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EC number: 221-328-2 | CAS number: 3068-76-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]aniline
- EC Number:
- 221-328-2
- EC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Cas Number:
- 3068-76-6
- Molecular formula:
- C12H21NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Details on test material:
- - Name of test material (as cited in study report): SILQUEST Y-9669 Silane
- Physical state: clear colourless liquid
- Analytical purity: 97.1%
- Lot/batch No.: 16984-17
- Storage condition of test material: original container at room temperature, protected from light
Constituent 1
Method
- Target gene:
- his operon
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- preincubation test: 100, 333, 1000, 3333, 5000 µg/plate (experiment B1; valid for all strains)
preincubation test: 100, 333, 1000, 3333, 5000 µg/plate (experiment B3; valid for WP2 uvrA)
preincubation test: 3.3, 10, 33, 100, 333, 1000, 5000 µg/plate (experiment B4; valid for all Salmonella strains) - Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Remarks:
- +S9: 2-AA (all salmonella strains + WP2uvrA; 1 + 10 µg/plate); sterigmatocystin (WP2; 100 µg/plate); -S9: 2-NF (TA 98; 1 µg/plate); SA (TA 100, TA 1535; 1 µg/plate); 9-AA (TA 1537; 75 µg/plate); MMS (both E. coli strains; 1000 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 2 independent experiments with 3 plates/concentration.
DETERMINATION OF CYTOTOXICITY
- Method: reduction of bacterial background lawn; mean number of revertants per plate - Evaluation criteria:
- Cytotoxicity:
- reduction of colony background lawn (code 1-5)
- reduction of mean number of revertants per plate as compared to the mean vehicle control value of >50%
Mutagenicity:
Positive reaction: dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article. Data sets for strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for strains TA98, TA100 and WP2 uvrA (pKM101) and WP2 (pKM101) were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and 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
- Species / strain:
- E. coli WP2 uvr A
- 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: not observed up to 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: In the preliminary test cytotoxicity was not observed up to 5000 µg/plate
Any other information on results incl. tables
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate in the plate incorporation test |
|||||
(µg/plate) |
(average of 3 plates±standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
||
– |
Solvent control |
225±6 |
7±3 |
13±2 |
13±3 |
3±1 |
|
– |
100 |
232±9 |
7±3 |
15±1 |
14±2 |
4±1 |
|
– |
333 |
220±18 |
8±3 |
14±1 |
13±3 |
5±3 |
|
– |
1000 |
209±14 |
8±1 |
16±2 |
14±4 |
3±2 |
|
– |
3333 |
215±23 |
6±5 |
11±3 |
11±1 |
4±3 |
|
– |
5000 |
229±28 |
6±3 |
10±1 |
16±4 |
3±2 |
|
Positive controls, –S9 |
Name |
sodium azide |
sodium azide |
methyl methane sulfonate |
2-nitrofluorene |
9-amino-acridine |
|
Concentrations (µg/plate) |
1 |
1 |
1000 |
1 |
75 |
||
Average of 3 plates±sd |
678±17 |
399±38 |
445±215 |
289±54 |
623±36 |
||
+ |
Solvent control |
234±2 |
7±3 |
13±2 |
14±3 |
3±1 |
|
+ |
100 |
272±10 |
7±3 |
15±1 |
16±3 |
4±1 |
|
+ |
333 |
272±9 |
8±3 |
14±1 |
16±5 |
5±3 |
|
+ |
1000 |
232±15 |
8±1 |
16±2 |
14±4 |
3±2 |
|
+ |
3333 |
212±12 |
6±5 |
11±3 |
24±2 |
4±3 |
|
+ |
5000 |
237±44 |
6±3 |
10±1 |
22±8 |
3±2 |
|
Positive controls, +S9 |
Name |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
|
Concentrations (µg/plate) |
1 |
1 |
10 |
1 |
1 |
||
Average of 3 plates±sd |
1022±56 |
272±18 |
72±13 |
813±79 |
413±101 |
Table 1: Test results of main test B1.
Table 2: Test results of the repeat experiment B3 (WP2 uvrA) and B4 (all Salmonella strains).
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate in the plate incorporation test |
|||||
(µg/plate) |
(average of 3 plates±standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
||
– |
Solvent control |
126±5 |
8±2 |
20±2 |
14±3 |
3±2 |
|
– |
3.3 |
114±13 |
14±1 |
- |
17±4 |
4±1 |
|
– |
10 |
111±6 |
9±0 |
- |
17±5 |
5±4 |
|
– |
33 |
108±20 |
6±2 |
- |
16±3 |
6±0 |
|
– |
100 |
123±5 |
7±2 |
14±4 |
14±6 |
5±2 |
|
– |
333 |
76±23 |
12±3 |
11±3 |
16±5 |
4±1 |
|
– |
1000 |
104±13 |
6±3 |
12±4 |
16±7 |
4±2 |
|
– |
3333 |
- |
- |
12±1 |
- |
- |
|
– |
5000 |
594±5 |
7±4 |
13±3 |
17±3 |
4±3 |
|
Positive controls, –S9 |
Name |
sodium azide |
sodium azide |
methyl methane sulfonate |
2-nitrofluorene |
9-amino-acridine |
|
Concentrations (µg/plate) |
1 |
1 |
1000 |
1 |
75 |
||
Average of 3 plates±sd |
594±5 |
657±69 |
363±4 |
260±20 |
52±18 |
||
+ |
Solvent control |
129±8 |
10±2 |
16±5 |
22±1 |
7±0 |
|
+ |
3.3 |
138±13 |
10±3 |
- |
19±2 |
8±5 |
|
+ |
10 |
134±10 |
11±6 |
- |
28±6 |
5±2 |
|
+ |
33 |
130±8 |
11±4 |
- |
22±2 |
4±1 |
|
+ |
100 |
138±8 |
8±4 |
14±6 |
20±7 |
6±2 |
|
+ |
333 |
143±12 |
9±1 |
17±2 |
25±7 |
5±2 |
|
+ |
1000 |
53±19 |
8±2 |
14±0 |
22±7 |
3±3 |
|
+ |
3333 |
- |
- |
17±5 |
- |
- |
|
+ |
5000 |
131±22 |
8±3 |
14±2 |
24±6 |
7±4 |
|
Positive controls, +S9 |
Name |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
|
Concentrations (µg/plate) |
1 |
1 |
10 |
1 |
1 |
||
Average of 3 plates±sd |
858±31 |
94±6 |
106±19 |
731±15 |
97±23 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
N-[3-(trimethoxysilyl)propyl]aniline has been tested for mutagenicity in bacteria, in a study which was conducted according to OECD 471 and in compliance with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without metabolic activation in a preincubation experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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