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EC number: 240-462-2 | CAS number: 16411-33-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- 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
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- Endpoint summary
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- Environmental data
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- 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
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Specific investigations
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro: Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 (OECD TG 471) (BSL Bioservice, 2004).
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)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw) S9 mix
- Test concentrations with justification for top dose:
- Experiment I:
10, 31.6, 100, 316, 1000, 2500, 5000 µg/plate
Experiment II:
150, 300, 500, 900, 1500, 3000, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and S9 activity. - Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 1537, TA 98, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535, TA 1537, TA 98, TA 100, TA 102, with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: The protein concentration in the S9 mx was 36 mg/ml. The S9 mix contained the following co-factors: 8 mM MgCl₂, 33 mM KCl, 5 mM glucose-6-phosphate, 5 mM NADP in 100 mM sodium ortho-phosphate-buffer, pH 7.4
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): Vogel-Bonner Medium E agar plates
NUMBER OF REPLICATIONS: triplicate plates were used, and the experiment repeated. The initial experiment used the plate incorporation method, the repeat experiment used preincubation.
DETERMINATION OF CYTOTOXICITY
- Method: condition of bacterial lawn/ reduction in number of revertants - Evaluation criteria:
- The results is considered positive when: a dose related increase in the number of revertants occurs and/or a reproducible biological relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
- Statistics:
- Relative statistics (standard deviation, mean) were calculated.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 1000 µg/plate (TA 1535 with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
Experiment I:
- TA 1537, TA 100, TA 102, TA 98: toxic effect at 2500 µg/plate and higher, with and without metabolic activation
- TA 1535: toxic effect at 2500 µg/plate and higher, without metabolic activation; toxic at 1000 µg/plate, with metabolic activation
Experiment II:
- TA 98, TA 100, TA 102, TA 1535: toxic effect at 1500 µg/plate, without metabolic activation and 3000 µg/plate, with metabolic activation
- TA 1537: toxic effect at 3000 µg/plate with and without metabolic activation
PRECIPITATION
No precipitation was observed in the study. - Conclusions:
- N,N', N''-Tributyl-1-methylsilanetriamine has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, compliant with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 102 in the initial plate incorporation experiment or the repeat assay using the preincubation method up to limit concentrations. Appropriate positive, solvent (ethanol) and negative (untreated) 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.
Reference
Table 1. Experiment 1, plate incorporation, revertant colonies per plate (mean of three plates), with and without metabolic activation
Concentration μg/plate |
TA 1535 |
TA 1537 |
TA 100 |
TA 98 |
TA 102 |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
A dest |
11 |
11 |
14 |
12 |
110 |
98 |
31 |
28 |
177 |
286 |
Ethanol |
16 |
13 |
13 |
15 |
101 |
102 |
36 |
37 |
205 |
266 |
10 |
21 |
16 |
14 |
16 |
126 |
110 |
38 |
28 |
203 |
276 |
31.6 |
16 |
15 |
14 |
14 |
130 |
123 |
36 |
31 |
215 |
245 |
100 |
15 |
15 |
19 |
12 |
109 |
131 |
42 |
40 |
206 |
261 |
316 |
14 |
18 |
15 |
14 |
105 |
100 |
31 |
27 |
194 |
200 |
1000 |
12 |
15 |
13 |
14 |
106 |
96 |
32 |
31 |
180 |
192 |
2500 |
0 |
9 |
4 |
2 |
75 |
0 |
23 |
0 |
73 |
89 |
5000 |
0 |
3 |
2 |
0 |
27 |
0 |
0 |
0 |
0 |
47 |
4-NOPD 10 |
|
|
|
|
|
|
856 |
|
|
|
2-AA 2.5 |
103 |
|
85 |
|
2306 |
|
1947 |
|
|
|
Sodium azide 10 |
|
1213 |
|
|
|
1131 |
|
|
|
|
MMS 1μL |
|
|
|
|
|
|
|
|
|
1789 |
2-AA 10 |
|
|
|
|
|
|
|
|
742 |
|
4-NOPD 40 |
|
|
|
185 |
|
|
|
|
|
|
Table 2. Experiment 2, preincubation, revertant colonies per plate (mean of three plates), with and without metabolic activation
Concentration µg/plate |
TA 1535 |
TA 1537 |
TA 100 |
TA 98 |
TA 102 |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
A dest |
14 |
16 |
9 |
11 |
110 |
64 |
38 |
32 |
198 |
343 |
Ethanol |
16 |
14 |
13 |
8 |
113 |
109 |
38 |
35 |
231 |
294 |
150 |
21 |
14 |
12 |
17 |
139 |
101 |
44 |
37 |
218 |
292 |
300 |
23 |
17 |
13 |
14 |
89 |
83 |
41 |
29 |
220 |
291 |
500 |
23 |
18 |
12 |
10 |
100 |
80 |
40 |
34 |
231 |
269 |
900 |
25 |
13 |
11 |
12 |
136 |
94 |
50 |
36 |
172 |
259 |
1500 |
21 |
6 |
13 |
13 |
114 |
69 |
36 |
24 |
188 |
188 |
3000 |
0 |
2 |
4 |
0 |
17 |
0 |
3 |
0 |
37 |
0 |
5000 |
0 |
0 |
1 |
0 |
7 |
0 |
0 |
0 |
6 |
0 |
4-NOPD 10 |
|
|
|
|
|
|
|
528 |
|
|
2-AA 2.5 |
140 |
|
105 |
|
941 |
|
592 |
|
|
|
Sodium azide 10 |
|
1402 |
|
|
|
1222 |
|
|
|
|
MMS 1μL |
|
|
|
|
|
|
|
|
|
1849 |
4-NOPD 40 |
|
|
|
130 |
|
|
|
|
|
|
2-AA 10 |
|
|
|
|
|
|
|
|
810 |
|
4 -NOPD: 4-nitro-o-phenylene-diamine
2 -AA: 2-aminoanthracene
MMS: methylmethanesulphonate
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
N,N',N''-Tributyl-1-methylsilanetriamine has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, in compliance with GLP (BSL Bioservice, 2004). No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 102 in the initial plate incorporation experiment or the repeat assay using the preincubation method up to limit concentrations. Appropriate positive, solvent (ethanol) and negative (untreated) 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.
Justification for classification or non-classification
Based on a reliable bacterial mutagenicity study, N,N',N''-tributyl-1-methylsilanetriamine is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
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