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EC number: 298-130-8 | CAS number: 93777-98-1
- 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
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- 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
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- Endpoint summary
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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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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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:
- S9 microsomal fraction of Phenobarbital and β-Naphthoflavone induced rat livers
- Test concentrations with justification for top dose:
- Experiment I, with and without metabolic activation:
- TA 98, TA 100: 31.6, 100, 316, 1000, 2500, 5000 µg/plate
- TA 1535, TA 1537, TA 102: 10, 31.6, 100, 316, 1000, 2500 µg/plate
Experiment II, with and without metabolic activation: 62.5, 125, 250, 500, 1000, 3000 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, TA1537, TA 98, TA 100, TA 102, with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: The protein concentration in the S9 preparation 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-orthophosphate-buffer, pH 7.4, and 8.5 parts of cofactor solution were added to 1.5 parts of S9. 0.5 ml S9 mix was added to 0.1 ml test solution and 2 ml of overlay agar, giving a final concentration of approximately 3% S9 in the plates.
METHOD OF APPLICATION: in agar: plate incorporation
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates were used, and an independent repeat experiment was conducted.
DETERMINATION OF CYTOTOXICITY
- Method: condition of bacterial lawn/reduction in number of revertants - Evaluation criteria:
- A test item is considered mutagenic when: a dose related increase in the number of revertants occurs; a reproducible biologically 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 calculates.
- 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 316 µg/plate, TA 102 without 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 1535, TA 1537, TA 100, TA 98: 2500 µg/plate and higher, with and without metabolic activation
- TA 102: at 316 µg/plate and higher, without metabolic activation; at 2500 µg/plate, with metabolic activation
Experiment II:
- TA 1535, TA 1537, TA 100, TA 98: at 3000 µg/plate, with and without metabolic activation
- TA 102: at 1000 and higher µg/plate, without metabolic activation; at 3000 µg/plate, with metabolic activation
PRECIPITATION
No precipitation of test item was observed. - Conclusions:
- 1,1-Dimethyl-N,N'-bis(1-methylpropyl)silanediamine has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, 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 Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 102 in the initial or the repeat experiments using the plate incorporation method up to limit concentrations. Appropriate positive, solvent and negative 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 I, 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 |
15 |
18 |
24 |
16 |
139 |
100 |
25 |
27 |
237 |
293 |
Ethanol |
16 |
20 |
24 |
15 |
120 |
122 |
37 |
30 |
237 |
237 |
31.6 |
19 |
19 |
28 |
18 |
139 |
97 |
31 |
41 |
219 |
212 |
100 |
22 |
14 |
21 |
19 |
140 |
111 |
22 |
37 |
175 |
251 |
316 |
27 |
16 |
21 |
17 |
116 |
105 |
27 |
41 |
165 |
249 |
1000 |
25 |
19 |
16 |
16 |
81 |
106 |
28 |
33 |
260 |
225 |
2500 |
16 |
15 |
21 |
13 |
59 |
72 |
14 |
25 |
235 |
234 |
5000 |
6 |
7 |
3 |
3 |
0 |
0 |
0 |
0 |
118 |
219 |
4-NOPD 10 |
|
|
|
|
|
|
|
798 |
|
|
4-NOPD 40 |
|
|
|
199 |
|
|
|
|
|
|
2-AA 2.5 |
190 |
|
147 |
|
1296 |
|
1269 |
|
|
|
2-AA 10 |
|
|
|
|
|
|
|
|
558 |
|
Sodium azide 10 |
|
1163 |
|
|
|
1121 |
|
|
|
|
MMS 1μL |
|
|
|
|
|
|
|
|
|
2136 |
Table 2. Experiment II, 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 |
14 |
14 |
18 |
14 |
118 |
109 |
37 |
19 |
214 |
311 |
Ethanol |
20 |
18 |
15 |
11 |
117 |
119 |
45 |
28 |
216 |
273 |
62.5 |
18 |
14 |
22 |
12 |
119 |
95 |
41 |
29 |
212 |
254 |
125 |
15 |
12 |
17 |
14 |
123 |
109 |
41 |
33 |
207 |
284 |
250 |
17 |
13 |
23 |
14 |
114 |
118 |
34 |
25 |
214 |
291 |
500 |
17 |
19 |
17 |
13 |
122 |
116 |
33 |
29 |
187 |
268 |
1000 |
19 |
16 |
18 |
10 |
107 |
97 |
40 |
27 |
202 |
189 |
3000 |
2 |
9 |
7 |
0 |
71 |
40 |
22 |
16 |
98 |
190 |
4-NOPD 10 |
|
|
|
|
|
|
|
1339 |
|
|
4-NOPD 40 |
|
|
|
228 |
|
|
|
|
|
|
2-AA 2.5 |
233 |
|
239 |
|
2227 |
|
1756 |
|
|
|
2-AA 10 |
|
|
|
|
|
|
|
|
521 |
|
Sodium azide 10 |
|
1324 |
|
|
|
1348 |
|
|
|
|
MMS 1μL |
|
|
|
|
|
|
|
|
|
1819 |
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:
1,1-Dimethyl-N,N'-bis(1-methylpropyl)silanediamine 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 or the repeat experiments using the plate incorporation method up to limit concentrations. Appropriate positive, solvent and negative 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 in vitro bacterial mutagenicity study, 1,1-dimethyl-N,N'-bis(1-methylpropyl)silanediamine is not classified for mutagenicity to bacteria in accordance with Regulation (EC) No 1272/2008.
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