Registration Dossier
Registration Dossier
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EC number: 277-551-0 | CAS number: 73609-36-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 (OECD TG 471) (LPT, 2002).
Mammalian cytogenicity: The analogous substance, [2-(perfluorohexyl)ethyl]triethoxysilane, was negative with and without metabolic activation in Chinese hamster V79 cells (OECD 473)(Eurofins Biopharma, 2016a).
Mammalian mutagenicity: The analogous substance, [2-(perfluorohexyl)ethyl]triethoxysilane, was negative with and without metabolic activation in mouse lymphoma L5178Y cells (OECD 490) (Eurofins Biopharma, 2016b).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-03 to 2002-08-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 10, 31.6, 100, 316, 1000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethylene glycol dimethylether
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (without activation)
- 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:
- 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:
- methylmethanesulfonate
- Remarks:
- TA 102 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide
- Remarks:
- TA 98, TA 102, TA 1537 (with activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 100, TA 1535 (with activation)
- Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration; the initial plate incorporation assay was repeated using the pre-incubation method.
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, relative colony counts
METABOLIC ACTIVATION
Aroclor induced rat liver S9 was tested for protein and P-450 content. S9 mix contained 5% S9, and glucose-6-phosphate and NADP as co-factors. 0.5 ml S9 mix were added to 2 ml top agar, 0.1 ml test material and 0.1 ml cell suspension, giving a final concentration of approximately 1% S9.- Evaluation criteria:
- A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both experiments.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking on histidine-free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn. - Statistics:
- MANN and WHITNEY and Spearman’s rank.
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 - 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 - 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 - 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 - 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane has been tested in a reliable study, conducted according to OECD 471 and in compliance with GLP. No test-substance related increase in the number of revertants was observed with and without metabolic activation when tested up to cytotoxic concentration in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102. The result of the initial plate incorporation assay was confirmed in an independent experiment using the pre-incubation method. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the substance is negative for mutagenicity to bacteria under the conditions of the test. - 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
- 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
- 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. - 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
- 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 - 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. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-21 to 2016-04-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 490 (In vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene) 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine Kinase (TK) Locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 complete medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/ β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 0.05, 0.10, 0.25, 0.50, 1.00, 1.50, 1.75 and 2.0 mg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
- Justification for choice of solvent/vehicle: The solvent used was chosen based on the results of the solubility test. - Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol 0.5% v/v
- 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 0.5% v/v
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol 0.5% v/v
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: The S9 supernatant was mixed with S9 cofactor solution to result in final protein concentration of 0.75 mg/mL in the cultures. The cofactors added were: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-phosphate-buffer pH 7.4.
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 2 days at 37 °C
- Selection time (if incubation with a selection agent): 12 days at 37 °C
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays): selective medium with TFT
NUMBER OF REPLICATIONS: duplicate cultures were used
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: relative cloning efficiency (RCE); relative total growth (RTG)
OTHER EXAMINATIONS:
- clastogenicity: Colony sizing was performed for the highest concentrations of the test item and for the negative and positive controls. - Evaluation criteria:
- The test item is considered mutagenic if the following criteria are met:
- The induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 mutants per 10⁶ cells
- A dose-dependent increase in mutant frequency is detected. - Statistics:
- Evaluation of statistical significance (p < 0.05)
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Effects of pH: The pH-values detected with the test item were within the physiological range.
- Precipitation: No precipitation of the test item was noted in the experiment
COMPARISON WITH HISTORICAL CONTROL DATA: All mutant frequencies for negative, solvent and positive controls of the main experiment were found within the historical range of the test facility.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Clastogenicity: none of the obtained values for small colonies exceeded 40% and all dose groups were considered as not clastogenic - Conclusions:
- Interpretation of results: negative with and without metabolic activation
[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested for mutagenicity in mouse lymphoma L5178Y cells according to OECD TG 490, and in compliance with GLP. No test substance induced increase in the number of mutations was observed when tested up to limit concentrations. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study.
