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EC number: 205-492-2 | CAS number: 141-63-9
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 February 2012 to 5 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Version / remarks:
- 1998
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Dodecamethylpentasiloxane
- EC Number:
- 205-492-2
- EC Name:
- Dodecamethylpentasiloxane
- Cas Number:
- 141-63-9
- Molecular formula:
- C12H36O4Si5
- IUPAC Name:
- 2,2,4,4,6,6,8,8,10,10-decamethyl-3,5,7,9-tetraoxa-2,4,6,8,10-pentasilaundecane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
MEM medium supplemented with:
10 % foetal bovine serum (FBS)
100 U/100 µg/mL Penicillin/Streptomycin solution
2 mM L-glutamine
0.25 mg/mL Amphotericin
25 µM HEPES
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and β naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 0-10 mM
- Vehicle / solvent:
- ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- no
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: Phenobarbital (80 mg/kg bw) and β naphthoflavone (100 mg/kg bw) induced rat liver S9 was included in the S9 mix to a final protein concentration of 0.75 mg/ml. Cofactors were added to the following concentrations: 8 mM MgCl2; 33 mM KCl; 5 mM Glucose-6-phosphate; 5 mM NADP.
METHOD OF APPLICATION: in medium;
DURATION
- Exposure duration: 4 hours (Experiment I, +/- MA, Experiment II +MA); 20 hours (Experiment II -MA).
- Expression time (cells in growth medium): 20 hours (Experiment I +/- MA and Experiment II +MA).
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: Experiments I and II: Stock cultures in exponential growth were seeded into Quadriperm dishes containing at four slides. Two days after seeding the culture medium was replaced with test item suspension (with S9 mix as appropriate). The slides were divided into sets of two and at least one slide from each set was counted. The experiment was repeated. In experiment III duplicate cultures were treated at each concentration and 100 metaphases were scored per culture.
NUMBER OF CELLS EVALUATED: At least 200 well spread metaphases (100 per slide), containing 22+/- 1 centromeres, per concentration and validity controls were scored for cytogenetic damage.
NUMBER OF CELLS EVALUATED: At least 200 well spread metaphases (100 per slide in experiments I and II, 100 per culture in experiment III), containing 22+/- 1 centromeres, per concentration and validity controls were scored for cytogenetic damage.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; relative cell density
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A positive result is determined by: a clear and dose-related increase in the number of cells with aberrations; a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (0.0% - 4.0% aberrant cells)
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- increased percentage of cells with aberrations, not dose dependent or reproducible
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- some reduction in Mitotic index observed at limit concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results of chromosome aberration assay
Concentration mM | Set | cells scored | Chromatid types | Chromosome types | Polyploid cells (mean) | MI % (mean) | mean aberrant cells | ||||||
b | f | d | ex | if | id | cx | inc gaps | exc gaps | |||||
Experiment I, without metabolic activation; 4h treatment, 20 h fixation | |||||||||||||
Negative control | 1 | 100 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0.5 | 100 | 3.5 | 3 |
2 | 100 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | |||||
Solvent control | 1 | 100 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0.5 | 100 | 1.5 | 0.5 |
2 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
2.5 | 1 | 100 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 90 | 2 | 1.5 |
2 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | |||||
5* | 1 | 100 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 89 | 5 | 3.5 |
2 | 100 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | |||||
10 | 1 | 100 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0.5 | 98 | 3.5 | 1.5 |
2 | 100 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |||||
Positive controls | 1 | 100 | 6 | 0 | 0 | 1 | 0 | 0 | 0 | 0.5 | 72 | 10 | 8 |
2 | 100 | 6 | 0 | 1 | 3 | 0 | 0 | 0 | |||||
Experiment I, with metabolic activation; 4h treatment, 20 h fixation | |||||||||||||
Negative control | 1 | 100 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 96 | 3 | 2 |
