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EC number: 201-081-7 | CAS number: 78-08-0
- 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
Genetic toxicity in vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test, OECD 471): negative with and without activation in all strains tested
Cytogenicity in mammalian cells (CA, OECD 473): negative with and without metabolic activation
Mutagenicity in mammalian cells (MLA, OECD 476): negative with and without metabolic activation
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:
- 15 Aug 2001 to 01 Mar 2002
- 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
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli strain)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary toxicity study: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, and 5000 µg/plate
Mutagenicity test, main study (with and without activation): 50, 150, 500, 1500, and 5000 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene (2-AA; +S9, 1 µg/plate for TA 100; 2 µg/plate for TA 1535, TA 1537; 10 µg/plate for WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates per experiment, 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: growth of background lawn - Evaluation criteria:
- The spontaneous reversion for the solvent control should be within historical control data. The positive controls should demonstrate that the test systems are responsive to known mutagens (induction of at least twice the respective vehicle control).
Positive reaction:
- number of revertants is statistically significantly increased compared to the solvent control in at least one strain
- the increase is reproducible and there is evidence of a dose-response relationship - Statistics:
- Dunnett´s method of linear regression (for assessment of dose-response relationship)
- 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
- 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
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: No toxicity was observed in the preliminary toxicity test in TA 100 and WP2 uvrA with and without metabolic activation up to the maximum concentration of 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: negative control data were within historical control values
Precipitates: No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. - Conclusions:
- Under test conditions, no mutagenic effect was observed for the test substance tested up to cytotoxic concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Jan to 16 Sep 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted equivalent to the appropriate OECD test guideline, and in compliance with GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Not applicable.
- Species / strain / cell type:
- other: Chinese hamster lung cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM medium with HEPES buffer ans Earle´s salts, inclusive 10% FBS and antibiotics
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbitone and beta-napthoflavone
- Test concentrations with justification for top dose:
- 6 hour treatment time with and without metabolic activation: 200, 400, 600, 800, 1000, auf 1200 µg/ml
24 hour treatment time without metabolic activation: 80, 160, 320, 480, 640, auf 800 µg/ml
48 hour treatment time without metabolic activation: 40, 80, 160, 320, 480, auf 640 µg/ml - Vehicle / solvent:
- - Vehicle/solvent used: Acetone
- Justification for choice of solvent/vehicle: based on the solubility of the test substance - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- 6 hour treatment without metabolic activation: 0.1 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- 6 hour treatment with metabolic activation: 5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- 24 and 48 hour treatment without metabolic activation Migrated to IUCLID6: 0.05 and 0.025 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure time: 6 hours with and without metabolic activation; 24 and 48 hours without metabolic activation.
- Expression time (cells in growth medium): 18 hours subsequent to 6 hour exposure; none following 24 and 48 hour exposure
- Fixation time (start of exposure up to fixation or harvest of cells): short-term exposure: 24 hours; 24 and 48 hour exposure: 24 and 48 hours, respectively.
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.1 µg/ml)
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 flasks per dose level
NUMBER OF CELLS EVALUATED: 100 per dose level for chromosome aberration
DETERMINATION OF CYTOTOXICITY
- Method: 1000 cells per dose level for mitotic index.
OTHER EXAMINATIONS: Polyploid and endoreduplicated cells were evaluated. - Evaluation criteria:
- Positive response: % cells with aberrations, excluding gaps, markedly exceed that seen in the concurrent control, either with or without a clear dose response relationship. For modest increases in aberration frequency a dose response relationship is generally required.
- Statistics:
- Fisher's exact test was used to analyse the percent aberrant cells. If necessary statistics was applied for assessment of dose response relationship.
- Key result
- Species / strain:
- other: Chinese hamster lung cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 600 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: observed at 1300 and 2600 µg/ml
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: metaphases were present at the 650 µg/ml dose levels (6 and 24 h) and at the 325 µg/ml dose level (48 h)
COMPARISON WITH HISTORICAL CONTROL DATA: included in report
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the 48 h treatment reduction of the mitotic index to>50% was not achieved with the highest concentration tested (640 µg/ml). Based on the results from the 24 h treatment and the assumption of a steep toxicity curve in the range of the used concentration it was concluded that the test substance was tested close to its toxic limit. - Conclusions:
- Triethoxy(vinyl)silane has been tested for clastogenic potential, in a study which was conducted equivalent to OECD 473 and in compliance with GLP. No evidence of a test related statistically significant increase in the percentage of cells with structural or numerical chromosome aberrations was observed with or without activation in the experiment. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for clastogenicity under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Jan 1990 to 01 Feb 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- lacking detailed material/methods section
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- TK locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Initial compound toxicity test: 0.005, 0.01, 0.05, 0.1, 0.5, 1.0, 5.0, and 10 µl/ml
Cloning data without S9: 0.1, 0.3, 0.4, 0.6, and 0.7 µl/ml
Cloning data with S9: 0.4, 0.6, 0.7, 0.8, and 0.9 µl/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: none given - Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- solvent control with DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- with metabolic activation system
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- solvent control with DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation system
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: no data
- Selection time (if incubation with a selection agent): no data
- Expression time (cells in growth medium): 2 days
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: 2 independent experiments per dose
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth
OTHER: Small and large colonies were differentiated, as small colonies are capable to indicate chromosomal mutations.
