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EC number: 219-863-1 | CAS number: 2554-06-5
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- Ecotoxicological Summary
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- Short-term toxicity to fish
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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:
- 08 February 2012 to 28 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- 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-tetraethenyl-2,4,6,8-tetramethyl-1,3,5,7,2,4,6,8-tetraoxatetrasilocane
- Test material form:
- other: liquid
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:
- Experiment I: 2.5, 5.0 and 10.0 mM (-MA); 0.25, 2.5, 5.0 and 10.0 mM (+MA). Experiment II: 0.025, 0.035 and 0.040 mM (-MA); 0.4, 8.0 and 10.0 mM (+MA)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol;
- Justification for choice of solvent/vehicle: The test item was dissolved in ethanol and diluted with cell culture medium (MEM) followed by ultrasonication for
around 5 min (final concentration of ethanol 1.0% v/v). After that the test item was well suspended. The solvent was compatible with the survival of the cells and the S9 activity at a concentration of 1.0% (v/v) ethanol in the culture medium
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 600 µg/ml, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- 0.83 µg/ml, 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.
Test substance: a solution in ethanol was prepared (344.7 mg/ml; m. wt. 344.66 g/mol). This solution was diluted in MEM, then treated with ultrasonication for around 5 min, to improve the homogeneity of the resulting suspension.
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: 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. Duplicate cultures were not used. The experiment was repeated.
NUMBER OF CELLS EVALUATED: At least 200 well spread metaphases (100 per set), 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
- Determination of endoreplication: the draft report states that "it is important to report polyploidy and/or endoreduplication when this is seen", but no further mention of endoreplication is made.
OTHER: Pre-Experiment for Toxicity I: with and without metabolic activation (exposure time 4 h): 0.0156, 0.0313, 0.0625, 0.125, 0.25, 0.50, 1.0, 2.5, 5.0 and 10.0 mM
Pre-Experiment II: without S9 metabolic activation (exposure time 20 h):
0.0005, 0.0010, 0.0025, 0.005, 0.010, 0.025, 0.050, 0.075 and 0.100 mM - 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 resultsopen allclose all
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- genotoxicity was observed only in the second experiment
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- mitotic index reduced to 68% at 10 mM in first experiment; mitotic index reduced to 63% at 0.035 mM -MA, experiment II.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- M. I. 55% at 10 mM in experiment I; 49% at 0.04 mM in experiment II
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: not reported
- Evaporation from medium: no information
- Water solubility: not soluble in water
- Precipitation: yes
RANGE-FINDING/SCREENING STUDIES:
COMPARISON WITH HISTORICAL CONTROL DATA:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Any other information on results incl. tables
Full tables of results are attached to this EPSR
Results Experiments I and II
Concentration mM | MI % | Cells counted | mean aberrant cells | |
inc gaps | exc gaps | |||
Without metabolic activation, 4 h exposure, Experiment I | ||||
0 (medium) | 100 | 200 | 3.5 | 3.0 |
0 (ethanol) | 100 | 200 | 1.5 | 0.5 |
2.5 | 80 | 200 | 4.0 | 3.0 |
5 | 89 | 200 | 2.0 | 1.0 |
10 | 55 | 200 | 1.0 | 0.5 |
Positive control | 100 | 200 | 10.0 | 8.0 |
With metabolic activation, 4 h exposure, Experiment I | ||||
0 (medium) | 96 | 200 | 3.0 | 2.0 |
0 (ethanol) | 100 | 200 | 1.5 | 1.0 |
0.25 | 82 | 200 | 1.5 | 1.0 |
2.5 | 90 | 200 | 2.0 | 1.0 |
5 | 102 | 300 | 3.7 | 2.3 |
10 | 68 | 200 | 4.0 | 3.0 |
Positive control | 79 | 200 | 10.5 | 10.0 |
Without metabolic activation, 20 h exposure, Experiment II | ||||
0 (medium) | 106 | 200 | 1.5 | 0.0 |
0 (ethanol) | 100 | 200 | 1.5 | 2.0 |
0.025 | 105 | 200 | 2.0 | 2.0 |
0.035 | 63 | 200 | 3.0 | 2.5 |
0.040 | 12.5 | 200 | 1.5 | 0.0 |
Positive control | 94 | 200 | 10.5 | 9.5 |
With metabolic activation, 4 h exposure, Experiment II | ||||
0 (medium) | 96 | 200 | 5.5 | 1.0 |
0 (ethanol) | 100 | 200 | 2.5 | 1.0 |
0.4 | 99 | 400 | 5.3 | 3.3 |
8 | 101 | 400 | 5.3 | 3.8 |
10 | 88 | 200 | 8.0 | 6.5 |
Positive control |
| 200 | 12.5 | 10 |
Applicant's summary and conclusion
- Conclusions:
- 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane has been tested according to OECD 474 and in compliance with GLP, using Chinese hamster V79 cells. No evidence for induction of numerical chromosome aberrations was observed in either the initial or the repeat assay. Without metabolic activation, no biologically relevant increase in the proportion of cells with structural aberrations was observed in either of the two experiments. With metabolic activation, the negative result obtained in the first experiment was not reproduced in the second experiment. Replicate slides were counted in each experiment, but only single cultures were exposed to the controls and to each concentration the test item. It is noted that there is considerable variation between the replicate slides (for example, high dose metabolic activation group replicates providing results of 0 and 8 in experiment I; mid-dose replicates in experiment II results 4 and 1 without MA, 5 and 10 with MA). It is assumed that this lack of reproducibility was the reason that extra cells were counted. Appropriate positive, solvent and medium controls were included and gave results within the range of the historical controls. It was concluded by the authors of the draft report that the test substance is positive for the induction of structural chromosome aberrations under the conditions of the test. The reviewer notes that the differences between replicate slides; the lack of dose response in experiment 1; the unexplained differences between the solvent and medium controls; the different results in experiments 1 and 2 all call into question the biological relevance of the results. In addition, the differences between replicates mean that the absence of duplicate cultures may have had an impact on the results.
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