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EC number: 213-603-0 | CAS number: 993-07-7
- 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
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative
with and without metabolic activation in Salmonella typhimurium
TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA / pKM101
(OECD TG 471) (Japan Bioassay Research Center 2001a).
Cytogenicity in mammalian cells: negative with and without metabolic
activation in Chinese hamster lung IU cells (OECD TG 473) (Japan
Bioassay Research Center 2001b).
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:
- 2001-02-01 to 2001-05-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only duplicate plates were used, and 2-aminoacridine was the only positive control with metabolic activation
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine operon (S. typhimurium); tryptophan operon (E. coli)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: E. coli is strain WP2 uvrA / pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and 5,6-benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 0.5, 1, 2, 5, 10, 20, 50%
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: HEPA filtered air
- Justification for choice of solvent/vehicle: none given in study report - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 without metabolic activation; 0.5 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- TA 100 (0.01μg/plate), TA 98 (0.1 μg/plate) and E. coli (0.005 μg/plate), without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537, 80 μg/plate, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains with metabolic activation (0.5 μg/plate TA 98; 1 μg/plate TA 100, 2 μg/plate other strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: other: the substance was prepared by mixing a volume of the gas with a fixed volume of air in a 10 l gas sampling bag (20-1 TEDLER bag).
DURATION
- Exposure duration: 24 hours with lids off; then removed, test substance allowed to evaporate for 20-30 minutes, covered and inverted and returned to the appropriate gas sampling bag and incubated for a further 24 hours.
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT (mutation assays): histidine or tryptophan deficient agar.
NUMBER OF REPLICATIONS: duplicate plates; initial dose determination test was repeated in an independent main test.
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn; number and size of revertant colonies
METABOLIC ACTIVATION: phenobarbital and 5,6-benzoflavone induced rat liver S9 was purchased from Kikkoman Co., containing 26.02 mg/ml protein. S9 mix contained 10% S9, and glucose-6-phosphae, NADP and NADPH as co-factors. 0.1 ml culture and 0.5 ml S9 were added to 2.0 ml of top agar, giving a final concentration of approximately 2% S9. - Evaluation criteria:
- The test substance is considered to be mutagenic when a reproducible dose-related increase in the number of revertant colonies is observed and the number of revertant colonies per plate is more than twice that of the solvent control.
- Statistics:
- None
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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
- 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
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitate was observed
COMPARISON WITH HISTORICAL CONTROL DATA: results were within the range of the historical controls - Conclusions:
- Trimethylsilane has been tested in a study conducted according to a national standard (Japanese) method that is similar to OECD 471, and in compliance with GLP. No increase in the number of revertants was observed in the presence or absence of metabolic activation when tested using the gas exposure method at concentrations up to 50%. The observations made in the initial dose-ranging study were reproduced in the main test. The strains tested were Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA / pKM101, and duplicate plates were used. Appropriate vehicle (air) and positive controls were used and gave expected responses; only 2-aminoanthracene was used as positive control with metabolic activation.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-01-08 to 2001-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster lung I/U
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and 5,6-benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 5, 10, 20, 40, 80%
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: HEPA filtered air
- Justification for choice of solvent/vehicle: none given in study report - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylchloride
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: vinylchloride
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: other: the test gas or the positive control gas was supplied at fixed concentrations to square glass culture vessels which were then rotated at 1 rpm, so that the cells were directly and repeatedly exposed to a gas and then to a medium solution for a fixed period of time during rotation.
DURATION
- Exposure duration: 6 hours (short treatment with and without metabolic activation) 24 and 48 hours (continuous treatment, without metabolic activation)
- Expression time (cells in growth medium): 18 hours (short treatment)
- Fixation time (start of exposure up to fixation or harvest of cells): 24 or 48 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid added 2 hours before chromosome preparations made.
