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EC number: 274-936-5 | CAS number: 70851-50-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-13 to 2002-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns SozialesFreie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dimethoxymethyloctadecylsilane
- EC Number:
- 274-936-5
- EC Name:
- Dimethoxymethyloctadecylsilane
- Cas Number:
- 70851-50-2
- Molecular formula:
- C21H46O2Si
- IUPAC Name:
- dimethoxymethyloctadecylsilane
- Details on test material:
- - Name of test material (as cited in study report): Silan ODM-Dimethoxy
- Stability under test conditions: at + 4 °c in the dark: > 1 day
- Storage condition of test material: at room temperature, dark, tightly closed, dry
Constituent 1
Method
- Target gene:
- His operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 3.16, 10, 31.6, 100 and 316 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- - S9: 10 µg/plate in water for strains TA 1535 and TA 100.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9: 10 µg/plate in DMSO for strain TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- -S9: 100 µg/plate in ethanol for strain TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- -S9: 1300 µg/plate in DMSO for strain TA 102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide
- Remarks:
- +S9: 2 µg/plate in DMSO for strains TA 98, TA 102, TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- +S9: 1500 µg/plate in aqua ad iniectabilia for stains TA 100 and TA 1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, revertant colony counts - Evaluation criteria:
- 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 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both experiments.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking on histidine-free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn. - Statistics:
- MANN and WHITNEY and Spearman’s rank.
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- 316 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316 μg/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
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
148 |
140 |
No |
0.316 |
160 |
151 |
No |
1 |
148 |
141 |
No |
3.16 |
153 |
149 |
No |
10 |
138 |
141 |
No |
31.6 |
162 |
149 |
No |
100 |
132 |
162 |
No |
316 |
171 |
157 |
Yes |
1000 |
0 |
0 |
Yes |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with acetone
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
30.3 |
39 |
No |
152.3 |
164.7 |
No |
273.7 |
275.7 |
No |
3.16 |
34.7 |
38.3 |
No |
152 |
159.7 |
No |
275.7 |
278 |
No |
10 |
26.3 |
33.3 |
No |
155 |
164.3 |
No |
274.3 |
266 |
No |
31.6 |
26.7 |
39 |
No |
149 |
169 |
No |
270 |
273 |
No |
100 |
22.7 |
36.3 |
No |
152 |
162 |
No |
270.7 |
262.7 |
No |
316 |
31.7 |
36 |
Yes |
150 |
164.7 |
Yes |
272.3 |
260.7 |
Yes |
Positive control |
726.3 |
736.3 |
No |
1091.7 |
1093.3 |
No |
1105.3 |
1115 |
No |
*solvent control with acetone
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
17.3 |
17.7 |
No |
4 |
5 |
No |
3.16 |
16 |
15 |
No |
4 |
3.7 |
No |
10 |
17.3 |
18 |
No |
2.7 |
4 |
No |
31.6 |
15.7 |
12 |
No |
3 |
3.3 |
No |
100 |
16 |
17 |
No |
3.7 |
4.7 |
No |
316 |
15.3 |
18.3 |
Yes |
3 |
4.3 |
Yes |
Positive control |
529.3 |
530.7 |
No |
518.3 |
528.3 |
No |
*solvent control with acetone
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
32 |
35.3 |
No |
151.3 |
176.7 |
No |
271.7 |
287.7 |
No |
3.16 |
31 |
35 |
No |
136.3 |
162.3 |
No |
285 |
260.3 |
No |
10 |
30.7 |
36 |
No |
146.7 |
165 |
No |
278 |
269.3 |
No |
31.6 |
25.3 |
26.7 |
No |
161 |
171 |
No |
278 |
268.3 |
No |
100 |
25 |
27 |
No |
152 |
170.7 |
No |
274 |
271.3 |
No |
316 |
26.7 |
32.7 |
Yes |
157 |
173.3 |
Yes |
277 |
292 |
Yes |
Positive control |
876.7 |
1062.3 |
No |
1300.3 |
1264 |
No |
1294.3 |
1267.3 |
No |
*solvent control with acetone
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
15.3 |
14.7 |
No |
4 |
3.3 |
No |
3.16 |
15 |
12.3 |
No |
3 |
4 |
No |
10 |
11.3 |
12.3 |
No |
2.3 |
4 |
No |
31.6 |
12 |
14.3 |
No |
3.3 |
4.7 |
No |
100 |
13.7 |
12.7 |
No |
3 |
4 |
No |
316 |
12 |
12 |
Yes |
3 |
4 |
Yes |
Positive control |
491.7 |
451 |
No |
443.3 |
446.7 |
No |
*solvent control with acetone
MA - Metabolic activation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
In a 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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