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EC number: 253-634-7 | CAS number: 37697-65-7
- 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
Bacterial reverse mutation assay: the substance 1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine was negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535, TA1537 and TA 1538 (OECD TG 471) (Wacker, 1989).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-05-10 to 1989-10-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The restrictions were that the range of strains does not comply with the current guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- The range of strains does not comply with the current guideline
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- 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:
- biphenyl polychloride induced rat liver S9
- Test concentrations with justification for top dose:
- 0.1, 0.5, 1, 2.5 and 5 ml/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: no justification given in study report. - 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, TA 1538 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 100 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 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)
- Details on test system and experimental conditions:
- ACTIVATION: Cofactors were added to the S9 mix to reach the following concentrations: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 4 mM NADP in 100 mM potassium-phosphate-buffer pH 7.4. The concentration of S9 in the mix was 5%, and 0.5 ml of S9 mix were added to test substance, overlay agar and bacterial suspension giving a final concentration of approximately 1% S9 in the plates.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration; experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: reduction in mean number of revertants, background lawn assessment - Evaluation criteria:
- A result is positive if the number of colonies apparent in the presence of the test article is greater or equal to twice the number of colonies apparent in the negative control.
- Statistics:
- The mean number of colonies apparent in the dishes and the standard deviation were calculated.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 2.5 mg/plate (Strain TA98 without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2.5 mg/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
- Conclusions:
- 1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine has been tested for mutagenicity to bacteria in a study conducted according to OECD 471 (1981) and in compliance with GLP. No test-substance induced increase in the number of revertants was observed for the test substance up to limit concentrations in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 or TA 1538 without and with metabolic activation in two independent experiments. It is concluded that the the test substance is not mutagenic to bacteria under the conditions of the test.
Reference
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 (-MA) |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
87 |
95 |
No |
0.05 |
103 |
83 |
No |
0.1 |
81 |
85 |
No |
0.5 |
98 |
77 |
No |
1 |
80 |
74 |
No |
2.5 |
96 |
91 |
No |
5 |
103 |
99 |
No |
*solvent control with Acetone
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1538 |
||||||
Conc. mg/dish |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
24 |
28 |
No |
95.3 |
101 |
No |
41.3 |
43 |
No |
0.1 |
23 |
31.3 |
No |
87.7 |
99 |
No |
34.7 |
44 |
No |
0.5 |
25.3 |
37 |
No |
88.7 |
98.3 |
No |
37.7 |
47.7 |
No |
1 |
29.7 |
29 |
No |
98 |
104.7 |
No |
25 |
38.7 |
No |
2.5 |
26.7 |
31.3 |
Yes |
78.7 |
97.3 |
No |
21 |
35 |
No |
5 |
27.3 |
40 |
Yes |
84 |
99.3 |
Yes |
7.3 |
24.3 |
Yes |
Positive control |
551.5 |
1135.5 |
No |
308.5 |
1538 |
No |
240 |
1258 |
No |
*solvent control with Acetone
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. mg/dish |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
8.3 |
10.7 |
No |
10 |
10.3 |
No |
0.1 |
9 |
11.7 |
No |
13.7 |
10 |
No |
0.5 |
7 |
9.7 |
No |
12 |
8.3 |
No |
1 |
8.3 |
9.3 |
No |
10 |
9 |
No |
2.5 |
9 |
8.7 |
No |
7.3 |
8.7 |
No |
5 |
3 |
10 |
Yes |
3 |
5 |
Yes |
Positive control |
1002.5 |
185 |
No |
331.5 |
93.5 |
No |
*solvent control with Acetone
Table 4: Experiment 2 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1538 |
||||||
Conc. mg/dish |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
30 |
24.3 |
No |
109 |
107 |
No |
41.3 |
43 |
No |
0.1 |
18 |
32.3 |
No |
113.7 |
111.3 |
No |
34.7 |
44 |
No |
0.5 |
26.7 |
24.3 |
No |
117.7 |
127.3 |
No |
37.7 |
47.7 |
No |
1 |
23.3 |
25.3 |
No |
107.7 |
104.7 |
No |
25 |
38.7 |
No |
2.5 |
17.7 |
32.3 |
Yes |
147 |
124.7 |
No |
21 |
35 |
Yes |
5 |
3.3 |
20 |
Yes |
64.3 |
92.3 |
Yes |
7.3 |
24.3 |
Yes |
Positive control |
408.5 |
1106 |
No |
293.5 |
1118.5 |
No |
240 |
1258 |
No |
*solvent control with Acetone
Table 4: Experiment 2 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. mg/dish |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
11.3 |
11.7 |
No |
11.3 |
7.7 |
No |
0.1 |
9.7 |
10.3 |
No |
11 |
8 |
No |
0.5 |
10 |
13.7 |
No |
10 |
9 |
No |
1 |
8.7 |
15 |
No |
12.3 |
8.3 |
No |
2.5 |
11 |
10 |
No |
5.7 |
8.7 |
Yes |
5 |
7.7 |
8 |
Yes |
0.3 |
9.3 |
Yes |
Positive control |
1295.5 |
133 |
No |
216.5 |
62.5 |
No |
*solvent control with Acetone
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471 (1989), and under GLP, using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 1538 (Wacker, 1989).
