Registration Dossier
Registration Dossier
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EC number: 215-628-2 | CAS number: 1335-30-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro data
In the S. typhimurium test using five mutant strains (TA 97a, TA 98, TA100, TA 102 and TA1535), silicic acid, aluminium salt was found to be not mutagenic with or without metabolic activation (Paulus, 2010, RL1).
No further experimental data are available for silicic acid, aluminium salt on genetic toxicity in vitro. However, there are data for structurally related compounds:
Silicic acid, aluminium sodium salt did not show mutagenic activity in a mammalian chromosome aberration test in human embryonic lung cells (Wi-38) without metabolic activation (Litton Bionetics, 1974, RL2). Amorphous Silica is also negative in HGPRT assay in Chinese hamster ovary cells with and without metabolic activation (Harbell et al., 1990, RL2). Silica, amorphous, fumed and cryst.-free was also negative in a DNA repair system, an UDS test, in primary rat hepatocytes (Curren, 1989, RL2).
In vivo data
There are no in vivo data for silicic acid, aluminium salt. However, there are data available for structural analogue substances. Synthetic amorphous silica did not lead to an increase in chromosomal aberrations in bone-marrow cells from orally treated rats (Litton Bionetics, 1974, RL2). 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, 1974, RL2).
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, RL2).
Short description of key information:
Based on the negative results of silicic acid, aluminium salt in the S. typhimurium Ames test and all tested synthetic amorphous silica (structural analogues) in the additional mammalian in vitro and in vivo studies, no mutagenic potential is expected from exposure to silicic acid, aluminium salt.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No need for classification as the Ames test with silicic acid, aluminium salt and all in vitro and in vivo studies consistently demonstrate negative results for all tested structurally related compounds.
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