- Evaluation criteria:
- Mutation frequency and colony size distribution were assessed, it is assumed by the reviewer that a dose-dependant increase in mutant frequency was evaluated as a positive response.
- Statistics:
- Mutant frequency, % total growth based on cell concentration and colony size were recorded. There was no statistical treatment of results.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1.0 µl/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The substance was tested in an in vitro mutagenicity assay in mouse lymphoma L5178Y cells, under GLP and using a method similar to OECD 476. The test substance is non-mutagenic in mouse lymphoma cells under the conditions of the test.
Referenceopen allclose all
Table 1: Results of the first experiment with and without metabolic activation.
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
TA 98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
||
– |
0 |
23±5 |
77±7 |
13±1 |
7±2 |
20±1 |
– |
50 |
15±1 |
81±7 |
12±6 |
6±5 |
17±4 |
– |
150 |
16±2 |
87±2 |
12±6 |
9±2 |
19±6 |
– |
500 |
14±3 |
85±10 |
14±1 |
8±1 |
13±3 |
– |
1500 |
21±3 |
88±15 |
12±3 |
12±3 |
18±4 |
– |
5000 |
24±5 |
88±5 |
17±4 |
8±2 |
18±6 |
Positive controls, –S9 |
Name |
4-NQO |
ENNG |
ENNG |
9-AA |
ENNG |
Concentrations (µg/plate) |
0.2 |
3 |
5 |
80 |
2 |
|
Revertants per plate |
91±9 |
439±29 |
221±22 |
2741±121 |
356±28 |
|
+ |
0 |
25±1 |
82±12 |
10±2 |
9±2 |
23±3 |
+ |
50 |
24±5 |
85±9 |
10±4 |
13±6 |
18±4 |
+ |
150 |
26±4 |
81±3 |
11±5 |
13±1 |
26±9 |
+ |
500 |
22±7 |
77±9 |
12±2 |
13±3 |
20±1 |
+ |
1500 |
23±2 |
88±8 |
10±3 |
11±4 |
19±3 |
+ |
5000 |
24±7 |
91±10 |
11±3 |
11±5 |
24±6 |
Positive controls, +S9 |
Name |
BP |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (µg/plate) |
5 |
1 |
2 |
2 |
10 |
|
Revertants per plate |
206±12 |
825±65 |
235±7 |
284±11 |
801±20 |
Table 2: Results of the second experiment with and without metabolic activation.
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
TA 98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
||
– |
0 |
17±3 |
95±12 |
15±6 |
9±6 |
19±5 |
– |
50 |
22±2 |
109±10 |
13±5 |
7±4 |
19±4 |
– |
150 |
15±4 |
88±6 |
18±6 |
9±4 |
18±3 |
– |
500 |
23±5 |
95±2 |
14±3 |
9±1 |
18±2 |
– |
1500 |
20±8 |
104±3 |
23±5 |
8±1 |
22±5 |
– |
5000 |
24±9 |
104±2 |
17±7 |
8±2 |
21±3 |
Positive controls, –S9 |
Name |
4-NQO |
ENNG |
ENNG |
9-AA |
ENNG |
Concentrations (µg/plate) |
0.2 |
3 |
5 |
80 |
2 |
|
Revertants per plate |
160±11 |
104±2 |
187±19 |
8±2 |
21±3 |
|
+ |
0 |
29±6 |
111±4 |
18±7 |
9±4 |
22±5 |
+ |
50 |
26±4 |
102±5 |
22±4 |
6±1 |
17±3 |
+ |
150 |
33±5 |
105±15 |
14±3 |
9±4 |
22±4 |
+ |
500 |
36±6 |
112±8 |
18±2 |
7±3 |
24±6 |
+ |
1500 |
25±8 |
103±7 |
20±6 |
7±1 |
19±4 |
+ |
5000 |
30±7 |
112±9 |
22±6 |
10±2 |
23± |
Positive controls, +S9 |
Name |
BP |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (µg/plate) |
5 |
1 |
2 |
2 |
10 |
|
Revertants per plate |
466±28 |
1152±67 |
408±28 |
536±26 |
909±177 |
4-NQO: 4-Nitroquinoline-1-oxide
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
9-AA: 9-Aminoacridine
2 -AA: 2 -Aminoanthracene
BP: Benzo(a)pyrene
Table 1: Summary table of cytogenetic analysis of CHL cells in the absence and presence of metabolic activation.
