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CEFIC-LRI N1 Project: Oral toxicity of a synthetic amorphous silica (SAS) in rats

: Buschmann, Jochen; Lewin, Geertje; Creutzenberg, Otto H.

The Toxicologist 53 (2014), No.1, pp.157, PS 599
ISSN: 0731-9193
Society of Toxicology (Annual Meeting) <53, 2014, Phoenix/Ariz.>
Fraunhofer ITEM ()

The test item was a synthetic amorphous silica (SAS) coded NM-200 and available at the EU JRC nanomaterials repository. It is a nanostructured, precipitated SAS. As NM-200 is used as an ingredient in food it was the objective of this study to evaluate oral toxicity. The toxicity of NM-200 after daily oral gavage in male rats for 28 days with an additional 14-day recovery period (OECD TG 407; in addition: Si ion and Si particle analysis in selected organs) was tested. Dose levels of 100, 300 and 1000 mg/kg bw (vehicle: 0.5% methylhydroxypropylcellulose) were used. Extra groups (control recovery; high dose recovery) were kept for additional 14 days of post-observation. Body weights, food consumption, the functional observational battery (FOB) and hematology and clinical chemistry did not reveal any treatment-related effects. Also organ weights, necropsy, and histopathological examination did not show any substance-related findings in the high dose group, as compared to controls. Chemical analysis of silicon ions in blood, kidney and liver tissues did not reveal differences between the control and the high dose group. As a result, NM-200 did not cause any substance-related effects at doses up to 1000 mg/kg b.w. after oral exposure for 28 days in male Wistar (WU) rats. Therefore, the highest dose tested (1000 mg/kg b.w.) was determined to represent the NOAEL in this study. By exemplary TEM analysis no particles of NM 200 could be detected in selected tissues.