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EC number: 219-588-7 | CAS number: 2469-55-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-10-18 to 2005-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- EC Number:
- 219-588-7
- EC Name:
- 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- Cas Number:
- 2469-55-8
- Molecular formula:
- C10H28N2OSi2
- IUPAC Name:
- 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- Reference substance name:
- 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- IUPAC Name:
- 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Method
Species / strain
- 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 and Beta-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- See table 1
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 (without activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 98, TA 1537 (without activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102 (without activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1537, TA 102 (with activation)
- Details on test system and experimental conditions:
- ACTIVATION: The S9 supernatant was mixed S9 cofactor solution to result in a final protein concentration of 36 mg/mL in the cell cultures. The cofactors were: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-ortho-phosphat-buffer pH 7.4.
METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, revertant colony counts - Evaluation criteria:
- Mean values of the spontanious reversion frequency are within historical control data range.
Positive controls should show a distinct enhancement of revertant rates over the control plate.
A test system is considered as mutagenic if there is a clear and dose-related increase in the number of revertants and / or a biologically relevant positive response for at least one of the dose groups in at least one tester strain with or without metabolic activation.
A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 100 and TA 102 and 3-fold of the solvent control for TA 98, TA 1535 and TA 1537.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 300 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 800 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 300 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 -2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 100 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 800 - 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
-
COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (2 plates per strain)
TA 98 |
TA 100 |
|||||
Concentration (μg/Plate) |
Plate 1 - MA |
Plate 2 + MA |
Cytotoxic (Yes/No) |
Plate 1 - MA |
Plate 2 + MA |
Cytotoxic (Yes/No) |
0* |
1 |
1 |
No |
1 |
1 |
No |
3.16 |
1 |
0.8 |
No |
1 |
1 |
No |
10 |
0.9 |
0.9 |
No |
1 |
1.3 |
No |
31.6 |
0.8 |
1.2 |
No |
1.1 |
1.3 |
No |
100 |
1.1 |
1.2 |
No |
1 |
1.2 |
No |
316 |
1.1 |
1.2 |
No |
1 |
1 |
Yes |
1000 |
0.3 |
0.8 |
Yes |
0 |
1.8 |
Yes |
2500 |
0 |
0 |
Yes |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive Control |
26.9 |
19.1 |
No |
9.9 |
13 |
No |
*solvent control with DMSO
Table 3: Experiment 1 Plate-incorporation Number of revertants per plate (mean of 3 plates)
|
TA 98 |
TA 100 |
TA 102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control |
31 |
45 |
No |
116 |
104 |
No |
210 |
235 |
No |
0* |
26 |
40 |
No |
101 |
95 |
No |
167 |
180 |
No |
3.16 |
26 |
32 |
No |
104 |
99 |
No |
165 |
225 |
No |
10 |
23 |
35 |
No |
102 |
118 |
No |
171 |
225 |
No |
31.6 |
21 |
47 |
No |
107 |
125 |
No |
146 |
226 |
No |
100 |
27 |
50 |
No |
100 |
110 |
No |
88 |
191 |
Yes |
316 |
27 |
50 |
No |
98 |
99 |
Yes |
24 |
142 |
Yes |
1000 |
7 |
33 |
Yes |
2 |
172 |
Yes |
0 |
48 |
Yes |
2500 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
690 |
762 |
No |
1001 |
1234 |
No |
1934 |
564 |
No |
*solvent control with DMSO
Table 3: Experiment 1 Plate-incorporation Number of revertants per plate (mean of 3 plates)
|
TA 1535 |
TA 1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control |
13 |
8 |
No |
12 |
12 |
No |
0* |
7 |
11 |
No |
15 |
9 |
No |
3.16 |
12 |
11 |
No |
11 |
17 |
No |
10 |
13 |
12 |
No |
14 |
15 |
No |
31.6 |
13 |
13 |
No |
15 |
17 |
No |
100 |
9 |
9 |
No |
16 |
19 |
No |
316 |
5 |
12 |
Yes |
10 |
27 |
Yes |
1000 |
0 |
3 |
Yes |
0 |
4 |
Yes |
2500 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
660 |
87 |
No |
233 |
56 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA 98 |
TA 100 |
TA 1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control |
30 |
37 |
No |
107 |
127 |
No |
11 |
9 |
No |
0* |
25 |
40 |
No |
111 |
113 |
No |
6 |
9 |
No |
50 |
17 |
- |
No |
109 |
- |
No |
9 |
- |
No |
100 |
31 |
34 |
No |
98 |
99 |
No |
13 |
9 |
No |
200 |
32 |
49 |
No |
96 |
97 |
No |
7 |
10 |
No |
300 |
25 |
48 |
No |
118 |
102 |
Yes |
7 |
10 |
Yes |
500 |
22 |
40 |
Yes |
75 |
88 |
Yes |
2 |
10 |
Yes |
800 |
23 |
41 |
Yes |
18 |
86 |
Yes |
0 |
11 |
Yes |
1200 |
8 |
25 |
Yes |
0 |
134 |
Yes |
0 |
6 |
Yes |
1600 |
0 |
19 |
Yes |
0 |
192 |
Yes |
1 |
0 |
Yes |
2000 |
- |
16 |
Yes |
- |
46 |
Yes |
- |
0 |
Yes |
Positive control |
1000 |
2114 |
No |
1010 |
2545 |
No |
720 |
125 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA 1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
Negative control |
13 |
11 |
No |
0* |
14 |
8 |
No |
50 |
9 |
- |
No |
100 |
14 |
14 |
No |
200 |
11 |
17 |
No |
300 |
9 |
21 |
No |
500 |
8 |
16 |
Yes |
800 |
9 |
8 |
Yes |
1200 |
0 |
13 |
Yes |
1600 |
0 |
2 |
Yes |
2000 |
- |
0 |
Yes |
Positive control |
202 |
214 |
No |
*solvent control with DMSO
|
TA 102 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
Negative control |
220 |
308 |
No |
0* |
206 |
238 |
No |
25 |
168 |
- |
No |
50 |
151 |
- |
No |
100 |
129 |
217 |
No |
200 |
79 |
222 |
Yes |
300 |
39 |
207 |
Yes |
500 |
0 |
123 |
Yes |
800 |
0 |
81 |
Yes |
1200 |
- |
52 |
Yes |
Positive control |
1891 |
871 |
No |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- In a highly reliable test, conducted under OECD 471, with GLP, no mutagenic effect was observed for the test substance tested up to cytotoxic concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.
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