STAIN (for cytogenetic assays): Giesma
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 100 cells per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cell growth index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes
_ METABOLIC ACTIVATION:
phenobarbital and 5,6-benzoflavone induced rat liver S9 was purchased from Kikkoman Co., containing 26.02 mg/ml protein. S9 mix contained 30% S9, and glucose-6-phosphae, NADP and NADPH as co-factors. Final concentration of S9 was 5%. - Evaluation criteria:
- Cells were examined for chromatid breaks and exchanges; chromosome breaks and exchanges; fragmentation; gaps; polyploidy; endoreduplication. Substances which caused more than 10% aberrations were considered as positive.
- Statistics:
- No statistical analysis was performed
- Key result
- Species / strain:
- mammalian cell line, other: CHL/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Trimethylsilane has been tested according to a national standard method (Japanese) that is equivalent to OECD 473, and in compliance with GLP. No increase in the incidence of chromosome aberrations was observed when tested using a gas exposure method at concentrations up to 80% with and without metabolic activation in Chinese hamster lung cells. Appropriate vehicle and positive controls were used and gave expected results. It is concluded that the test material is negative for the induction of chromosome aberrations under the conditions of the test.
Referenceopen allclose all
Table 1 Pre-incubation. Revertants per plate (mean of 2 plates)
Concentration (%) |
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
0* |
105 |
114 |
14 |
13 |
77 |
90 |
21 |
28 |
8 |
10 |
0.05 |
99 |
103 |
12 |
15 |
75 |
100 |
20 |
23 |
8 |
10 |
0.1 |
98 |
116 |
13 |
9 |
66 |
103 |
14 |
20 |
11 |
9 |
0.5 |
101 |
96 |
17 |
11 |
64 |
101 |
14 |
26 |
3 |
8 |
1.0 |
101 |
105 |
15 |
11 |
69 |
93 |
14 |
27 |
5 |
10 |
5.0 |
104 |
118 |
15 |
12 |
79 |
97 |
14 |
23 |
7 |
6 |
10 |
109 |
102 |
14 |
10 |
64 |
91 |
16 |
22 |
6 |
10 |
50 |
98 |
87 |
15 |
15 |
64 |
75 |
12 |
22 |
8 |
5 |
Positive control |
512 |
1373 |
355 |
283 |
595 |
1208 |
556 |
375 |
379 |
261 |
*Solvent control (air)
Table 2 Pre-incubation. Revertants per plate (mean of 2 plates)
Concentration (%) |
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
0* |
104 |
107 |
11 |
11 |
63 |
91 |
14 |
21 |
8 |
9 |
0.5 |
92 |
112 |
8 |
6 |
78 |
89 |
13 |
20 |
5 |
9 |
1.0 |
97 |
108 |
10 |
6 |
73 |
92 |
17 |
23 |
5 |
5 |
2.0 |
94 |
124 |
11 |
8 |
57 |
78 |
14 |
22 |
10 |
6 |
5.0 |
100 |
106 |
6 |
7 |
66 |
99 |
13 |
19 |
4 |
7 |
10 |
108 |
116 |
12 |
9 |
71 |
99 |
18 |
21 |
6 |
7 |
20 |
75 |
103 |
8 |
8 |
61 |
90 |
12 |
22 |
4 |
6 |
50 |
85 |
80 |
6 |
8 |
58 |
79 |
18 |
16 |
6 |
7 |
Positive control |
492 |
1147 |
329 |
263 |
857 |
1209 |
559 |
322 |
321 |
228 |
*Solvent control (air)
Summary of results of chromosome aberration study
Preliminary test, 6 hours exposure, without metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
100 |
100 |
0 |
0 |
0 |
5 |
100 |
87 |
1 |
0 |
0 |
10 |
100 |
102 |
0 |
0 |
0 |
20 |
100 |
101 |
0 |
0 |
0 |
40 |
100 |
89 |
0 |
1 |
1 |
80 |
100 |
92 |
0 |
0 |
0 |
Positive control |
100 |
- |
63 |
0 |
0 |
Preliminary test, 6 hours exposure, with metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
100 |
100 |
0 |
0 |
0 |
5 |
100 |
97 |
0 |
0 |
1 |
10 |
100 |
104 |
2 |
0 |
1 |
20 |
100 |
104 |
0 |
0 |
0 |
40 |
100 |
94 |
0 |
0 |
0 |
80 |
100 |
86 |
0 |
0 |
0 |
Positive control |
