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Diss Factsheets
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EC number: 215-685-3 | CAS number: 1344-01-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was conducted using a guideline similar to OECD Testing Guideline 473, with one ammendment. Limited documentation is available. Read-across from the results on the test substance has been made to the registered substance based on the similar structure of the two substances.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- without external metabolic enzyme system
- Principles of method if other than guideline:
- Method: Culture technique, determination of cytotoxicity and test for chromosomal aberrations decribed and similar to current guideline
(OECD 473) - GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Details on test material:
- FDA-Compound 71-45 ("sodium silicoaluminate")
synthetic silica
Lot no. SR-1621
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Human embryonic lung cells (Wi-38)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: no data
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 1, 10 and 100 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water, 0.85 % saline
- Justification for choice of solvent/vehicle: suspension
Controls
- Untreated negative controls:
- yes
- Remarks:
- = vehicle control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- saline
- Positive controls:
- yes
- Positive control substance:
- triethylenemelamine
- Remarks:
- Migrated to IUCLID6: 0.1 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension, 5 x 10^5 cells/ml
Mutations were quantified by counting anaphase aberrations.
DURATION
- Incubation temperature: 37 °C
- Exposure duration: 24 - 48 h
Fixation: absolute methanol:glacial acetic acid (3:1) for 30 min after centrifugation
STAIN (for cytogenetic assays): acetic acid-orcein stain (2.0 %)
NUMBER OF REPLICATIONS: 3/dose level
NUMBER OF CELLS EVALUATED: 100/dose level
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; other: "any cytopathic effect" at 24, 48, and 72 h after exposure to dose levels logarithmatically spaced (p. 127).
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
Results and discussion
Test results
- Species / strain:
- other: Human embryonic lung cells (Wi-38)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 250 µg/ml (p. 6/7), incipient inhibition of mitosis and cell toxicity as criterion for maximum dose selection
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Human embryonic lung cells (Wi-38)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Anaphase aberrations
Mitotic index1) |
No. of cells |
% cells with acentric frag. |
% cells with bridges |
% multipolar cells |
% cells other aberr.2) |
% cells with aberr. |
|
Silene |
|||||||
1.0 µg/ml |
5 |
100 |
1 |
0 |
0 |
0 |
1 |
10 µg/ml |
3 |
100 |
0 |
0 |
0 |
0 |
0 |
100 µg/ml |
2 |
100 |
1 |
1 |
0 |
0 |
2 |
Saline |
3 |
100 |
2 |
0 |
0 |
0 |
2 |
TEM (0.1 µg/ml) |
2 |
100 |
12 |
3 |
0 |
4 (pp) |
19 |
1)% cells in mitosis: 200 cells observed/dose level
2)Cells with polyploidy, pulverisation (pp), or greater than 10 aberrations
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
The test substance was found to be negative for genetic toxicity according to the conditions of this study. - Executive summary:
The genetic toxicity of the test substance was determined via use of a guideline similar to the OECD Guideline for Testing of Chemicals 473, with the ammendment from OECD 473 being that no study was conducted in the presence of an external, metabolic activation system. The test was conducted using Human embryonic lung cells (Wi-38) to investigate the occurence of chromosome aberrations in the presence of the test substance. The results were negative in the absence of metabolic activation, therefore the substance is not classified as a genetic toxin. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.
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