In vitro toxicity of silica nanoparticles in human lung cancer cells

TL;DR: Exposure to SiO(2) nanoparticles results in a dose-dependent cytotoxicity in cultural human bronchoalveolar carcinoma-derived cells that is closely correlated to increased oxidative stress.
Journal ArticleDOI

In vitro cytotoxicitiy of silica nanoparticles at high concentrations strongly depends on the metabolic activity type of the cell line

TL;DR: The cytotoxicity of silica to human cells depends strongly on their metabolic activities but that it could be significantly reduced by synthesizing silica with chitosan.
Journal ArticleDOI

The absorption, distribution, excretion and toxicity of mesoporous silica nanoparticles in mice following different exposure routes

TL;DR: A systematic investigation of the absorption, distribution, excretion and toxicity of silica nanoparticles with the average size of 110 nm after four different exposure routes including intravenous, hypodermic, intramuscular injection and oral administration to mice showed that a fraction of the SNs administrated by the intramuuscular and hypODermic injection could cross different biological barriers into the liver but with a low absorption rate.
Journal ArticleDOI

Biodistribution and toxicity of intravenously administered silica nanoparticles in mice.

TL;DR: The results indicated that SiNPs accumulate mainly in lungs, liver and spleen and are retained for over 30 days in the tissues because of the endocytosis by macrophages, and could potentially cause liver injury when intravenously injected.
Journal ArticleDOI

Reproducible Comet Assay of Amorphous Silica Nanoparticles Detects No Genotoxicity

TL;DR: No significant genotoxicity was observed for the nanoparticles tested under the conditions described, and results were independently validated in two separate laboratories, showing that in vitro toxicity testing can be quantitatively reproducible.
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