Undetactable levels of genotoxicity of SiO2 nanoparticles in in vitro and in vivo tests.

BACKGROUND: Silica dioxide (SiO2) has been used in various industrial products, including paints and coatings, plastics, synthetic rubbers, and adhesives. Several studies have investigated the genotoxic effects of SiO2; however, the results remain controversial due to variations in the evaluation methods applied in determining its physicochemical properties. Thus, well characterized chemicals and standardized methods are needed for better assessment of the genotoxicity of nanoparticles. METHODS: The genotoxicity of SiO2 was evaluated using two types of well characterized SiO2, ie, 20 nm (-) charge (SiO (EN20(-))2) and 100 nm (-) charge (SiO (EN100(-))2). Four end point genotoxicity tests, ie, the bacterial mutation assay, in vitro chromosomal aberration test, in vivo comet assay, and in vivo micronucleus test, were conducted following the test guidelines of the Organization for Economic Cooperation and Development (OECD) with application of Good Laboratory Practice. RESULTS: No statistically significant differences were found in the bacterial mutation assay, in vitro chromosomal aberration test, in vivo comet assay, and in vivo micronucleus test when tested for induction of genotoxicity in both two types of SiO2 nanoparticles. CONCLUSION: These results suggest that SiO2 nanoparticles, in particular SiO2 (EN20(-)) and SiO2 (EN100(-)), are not genotoxic in both in vitro and in vivo systems under OECD guidelines. Further, the results were generated in accordance with OECD test guidelines, and Good Laboratory Practice application; it can be accepted as reliable information regarding SiO2-induced genotoxicity.