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EC number: 215-684-8 | CAS number: 1344-00-9
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Neither the studies in Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) nor that in the read-across substance Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6, SMAS) showed genotoxicity nor cytotoxicity.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Cytogenetic study to determine chromosomal damage: This is accomplished
by observing cells in anaphase. As the chromatids separate and move along the spindle, aberrations may occur. - GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- Sodium aluminosilicate (Compound FDA 71-45, Synthetic Silica, Lot Number SR-1621, as supplied by the Food and Drug Administration), from the study report it cannot be ascertained wether a crystalline or amorphous form was used
- Species / strain / cell type:
- mammalian cell line, other: human embryonic lung cultures (WI-38)
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 1, 10, 100 µg/ml
- Vehicle / solvent:
- saline
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- triethylenemelamine
- Key result
- Species / strain:
- mammalian cell line, other: human embryonic lung cultures (WI-38)
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The negative controls, medium level and low level tested exhibited 2, 0, and 1 percent acentric fragments, respectively. The high level had one cell with an acentric fragment and one cell with a bridge. This was not considered significant. The positive controls contained four cells with pulverization together with other aberrations.
- Conclusions:
- The compound produced no significant aberration in the anaphase chromosomes of human tissue culture cells when tested at the dosage levels employed in this study.
- Executive summary:
This study investigated into the potential of Sodium aluminosilicate to produce cytotoxicity in human embryonic lung cultures (WI-38). No significant changes to the control were observed.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, comprehensive testing programme (NTP/USA)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 4 instead of 5 strains
- Principles of method if other than guideline:
- Test protocol according to Haworth S et al. (1983): Salmonella mutagenicity results for 250 chemicals. Environ. Mutagen., 5(Suppl. 1), 3 - 142
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: Salmonella typhimurium TA 98, TA100, TA1535, and TA 1537 (see Table 204 p. 95)
- Metabolic activation:
- with and without
- Metabolic activation system:
- from Arochlor-1254 induced livers (male SD rat and male Syrian hamster)
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333, and 4000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: used as dispersant rather than solvent (very slight water solubility) - Negative solvent / vehicle controls:
- yes
- Remarks:
- + distilled water
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (TA 1535, TA100); 9-aminoacridine (TA97, TA1537); 4-nitro-o-phenylenediamine (TA98) // +S9: 2-aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation, 37 °C
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Expression time (on agar): 48 h at 37 °C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: clearing in the density of the background lawn of TA 100)
- Evaluation criteria:
- positive: reproducible, dose-related increase over the solvent control
- Species / strain:
- other: Salmonella typhimurium TA 98, TA100, TA1535, and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Precipitation at the two highest doses
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative - Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- cytotoxicity and genotoxicity in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- experimental phase: Jun. 16, 2016; Sep. 19, 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Cytotoxicity: DB-ALM Protocol No. 17: MTT Assay; Genotoxicity: ASTM-E2186
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Specific details on test material used for the study:
- Sodasil P95
- Species / strain / cell type:
- mammalian cell line, other: Human hepatoma HepG2
- Species / strain / cell type:
- mammalian cell line, other: Human lung carcinoma A549
- Species / strain / cell type:
- mammalian cell line, other: Human colorectal carcinoma CaCo-2
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 2.6, 8.1, 25.6, 81.0 and 256 μg/mL
- Vehicle / solvent:
- The culture medium used for growth of the cells was based in Eagle's minimum essential medium (MEM) supplemented with 10% fetal bovine serum (FBS) inactivated, 2 mM L-glutamine, 1% nonessential amino acids (NEAA), 1% sodium pyruvate, 100 μg/mL penicillin/streptomycin. The cells were maintained into an incubator at 37ºC at 5% CO2 in humidified atmosphere.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The solvent for disperse the test items 0.05% BSA in water at 10% v/v in culture medium was used as negative control.
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- other:
- Details on test system and experimental conditions:
- Seed process
Cells from a growing culture were used. They were seeded at a density between 1-3 x 10^5 cells/mL in 96-well plates. Cells were kept in the incubator for 20 hours at 35-37ºC and 5% CO2 for proper adhesion, before being exposed to the test items.
Treatment
The test items were mixed with medium according to concentration just prior to apply. Then, the growth medium of cells in 96-well plate was removed and 100 μL of treatment was added. Each treatment was done in duplicate and the exposure time was approximately 24 hours. - Rationale for test conditions:
- Cytotoxicity
Upon completion of the treatment time:
o The culture medium was removed and cells were washed with 50 μL/well with PBS tempered at 37ºC.
o MTT working solution was prepared mixing 1 mL of MTT at 5 mg/mL in water with 9 mL of culture medium without FBS.
o A total 100 μL of the MTT working solution was applied to each well.
o The plates were incubated at 37°C in humid atmosphere and 5% CO2 for three hours.
o After incubation, the culture medium was removed and it was added 100 μL per well of dimethyl sulfoxide (DMSO).
o The plates were shaken for five minutes and the absorbance was read at 570 nm.
