Registration Dossier
Registration Dossier
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EC number: 215-478-8 | CAS number: 1327-43-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro data
In the S. typhimurium spot test using five mutant strains (TA98, TA100, TA1535, TA1537, TA1538), Silicic acid, aluminium magnesium salt was found to be not mutagenic with or without metabolic activation (Blevins and Taylor, 1982).
No further experimental data are available for Silicic acid, aluminium magnesium salt on genetic toxicity in vitro.However, there are data for structurally related compounds.
Various types of synthetic amorphous silica did not show mutagenic activity inin vitrosystems in the presence and absence of an external metabolising system: These included a cytogenetic mammalian cell system including chromosomal aberrations in human embryonic cells (WI-38) (Litton Bionetics 1974), a gene mutation assay in mammalian cells, HPRT assay in Chinese hamster ovary cells (Cabot 1990) as well as a DNA repair system, an UDS test, in primary rat hepatocytes (Curren 1989).
In vivo data
No experimental data are available for Silicic acid, aluminium magnesium salt on genetic toxicity in vivo. However, there are data for structurally related compounds.
Synthetic amorphous silica did not lead to an increase in chromosomal aberrations in bone-marrow cells from orally treated rats (Litton Bionetics 1974a+b). Also dominant lethal assays conducted in rats did not produce significant adverse effects on reproductive performance parameters after exposure of male rats to synthetic amorphous silica (Litton Bionetics 1974a+b).
Following a repeated dose inhalation exposure (13 weeks) of rats to a mean dust concentration of 50 mg/m³ Aerosil 200, alveolar type-II cells were isolated from the broncho-alveolar lavage fluid (BAL) and subjected to the HPRT gene-mutation assay in vitro. There was no increase in 6TG-resistant mutants compared to controls (Johnston et al. 2000).
Short description of key information:
Based on the negative results of Silicic acid, aluminium magnesium salt in the S. typhimurium spot test and of all tested synthetic amorphous silica in the additional in vitro and in vivo studies, no mutagenic potential is expected from the exposure to Silicic acid, aluminium magnesium salt.
Endpoint Conclusion:
Justification for classification or non-classification
No need for classification as the in vitro and in vivo studies consistently demonstrate negative results.
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