100 |
- |
29 |
0 |
3.9 |
Main test, 6 hours exposure, without metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
200 |
100 |
0.5 |
0 |
0 |
20 |
200 |
103 |
1.0 |
0 |
0 |
40 |
200 |
102 |
0 |
0 |
0 |
60 |
200 |
93 |
0 |
0 |
0.5 |
80 |
200 |
94 |
0.2 |
0 |
1.5 |
Positive control |
200 |
- |
33 |
0 |
0 |
Main test, 6 hours exposure, with metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
200 |
100 |
0 |
0 |
0 |
20 |
200 |
92 |
0 |
0 |
0 |
40 |
200 |
93 |
0.5 |
0 |
0 |
60 |
200 |
93 |
0 |
0 |
0.5 |
80 |
200 |
72 |
0.5 |
0 |
0 |
Positive control |
200 |
- |
49 |
0 |
0.5 |
Preliminary test 24 hours exposure, without metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
100 |
100 |
0 |
0 |
1 |
5 |
100 |
104 |
2 |
0 |
0 |
10 |
100 |
101 |
0 |
0 |
1 |
20 |
100 |
85 |
0 |
1 |
0 |
40 |
100 |
82 |
0 |
0 |
2 |
80 |
100 |
66 |
|
0 |
2 |
Positive control |
100 |
- |
42 |
1 |
0 |
Preliminary test 48 hours exposure, without metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
100 |
100 |
0 |
0 |
1 |
5 |
100 |
92 |
0 |
0 |
0 |
10 |
100 |
96 |
0 |
0 |
0 |
20 |
100 |
76 |
0 |
0 |
0 |
40 |
100 |
72 |
0 |
0 |
1 |
80 |
100 |
61 |
0 |
0 |
1 |
Positive control |
100 |
- |
41 |
1 |
0 |
Main test 24 hours exposure, without metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
200 |
100 |
1 |
0 |
0.5 |
20 |
200 |
92 |
0 |
0 |
0 |
40 |
200 |
84 |
0.5 |
0 |
0 |
60 |
200 |
66 |
0 |
0 |
1.0 |
80 |
200 |
60 |
0 |
0 |
1.0 |
Positive control |
200 |
- |
61 |
3.5 |
0 |
Main test 48 hours exposure, without metabolic activation |
|||||
Concentration (%) |
Cells observed |
Growth Index |
% cells with aberrations |
% cells with gaps
|
% cells with polyploidy
|
0* |
200 |
0 |
0.5 |
100 |
0 |
20 |
200 |
0 |
0 |
97 |
0 |
40 |
200 |
0 |
0 |
98 |
1.5 |
60 |
200 |
0 |
0 |
84 |
2 |
80 |
200 |
0 |
0 |
73 |
1.5 |
Positive control |
200 |
5 |
64.5 |
- |
0 |
* Solvent control (air)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Trimethylsilane has been tested in a study conducted according to a national standard (Japanese) method that is similar to OECD 471, and in compliance with GLP (Japan Bioassay Research Center 2001a). No increase in the number of revertants was observed in the presence or absence of metabolic activation when tested using the gas exposure method at concentrations up to 50%. The observations made in the initial dose-ranging study were reproduced in the main test. The strains tested were Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA / pKM101, and duplicate plates were used. Appropriate vehicle (air) and positive controls were used and gave expected responses; only 2-aminoanthracene was used as positive control with metabolic activation.
Trimethylsilane has been tested according to a national standard method (Japanese) that is equivalent to OECD 473, and in compliance with GLP. No increase in the incidence of chromosome aberrations was observed when tested using a gas exposure method at concentrations up to 80% with and without metabolic activation in Chinese hamster lung cells. Appropriate vehicle and positive controls were used and gave expected results. It is concluded that the test material is negative for the induction of chromosome aberrations under the conditions of the test.
Justification for classification or non-classification
Based on the available in vitro genotoxicity data, trimethylsilane is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
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