Registration Dossier
Registration Dossier
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EC number: 231-701-1 | CAS number: 7691-02-3
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 98, TA 100, TA 102, TA 1535 and TA 1537 (OECD Test Guideline 471) (LPT, 2002).
Cytogenicity in mammalian
cells: negative with and without metabolic activation in Chinese hamster
V79 cells (OECD Test Guideline 473)
(BSL Bioservice, 2012a).
Mutagenicity in mammalian
cells: negative with and without metabolic activation in mouse lymphoma
L5178T cells (OECD Test Guideline
476) (BSL Bioservice, 2012b).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-10 to 2002-09-16
- 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
- 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:
- Experiment 1: 100, 316, 1000, 3160, 5000 µg/plate; Experiment 2: 31.6, 100, 316, 1000, 3160 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 agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 3 plates per concentration
DETERMINATION OF CYTOTOXICITY
- Method: condition of bacterial lawn and reduction in the number of revertants
METABOLIC ACTIVATION: The S9 mix contained 5% S9 from Aroclor 1254-induced rat liver, and NADP and glucose-9-phosphate as co-factors. 0.5 ml of S9 mix were added to top agar, bacterial suspension and test material (or solvent or positive control) to a final volume of 2.7 ml and a final S9 concentration of approximately 1%. - Evaluation criteria:
- A result is considered 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.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 3160 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 3160 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 3160 and 5000 µg/plate
- 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:
- cytotoxicity
- Remarks:
- 3160 and 5000 µg/plate
- 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:
- cytotoxicity
- Remarks:
- 3160 and 5000 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:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine has been tested for mutagenicity to bacteria in a reliable study conducted according to OECD Test Guideline 471, and in compliance with GLP. No test-substance meditated increase in the number of revertants was observed when the substance was tested up to cytotoxic concentration in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 either with or without metabolic activation. The results were confirmed in a second independent experiment. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test 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:
- 2011-10-12 to 2011-12-29
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- 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: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and ß-naphthoflavone-induced Wistar rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-expt: 0.020, 0.039, 0.078, 0.16, 0.31, 0.63, 1.25, 2.5, 5.0 and 10.0 mM (+/-MA); Expt I: 7.0, 8.5 and 10.0 mM (-MA); 5.0, 7.5 and 10.0 mM (+MA); Expt II: 8, 9 and 10 mM (+/-MA)
- Vehicle / solvent:
- -Vehicle (s)/solvent(s) used: cell culture medium
-Justification for choice of solvent/vehicle: due to the nature of the test item N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine it could be dissolved in Acetone at a concentration of 4 M. To reach a final concentration of 0.25% solvent v/v in the treatment medium the solution was diluted in cell culture medium (MEM) and treated with ultrasound for around 2 to 3 minutes. The solvent was compatible with the survival of the cells and the S9 activity. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation 400 and 900 µg/ml
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation 0.83 µg/ml
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Experiment I with and without metabolic activation, experiment II with metabolic activation)
20 hours (Experiment II without metabolic activation)
FIXATION INTERVAL: 20 hours (Experiment I and II with and without metabolic activation)
NUMBER OF REPLICATIONS: 2 independent experiments
NUMBER OF CELLS SEEDED: 1 x 10^4 - 5 x 10^4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture), except at the concentration of 10 mM in experiment II with metabolic activation: 400 cells
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell density - Evaluation criteria:
- There are several criteria for determining a positive result:
- a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (0.0% - 4.0% aberrant cells (with and without metabolic activation)). - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- RTG Expt 1: 23.2% at 10 mM without MA; Expt 2: 32.2% at 10 mM +MA, 10.3% at 4mM -MA
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine has been tested in a reliable study conducted according to OECD TG 473 and under GLP. No test substance related increase in the incidence of structural or numerical chromosome aberrations was observed when tested up to cytotoxic concentrations with and without metabolic activation, in Chinese hamster V79 cells. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the substance is not clastogenic or aneugenic (i.e. it does not induce structural or numerical chromosome aberrations) under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-10-11 to 2012-01-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: IWGT Recommendations
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment I: 0.1, 0.5, 2.5, 5.0, 7.5 and 10.0 mM (+/-MA); Pre-experiment II: 0.1, 1.0 and 4.0 mM (-MA, 24 h exp); Experiment I: 0.2, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0 and 10.0 mM (+/-MA); Experiment II: 0.1, 0.3, 0.7, 1.5, 3.0, 7.5, 9.5 and 10.0 mM (+MA), 0.2, 0.5, 1.0, 2.0, 2.5, 3.0, 3.5 and 4.0 mM (-MA)
- Vehicle / solvent:
- Based on the results of the solubility test acetone (0.25% v/v final concentration in the samples) was used as solvent.
