Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-912-9 | CAS number: 6834-92-0
- 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 gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD 476
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Guideline:
- other: Japanese Guidelines: Kanpoan No. 287, Environment Protection Agency; Eisei No. 127, Ministry of Health and Welfare; Heisei 09/10/31 Kikyoku No. 2, Ministry of International Trade and Industry
- Principles of method if other than guideline:
- first experiment 4 hours treatment with and without metabolic activation
second experiment 24 hours treatment without metabolic activation and 4 hours treatment with metabolic activation - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Cytotest Cell Research GmbH
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- C-SAT 080094
- IUPAC Name:
- C-SAT 080094
- Reference substance name:
- Silicic acid, sodium salt
- EC Number:
- 215-687-4
- EC Name:
- Silicic acid, sodium salt
- Cas Number:
- 1344-09-8
- Molecular formula:
- Na2O x (SiO2)n with Molar Ratio (MR) (SiO2/Na2O): 1.5 – 4
- IUPAC Name:
- Silicic acid, sodium salt
- Details on test material:
- Identity: C-SAT 080094; Sodium silicate solution (weight ratio 3.35)
Tradename: Natronwasserglas 37/40PE (Sodium Silicate 37/40PE, aqueous Sodium
Silicate Solution WR 3.35)
Batch No.: 248908210
Molecular Weight: 263 g/mol
Purity: 36% active ingredient, 64% water
Stability in Solvent: Not indicated by the sponsor
Storage: At room temperature
Expiration Date: September 10, 2009
On the day of the experiment (immediately before treatment), the test item was dissolved in deionised water.
The final concentration of deionised water in the culture medium was 10 % v/v.
In the pre-experiment the pH at the three highest concentrations was adjusted with 2N hydrochloric acid.
Constituent 1
Constituent 2
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- Experiment I:
without S9 mix: 28.1; 56.3; 112.5; 225.0; 337.5; 450 µg/mL
with S9 mix: 56.3; 112.5; 225.0; 450.0; 675.0; 900.0 µg/mL
Experiment II:
without S9 mix: 28.1; 56.3; 112.5; 225.0; 450.0; 675.0 µg/mL
with S9 mix: 112.5; 225.0; 450.0; 900.0; 1350.0; 1800 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: solubility properties
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: 7,12-dimethylbenz(a)anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours with and without metabolic activation in experiment 1, 24 hours without metaoblic activation in experiment 2
- Expression time (cells in growth medium): 72 hours
- Selection time (if incubation with a selection agent): 10 days
SELECTION AGENT (mutation assays): Thioguanine
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: >1,5x10exp.6
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
- Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points.
A test item producing neither a concentration- related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system.
A positive response is described as follows:
A test item is classified as mutagenic if it reproducibly induces a mutation frequency that is three times above the spontaneous mutation fre¬quency at least at one of the concentrations in the experiment.
The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
However, in a case by case evaluation this decision depends on the level of the corre-sponding negative control data. If there is by chance a low spontaneous mutation rate in the range normally found (0.5 – 31.8 mutants per 10exp.6 cells) a concentration-related in-crease of the mutations within this range has to be discussed. The variability of the mutation rates of negative and solvent controls within all experiments of this study was also taken into consideration. - Statistics:
- Linear regression analysis (least squares) .
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary Table
|
|
relative |
relative |
mutant |
|
relative |
relative |
mutant |
|
|
|
conc. µg |
S9 |
cloning |
cloning |
colonies/ |
induction |
cloning |
cloning |
colonies/ |
induction |
|
per mL |
mix |
efficiency I |
efficiency II |
106 cells |
factor |
efficiency I |
efficiency II |
106 cells |
factor |
|
|
% |
% |
|
% |
% |
|
|||
column |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
Experiment I / 4 h treatment |
culture I |
culture II |
||||||||
