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EC number: 930-915-9 | CAS number: 1318-02-1
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Urinary silicon excretion by rats following oral administration of silicon compounds.
- Author:
- Benke, G.M. and Osborn, T.W.
- Year:
- 1 979
- Bibliographic source:
- Food Cosmet. Toxicol. 27:123-127
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- The rate of Zeolite Type A excretion was obtained from data on urinary excretion in rats after single oral administration.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- EC Number:
- 930-915-9
- Cas Number:
- 1318-02-1
- Molecular formula:
- M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
- IUPAC Name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Test material form:
- solid: particulate/powder
- Remarks:
- no surface treatment
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Zeolite Type A (sodium aluminosilicate)(Huber Corporation)
- Analytical purity: no data
- Analyses showed that it contained 14.7 % silicon and 16.4% aluminium. - Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Sprague-Dawley Cox
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 240-260 g
- Diet (e.g. ad libitum): Purina Rat Chow (1500-2000 ppm silicon)
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 4-5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- quartz-distilled (QD) water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All suspensions were prepared in quartz-distilled water which contained < 0.5 ppm silicon and aluminium. Concentrations (w/w) of dosing materials were adjusted so that all groups received the same dosage volume (10 mL/kg). The acutal weights administered were calculated by difference.
- Duration and frequency of treatment / exposure:
- once
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg bw (total dose)
- Dose / conc.:
- 200 mg/kg bw (total dose)
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- For the determination of silicon in urine, the samples were dry-ashed, fluxed with Na2COJ, and then dissolved in hydrochloric acid. The concentrations of silicon in solution were measured by induction-coupled RF plasma optical emission spectrometry.
- Details on dosing and sampling:
- Rats were fasted for 17-18 hr, then dosed using a no. 10 French rubber feeding tube attached to a 3-ml plastic syringe. Concentrations (w/w) of dosing materials were adjusted so that all groups received the same dosage volume (10 ml/kg). The actual weights administered were calculated by difference. All suspensions were prepared in quartz-distilled (QD) water which contained <0.5 ppm silicon. Rats were dosed with 40, 200 or 1000 mg of test material/kg body weight. For each study a group of four or six control rats were given 10 ml QD water/kg body weight. Tail cups to collect faeces were used to prevent contamination of urine samples.
- Statistics:
- Group means were compared by Student’s t-test, except that when the values were not normally distributed a non-parametric test was used (Gibbons, 1971). The rates of excretion were fitted to zero-order and first-order kinetic equations (Barr, Goodnight, Sail, & Hellwig, 1976).
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Zeolite Type A had an urinary excretion rate half-life time of 6-8 hr.
Particulare and total silicon in rat urine in the first 8 hours after the administration of Zeolite type A:
control group: 6.5 +/- 0.6 µg/ml urine (total); 2.2 +/- 1.1 µg/ml urine (particulate)
40 mg/kg group: 26.2 +/- 3.4 µg/ml urine (total); 1.4 +/- 0.3 µg/ml urine (particulate)
200 mg/kg group: 64.7 +/- 6.8 µg/ml urine (total); 1.6 +/- 1.3 µg/ml urine (particulate)
1000 mg/kg group: 80.9 +/- 13.5 µg/ml urine (total); 2.2 +/- 0.8 µg/ml urine (particulate)
It was of interest to find out whether particulate, or filterable, forms of silicon were produced during the time of maximum excretion in rats dosed with Zeolite Type A. While the total silicon concentration increased sharply with dose, the particulate silicon was not increased above control levels. The authors would, therefore, predict that toxic effects in the urinary tract would not result from single high doses of Zeolite type A.
Applicant's summary and conclusion
- Conclusions:
- Zeolite Type A had an urinary excretion rate half-life time of 6-8 hr.
- Executive summary:
The rate and extent of urinary excretion of silicon was determined in rats after oral administration of magnesium trisilicate, food-grade sodium aluminosilicate, sodium silicate or Zeolite type A. Only the results on the latter are documented here.
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