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Diss Factsheets
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EC number: 930-985-0 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, scientifically acceptable
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacokinetic Study of Zeolite A, Sodium Aluminosilicate, Magnesium Silicate, and Aluminium Hydroxide in Dogs
- Author:
- Cefali E, Nolan JC, McConbell WR and Walters DL
- Year:
- 1 995
- Bibliographic source:
- Pharmaceut. Res., 12 (2), 270-274
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- The bioavailability of silicon and aluminium from zeolite A, sodium aluminosilicate, magnesium trisilicate and aluminium hydroxide was compared in dogs.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Zeolite A (N-0974) raw material
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Analytical purity: no data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- individually housed female dogs (10-13 months; 7.3-11.6 kg of weight)
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- other: gelatine
- Details on exposure:
- Twelve individually housed female dogs received each compound as a single oral dose separated by one week in a randomized four-way crossover-design. Dosing was equimolar based upon silicon content and adjusted to each dog's weight.
- Duration and frequency of treatment / exposure:
- single oral dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30 mg/kg
- No. of animals per sex per dose / concentration:
- 12
- Control animals:
- no
Results and discussion
Any other information on results incl. tables
SILICON
-----------------
The absorption of silicon from Zeolite A was variable revealing elevated
mean silicon AUC and Cmax values when compared to a baseline; however,
only the AUC from zeolite A was significantly elevated** (One way ANOVA
p=0.041, and Tukey's standardized range test p0.05):
Mean plasma silicon AUC values (± SD) mg / h /L
zeolite A** 9.5
± 4.5
sodium alumino-silicate 7.7
± 1.6
magnesium trisilicate 8.8
± 3.0
aluminum hydroxide 6.1
± 1.9
mean plasma silicon Cmax values (± SD) mg/L
zeolite A 1.07
± 1.06
sodium alumino-silicate 0.67
± 0.27
magnesium trisilicate 0.75
± 0.31
aluminum hydroxide 0.44
± 0.17
mean plasma silicon Tmax values (± SD) hr
zeolite A 7.9
± 6.4
sodium alumino-silicate 5.8
± 4.6
magnesium trisilicate 6.9
± 6.3
aluminum hydroxide 8.5
± 3.4
ALUMINUM
--------------------
Although the silicon doses were equimolar, the corresponding aluminum
doses differed by more than an order of magnitude. The amounts of
aluminum delivered by zeolite A and sodium alumino-silicate were 3.36
and 0.90 mg/kg respectively, while the aluminum hydroxide dose of 675 mg
was approximately equivalent to 27.77 mg/kg aluminum based on the
average weight of the dogs on the day of dosing. The plasma aluminum
data during magnesium trisilicate dosing serves as the control treatment
for the dietary absorption of aluminum as this compound contains no
appreciable amount of aluminum.
There was no statistically significant absorption of aluminum from the
other aluminum-containing compounds:
Mean plasma aluminum AUC values (± SD) µg / h /L
zeolite A 342
± 111
sodium alumino-silicate 338
± 167
magnesium trisilicate 315
± 69
aluminum hydroxide 355
± 150
mean plasma aluminum Cmax values (± SD) µg/L
zeolite A 29
± 9
sodium alumino-silicate 27
± 14
magnesium trisilicate 24
± 5
aluminum hydroxide 29
± 11
mean plasma aluminum Tmax values (± SD) hr
zeolite A 3.5
± 4.1
sodium alumino-silicate 4.2
± 4.3
magnesium trisilicate 5.7
± 7.3
aluminum hydroxide 5.0
± 4.7
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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