No increase in the number of revertants was observed in any test strain, with or without metabolic activation in two separate experiments up to limit concentrations. Appropriate positive and solvent controls were added and gave expected results. It was concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. The study is considered reliability 2 due to the lack of inclusion of a bacterial strain capable of detecting cross-linking or oxidising mutagens.
In order to address the missing strain, data are read-across from the related substances 1,1-dimethyl-N,N'-bis(1-methylpropyl)silanediamine CAS 93777-98-1 and N,N',N''-tributyl-1-methylsilanetriamine CAS 16411-33-9, both of which gave negative results with and without metabolic activation in all strains tested (Bioservice, 2004a and 2004b).
Non-testing methods including read-across from surrogate substances are able to provide information on genetic toxicity (REACH Guidance part 07a, R.7.7.3). In the case of genetic toxicity the presence or absence of functional groups that are known to be related to genetic toxicity is considered important, as the presence or absence of reactive groups and molecular substructures is associated with mutagenic and carcinogenic properties of chemicals (Benigni and Bossa, 2006). Consideration is therefore given to the structural similarity, particularly presence or absence of structural alerts for genetic toxicity, when selecting surrogate substances for genetic toxicity endpoints.
Read-across hypothesis
The hypothesis is that that source (read-across) substances and registration (target) substance have similar systemic toxicological properties because they hydrolyse to similar silanol hydrolysis products, methylsilanetriol and dimethylsilanediol and similar amines, n-butylamine and sec-butylamine. None of the substances or hydrolysis products have structural alerts for genetic toxicity.
Read-across justification
(a) Structural similarity of parent substance and silicon-containing hydrolysis products
The target and source substances are structurally similar and hydrolyse rapidly to methylsilanetriol or dimethylsilanediol.
The registered substance (target) 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine CAS 37697-65-7 hydrolyses very rapidly (hydrolysis half-lives at 25°C, < 2 min at pH 4 and pH7 and 5.0 min at pH9). The products of hydrolysis are the amine-functional leaving group, sec-butylamine (CAS 13952-84-6) and the silanol, methylsilanetriol (CAS 2445-53-6).
N,N',N''-Tributyl-1-methylsilanetriamine CAS 16411-33-9 hydrolyses very rapidly (hydrolysis half-lives at 25°C, < 2 min at pH 4, 7 and 9). The products of hydrolysis are the amine-functional leaving group, n-butylamine (CAS 109-73-9) and the silanol, methylsilanetriol (CAS 2445-53-6). This source substance has the same silanol hydrolysis product as the target substance and a similar amine-functional leaving group.
1,1-Dimethyl-N,N'-bis(1-methylpropyl)silanediamine CAS 93777-98-1 hydrolyses rapidly (hydrolysis half-lives at 25°C, < 2 min at pH 4, 7 and 9). The products of hydrolysis are the amine-functional leaving group, sec-butylamine (CAS 13952-84-6) and the silanol, dimethylsilanediol (CAS 1066-42-8). This source substance has the same amine-functional leaving group as the target substance and a similar silanol hydrolysis product.
(b) Lack of structural alerts
None of the substances or hydrolysis products has structural alerts for genotoxicity (Benigni et al, 2008).
(c) Lack of genetic toxicity of the silicon hydrolysis product
Dimethylsilanediol is not mutagenic in a study which included an appropriate 5th strain (unpublished data). No data are available for methylsilanetriol, but other substances which also hydrolyse to methylsilanetriol give negative results in appropriate strains.
(d) Lack of genetic toxicity of the non-silicon hydrolysis product.
The non-silicon hydrolysis product of the registered product, sec-butylamine does not have data in the disseminated dossier from a bacterial mutagenicity study which tested an appropriate strain. However, a wide range of in vitro and in vivo data are presented which conclude that the substance is not a genetic toxin.
The data available for the rapidly hydrolysing read-across substances indicates that sec-butylamine is not of concern for genetic toxicity.
Benigni and Bossa (2006). Current Computer-Aided Drug Design 2, (2), 169-176.
Benigni et al (2008). The Benigni/Bossa rule base for mutagenicity and carcinogenicity JR Scientific report EUR 23241 EN
Justification for classification or non-classification
Based on the available bacterial mutagenicity data, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.
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