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EC number: 215-478-8 | CAS number: 1327-43-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
After oral uptake most of the ingested sodium silicoaluminate is excreted via faeces. The minor part is hydrolysed in the gastrointestinal tract, absorbed and then rapidly excreted in the urine. Even after administration of up to 1000 mg/kg sodium silicoaluminate to rats, only about 1% of the dose was absorbed (Benke and Osborne 1979). After probable decomposition of sodium silicoaluminate in the gastrointestinal tract, the aluminium component was only poorly absorbed in dogs (Cefali et al. 1995).
The slightly soluble particles of silicic acid aluminium magnesium salt are small enough to reach the alveoli (see 1.3). In subchronic inhalation studies with synthetic amorphous silica having comparable or even smaller particle size, silica particles deposited in the lung causing exclusively local inflammatory effects. After a recovery period, none or only small amounts of silica could be recovered from the animals suggesting reversibility (Reuzel et al. 1991 and Johnston et al. 2000).
Sodium and magnesium are essential elements of the mammalian body. Salts of both metal ions are natural constituents of the regular human diet and are commonly used in low concentrations in pharmaceutical products (oral and inhalative route). No other than the physiological effects are expected to occur from the ingestion or inhalation of these ions.
Referring to the toxicokinetic properties of structurally related compounds, no risk potential is expected for MAS.
Key value for chemical safety assessment
Additional information
See basic toxicokinetics.
Discussion on bioaccumulation potential result:
Studies in animals
Cefali et al. (1995) compared the oral bioavailability of silicium and aluminum from sodium silicoaluminate, Zeolite A, magnesium trisilicate and aluminum hydroxide in dogs. The test animals received each test compound as a single oral dose (capsule) separated by one week. The administration of 16 mg/kg sodium silicoaluminate lead to elevated silicon AUC (area under the curve) and Cmaxvalues compared to controls. Mean plasma silicon AUC values were 7.7 ± 1.6 and 6.1 ± 1.9 mg*h/L, mean plasma silicon Cmaxvalue were 0.67 ± 0.27 and 0.44 ± 0.17 mg/L for sodium silicoaluminate and the internal control aluminum hydroxide, respectively. However, the differences were not significant. There was also no statistically significant absorption of aluminum from the sodium aluminosilcate treatment compared to the control treatment with magnesium trisilicate.
The rate and extent of urinary excretion of silicon was determined in rats after a single oral administration of sodium silicoaluminate, Zeolite A, sodium silicate and magnesium trisilicate (Benke and Osborn 1979). Urinary silicon excretion increased rapidly after dosing and peak excretion rates occurred within 24 h in all test groups. The urinary excretion half-life for ingested sodium silicoaluminate was calculated to be 38 hours. The percentage of silicon that appeared in urine varied independently of the applied dose indicating that limiting factors are rather the production of soluble (absorbable) silicon in the gastrointestinal tract and the rate of gastro-intestinal absorption. No significant increases in aluminium levels were detected in the urine of sodium alumionsilicate treated rats compared to controls. Daily urinary aluminium excretion averaged 17.7 ± 3.2 µg for control and 15.1 ± 4.3 µg for sodium silicoaluminate treated rats.
Studies in humans
In 12 human volunteers, no significant increased renal excretion of SiO2was found following single oral ingestion of 2500 mg synthetic amorphous silica (Aerosil or FK 700). For each test item, 5 males and 1 female (aged 22-28) received 2 x 1.25 g of the test compound each suspended in 250 mL apple juice each at day 4 (morning and midday) of an experimental period of 7 days. The urine was collected daily and analysed for the monomer SiO2content. After ingestion of Aerosil at day 4, in 3 of 6 subjects, the SiO2content was increased in urine (20-38 mg SiO2) compared to day 3. For the other 3 subjects, the SiO2excretion was decreased or unchanged.After ingestion of FK700 at day 4, the SiO2excretion was increased in 5 of 6 subjects in urine (7-23 mg SiO2) compared to day 3. One of 6 subjects showed a decreased SiO2excretion (26 mg).Overall, increases in excretion were not unequivocally detectable. The small apparent increases were in marked contrast to the high dose of 2500 mg SiO2applied.
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