Solvent control with water |
- |
100.0 |
100.0 |
18.4 |
1.0 |
100.0 |
100.0 |
17.1 |
1.0 |
|
Positive control with |
150.0 |
- |
76.2 |
94.8 |
137.7 |
7.5 |
84.7 |
86.2 |
132.3 |
7.7 |
Test item |
28.1 |
- |
98.4 |
114.2 |
15.4 |
0.8 |
92.7 |
104.2 |
13.0 |
0.8 |
Test item |
56.3 |
- |
100.0 |
110.3 |
12.0 |
0.7 |
97.1 |
98.0 |
16.8 |
1.0 |
Test item |
112.5 |
- |
102.8 |
101.8 |
16.7 |
0.9 |
88.2 |
96.3 |
15.5 |
0.9 |
Test item |
225.0 |
- |
87.2 |
102.0 |
21.5 |
1.2 |
76.9 |
95.5 |
19.9 |
1.2 |
Test item |
337.5 |
- |
0.2 |
98.4 |
14.6 |
0.8 |
8.8 |
89.2 |
20.5 |
1.2 |
Test item |
450.0 |
- |
0.0 |
culture was not continued# |
0.0 |
culture was not continued# |
||||
Solvent control with water |
+ |
100.0 |
100.0 |
24.6 |
1.0 |
100.0 |
100.0 |
17.9 |
1.0 |
|
Positive control with DMBA |
1.1 |
+ |
43.9 |
89.0 |
636.4 |
25.9 |
36.6 |
99.5 |
620.9 |
34.7 |
Test item |
56.3 |
+ |
94.4 |
culture was not continued## |
97.3 |
culture was not continued## |
||||
Test item |
112.5 |
+ |
89.5 |
94.1 |
16.9 |
0.7 |
95.7 |
105.9 |
22.3 |
1.2 |
Test item |
225.0 |
+ |
94.1 |
89.8 |
17.6 |
0.7 |
94.2 |
85.8 |
20.6 |
1.2 |
Test item |
450.0 |
+ |
84.7 |
90.5 |
16.3 |
0.7 |
94.5 |
81.5 |
20.9 |
1.2 |
Test item |
675.0 |
+ |
88.5 |
114.3 |
13.2 |
0.5 |
93.6 |
92.6 |
17.9 |
1.0 |
Test item |
900.0 |
+ |
85.0 |
85.7 |
27.8 |
1.1 |
92.9 |
96.4 |
15.5 |
0.9 |
Experiment II / 24 h treatment |
culture I |
culture II |
||||||||
Solvent control with water |
- |
100.0 |
100.0 |
13.7 |
1.0 |
100.0 |
100.0 |
14.1 |
1.0 |
|
Positive control with |
75.0 |
- |
92.5 |
97.7 |
132.5 |
9.7 |
102.2 |
93.2 |
105.6 |
7.5 |
Test item |
28.1 |
- |
104.7 |
culture was not continued## |
101.8 |
culture was not continued## |
||||
Test item |
56.3 |
- |
102.5 |
95.7 |
16.9 |
1.2 |
102.2 |
69.3 |
18.8 |
1.3 |
Test item |
112.5 |
- |
88.0 |
94.5 |
17.4 |
1.3 |
102.7 |
97.8 |
9.0 |
0.6 |
Test item |
225.0 |
- |
95.1 |
88.7 |
23.2 |
1.7 |
102.0 |
71.3 |
17.4 |
1.2 |
Test item |
450.0 |
- |
94.1 |
84.2 |
23.6 |
1.7 |
101.4 |
65.3 |
17.7 |
1.3 |
Test item |
675.0 |
- |
43.3 |
90.9 |
16.2 |
1.2 |
102.9 |
63.5 |
28.4 |
2.0 |
Experiment II / 4 h treatment |
culture I |
culture II |
||||||||
Solvent control with water |
+ |
100.0 |
100.0 |
13.7 |
1.0 |
100.0 |
100.0 |
16.1 |
1.0 |
|
Positive control with DMBA |
1.1 |
+ |
55.9 |
73.5 |
809.9 |
59.1 |
51.2 |
78.8 |
595.5 |
36.9 |
Test item |
112.5 |
+ |
114.6 |
78.2 |
20.1 |
1.5 |
95.6 |
90.4 |
22.6 |
1.4 |
Test item |
225.0 |
+ |
91.3 |
101.5 |
24.6 |
1.8 |
107.2 |
98.0 |
14.5 |
0.9 |
Test item |
450.0 |
+ |
95.5 |
109.1 |
22.9 |
1.7 |
99.1 |
83.9 |
20.5 |
1.3 |
Test item |
900.0 |
+ |
111.7 |
99.4 |
26.1 |
1.9 |
112.6 |
80.5 |
20.8 |
1.3 |
Test item |
1350.0 |
+ |
10.6 |
100.7 |
11.4 |
0.8 |
7.4 |
102.9 |
8.8 |
0.5 |
Test item |
1800.0 |
+ |
0.0 |
culture was not continued# |
0.0 |
culture was not continued# |
# culture not continued due to exceedingly strong toxic effects
## culture was not continued since a minimum of only four analysable concentrations is required
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.
Therefore, C-SAT 080094 is considered to be non-mutagenic in this HPRT assay. - Executive summary:
The study was performed to investigate the potential of C-SAT 080094 to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster.
The assay was performed in three independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The experimental part without metabolic activation was terminated prematurely due to exceedingly severe cytotoxic effects even al low concentrations. This part of the first experiment was repeated in experiment IA using a lower concentration range. The data of the repeat experiment IA are included in the first experiment.
The second experiment was performed in the absence of metabolic activation with a treatment period of 24 hours and in the presence of metabolic activation with a treatment period of 4 hours.
The highest applied concentration in the pre-test on toxicity (7300 µg/mL) was based on the purity of the test item (36 % active ingredient). The dose range of the main experiments was limited by toxicity of the test item.
No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments.
Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test item and the activity of the metabolic activation system.
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.