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EC number: 257-473-3 | CAS number: 51851-37-7
- 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
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-03-13 to 1997-03-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The range of strains does not comply with the current guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- yes
- Remarks:
- only 4 strains used
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [2-(Perfluorohexyl)ethyl]triethoxysilane
- IUPAC Name:
- [2-(Perfluorohexyl)ethyl]triethoxysilane
- Reference substance name:
- Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- EC Number:
- 257-473-3
- EC Name:
- Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- Cas Number:
- 51851-37-7
- Molecular formula:
- C14H19F13O3Si
- IUPAC Name:
- triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and Beta-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Plate incorporation (+ / - MA) 50, 160, 500, 1600, 5000 µg/plate
Pre-incubation (+ / - MA) 50, 160, 500, 1600, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: It is assumed by the reviewer that the solvent was chosen for its solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains (with activation)
- Details on test system and experimental conditions:
- ACTIVATION: One part of S9 fraction was mixed with 9 parts of a cofactor solution resulting in the following mixture: 10% S9 fraction, 22 mM KCl, 5 mM glucose-6-phosphate, 4mM NADP, 100 mM Na2HPO4/NaH2PO4 (pH 7.4), 8 mM MgCl2
APPLICATION: plate incorporation; pre-incubation
DURATION
- Preincubation period: 30 minutes at 30°C with gentle agitation
- Exposure duration: 72 hours at 37°C
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated. Initial experiment used plate incorporation method, the repeat used pre-incubation.
SELECTION AGENT (mutation assays): histidine-deficient agar
DETERMINATION OF CYTOTOXICITY: condition of bacterial lawn/reduction in number of revertants - Evaluation criteria:
- For a test compound to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase must be accompanied by a dose response towards increasing concentrations of the test article.
- Statistics:
- For all replicate platings, the mean number of revertants per plate and the standard deviation around the mean were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Plate incorporation test: revertants per plate (mean of three plates)
Dose/plate (µg) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
|
untreated |
30 |
12 |
184 |
133 |
16 |
9 |
18 |
18 |
ethanol |
28 |
17 |
160 |
129 |
9 |
8 |
25 |
15 |
50 |
26 |
15 |
142 |
157 |
16 |
10 |
18 |
16 |
160 |
26 |
12 |
167 |
156 |
16 |
7 |
20 |
15 |
500 |
29 |
16 |
169 |
132 |
13 |
6 |
24 |
13 |
1600 |
27 |
12 |
150 |
119 |
20 |
8 |
21 |
14 |
5000 |
35 |
17 |
175 |
157 |
14 |
9 |
20 |
8 |
positive control (2.5) |
1305 |
110 |
1497 |
- |
189 |
396 |
147 |
- |
positive control (5) |
- |
- |
- |
621 |
- |
- |
- |
- |
positive control (40) |
- |
- |
- |
- |
- |
- |
- |
150 |
Table 2: Preincubation test: revertants per plate (mean of three plates)
Dose/plate (µg) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
|
untreated |
19 |
16 |
161 |
165 |
14 |
12 |
17 |
19 |
ethanol |
18 |
17 |
151 |
173 |
16 |
10 |
13 |
14 |
50 |
18 |
16 |
143 |
175 |
13 |
9 |
8 |
20 |
160 |
15 |
13 |
142 |
139 |
13 |
7 |
15 |
16 |
500 |
25 |
19 |
161 |
165 |
16 |
10 |
15 |
17 |
1600 |
18 |
11 |
161 |
149 |
14 |
11 |
13 |
15 |
5000 |
22 |
17 |
163 |
170 |
18 |
12 |
16 |
13 |
positive control (2.5) |
1189 |
103 |
1586 |
- |
234 |
440 |
163 |
- |
positive control (5) |
- |
- |
- |
682 |
- |
- |
- |
- |
positive control (40) |
- |
- |
- |
- |
- |
- |
- |
153 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD Guideline 471, compliant with GLP. The range of strains does not comply with the current guideline. No evidence of a test-substance related increase in the number of revertants was observed in Salmonella typhimurium strains TA 98, TA 100, TA 1535 or TA 1537 when tested with or without metabolic activation in the initial plate incorporation assay or the repeat preincubation experiment up to cytotoxic/limit concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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