Referenceopen allclose all
Table 2: Dose range-finding study Number of revertants per plate (mean of 2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
112 |
115 |
No |
0.316 |
117 |
105 |
No |
1 |
111 |
110 |
No |
3.16 |
126 |
112 |
No |
10 |
101 |
114 |
No |
31.6 |
116 |
121 |
No |
100 |
172 |
181 |
No |
316 |
165 |
173 |
No |
1000 |
132 |
154 |
Yes |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with Ethylene glycol dimethylether
Table 3a: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
42 |
51.7 |
No |
133 |
158 |
No |
278 |
295 |
No |
10 |
36.3 |
48.7 |
No |
154 |
148 |
No |
274.7 |
273.7 |
No |
31.6 |
34.7 |
53 |
No |
139 |
153.3 |
No |
268.3 |
275 |
No |
100 |
34.3 |
57 |
No |
137.7 |
131.3 |
No |
271.3 |
270 |
No |
316 |
47.7 |
47.3 |
No |
143.3 |
139.3 |
No |
258 |
272.3 |
No |
1000 |
31.3 |
40.3 |
Yes |
131 |
160.7 |
Yes |
286.7 |
267.3 |
Yes |
Positive control |
1145.7 |
1100 |
No |
1194.3 |
1196.3 |
No |
1320 |
1150.3 |
No |
*solvent control with Ethylene glycol dimethylether
Table 3b: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc.µg/plate |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
13 |
15.3 |
No |
6 |
4 |
No |
10 |
13 |
12 |
No |
3.7 |
4.7 |
No |
31.6 |
14.7 |
14 |
No |
3.3 |
5.7 |
No |
100 |
14.3 |
13 |
No |
3 |
2.7 |
No |
316 |
11 |
13 |
No |
3.7 |
4.7 |
No |
1000 |
12 |
16.3 |
No |
4.3 |
3.3 |
No |
Positive control |
1187 |
1189 |
No |
1191.3 |
1241.7 |
No |
*solvent control with Ethylene glycol dimethylether
Table 4a: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
37.3 |
30.7 |
No |
143.7 |
154 |
No |
280.3 |
290.3 |
No |
10 |
31.7 |
30.3 |
No |
187 |
160.7 |
No |
276.3 |
283.7 |
No |
31.6 |
38 |
35.7 |
No |
171.7 |
144.7 |
No |
288.7 |
286.3 |
No |
100 |
35 |
36.3 |
No |
178 |
152 |
No |
283.3 |
281.7 |
No |
316 |
0 |
36 |
Yes |
162.7 |
144.7 |
No |
297.3 |
265 |
Yes |
1000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
894.3 |
983.7 |
No |
1326.3 |
1333.3 |
No |
1338.3 |
1344.3 |
No |
*solvent control with Ethylene glycol dimethylether
Table 4b: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
13.7 |
13 |
No |
3 |
4.3 |
No |
10 |
13.3 |
13.7 |
No |
3 |
4.7 |
No |
31.6 |
14.3 |
12 |
No |
3 |
3.3 |
No |
100 |
12.3 |
12.3 |
No |
2.3 |
4.3 |
No |
316 |
14.3 |
12 |
Yes |
4 |
4.3 |
Yes |
1000 |
0 |
12.7 |
Yes |
0 |
0 |
Yes |
Positive control |
487.3 |
499.7 |
No |
502 |
503 |
No |
*solvent control with Ethylene glycol dimethylether
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
Table 1: Main Experiment results, without metabolic activation
|
Test Group |
Concentrations µL/ml |
RCE % |
RTG % |
MF (mutants/106cells) |
IMF (mutants/106cells) |
GEF exceeded |
Statistical Significant Increase |
Experiment: without metabolic activation |
C1 |
0 |
117.3 |
118.1 |
114.7 |
/ |
/ |
- |
C2 |
0 |
93.8 |
95.6 |
/ |
/ |
- |
||
S1 |
0 |
100.0 |
100.0 |
100.9 |
/ |
/ |
- |
|
S2 |
0 |
/ |
/ |
- |
||||
3 |
0.05 |
105.3 |
87.1 |
113.9 |
13.0 |
- |
- |
|
4 |
0.10 |
86.8 |
77.0 |
111.6 |
10.7 |
- |
- |
|
5 |
0.25 |
95.3 |
93.9 |
95.7 |
-5.2 |
- |
- |
|
6 |
0.50 |
95.3 |
94.6 |
98.1 |
-2.8 |
- |
- |
|
7 |
1.00 |
101.8 |
86.5 |
86.0 |
-14.9 |
- |
- |
|
8 |
1.50 |
93.8 |
86.9 |
142.2 |
41.3 |
- |
+ |
|
9 |
1.75 |
103.6 |
89.0 |