Treatment µg/ml |
S9 Activation |
Treatment time |
Mean mitotic index |
Cells scored |
Cells with aberrations |
|
Numerical (%) |
Structural (%) |
|||||
Solvent control |
- |
6 |
100 |
200 |
0 |
0.5 |
200 |
- |
6 |
106 |
200 |
0.5 |
0 |
400 |
- |
6 |
105 |
200 |
0.5 |
2.0 |
600 |
- |
6 |
65 |
200 |
0.5 |
2.5 |
800 |
- |
6 |
0 |
Toxic |
- |
- |
MMC (0.1) |
|
6 |
81 |
200 |
0 |
26* |
|
|
|
|
|
|
|
Solvent control |
+ |
6 |
100 |
200 |
0 |
1.5 |
200 |
+ |
6 |
91 |
200 |
0 |
1.5 |
400 |
+ |
6 |
120 |
200 |
0 |
1 |
600 |
+ |
6 |
34 |
200 |
0 |
2.0 |
800 |
+ |
6 |
33 |
200 |
0 |
4.5 |
CP (5) |
|
6 |
49 |
100 |
0 |
67* |
|
|
|
|
|
|
|
Solvent control |
- |
24 |
100 |
200 |
0 |
1.5 |
480 |
- |
24 |
129 |
200 |
1.5 |
2.0 |
640 |
- |
24 |
100 |
200 |
0.5 |
1.5 |
800 |
- |
24 |
42 |
194 |
0.5 |
3.1 |
MMC (0.05) |
- |
24 |
112 |
150 |
0 |
26.7* |
|
|
|
|
|
|
|
Solvent control |
- |
48 |
100 |
200 |
1 |
2 |
320 |
- |
48 |
90 |
200 |
1.5 |
5.5 |
480 |
- |
48 |
126 |
200 |
0.5 |
2 |
640 |
- |
48 |
76 |
200 |
0 |
1.5 |
MMC (0.025) |
- |
48 |
84 |
150 |
0 |
26* |
*: p<0.001
Table 2: Results of Mammalian Mutagenicity assay (Trial 1) with tester strain L5178Y (mean of 3 plates)
Concentration µl/ml |
Mutant* Frequency |
Mutant* Frequency |
% Total Growth |
% Total Growth |
Cytotoxicity |
|
- MA |
+ MA |
- MA |
+ MA |
|
Untreated 1 |
1.13 |
1.16 |
107 |
105 |
No |
Untreated 2 |
1.26 |
1.44 |
96 |
106 |
No |
0.1 |
1.14 |
1.43 |
95 |
105 |
No |
0.1 |
1.16 |
1.54 |
105 |
102 |
No |
0.3 |
0.95 |
1.42 |
91 |
75 |
No |
0.3 |
1.19 |
1.43 |
83 |
90 |
No |
0.4 |
1.13 |
1.49 |
77 |
68 |
No |
0.4 |
0.96 |
1.1 |
87 |
65 |
No |
0.6 |
0.44 |
0.92 |
25 |
34 |
Yes |
0.6 |
0.53 |
0.89 |
42 |
27 |
Yes |
0.7 |
0.36 |
0.67 |
6 |
22 |
Yes |
0.7 |
- |
0.91 |
- |
28 |
Yes |
Solvent 1 |
1.16 |
1.49 |
- |
- |
- |
Solvent 2 |
1.02 |
1.26 |
- |
- |
- |
Solvent 3 |
1.13 |
1.37 |
- |
- |
- |
Solvent 4 |
1.02 |
1.35 |
- |
- |
- |
Positive Control |
ND |
ND |
ND |
ND |
ND |
*Per 104surviving cells
solvent control with DMSO
ND: (No data available)
Table 3: Results of Mammalian Mutagenicity assay (Trial 2) with tester strain L5178Y (mean of 3 plates)
Concentration µl/ml |
Mutant* Frequency |
Mutant* Frequency |
% Total Growth |
% Total Growth |
Cytotoxicity |
|
- MA |
+ MA |
- MA |
+ MA |
|
Untreated 1 |
0.34 |
0.43 |
113 |
135 |
No |
Untreated 2 |
0.3 |
0.64 |
116 |
123 |
No |
0.1 |
0.38 |
- |
94 |
- |
No |
0.1 |
0.29 |
- |
88 |
- |
No |
0.3 |
0.39 |
- |
91 |
- |
No |
0.3 |
0.33 |
- |
94 |
- |
No |
0.4 |
0.29 |
0.88 |
88 |
90 |
No |
0.4 |
0.25 |
0.91 |
98 |
72 |
No |
0.6 |
0.24 |
0.75 |
53 |
56 |
Yes |
0.6 |
0.35 |
0.7 |
68 |
59 |
Yes |
0.7 |
0.19 |
0.84 |
50 |
44 |
Yes |
0.7 |
0.24 |
0.48 |
12 |
63 |
Yes |
0.8 |
- |
0.85 |
- |
27 |
Yes |
0.8 |
- |
0.64 |
- |
29 |
Yes |
0.9 |
- |
0.53 |
- |
24 |
Yes |
0.9 |
- |
0.47 |
- |
31 |
Yes |
Solvent 1 |
0.41 |
0.81 |
- |
- |
No |
Solvent 2 |
0.42 |
0.85 |
- |
- |
No |
Solvent 3 |
0.31 |
0.85 |
- |
- |
No |
Solvent 4 |
0.28 |
0.75 |
- |
- |
No |
Positive Control |
3.3 |
ND |
53 |
ND |
No |
*Per 104surviving cells
solvent control with DMSO
ND: (No data available)
Positive control substance: Ethyl Methanesulfonate
Table 4: Results of Mammalian Mutagenicity assay (Trial 3) with tester strain L5178Y (mean of 3 plates)
Concentration µl/ml |
Mutant* Frequency |
Mutant* Frequency |
% Total Growth |
% Total Growth |
