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EC number: 237-511-5 | CAS number: 13822-56-5
- 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
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Genetic toxicity: in vitro
Administrative data
- 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:
- 1997-08-07 to 1997-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Properties of test substance not determined by testing laboratory
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(trimethoxysilyl)propylamine
- EC Number:
- 237-511-5
- EC Name:
- 3-(trimethoxysilyl)propylamine
- Cas Number:
- 13822-56-5
- Molecular formula:
- C6H17NO3Si
- IUPAC Name:
- 3-(trimethoxysilyl)propylamine
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- 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:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 75-5000 µg/plate (Test 1); 33-5000 µg/plate (Test 2)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: 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:
- All Strains (with 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:
- sodium azide
- Remarks:
- TA 100 TA 1535 (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:
- WP2 uvrA (without activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 - 72 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 12 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- All Salmonella tester strain cultures must demonstrate the presence of the deep rough mutation and the deletion of the uvrB gene.
Cultures of tester strains TA 98 and TA 100 must demonstrate the presence of the pKM101 plasmid R-factor.
All WP2uvrA cultures must demonstrate the deletion in the uvrA gene.
Results must be within range of historical data: TA 98 10-50, TA 100 80-240, TA 1535 5-45, TA 1537 3-21, WP2uvrA 10-60.
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 WP2uvrA 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 mean number of revertants per plate by >50% compared with the mean vehicle control. The reduction
must be accompanied by an abrupt dose-dependant drop in the revertant count, and/or a reduction in background lawn.
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:
- 600 - 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate, without activation
- 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:
- 600 - 5000 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 and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 5000 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:
- 600 - 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
Any other information on results incl. tables
Table 2: Dose range-finding study, Number of revertants per plate (2 plates per strain)
TA 100 |
WP2 uvrA |
|||||
Concentration (µg/Plate) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
0 |
130 |
95 |
No |
17 |
9 |
No |
6.7 |
137 |
102 |
No |
8 |
15 |
No |
10 |
120 |
105 |
No |
15 |
14 |
No |
33 |
135 |
100 |
No |
16 |
7 |
No |
67 |
102 |
91 |
No |
15 |
15 |
No |
100 |
114 |
105 |
No |
31 |
12 |
No |
333 |
138 |
103 |
No |
13 |
19 |
No |
667 |
135 |
89 |
No |
17 |
18 |
No |
1000 |
95 |
98 |
No |
15 |
16 |
No |
3333 |
60 |
89 |
No |
11 |
15 |
No |
5000 |
59 |
66 |
No |
11 |
9 |
Yes |
*solvent control with DMSO
Table 3: Experiment 1 Mutagenicity Assay, Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
14 |
16 |
No |
112 |
125 |
No |
10 |
12 |
No |
75 |
16 |
18 |
No |
129 |
119 |
No |
8 |
8 |
No |
200 |
16 |
18 |
No |
100 |
140 |
No |
9 |
7 |
No |
600 |
13 |
17 |
No |
109 |
118 |
No |
6 |
9 |
No |
1800 |
7 |
15 |
No |
8 |
70 |
Yes |
3 |
10 |
Yes |
5000 |
0 |
17 |
Yes |
0 |
61 |
Yes |
0 |
10 |
Yes |
Positive control |
553 |
1377 |
No |
528 |
1103 |
No |
397 |
100 |
No |
*solvent control with DMSO
Table 4: Experiment 1 Mutagenicity Assay, Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
5 |
7 |
No |
13 |
15 |
No |
75 |
3 |
5 |
No |
15 |
14 |
No |
200 |
4 |
4 |
No |
15 |
15 |
No |
600 |
1 |
4 |
Yes |
14 |
17 |
No |
1800 |
1 |
1 |
Yes |
11 |
14 |
No |
5000 |
0 |
2 |
Yes |
1 |
15 |
Yes |
Positive control |
860 |
141 |
No |
389 |
407 |
No |
*solvent control with DMSO
Table 5: Experiment 2 Mutagenicity Assay, Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc.µg/plate |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
12 |
18 |
No |
131 |
140 |
No |
9 |
11 |
No |
33 |
13 |
17 |
No |
112 |
134 |
No |
9 |
11 |
No |
100 |
13 |
13 |
No |
98 |
124 |
No |
7 |
9 |
No |
333 |
12 |
13 |
No |
123 |
117 |
No |
8 |
9 |
No |
1000 |
12 |
17 |
No |
104 |
105 |
No |
6 |
7 |
No |
5000 |
10 |
7 |
Yes |
30 |
67 |
Yes |
1 |
4 |
Yes |
Positive control |
749 |
1149 |
No |
645 |
986 |
No |
482 |
94 |
No |
*solvent control with DMSO
Table 6: Experiment 2 Mutagenicity Assay, Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2 uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
5 |
8 |
No |
13 |
14 |
No |
33 |
5 |
4 |
No |
13 |
11 |
No |
100 |
5 |
4 |
No |
13 |
11 |
No |
333 |
5 |
5 |
No |
11 |
10 |
No |
1000 |
3 |
3 |
Yes |
13 |
9 |
No |
5000 |
1 |
1 |
Yes |
5 |
12 |
Yes |
Positive control |
638 |
110 |
No |
402 |
248 |
No |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
3-(trimethoxysilyl)propylamine has been tested in a valid and reliable study according to OECD 471 and under GLP. No mutagenic effect was observed for the test substance tested up to limit concentration in any of the test strains with and without metabolic activation in Salmonella typhimurium strains TA 98, 100, 1535, 1537 and E.coli WP2 uvrA. The result of the first experiment was confirmed in an independent repeat experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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