Genotoxicity
o After the treating time of the cells, the culture medium was removed and cells were washed with 50 μL/well with PBS tempered at 37ºC.
o A volume of 80 μL of the cells suspension were mixed with a suspension of 160 μL of low melting agarose, at 0.9%, and spread on slides precoated with a layer of 1% agarose. After solidification of the agarose, the slides were immersed in lysis buffer (2,5 M NaCl, 100 mM Na2·EDTA, 10 mM Tris, 1% of Triton X-100, 1% of Lauryl Sarcosine at pH 10) for 1 hour at 4ºC to break the membranes and sequester the proteins. Subsequently the slides were kept 40 minutes in lectrophoresis buffer (1 mMNa2·EDTA, 300 mM NaOH) at 4ºC to allow DNA unwinding and finally electrophoresis at 25 V and 300 mA (at 4°C) for 30 minutes was carried out. To adhere the DNA mobilized, three washes were performed with Tris buffer (1 M Tris at pH 7.5). The slides were dried and kept protected from light until analysis.
o For analysis, the slides were humidified in water and then stained with the
fluorochrome DAPI (4,6-Diamidin-2-phenylindole, at a concentration of 5 μg/mL). - Evaluation criteria:
- Cytotoxicity assay
The means and standard deviations of absorbance were calculated for each condition. The percentage of viability was calculated comparing absorbance of treatments versus negative control. Means and standard deviations of each replica were calculated.
Validity criteria
Test results are acceptable if the following criteria are reached:
a) Viability of the solvent control is ≥80% with regard to the medium control.
b) The cell viability obtained with the positive control is within two standard deviations of the historical mean or between 0% and 5%.
Genotoxicity assay
For genotoxicity assay, the analysis of DNA breakage was carried out by image analyzer software Comet Assay IV (version 4.11). Tail intensity of the 50 nucleotides was evaluated for each sample.
The results were expressed as the intensity percentage of the tail versus to the total intensity of the DNA, called Tail Intensity. The median of each replicate was calculated. The mean and standard deviation of each treatment was calculated.
Validity criteria
Test results are acceptable if the tail intensity of the positive control is ≥60%. - Key result
- Species / strain:
- mammalian cell line, other: Human hepatoma HepG2
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- mammalian cell line, other: Human lung carcinoma A549
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- mammalian cell line, other: Human colorectal carcinoma CaCo-2
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Sodasil P95 was non-cytotoxic when tested up to 256 μg/mL in human lung A549, human hepatoma HepG2 and human colorectal carcinoma CaCo-2 cells. Further, it did not show any genotoxic effect at 256 μg/mL by using the comet assay.
- Executive summary:
The aim of this study was to carry out an in vitro test battery with different cell lines addressed to the determination of the basal cytotoxicity, genotoxicity, acute ocular irritation, sensitization and inflammation potentials and bioavailability of eight nanosilicates in order to provide a comprehensive knowledge of the safety profile of these test items. In this endpoint only the results on cytotoxicity and genotoxicity for Sodasil P95 are documented
Referenceopen allclose all
In the cytotoxicity assay, no differences were observed in the effect of Sodasil P95 at the concentration range assessed (2.6–256 μg/mL) on A549, HepG2 and CaCo-2 cell lines. The highest concentration allowed complete dissolution in ethanol:BSA under sonication.
The estimated IC30 value for Sodasil P95 is 446 μg/mL in CaCo-2 cells.
In the genotoxicity assay, no biologically relevant effects were observed for any compound. All tail intensities remained below 1.6% as compared to positive compounds that reach values clearly over 10%. Hence, all the test compounds are devoid of genotoxic effects.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
All genetic toxicity studies in vivo were carried out with the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS). Their results were all negative.
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The host organism is inoculated by intraperitoneal injection with a common indicator microorganism/tester strain before treatment with the test substance. After "incubation" in the host organism, the tester strain is withdrawn from the ascites and tested for mutation on minimal agar plate., e.g. according to Ames.
