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EC number: 219-863-1 | CAS number: 2554-06-5
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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:
- 2012-01-20 to 2012-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane
- EC Number:
- 219-863-1
- EC Name:
- 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane
- Cas Number:
- 2554-06-5
- Molecular formula:
- C12H24O4Si4
- IUPAC Name:
- 2,4,6,8-tetramethyl-2,4,6,8-tetravinyl-1,3,5,7,2,4,6,8-tetroxatetrasilocane
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- Histidin operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and beta-naphthoflavone induced rat S9 liver microsomal fraction
- Test concentrations with justification for top dose:
- Expt I: 31.6, 100, 316, 1000, 2500 and 5000 µg/plate; Expt II: 15.8, 50.0, 158, 500, 1580 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest., BSL Lot No. 111219, 120105
- Negative solvent / vehicle controls:
- yes
- Remarks:
- EtOH, Applichem Lot No. 1R002540
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- Positive control without metabolic activation: sodium azide for tester strains TA100, TA1535; 4-nitro-o-phenylene-diamine for TA98, TA1537; methylmethanesulfonate for TA102. Positive control with metabolic activation: 2-aminoanthracene for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: at least 48 h; After solidification the plates were inverted and incubated at 37 °C for at least 48 h in the dark.
NUMBER OF REPLICATIONS: For each strain and dose level, including the controls, three plates were used. The experiment was repeated.
DETERMINATION OF CYTOTOXICITY
- Method: clearing or diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control
- ACTIVATION
phenobarbiotol and beta-naphthoflavone induced rat liver S9. S9 mix included 5% S9 and glucose-6-phosphate and NADP as cofactors. 0.5 ml of S9 mix were added to 2.7 ml overlay agar including test substance or control and bacterial suspension, giving a final concentration of S9 of approximately 1%. - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation was observed in all tester strains used in Experiment I and II (with and without metabolic activation). In Experiment I, precipitation of the test item was noted at dose levels of 2500 µg/plate and higher (without metabolic activation) and 5000 µg/plate (with metabolic activation). In Experiment II, precipitation of the test item was noted at 1580 µg/plate and higher (without metabolic activation) and 5000 µg/plate (with metabolic activation).
Any other information on results incl. tables
Mean number of revertant colonies - Experiment 1
Treatment µg/plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Negative control |
22 |
31 |
104 |
120 |
7 |
11 |
5 |
6 |
225 |
311 |
Solvent control |
22 |
31 |
87 |
112 |
6 |
12 |
4 |
4 |
244 |
315 |
31.6 |
27 |
35 |
102 |
136 |
8 |
11 |
7 |
5 |
236 |
292 |
100.0 |
17 |
33 |
106 |
126 |
8 |
15 |
8 |
5 |
227 |
342 |
316.0 |
24 |
35 |
92 |
121 |
4 |
15 |
4 |
3 |
248 |
317 |
1000 |
24 |
35 |
102 |
121 |
4 |
14 |
6 |
5 |
254 |
329 |
2500 |
32 |
39 |
109 |
114 |
2 |
9 |
3 |
4 |
256 |
295 |
5000 |
29 |
34 |
97 |
113 |
3 |
14 |
6 |
8 |
250 |
306 |
Positive control |
372 |
2860 |
893 |
2060 |
726 |
123 |
105 |
246 |
1527 |
763 |
Mean number of revertant colonies - Experiment 2
Treatment µg/plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Negative control |
20 |
25 |
132 |
127 |
11 |
7 |
7 |
8 |
230 |
300 |
Solvent control |
25 |
30 |
110 |
115 |
13 |
7 |
6 |
7 |
201 |
279 |
15.8 |
28 |
35 |
129 |
133 |
12 |
15 |
7 |
10 |
246 |
340 |
50.0 |
27 |
37 |
114 |
137 |
9 |
14 |
4 |
7 |
223 |
342 |
158.0 |
26 |
30 |
117 |
151 |
6 |
15 |
4 |
8 |
249 |
346 |
500.0 |
25 |
30 |
118 |
136 |
9 |
12 |
2 |
4 |
243 |
308 |
1580.0 |
27 |
32 |
130 |
140 |
9 |
13 |
9 |
9 |
300 |
336 |
5000.0 |
30 |
24 |
122 |
138 |
12 |
14 |
5 |
7 |
257 |
350 |
Positive control |
851 |
2524 |
855 |
2380 |
1212 |
152 |
149 |
188 |
2054 |
593 |
Applicant's summary and conclusion
- Conclusions:
- 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane has been tested in a reliable bacterial mutagenicity study conducted according to OECD TG 471 and in compliance with GLP. No test-substance related increase in the number of revertants was observed when Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 were exposed with and without metabolic activation up to limit concentrations. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 of S. typhimurium were exposed to 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane at concentrations of 31.6, 100, 316, 1000, 2500 and 5000 µg/plate (Experiment I) and 15.8, 50.0, 158, 500, 1580 and 5000 µg/plate (Experiment II), in the presence and absence of mammalian metabolic activation according to the plate incorporation method (Experiment I and II).
2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane was tested up to the limit concentration of 5000 µg/plate in all tester strains used.
The positive controls induced the appropriate responses in the corresponding strains.There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5100; OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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