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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenicity in bacteria (OECD 471, Ames): not mutagenic
Mutagenicity in mammalian cells: data lacking
Clastogenicity in mammalian cells: data lacking
Mutagenicity/clastogenicity in vivo: data lacking
Link to relevant study records
- 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
- 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
- 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
- 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. - 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 - 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. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- 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: 10, 33, 100, 333, 1000, 5000 µg/plate (all strains except WP2 (pKM101))
preincubation test: 0.033, 0.1, 0.33, 1, 3.3, 10, 33, 100, 333, 1000, 5000 µg/plate (WP2 (pKM101)) - Vehicle / solvent:
- Acetone
- 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, sterigmatocystin
- 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. - Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 1000 µg/plate in main tests
- 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:
- from 1000 µg/plate in main tests
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate in main tests
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: =10 µg/plate (first test), no precipitation in second experiment
RANGE-FINDING/SCREENING STUDIES: In the preliminary test cytotoxicity was observed from 667 µg/plate onwards.
Based on the inconsistencies regarding precipitation and toxicity a new study was conducted with a new sample of the test article. - 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. Based on the inconsistencies regarding precipitation and toxicity between experiment 1 and 2 a new study was conducted with a new sample of the test article.
Referenceopen allclose all
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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 (Microbial Associates, 1996a). 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. Based on inconsistencies regarding precipitation and toxicity between experiment 1 and 2 a new study was conducted with a new sample of the test article to confirm the negative genotoxic results.
The mutagenicity of N-[3-(trimethoxysilyl)propyl]aniline in bacteria was assessed in a repeat experiment according to OECD Guideline 471 with Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100 and the Escherichia coli strain WP2 uvrA (Microbiological Associates, 1996b). The tester strains were treated using the pre incubation method both with and without S9-mix. The concentrations tested were 100 - 5000 µg/plate (Salmonella strains experiment B1, Escherichia coli strain experiments B1+B3) and 3.3 - 5000 µg/plate (Salmonella strains experiment B4). Results achieved with vehicle (Acetone) and positive controls were valid. No genotoxicity was observed in the presence and absence of metabolic activation. No precipitation was observed up to the highest dose tested. No appreciable cytotoxicity (defined as reduction of colonies by more than 50% and/or by a scarce background lawn) was observed in any strains.
In conclusion, N-[3-(trimethoxysilyl)propyl]aniline did not induce mutations in bacteria under the test conditions applied.
Justification for classification or non-classification
The available in vitro data are reliable and suitable for classification and fulfil the standard requirements given in Annex VII of Regulation (EC) 1272/2008. Based on the available data, there is no indication that the substance induces genetic toxicity. Nevertheless, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 or Directive 67/548/EEC can be made, as no information on mutagenicity and clastogenicity in mammalian cells/in vivo is available.
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