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EC number: 219-842-7 | CAS number: 2550-02-9
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-01-31 to 1996-02-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trimethoxypropylsilane
- EC Number:
- 213-926-7
- EC Name:
- Trimethoxypropylsilane
- Cas Number:
- 1067-25-0
- Molecular formula:
- C6 H16 O3 Si
- IUPAC Name:
- trimethoxy(propyl)silane
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa, uvrB (TA 98 and 100: pKM101)
- 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:
- 50 - 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: It is assumed by the reviewer that the solvent was chosen for its solubility properties and relative non-toxicity to bacteria.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- + S9: All strains: 2.5µg/plate in DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9: TA 98: 2.5 µg/plate in DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- -S9: TA 100 and TA 1535: 5.0 and 2.5 µg/plate in aqua bidest, respectively.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- - S9: TA 1537: 25 µg/plate in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 minutes
- Expression time (cells in growth medium): 72 hours
NUMBER OF REPLICATIONS: 3 Plates per test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, background lawn assessment
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
OTHER: S9 mix was prepared freshly before use. One part of S9 fraction was mixed with 9 parts of a cofactor solution resulting in the following mixture:
-10% S9 fraction
- 33 mM KCl
- 8 mM MgCl2
- 5 mM glucose-6-phosphate
- 4 mM NADP
- 100 mM Na2HPO4/NaH2PO4, pH 7.4. - Evaluation criteria:
- For a test substance to be considered positive, it must cause at least a doubling in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article.
The increase must be accompanied by a dose response towards increasing concentrations of the test article.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 2: Experiment 1 Plate incorporation assay Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
21 |
42 |
No |
91 |
109 |
No |
8 |
11 |
No |
50 |
24 |
46 |
No |
141 |
121 |
No |
16 |
11 |
No |
160 |
20 |
45 |
No |
134 |
131 |
No |
8 |
10 |
No |
500 |
25 |
36 |
No |
113 |
134 |
No |
7 |
16 |
No |
1600 |
25 |
39 |
No |
130 |
135 |
No |
9 |
11 |
No |
5000 |
30 |
31 |
No |
137 |
115 |
No |
9 |
15 |
No |
Positive Control |
142 |
1324 |
No |
544 |
1474 |
No |
322 |
195 |
No |
*solvent control with DMSO
Table 2: Experiment 1 Plate incorporation assay Number of revertants per plate (mean of 3 plates)
|
TA1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
0* |
2 |
23.4 |
No |
50 |
6 |
14 |
No |
160 |
8 |
16 |
No |
500 |
9 |
9 |
No |
1600 |
6 |
13 |
No |
5000 |
2 |
16 |
No |
Positive Control |
3 |
152 |
No |
*solvent control with DMSO
Table 3: Experiment 2 Pre incubation assay Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
23 |
35 |
No |
147 |
119 |
No |
9 |
11 |
No |
50 |
19 |
38 |
No |
108 |
111 |
No |
6 |
13 |
No |
160 |
20 |
29 |
No |
110 |
137 |
No |
6 |
13 |
No |
500 |
18 |
25 |
No |
104 |
137 |
No |
6 |
11 |
No |
1600 |
21 |
32 |
No |
123 |
148 |
No |
6 |
13 |
No |
5000 |
6 |
12 |
Yes |
48 |
76 |
Yes |
0 |
1 |
Yes |
Positive Control |
110 |
1264 |
No |
527 |
1466 |
No |
306 |
220 |
No |
*solvent control with DMSO
Table 3: Experiment 2 Pre incubation assay Number of revertants per plate (mean of 3 plates)
|
TA1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
0* |
5 |
15 |
No |
50 |
6 |
10 |
No |
160 |
5 |
11 |
No |
500 |
5 |
9 |
No |
1600 |
3 |
12 |
No |
5000 |
0 |
5 |
Yes |
Positive Control |
100 |
164 |
No |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
Under test conditions, no mutagenic effect was observed for trimethoxy(propyl)silane (CAS: 1067-25-0) without and with metabolic activation.
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