- GLP compliance:
- no
- Type of assay:
- other: Host mediated assay
- Specific details on test material used for the study:
- FDA-Compound 71-45, "sodium silicoaluminate", synthetic silica, Lot no. SR-1621, from the study report it cannot be ascertained wether a crystalline or amorphous form was used
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- saline
- Duration of treatment / exposure:
- single administration ("acute") and repeated administration (5 times, "subacute")
- Frequency of treatment:
- 1x and 5x (1x/d)
- Remarks:
- Doses / Concentrations:
4.25, 42.5 and 425 mg/kg bw, suspended in 0.85 % saline, administered 1x/d (Test I), 5000 mg/kg bw (Test II)
Basis: - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Ethyl Methane Sulfonate: 350 mg/kg bw
Dimethyl Nitrosamine: 100 mg/kg bw - Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, detailed documentation, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- GLP compliance:
- no
- Type of assay:
- rodent dominant lethal assay
- Specific details on test material used for the study:
- FDA-Compound 71-45, "sodium silicoaluminate", synthetic silica, Lot no. SR-1621,
from the study report it cannot be ascertained wether a crystalline or amorphous form was used - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 10 - 12 weeks - Route of administration:
- oral: gavage
- Vehicle:
- - vehicle: 0.85 % saline
- Volume of the vehicle: no data
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: no data - Duration of treatment / exposure:
- single administration ("acute") and repeated administration (5 times, "subacute")
- Frequency of treatment:
- 1x and 5x (1x/day)
- Remarks:
- Doses / Concentrations:
4.25, 42.5 and 425 mg/kg bw, suspended in 0.85 % saline, administered 1x/d (Test I), 5000 mg/kg bw (Test II)
Basis: - No. of animals per sex per dose:
- 10 males (treated) mated to virgin female rats (2 females/1 male)
- Control animals:
- yes, concurrent vehicle
- yes, historical
- Positive control(s):
- triethylene melamine
- Route of administration: i.p.
- Doses / concentrations: 0.3 mg/kg bw - Tissues and cell types examined:
- Fertility index = No. pregnant females / No. mated
Total No. of implantations
Total number of corpora lutea
Preimplantation losses
see Report p. 132 - 135:
Dead implants
Females with one or more dead implants
Dead implants per total implants - Statistics:
- Chi-square test, Armitage´s trend test, regression analyses, Freeman-Tukey transformation, t-test (Report p. 128 - 132)
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, basic data given, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Principles of method if other than guideline:
- Analysis of metaphase-chromosomes from isolated bone-marrow cells after colcemid-induced arrest of cell division in the metaphase
- GLP compliance:
- no
- Type of assay:
- mammalian bone marrow chromosome aberration test
- Specific details on test material used for the study:
- FDA-Compound 71-45, "sodium silicoaluminate", synthetic silica, Lot no. SR-1621, from the study report it cannot be ascertained wether a crystalline or amorphous form was used
- Species:
- rat
- Sex:
- male
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
Referenceopen allclose all
There was a high increase in mutants following oral
treatment with Dimethylnitrosamine(DMN), but no significant increases in mutation
rates at any dose and dose regimen.
For single and repeated dosage of 4.25, 42.5, and 425 mg/kg bw (Report p. 77 - 94) as well as single and repeated
dosage of 5000 mg/kg bw (Report p. 95 - 112), there was no dose-response and time-trend pattern of effects
following the silicate treatment: The values calculated for reproduction parameters (see "Examinations" above)
that related to the treated animals did not significantly vary from those obtained from the negative controls,
whereas TEM caused a significant preimplantation loss and embryo resorption during the first five weeks.
Metaphase aberrations: single dose (from Report Table p. 74)
Silene Dosage [mg/kg bw] |
Time [h] |
No. of cells |
Mitotic index1) |
% cells with breaks |
% cells with reunion |
% cells with other aberr.2) |
% cells aberr. |
4.25 |
6 |
250 |
11 |
2 |
0 |
0 |
2 |
|
24 |
250 |
11 |
1 |
0 |
0 |
1 |
48 |
250 |
11 |
3 |
0 |
0 |
3 |
|
42.5 |
6 |
250 |
8 |
0 |
0 |
0 |
0 |
24 | 250 | 9 | 1 | 0 | 0 | 1 | |
48 | 250 | 10 | 0 | 0 | 0 | 0 | |
425 | 6 | 250 | 12 | 2 | 0 | 0 | 2 |
24 | 250 | 6 | 0 | 0 | 0 | 0 | |
48 | 250 | 10 | 2 | 0 | 0 | 2 | |
Saline | 6 | 150 | 10 | 2 | 0 | 0 | 2 |
24 | 150 | 11 | 3 | 0 | 0 | 3 | |
48 | 150 | 9 | 3 | 0 | 0 | 3 | |
TEM (0.3) | 48 | 250 | 3 | 32 | 12 | 5(a); 1(pp) | 48 |
1)% cells in mitosis: 500 cells observed/animal
2)Cells with polyploidy, pulverisation (pp), or greater than 10 aberrations (a)
Metaphase aberrations: repeated dose (5x, 1x/d) (from Report Table p. 75)
Silene Dosage [mg/kg bw] |
Time after last dose [h] |
No. of cells |
Mitotic index1) |
% cells with breaks |
% cells with reunion |
% cells with other aberr.2) |
% cells aberr. |
4.25 |
6 |
250 |
10 |
2 |
0 |
0 |
2 |
42.5 |
6 |
250 |
11 |
2 |
0 |
0 |
2 |
425.0 | 6 | 250 | 8 | 3 | 0 | 0 | 3 |
Saline | 6 | 150 | 8 | 3 | 0 | 0 | 3 |
1)% cells in mitosis: 500 cells observed/animal
2)Cells with polyploidy, pulverisation (pp), or greater than 10 aberrations (a)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
As no adverse effects were observed, there is no need for classification.
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.
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