2 | 100 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | |||||
Solvent control | 1 | 100 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2.5 | 100 | 1.5 | 1 |
2 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | |||||
2.5 | 1 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 78 | 1 | 0 |
2 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
5 | 1 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 85 | 4 | 1.5 |
2 | 100 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | |||||
10 | 1 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 76 | 1.5 | 1 |
2 | 100 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
Positive controls | 1 | 100 | 7 | 0 | 0 | 5 | 0 | 0 | 0 | 0.5 | 79 | 10.5 | 10 |
2 | 100 | 16 | 0 | 0 | 4 | 0 | 0 | 0 | |||||
Experiment II, without metabolic activation; 20h treatment, 20 h fixation | |||||||||||||
Negative control | 1 | 100 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0.5 | 111 | 6.5 | 3 |
2 | 100 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
Solvent control | 1 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 3.5 | 0.5 |
2 | 100 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
0.125 | 1 | 100 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 95 | 5 | 2 |
2 | 100 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |||||
7.5 | 1 | 200 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0.5 | 103 | 3.5 | 2.3 |
2 | 200 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | |||||
10 | 1 | 200 | 4 | 3 | 1 | 2 | 1 | 0 | 0 | 0.75 | 108 | 4.3 | 3.3 |
2 | 200 | 2 | 11 | 0 | 0 | 0 | 0 | 0 | |||||
Positive controls** | 1 | 100 | 9 | 1 | 0 | 2 | 0 | 0 | 1 | 0.5 | 88 | 12.5 | 10.5 |
2 | 100 | 4 | 1 | 0 | 6 | 0 | 0 | 0 | |||||
Experiment II, with metabolic activation; 4h treatment, 20 h fixation | |||||||||||||
Negative control | 1 | 100 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 96 | 5.5 | 2.5 |
2 | 100 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | |||||
Solvent control | 1 | 100 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 100 | 2.5 | 1 |
2 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
4 | 1 | 100 | 7 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 72 | 8.5 | 6 |
2 | 100 | 4 | 0 | 0 | 0 | 0 | 0 | 1 | |||||
7 | 1 | 200 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0.75 | 83 | 5.8 | 3.3 |
2 | 200 | 4 | 1 | 2 | 0 | 1 | 0 | 0 | |||||
10* | 1 | 200 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0.5 | 84 | 6.8 | 4.8 |
2 | 200 | 11 | 2 | 0 | 1 | 0 | 0 | 0 | |||||
Positive controls | 1 | 100 | 5 | 0 | 0 | 9 | 0 | 0 | 0 | 0.5 | 88 | 12.5 | 11 |
2 | 100 | 4 | 1 | 0 | 4 | 0 | 0 | 0 |
Experiment III, with metabolic activation; 4h treatment, 20 h fixation |
|||||||||||||
Negative control |
1 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
69 |
4.0 |
1.0 |
2 |
100 |
4 |
0 |
0 |
1 |
0 |
0 |
0 |
|||||
Solvent control |
1 |
100 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
63 |
2.5 |
1.0 |
2 |
100 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
2.5 |
1 |
100 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
81 |
3.5 |
1.0 |
2 |
100 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
5.0 |
1 |
100 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
75 |
3.0 |
1.5 |
2 |
100 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
10 |
1 |
100 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
67 |
3.0 |
1.5 |
2 |
100 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|||||
Positive controls** |
1 |
100 |
4 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
90 |
9.0 |
7.5 |
2 |
100 |
6 |
0 |
0 |
4 |
0 |
0 |
0 |
* one cd at this concentration; ** one ma at this concentration; *** one ib at this concentrationb/ib break/isobreak f/if fragment/isofragment d/id deletion/isodeletion ex chromatid exchange cx chromosome exchange cd chromosome deletion ma multiple aberration (>4 events including gaps)
Applicant's summary and conclusion
- Conclusions:
- Dodecamethylpentasiloxane has been tested according to OECD 473 and in compliance with GLP. An increase in the number of aberrations was observed in the second experiment with metabolic activation but the response was not clearly dose related or reproducible. In a third experiment with metabolic activation there was no increase in the number of aberrations. Therefore, dodecamethylpentasiloxane was considered to be non-clastogenic under the conditions of the test.
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