91.2 |
-9.7 |
- |
- |
|
10 |
2.00 |
96.9 |
87.8 |
112.3 |
11.4 |
- |
- |
|
EMS |
300 μg/mL |
73.7 |
59.0 |
857.5 |
756.6 |
+ |
+ |
|
MMS |
10 μg/mL |
61.2 |
43.7 |
492.0 |
391.2 |
+ |
+ |
Table 2: Main Experiment results, with metabolic activation
|
Test Group |
Concentrations µL/ml |
RCE % |
RTG % |
MF (mutants/106cells) |
IMF (mutants/106cells) |
GEF exceeded |
Statistical Significant Increase |
Experiment: with metabolic activation |
C1 |
0 |
99.7 |
89.9 |
112.5 |
/ |
/ |
- |
C2 |
0 |
108.0 |
101.6 |
/ |
/ |
- |
||
S1 |
0 |
100.0 |
100.0 |
132.4 |
/ |
/ |
- |
|
S2 |
0 |
/ |
/ |
- |
||||
3 |
0.05 |
109.8 |
105.0 |
116.8 |
-15.6 |
- |
- |
|
4 |
0.10 |
96.6 |
99.1 |
137.8 |
5.4 |
- |
- |
|
5 |
0.25 |
74.2 |
82.5 |
191.8 |
59.3 |
- |
+ |
|
6 |
0.50 |
113.6 |
119.0 |
141.4 |
9.0 |
- |
- |
|
7 |
1.00 |
83.2 |
82.2 |
152.4 |
20.0 |
- |
- |
|
8 |
1.50 |
117.5 |
129.4 |
110.5 |
-21.9 |
- |
- |
|
9 |
1.75 |
111.7 |
120.5 |
103.2 |
-29.2 |
- |
- |
|
10 |
2.00 |
108.0 |
119.6 |
91.7 |
-40.7 |
- |
- |
|
B[a]P |
2.5 μg/mL |
74.2 |
25.6 |
721.6 |
589.2 |
+ |
+ |
C: Negative Controls
S: Solvent Controls (ethanol)
EMS: Ethylmethanesulfonate [300 μg/mL]
MMS: Methylmethanesulfonate [10 μg/mL]
B[a]P: Benzo[a]pyrene [2.5 μg/mL]
RCE: Relative Cloning Efficiency
RTG: Relative Total Growth
MF: Mutant Frequency
IMF: Induced Mutant Frequency
GEF: Global Evaluation Factor
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane has been tested in a reliable bacterial mutagenicity study, conducted according to OECD 471 and in compliance with GLP (LPT, 2002). No test-substance related increase in the number of revertants was observed with and without metabolic activation when tested up to cytotoxic concentrations in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102. The result of the initial plate incorporation assay was confirmed in an independent experiment using the pre-incubation method. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the substance is negative for mutagenicity to bacteria under the conditions of the test.
The analogous substance, [2-(perfluorohexyl)ethyl]triethoxysilane, has also been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD Guideline 471, compliant with GLP (Hüls, 1997). 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.
The analogue substance, [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, 2016a). No increase in the number of cells with aberrations was observed either with or without metabolic activation 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.
The analogue substance, [2-(perfluorohexyl)ethyl]triethoxysilane has been tested for mutagenicity in mouse lymphoma L5178Y cells according to OECD TG 490, and in compliance with GLP (Eurofins BioPharma, 2016b). No test-substance induced increase in the number of mutations was observed when tested up to limit concentrations. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study.
Justification for classification or non-classification
Based on the available in vitro bacterial mutagenicity data, [2-(perfluorohexyl)ethyl]dichloro(methyl)silane does not require classification for mutagenicity according to Regulation (EC) No 1272/2008
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