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EC number: 231-130-8
CAS number: 7440-21-3
Animal data on acute toxicity of synthetic amorphous silica which can be used for read-across do not show acute oral, inhalation or dermal toxicity.
Acute toxicity studies have not been
performed with silicon. Repeated dose inhalation tests with silicon (14-
and 90 -day studies in rats) did not show any signs of acute effects.
Data are available on the acute toxicity
of synthetic amorphous silica. The
surface of silicon is composed of a thin oxidized silicon layer
resembling the surface of amorphous silicon dioxide. Both silicon and
amorphous silica release silicon from particles. Based on the
comparative in vitro data on the dissolution kinetics of silicon
and synthetic amorphous silica in different artificial biological
fluids, it can be presumed that the bioavailabity of silicon from
silicon particles is similar or slightly lower than that for synthetic
amorphous silica. Therefore, the assessment of acute toxicity may lean
on data from amorphous silica. A detailed description of
the justifications for read-across is available in Section 13 of the
According to available data, the acute
oral toxicity of synthetic amorphous silica is very low: no signs of
toxicity were observed at doses of up to 5,000 mg SiO2/kg bw.
LD50values for the various types of synthetic amorphous
silica studied were quite similar. Amorphous silica is not toxic via the
Based on the facts that
1) the solubility of silicon in
biological fluids is similar or lower than the solubility of amorphous
2) the systemic toxicity of the silicon
ion is low (as shown by the low acute oral toxicity),
3) no systemic effects were observed
after repeated exposure to silicon
it can be surmised that no acute
inhalation toxicity of silicon is expected, either.
is not acutely toxic via oral, inhalation or dermal routes. No
classification is suggested.
Read-across to synthetic amorphous
silica. All LD50 are above classification cut-off limits.
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