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EC number: 250-437-8 | CAS number: 31024-56-3
- 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
Gene mutation (Bacterial reverse mutation assay / Ames test): S.
typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA 102: negative with
and without metabolic activation (similar to OECD TG 471)
Mammalian cytogenicity (CHO chromosome aberration assay, RA from CAS
157923-74-5: negative with and without metabolic activation
(according to OECD TG 473)
Mammalian Mutagenicity (HPRT Test, RA from CAS 36957-84-3): negative
with and without metabolic activation (similar to OECD TG 476)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- (no strain was included for detection of oxidising or cross-linking substances)
- 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:
- S. typhimurium TA 1538
- 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:
- 0.05-5 mg/plate
- Vehicle / solvent:
- - Solvent: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-anthramine (TA 98, TA 100, TA 1535, TA 1537, TA 1538); -S9: 2-nitrofluorene (TA98); methyl methanesulfonate (TA 100); ethyl methanesulfonate (TA 1535); 9-aminoacridine (TA 1537); 2-nitrofluorene (TA 1538)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Cytotoxicity was determined in a preliminary study using strain TA 98 and also within the main study cytotoxicity was determined. No further information was given about the method applied.
POSITIVE CONTROLS:
+S9: 2-anthramine (TA 98, TA 100, TA 1535, TA 1537, TA 1538: 0.002 mg/plate)
-S9: 2-nitrofluorene (TA98: 0.001 mg/plate); methyl methanesulfonate (TA 100: 0.1 mg/plate); ethyl methanesulfonate (TA 1535: 10 mg/plate); 9-aminoacridine (TA 1537: 0.05 mg/plate); 2-nitrofluorene (TA 1538: 0.001 mg/plate) - Evaluation criteria:
- No significant effects: number of colonies after treatment with test substance is less than 2-fold the number of colonies of the solvent control.
Significant effects: number of colonies after treatment with test substance is at least 2-fold the number of colonies of the solvent control. - Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: TA 98, TA 1535 (5 mg/plate), TA 100, TA 1537, TA 1538 (1 and 5 mg/plate); +S9: TA 1537 (5 mg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In a preliminary study the test substance was applied to bacteria (TA 98) from 0.5 to 100 mg/plate. Cytotoxicity was observed from 5 mg/plate upwards. - Conclusions:
- Interpretation of results: negative
In a bacterial mutagenicity assay similar to OECD 471 and GLP, no mutagenic effect was observed for the test substance tested up to the top dose of 5000 µg/plate in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic under the applied conditions. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see attached document for justification of read-across
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
One study is available from the structural analogue 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5). In this study it was observed that the source substance does not induce chromosomal aberration in mammalian cells. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the genetic toxicity potential that are higher than the typical experimental error of the test method. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see attached document for justification of read-across
- Reason / purpose for cross-reference:
- read-across source
- Type of assay:
- other: mammalian cell gene mutation assay
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reduced cloning efficiency at 2 mg/ml in 1 experiment (decrease of 20%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
One study is available from the structural analogue 2-(triethoxysilyl)propylamine (CAS 36957-84-3). In this study it was observed that the source substance does not induce chromosomal aberration in mammalian cells. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the genetic toxicity potential that are higher than the typical experimental error of the test method.
Referenceopen allclose all
Table 1: Test results of experiment 1.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
|
|
|||||
|
TA 98 |
TA 100 |
TA1535 |
TA1537 |
TA1538 |
||
– |
0 |
28±4 |
83±4 |
9±3 |
5±1 |
22±1 |
|
– |
50 |
25±1 |
91±5 |
9±4 |
4±1 |
26±1 |
|
– |
100 |
26±8 |
90±11 |
6±2 |
5±0 |
23±4 |
|
– |
500 |
21±5 |
101±9 |
7±0 |
6±2 |
19±5 |
|
– |
1000 |
21±2 |
78±6 |
11±4 |
8±5 |
26±4 |
|
– |
5000 |
T |
53±8 |
5±1 |
T |
5±2 |
|
Positive controls, –S9 |
Name |
2-NF |
MMS |
EMS |
9-AA |
2-NF |
|
Concentrations (μg/plate) |
1 |
100 |
10000 |
50 |
1 |
||
Mean No. of colonies/plate (average of 3) |
472 |
299 |
1035 |
131 |
248 |
||
+ |
0 |
39±4 |
112±12 |
13±5 |
5±2 |
34±9 |
|
+ |
50 |
35±5 |
107±2 |
8±2 |
7±4 |
40±4 |
|
+ |
100 |
36±5 |
107±20 |
8±2 |
5±2 |
35±13 |
|
+ |
500 |
37±1 |
108±6 |
12±3 |
7±2 |
33±3 |
|
+ |
1000 |
34±7 |
102±8 |
10±3 |
4 |
33±8 |
|
+ |
5000 |
36±3 |
111±4 |
9±4 |
