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EC number: 257-473-3 | CAS number: 51851-37-7
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-08-27 to 2016-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 2014
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- 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
- Reference substance name:
- [2-(Perfluorohexyl)ethyl]triethoxysilane
- IUPAC Name:
- [2-(Perfluorohexyl)ethyl]triethoxysilane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimum essential medium (MEM)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw) induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I:
20, 50, 100 and 200 μg/mL without metabolic activation
50, 100, 200 and 500 μg/mL with metabolic activation
Experiment II:
100, 200 and 500 μg/mL without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: According to the solubility test, the test item was soluble in ethanol. The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
ACTIVATION: S9 supernatant was mixed with S9 co-factor solution to result in a final protein concentration of 0.75 mg/mL in the cultures. The co-factors added were: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-phosphate-buffer pH 7.5.
DURATION
- Exposure duration:
Experiment I: 4 hours, with and without metabolic activation
Experiment II: 21 hours, without metabolic activation
- Expression time (cells in growth medium): Experiment I, 16 +/- 2 hours with and without metabolic activation
- Fixation time (start of exposure up to fixation or harvest of cells): 21 hours after start of exposure
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.2 μg/mL culture medium) was added to the cultures about 2.5 hours before preparation of the cells
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 300 metaphases per concentration were scored for chromosome analysis
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index and relative increase in cell count (RICC) (%)
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- The result is considered positive when:
- at least one of the test concentrations exhibits a statistically significant increase compared to the concurrent negative control
- the increase is dose-related when evaluated with an appropriate trend test
- any of the results are outside the distribution of the historical negative control data - Statistics:
- Fisher´s exact test was used to verify the results in the experiment
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
Experiment I: at 100 μg/mL and higher without metabolic activation, and at 200 μg/mL and higher with metabolic activation
Experiment II: at 500 μg/mL without metabolic activation
Any other information on results incl. tables
Table 1: Summary, experiment I and II, with and without metabolic activation
|
Dose Group |
Concentration µg/mL |
Relative Mitotic Index (%) |
RICC (%) |
Mean % Aberrant Cells |
Historical Laboratory Negative Control Range |
Precipitation |
||
Including Gaps |
Excluding Gaps |
||||||||
Experiment I and II, without metabolic activation |
|||||||||
Experiment I 4 hour treatment, 21 hour preparation interval |
C |
0 |
100 |
105 |
4.0 |
2.0 |
0.0% - 4.0 % aberrant cells |
- |
|
S |
0 |
100 |
100 |
3.3 |
1.7 |
- |
|||
3 |
20 |
101 |
94 |
2.3 |
0.3 |
- |
|||
4 |
50 |
95 |
105 |
4.3 |
1.3 |
- |
|||
5 |
100 |
101 |
89 |
1.7 |
1.0 |
+ |
|||
6 |
200 |
99 |
100 |
2.3 |
1.7 |
+ |
|||
EMS |
900 |
117 |
120 |
9.7 |
8.3 |
- |
|||
|
|||||||||
Experiment II 21 hour treatment, 21 hour preparation interval |
C |
0 |
99 |
119 |
1.7 |
0.3 |
0.0 % - 4.0 % aberrant cells |
- |
|
S |
0 |
100 |
100 |
3.3 |
2.0 |
- |
|||
4 |
100 |
101 |
110 |
3.3 |
1.7 |
- |
|||
5 |
200 |
105 |
93 |
2.3 |
1.0 |
- |
|||
6 |
500 |
109 |
92 |
1.7 |
0.7 |
+ |
|||
EMS |
400 |
78 |
78 |
12.3 |
9.0 |
- |
|||
Experiment I, with metabolic activation |
|||||||||
Experiment I 4 hour treatment, 21 hour preparation interval |
C |
0 |
109 |
114 |
2.3 |
1.0 |
0.0 % - 4.3 % aberrant Cells |
- |
|
S |
0 |
100 |
100 |
1.3 |
0.7 |
- |
|||
3 |
50 |
106 |
99 |
1.7 |
1.0 |
- |
|||
4 |
100 |
80 |
77 |
5.7 |
1.7 |
- |
|||
5 |
200 |
91 |
82 |
2.7 |
1.0 |
+ |
|||
6 |
500 |
74 |
79 |
1.7 |
1.0 |
+ |
|||
CPA |
1.5 |
98 |
150 |
8.7 |
7.3 |
- |
C: Negative Control (Culture Medium)
S: Solvent Control (EtOH 0.5 % v/v)
EMS: Ethylmethanesulfonate
CPA: Cyclophosphamide
+ : With precipitation
- : Without precipitation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested for ability to cause chromosome aberrations in Chinese hamster V79 cells according to OECD TG 473 and in compliance with GLP (Eurofins BioPharma, 2016). No increase in the number of cells with aberrations was observed either with or without metabolic activation when tested up to precipitating concentrations. Appropriate solvent, negative (treatment medium) and positive controls were included and gave the expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of this study.
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