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:
- 0.25% acetone v/v
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation 2.5 µg/mL
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.25% acetone v/v
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation 200 µg/mL and 300 µg/mL
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.25% acetone v/v
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation 10 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium (dissolved in acetone (final concentration of 0.25% solvent v/v in the samples)). As the test item formed precipitate upon addition to the samples, cells were incubated with a test item suspension.
DURATION: 4 h (short-term exposure), 24 h (long-term exposure)
Expression time (cells in growth medium): 48 h
Selection time (if incubation with selection agent): about 14 days
SELECTION AGENT ( mutation assay) 5 µg/mL trifluorothymidine
NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; cells were seeded in 4 plates and evaluated
NUMBER OF CELLS SEEDED: 2000 cells per well
DETERMINATION OF CYTOTOXICITY: relative total growth (RTG) - Evaluation criteria:
- The test item is considered mutagenic if following criteria are met:
-The induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 mutants per 10^6 cells
- A dose-dependent increase in mutant frequency is detected.
Besides, combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (≥40% of total colonies) is an indication for potential clastogenic effects and/or chromosomal aberrations.
According to the OECD guideline, the biological relevance is considered first for the interpretation of results. Statistical methods might be used as an aid in evaluation the test result.
A test item is considered to be negative if the induced mutant frequency is below the GEF and the trend test is negative. - Statistics:
- The non-parametric Mann-Whitney test is applied to the mutation data to prove the dose groups for any significant difference in mutant frequency compared to the solvent controls.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Expt 1, 4h exp -MA: RTG 23.2% at 10 mM; Expt 2 24h exp (-MA) RTG 10.3% at 4 mM
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine has been tested for mutagenicity to mammalian cells (thymidine kinase locus) in a reliable study conducted according to OECD 476 and in compliance with GLP. No biologically relevant increase in mutant frequency was observed when the substance was tested up to cytotoxic concentrations in mouse lymphoma L5178Y cells in the presence and absence of metabolic activation in either the first experiment (4h exposure) or the repeat experiment (4 h exposure with metabolic activation, 24 h exposure without metabolic activation). Appropriate solvent, negative (test medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of mutations in mammalian cells under the conditions of the test.
Referenceopen allclose all
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
141 |
156 |
No |
0.316 |
173 |
121 |
No |
1 |
159 |
138 |
No |
3.16 |
146 |
139 |
No |
10 |
154 |
192 |
No |
31.6 |
150 |
129 |
No |
100 |
122 |
132 |
No |
316 |
116 |
161 |
No |
1000 |
140 |
158 |
No |
3160 |
166 |
163 |
No |
5000 |
0 |
0 |
Yes |
*solvent control with ethylene glycol dimethyl ether
Table 3: 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* |
37.7 |
34.7 |
No |
155.3 |
150.3 |
No |
279.7 |
278 |
No |
100 |
33.3 |
32 |
No |
145 |
132.7 |
No |
270 |
270.7 |
No |
316 |
26 |
36 |
No |
150.3 |
140 |
No |
273.7 |
258.3 |
No |
1000 |
27 |
36.3 |
No |
152 |
140 |
No |
273.7 |
259 |
No |
3160 |
38.7 |
37 |
No |
146.3 |
157.3 |
No |
272 |
261 |
No |
5000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
826 |
543 |
No |
1039.3 |
1037.7 |
No |
1064.7 |
1063.7 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
13.7 |
13 |
No |
4.3 |
5.7 |
No |
100 |
14 |
15 |
No |
4 |
3 |
No |
316 |
13 |
13 |
No |
3 |
5 |
No |
1000 |
12.3 |
13.7 |
No |
3 |
4.7 |
No |
3160 |
13.7 |
12.7 |
No |
4 |
4 |
No |
5000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
468.3 |
477 |
No |
481.7 |
484 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 4: 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* |
31.3 |
51 |
No |
136 |
153.7 |
No |
280.3 |
284 |
No |
31.6 |
32 |
30.3 |
No |
156 |
163.7 |
No |
265.3 |
274 |
No |
100 |
35 |
32.3 |
