A toxicological evaluation of monomethylsilanetriol (MMST) stabilized in acacia gum, a novel silicon preparation.

ABSTRACT

Monomethylsilanetriol (MMST), a silicon-containing compound, has been sold in dietary supplements. However, toxicological studies on its safety profile are not readily available. To assess the safety of MMST stabilized in acacia gum, a novel delivery form of MMST, in accordance with internationally accepted standards, the genotoxic potential and repeated-dose oral toxicity of Living Silica® Acacia Gum Stabilized Monomethylsilanetriol (formerly known as Orgono Acacia Gum Powder®), a food grade product consisting of 80 ± 10% acacia gum and 2.8% (SD ± 10%) elemental silicon from MMST, was investigated. A bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, an in vivo mammalian micronucleus test, and a 90-day repeated-dose oral toxicity study in rats were performed. No evidence of mutagenicity or genotoxic activity was observed under the applied test systems. In the 90-day study, male and female Hsd.Han Wistar rats were administered daily doses of 0, 500, 1000, and 2000 mg/kg bw/day by gavage. No mortality or treatment-related adverse effects were observed, and no target organs were identified. Therefore, the no observed adverse effects level (NOAEL) was determined as 2000 mg/kg bw/day (201 mg MMST/kg bw/day), the highest dose tested.