4±2 |
38±7 |
|
Positive controls, +S9 |
Name |
2-A |
2-A |
2-A |
2-A |
2-A |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
2 |
||
Mean No. of colonies/plate (average of 3) |
554 |
1528 |
239 |
63 |
298 |
Table 2: Test results of experiment 2.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
|
|
|||||
|
TA 98 |
TA 100 |
TA1535 |
TA1537 |
TA1538 |
||
– |
0 |
28±5 |
78±7 |
7±2 |
6±2 |
32±6 |
|
– |
50 |
28±3 |
81±16 |
7±3 |
5±2 |
32±4 |
|
– |
100 |
29±2 |
73±17 |
7±3 |
4±1 |
30±3 |
|
– |
500 |
27±6 |
73±8 |
7±3 |
5±1 |
25±3 |
|
– |
1000 |
28±6 |
T |
5±3 |
2±1 |
7±6 |
|
– |
5000 |
T |
T |
7±1 |
T |
T |
|
Positive controls, –S9 |
Name |
2-NF |
MMS |
EMS |
9-AA |
2-NF |
|
Concentrations (μg/plate) |
1 |
100 |
10000 |
50 |
1 |
||
Mean No. of colonies/plate (average of 3) |
573 |
270 |
835 |
116 |
548 |
||
+ |
0 |
43±10 |
118±4 |
9±5 |
6±1 |
38±3 |
|
+ |
50 |
41±5 |
107±13 |
11±2 |
5±3 |
47±11 |
|
+ |
100 |
43±2 |
101±14 |
8±2 |
5±1 |
38±10 |
|
+ |
500 |
44±14 |
101±11 |
9±5 |
5±3 |
42±9 |
|
+ |
1000 |
46±11 |
98±17 |
9±1 |
6±2 |
49±4 |
|
+ |
5000 |
43±8 |
109±5 |
11±2 |
6±1 |
41±12 |
|
Positive controls, +S9 |
Name |
2-A |
2-A |
2-A |
2-A |
2-A |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
2 |
||
Mean No. of colonies/plate (average of 3) |
673 |
1337 |
185 |
35 |
579 |
MMS = methyl methanesulfonate
EMS = ethyl methanesulfonate
9AA = 9-aminoacridine
2-A = 2-anthramine
T = cytotoxic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data are available from a bacterial mutagenicity study on N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3). No further information is available for the registered substance, however, reliable data are available for the closely related substances, 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) and 2-(triethoxysilyl)propylamine (CAS 36957-84-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of N-[3 -(trimethoxysilyl)propyl]butylamine (CAS 31024 -56 -3). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Discussion of results:
In vitro genotoxicity
In the available key study (Hazleton France, 1989) N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3) was tested for bacterial mutagenicity similar to the OECD TG 471, and in compliance with GLP. No test-substance related increase in the number of revertants was observed when tested in two independent experiments with and without metabolic activation up to the top concentration of 5000 µg/plate in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 in the plate incorporation assay. Appropriate solvent and positive controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
No data are available for mutagenicity to a bacterial strain capable of detecting cross-linking or oxidising mutagens. In view of the lack of genetic toxicity demonstrated in studies on mammalian cells, and the absence of structural features that indicate that such mutagenicity is likely, testing in an appropriate 5th strain is not considered necessary. In addition, the only silicon-containing substance which has given a positive result in a bacterial strain capable of detecting cross-linking or oxidising mutagens contains an epoxy- side-chain (which is associated with cross-linking mutagenicity), and this substance was positive in Salmonella typhimurium strains TA 100, TA 1535 as well as in E.coli WP2uvrA.
In the available key study (RCC, 2001) 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) was tested for cytogenicity according to the OECD TG 473, and in compliance with GLP. The test substance did not induce structural chromosomal aberrations in the Chinese hamster lung fibroblasts (V79) cell line with and without metabolic activation up to limit concentrations. Appropriate solvent and positive controls were included into the test and gave expected results. It is concluded that 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) is negative for the induction of chromosome aberrations under the conditions of the test.
In the available key study (Bushy Run Research Center, 1985) 2-(triethoxysilyl)propylamine (CAS 36957-84-3) was tested for mammalian mutagenicity (HPRT Test) similar to the OECD TG 476, and in compliance with GLP. No increase in mutant frequency was observed at any concentration up to cytotoxicity with and without metabolic activation at 5 hours treatment. Expected results were obtained with positive, solvent, and negative controls. It is concluded that 2-(triethoxysilyl)propylamine (CAS 36957-84-3) is negative for the induction of mutations in Chinese hamster Ovary cells (CHO) under the conditions of the test.
In vivo genotoxicty
No data available.
Justification for classification or non-classification
The available in vitro genotoxicity data are reliable and suitable for classification. Based on this data, classification for mutagenicity according to Regulation (EC)1272/2008 is not warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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