No |
159.7 |
174 |
No |
263.3 |
267 |
No |
316 |
32 |
39.7 |
No |
161.3 |
163 |
No |
280 |
275 |
No |
1000 |
31 |
28 |
No |
161 |
148.3 |
No |
282.7 |
270.7 |
No |
3160 |
0 |
28.3 |
Yes |
0 |
155.3 |
Yes |
0 |
0 |
Yes |
Positive control |
895 |
780 |
No |
1011 |
1008.7 |
No |
1365 |
1398.3 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
14 |
13.7 |
No |
3.7 |
4.7 |
No |
31.6 |
13.3 |
13 |
No |
4.3 |
3.3 |
No |
100 |
13 |
14 |
No |
3.3 |
4.3 |
No |
316 |
13.3 |
14 |
No |
4.7 |
5 |
No |
1000 |
14 |
12.3 |
No |
3.7 |
4 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
487.3 |
468 |
No |
470.7 |
475.7 |
No |
*solvent control with ethylene glycol dimethyl ether
Results of chromosome analysis without metabolic activation |
|||||||||||||||
|
Scored cells |
Cytotoxicity |
Chromatid aberrations |
Isochromatid aberrations |
rel. Mitotic index (%) * |
rel. Cell density (%) |
Poly-ploidy |
mean % aberrant cells |
|||||||
gaps |
breaks |
inter-changes |
other |
gaps |
breaks |
inter-changes |
other |
incl. Gaps |
excl. Gaps |
||||||
Experiment I without metabolic activation |
|||||||||||||||
negative control |
200 |
- |
5 |
1 |
0 |
2 |
1 |
0 |
0 |
0 |
91 |
104 |
0 |
4.0 |
1.5 |
solvent control |
200 |
- |
5 |
2 |
1 |
0 |
0 |
0 |
3 |
0 |
100 |
100 |
0 |
5.5 |
3.0 |
0.5 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
92 |
n.d. |
n.d. |
n.d. |
n.d. |
1.0 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
96 |
n.d. |
n.d. |
n.d. |
n.d. |
2.0 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
97 |
n.d. |
n.d. |
n.d. |
n.d. |
4.0 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
87 |
n.d. |
n.d. |
n.d. |
n.d. |
5.0 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
93 |
n.d. |
n.d. |
n.d. |
n.d. |
6.0 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
95 |
n.d. |
n.d. |
n.d. |
n.d. |
7.0 mM |
200 |
no |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
103 |
99 |
0 |
1.5 |
0.0 |
8.5 mM |
200 |
yes |
3 |
2 |
1 |
0 |
0 |
0 |
1 |
0 |
67 |
93 |
2 |
3.5 |
2.0 |
10.0 mM |
200 |
yes |
5 |
2 |
0 |
0 |
1 |
0 |
1 |
0 |
49 |
79 |
1 |
4.0 |
1.5 |
EMS 900 µg/ml |
200 |
- |
3 |
13 |
2 |
1 |
0 |
0 |
3 |
0 |
68 |
90 |
0 |
9.5 |
8.5 |
Experiment II without metabolic activation |
|||||||||||||||
negative control |
200 |
- |
1 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
110 |
96 |
0 |
2.0 |
1.0 |
solvent control |
200 |
- |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
100 |
100 |
0 |
1.5 |
0.5 |
1 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
81 |
n.d. |
n.d. |
n.d. |
n.d. |
2 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
108 |
n.d. |
n.d. |
n.d. |
n.d. |
4 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
89 |
n.d. |
n.d. |
n.d. |
n.d. |
5 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
98 |
n.d. |
n.d. |
n.d. |
n.d. |
6 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
93 |
n.d. |
n.d. |
n.d. |
n.d. |
7 mm |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
92 |
n.d. |
n.d. |
n.d. |
n.d. |
8 mM |
200 |
no |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
96 |
95 |
0 |
2.0 |
1.0 |
9 mM |
200 |
no |
2 |
3 |
1 |
1 |
1 |
0 |
0 |
0 |
77 |
90 |
1 |
4.0 |
2.5 |
10 mM |
200 |
no |
3 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
84 |
72 |
1 |
2.0 |
1.0 |
EMS 400 µg/ml |
200 |
- |
2 |
16 |
5 |
0 |
0 |
0 |
3 |
0 |
96 |
95 |
0 |
9.5 |
9.0 |
Results of chromosome analysis with metabolic activation |
|||||||||||||||
|
Scored cells |
Cytotoxicity |
Chromatid aberrations |
Isochromatid aberrations |
rel. Mitotic index (%)* |
rel. Cell density (%) |
Poly-ploidy |
mean % aberrant cells |
|||||||
gaps |
breaks |
inter-changes |
other |
gaps |
breaks |
inter-changes |
other |
incl. Gaps |
excl. Gaps |
||||||
Experiment I with metabolic activation |
|||||||||||||||
negative control |
200 |
- |
2 |
1 |
2 |
0 |
0 |
0 |
2 |
0 |
97 |
104 |
1 |
2.0 |
1.0 |
solvent control |
200 |
- |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
100 |
100 |
0 |
2.0 |
0.5 |
0.63 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
107 |
n.d. |
n.d. |
n.d. |
n.d. |
1.25 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
115 |
n.d. |
n.d. |
n.d. |
n.d. |
2.5 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
106 |
n.d. |
n.d. |
n.d. |
n.d. |
5.0 mM |
200 |
no |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
111 |
102 |
2 |
2.5 |
1.0 |
