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EC number: 235-730-0 | CAS number: 12627-14-4
- 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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 04 Nov 2008 - 08 Jan 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-guideline study, tested with the source substance sodium silicate solution. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted July 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- 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:
- Hess. Ministerium für Umwelt, ländlicher Raum und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 1344-09-8 (content: 36%)
- IUPAC Name:
- 1344-09-8 (content: 36%)
- 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
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM supplemented with 10% fetal calf serum
- 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:
- cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of Wistar HsdCpb:WU rats treated with Phenobarbital/ß-Naphthoflavone
- Test concentrations with justification for top dose:
- Experiment I:
without S9 mix: 28.1, 56.3, 112.5, 225.0, 337.5 and 450 µg/mL (4h)
with S9 mix: 56.3, 112.5, 225.0, 450.0, 675.0 and 900.0 µg/mL (4h)
Experiment II:
without S9 mix: 28.1, 56.3, 112.5, 225.0, 450.0 and 675.0 µg/mL (24h)
with S9 mix: 112.5, 225.0, 450.0, 900.0, 1350.0 and 1800 µg/mL (4h) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: solubility properties
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethane sulfonate, 150 or 75 µg/mL in nutrient medium, without S9; 7,12-dimethylbenz(a)anthracene, 1.1 µg/mL in DMSO, with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 1st experiment: 4 h exposure with and without S9-mix; 2nd experiment: 24 h exposure without S9-mix and 4 h exposure with S9-mix
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 8 days
SELECTION AGENT (mutation assays): 11 µg/mL thioguanine (6-TG)
NUMBER OF REPLICATIONS: duplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency (cloning efficiency I (survival): cloning efficiency determined immediately after treatment to measure toxicity); cloning efficiency II (viability): cloning efficiency determined after expression period to measure viability of cells without selection agent)
- 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 corresponding negative control data. If there is by chance a low spontaneous mutation rate in the range normally found (0.5 – 31.8 mutants per 10E6 cells) a concentration-related increase 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) to assess a possible dose dependent increase of mutant frequencies;
p<0.05
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
- Remarks:
- 1st exp.: at 337.5 µg/mL, -S9; 2nd exp.: at 675 µg/mL, -S9 and at 1350 µg/mL and above, +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: In the pre-experiment the pH at the three highest concentrations was adjusted with 2N hydrochloric acid
- Effects of osmolality: In the pre-test the osmolarity of the medium was measured at the maximal concentration (301 mOsm) and the solvent control (280mOsm) and showed no relevant deviation.
- Precipitation: pre-test: Following 4 h treatment precipitation was observed at 1825, 3650 and 7300 μg/mL in the presence of s9-mix. Following continuous treatment precipitation occurred at the maximum concentration of 7300 μg/mL. Main experiments: No precipitation of the test item was observed up to the maximal concentration.
RANGE-FINDING/SCREENING STUDIES:
The highest concentration used in the pre-test was chosen with regard to the purity (36 % active ingredient) and the molecular weight of the test item (263 g/mol). Test item concentrations between 57.0 and 7300 μg/mL were used to evaluate toxicity in the presence (4 h treatment) and absence (4 h and 24 h treatment) of metabolic activation. Strong toxic effects occurred at 456.3 μg/mL in the absence of metabolic activation following 4 and 24 hours treatment. At higher concentrations the cell growth was completely inhibited. In the presence of metabolic activation the no cells survived at 912.5 μg/mL and above.
Based on the results of the pre-experiment, the concentration range of the main experiments was selected. - Remarks on result:
- other: strain/cell type: V79
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary Table
|
conc. µg/mL |
S9mix |
relative cloning efficiency I [%] |
relative cloning efficiency II [%] |
mutant colonies/ 106cells |
induction factor |
relative cloning efficiency I [%] |
relative cloning efficiency II [%] |
mutant colonies/106cells |
Induction 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
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