Registration Dossier
Registration Dossier
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EC number: 215-478-8 | CAS number: 1327-43-1
Carcinogenicity
Administrative data
Description of key information
Based on structure analogy of synthetic amorphous silica, no carcinogenicity is expected from the exposure to silicic acid, aluminium magnesium salt.
Taking into account that orally ingested aluminium from sodium silicoaluminate is poorly bioavailable, absorbed and rapidly excreted (see 5.1), no risk potential of aluminium will occur. Sodium and magnesium are natural constituents of the regular human diet.
Key value for chemical safety assessment
Justification for classification or non-classification
There is no need for classification of silicic acid, aluminium magnesium sodium salt as carcinogen.
Additional information
Oral
Long-term feeding studies are reported for synthetic amorphous silica (SAS) by Takizawa (1988). Three groups of rats and mice received Syloid 244 at dietary levels of 1.25, 2.5 and 5% for 103 and 93 weeks, respectively. This corresponded to average daily doses of 2000 mg/kg bw for the high-dose group of rats and to 4500 to 5800 mg/kg bw for the high-dose groups of female and male mice, respectively. The animals were in good condition throughout and showed high survival. The tumour responses in all organs of SAS-treated rats and mice were not statistically significantly different from the controls (Fisher´s exact test and Cochran-Armitage test for trend). Based on the negative results after long-term oral application of SAS, there is no evidence of a carcinogenic potential arising from ingestion of these amorphous minerals.
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