7.5 mM |
200 |
no |
3 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
93 |
103 |
4 |
2.0 |
0.5 |
10.0 mM |
200 |
no |
1 |
2 |
0 |
1 |
0 |
0 |
1 |
0 |
91 |
88 |
1 |
2.5 |
2.0 |
CPA 0.83 µg/ml |
200 |
- |
7 |
9 |
8 |
0 |
0 |
0 |
0 |
1 |
91 |
107 |
2 |
11.0 |
8.0 |
Experiment II with metabolic activation |
|||||||||||||||
negative control |
200 |
- |
7 |
4 |
0 |
1 |
1 |
0 |
0 |
0 |
92 |
96 |
1 |
6.5 |
2.5 |
solvent control |
200 |
- |
5 |
5 |
2 |
0 |
0 |
0 |
2 |
0 |
100 |
100 |
3 |
6.0 |
3.5 |
1.5 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
111 |
n.d. |
n.d. |
n.d. |
n.d. |
3 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
105 |
n.d. |
n.d. |
n.d. |
n.d. |
6 mM |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
102 |
n.d. |
n.d. |
n.d. |
n.d. |
7 mm |
- |
no |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
n.d. |
95 |
n.d. |
n.d. |
n.d. |
n.d. |
8 mM |
200 |
no |
3 |
3 |
0 |
1 |
1 |
0 |
0 |
0 |
87 |
93 |
1 |
4.0 |
2.0 |
9 mM |
200 |
no |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
81 |
91 |
0 |
1.0 |
1.0 |
10 mM |
400 |
no |
7 |
6 |
2 |
2 |
0 |
0 |
2 |
0 |
91 |
79 |
4 |
4.5 |
3.0 |
CPA 0.83 µg/ml |
200 |
- |
3 |
12 |
2 |
0 |
1 |
0 |
2 |
1 |
108 |
96 |
0 |
10.5 |
8.5 |
n.d. not determined
* determined from analysis of 1000 cells
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data are available for the registered substance from reliable in vitro studies on mutagenicity to bacterial and mammalian cells, and cytogenicity to mammalian cells. Where there was more than one result for an endpoint, the most reliable study was chosen as key study.
N-(Dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine has been tested for mutagenicity to bacteria in a reliable study conducted according to OECD Test Guideline 471 and in compliance with GLP (LPT, 2002). The study is considered to be reliability 1. No test-substance mediated increase in the number of revertants was observed when the substance was tested up to cytotoxic concentration in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 either with or without metabolic activation. The results were confirmed in a second independent experiment. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. Supporting data is also available from a study conducted according to a protocol that is similar to OECD Test Guideline 471. No increase in revertants was observed in S. typhimurium strains TA98, TA100, TA1535, TA1537 and TA 1538 (Microbial Associates, 1978).
Information on the potential for cytogenicity of N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine is available from a reliable study conducted according to OECD Test Guideline 473 and in compliance with GLP (BSL Bioservice, 2012a). The study is considered to be reliability 1. No test substance related increase in the incidence of structural or numerical chromosome aberrations was observed when tested up to cytotoxic concentrations with and without metabolic activation, in Chinese hamster V79 cells. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the substance is not clastogenic or aneugenic (i.e. it does not induce structural or numerical chromosome aberrations) under the conditions of the test.
N-(Dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine has been tested for mutagenicity to mammalian cells (thymidine kinase locus) in a reliable study conducted according to OECD Test Guideline 476 (1997) and in compliance with GLP (BSL Bioservice, 2012b). The study is considered to be reliability 1. No biologically relevant increase in mutant frequency was observed when the substance was tested up to cytotoxic concentrations in mouse lymphoma L5178Y cells in the presence and absence of metabolic activation in either the first experiment (4h exposure) or the repeat experiment (4 h exposure with metabolic activation, 24 h exposure without metabolic activation). Appropriate solvent, negative (test medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of mutations in mammalian cells under the conditions of the test.
In vivo testing is not required as no evidence for genetic toxicity was found in the in vitro studies.
Justification for classification or non-classification
Based on the available in vitro genotoxicity data, N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
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.