Cytotoxicity |
|
- MA |
+ MA |
- MA |
+ MA |
|
Untreated 1 |
ND |
0.86 |
ND |
110 |
No |
Untreated 2 |
ND |
0.91 |
ND |
106 |
No |
0.1 |
ND |
1.01 |
ND |
104 |
No |
0.1 |
ND |
1.1 |
ND |
96 |
No |
0.3 |
ND |
0.9 |
ND |
83 |
No |
0.3 |
ND |
0.95 |
ND |
90 |
No |
0.4 |
ND |
0.89 |
ND |
86 |
No |
0.4 |
ND |
0.85 |
ND |
98 |
No |
0.6 |
ND |
0.92 |
ND |
55 |
Yes |
0.6 |
ND |
0.77 |
ND |
70 |
Yes |
0.7 |
ND |
0.85 |
ND |
32 |
Yes |
0.7 |
ND |
0.94 |
ND |
30 |
Yes |
Solvent 1 |
ND |
0.93 |
ND |
- |
No |
Solvent 2 |
ND |
1 |
ND |
- |
No |
Solvent 3 |
ND |
0.84 |
ND |
- |
No |
Solvent 4 |
ND |
1.05 |
ND |
- |
No |
Positive Control (7.5) |
ND |
7.1 |
ND |
9 |
Yes |
Positive Control (5) |
ND |
5.2 |
ND |
40 |
Yes |
*Per 104surviving cells
solvent control with DMSO
ND: (No data available)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity (mutagenicity) in bacteria in vitro
The test substance was tested in a reliable bacterial mutagenicity study according to OECD 471 and in compliance with GLP. No increase in reversions in comparison with the solvent control was observed in the following Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA after treatment with up to 5000 µg/plate. Expected results were obtained with the positive controls. It is concluded that the test substance is not mutagenic under the conditions of the test (Safepharm Laboratories Limited, 2002a). Additional available studies also support the conclusion that the test substance is not a bacterial mutagen (Microbiological Associates Inc., 1990; Degussa AG, 2005; Bushy Run Research Center, 1987).
Genetic toxicity (cytogenicity) in mammalian cells in vitro
The test substance has been tested according to OECD 473 and under GLP for the induction of chromosome aberrations in mammalian cells. Chinese hamster lung cells were treated in a short term experiment for 6 h (with and without metabolic activation), and in two long term experiments for 24 and 48 h, respectively, without metabolic activation. No evidence of a test related statistically significant increase in the percentage of cells with structural or numerical chromosome aberrations was observed with or without activation in the experiment. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for clastogenicity under the conditions of the test (Safepharm Laboratories Limited, 2002b).
Genetic toxicity (mutagenicity) in mammalian cells in vitro
The test substance was tested in a reliable in vitro mutagenicity assay in mouse lymphoma L5178Y cells, according to GLP and using a method equivalent to OECD 476. The test substance was tested up to cytotoxic concentration (<31% total growth). No increase of mutant frequency was observed with or without metabolic activation. In conclusion, the test substance is non-mutagenic in mouse lymphoma cells under the conditions of the test (Microbiological Associates Inc., 1991).
The available information for the test substance indicates that when tested in vitro, triethoxy(vinyl)silane does not induce mutations in bacterial or mammalian cells and does not cause chromosomal aberration in vitro. Thus, the test substance is not genotoxic under the conditions of the tests.
Justification for classification or non-classification
The available data on genetic toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
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