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EC number: 278-947-6 | CAS number: 78560-45-9
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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:
- 03 August 2011 to 20 December 2011
- 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 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 675-62-7
- Reference substance name:
- Dichloromethyl(3,3,3-trifluoropropyl)silane
- EC Number:
- 211-623-4
- EC Name:
- Dichloromethyl(3,3,3-trifluoropropyl)silane
- Cas Number:
- 675-62-7
- Molecular formula:
- C4H7Cl2F3Si
- IUPAC Name:
- dichloro(methyl)(3,3,3-trifluoropropyl)silane
Constituent 1
Constituent 2
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
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar phenobarbital and ß-naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment:
with and without metabolic activation: 0.020, 0.039, 0.078, 0.16, 0.31, 0.63, 1.25, 2.5, 5.0, and 10.0 mM
Experiment I:
without metabolic activation: 0.63, 1.25, and 2.5 mM
with metabolic activation: 1.25, 2.5, and 5.0 mM
Experiment II:
without metabolic activation: 0.16, 0.63, and 1.75 mM
with metabolic activation: 2.0, 4.0, and 6.0 mM - Vehicle / solvent:
- -Vehicle (s)/solvent(s) used: cell culture medium (MEM)
-Justification for choice of solvent/vehicle: The test item was dissolved in medium. The solvent was compatible with the survival of the cells and the S9 activity.
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: 400 and 900 µg/ml
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation: 0.83 µg/ml
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Experiment I with and without metabolic activation, experiment II with metabolic activation)
20 hours (Experiment II without metabolic activation)
FIXATION INTERVAL: 20 hours (Experiment I and II with and without metabolic activation)
NUMBER OF REPLICATIONS: 2 independent experiments
NUMBER OF CELLS SEEDED: 1E4 - 5E4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture), (except in experiment I at a concentration of 0.63 mM without metabolic activation: 250 cells and in experiment II at a concentration of 2 mM with metabolic activation: 300 cells).
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell density - Evaluation criteria:
- There are several criteria for determining a positive result:
- 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 (with and without metabolic activation)). - 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 results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results of chromosome analysis | |||||||||||||||
without metabolic activation | |||||||||||||||
Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly- ploidy | mean % aberrant cells | |||||||||
Scored cells | gaps | breaks | inter- changes | other | gaps | breaks | inter- changes | other | incl. Gaps | excl. Gaps | |||||
Experiment I | |||||||||||||||
solvent control | 200 | - | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 1 | 1.5 | 0.5 |
0.16 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 83 | n.d. | n.d. | n.d. | n.d. |
0.31 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 98 | n.d. | n.d. | n.d. | n.d. |
0.63 mM | 250 | no | 5 | 4 | 1 | 0 | 0 | 0 | 2 | 0 | 93 | 93 | 3 | 4.8 | 2.8 |
1.25 mM | 200 | no | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 82 | 97 | 2 | 2.0 | 0.5 |
2.5 mM | 200 | yes | 7 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 40 | 71 | 0 | 4.0 | 1.5 |
5.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 18 | n.d. | n.d. | n.d. | n.d. |
EMS 900 µg/mL | 200 | - | 5 | 13 | 8 | 1 | 0 | 0 | 0 | 3 | 61 | 74 | 1 | 12.5 | 11.5 |
Experiment II | |||||||||||||||
solvent control | 200 | - | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 100 | 100 | 0 | 1.5 | 1.0 |
0.08 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 80 | n.d. | n.d. | n.d. | n.d. |
0.16 mM | 200 | no | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 85 | 92 | 2 | 2.0 | 0.0 |
0.31 mM | 200 | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 56 | n.d. | n.d. | n.d. | n.d. |
0.63 mM | 200 | yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 54 | 77 | 1 | 0.0 | 0.0 |
1.25 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 46 | n.d. | n.d. | n.d. | n.d. |
1.75 mM | 200 | yes | 5 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 48 | 56 | 0 | 4.5 | 2.5 |
2.5 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
5.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
EMS 400 µg/mL | 200 | - | 0 | 12 | 5 | 0 | 1 | 0 | 1 | 1 | 54 | 98 | 1 | 8.5 | 8.0 |
Results of chromosome analysis | |||||||||||||||
with metabolic activation | |||||||||||||||
Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly- ploidy | mean % aberrant cells | |||||||||
Scored cells | gaps | breaks | inter- changes | other | gaps | breaks | inter- changes | other | incl. Gaps | excl. Gaps | |||||
Experiment I | |||||||||||||||
solvent control | 200 | - | 8 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 2 | 5.5 | 2.5 |
0.63 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 98 | n.d. | n.d. | n.d. | n.d. |
1.25 mM | 200 | no | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 77 | 72 | 2 | 2.5 | 0.5 |
2.5 mM | 200 | yes | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 62 | 93 | 0 | 1.5 | 1.0 |
5.0 mM | 200 | yes | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 40 | 76 | 2 | 2.0 | 0.5 |
7.5 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 14 | n.d. | n.d. | n.d. | n.d. |
10.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
CPA 0.83 µg/mL | 200 | - | 3 | 9 | 6 | 1 | 1 | 1 | 0 | 1 | 74 | 81 | 1 | 10.0 | 8.5 |
Experiment II | |||||||||||||||
solvent control | 200 | - | 2 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 100 | 100 | 2 | 2.5 | 1.5 |
0.5 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 103 | n.d. | n.d. | n.d. | n.d. |
1.0 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 80 | n.d. | n.d. | n.d. | n.d. |
2.0 mM | 300 | no | 3 | 6 | 0 | 1 | 0 | 0 | 2 | 0 | 87 | 98 | 2.5 | 3.7 | 3.0 |
4.0 mM | 200 | no | 3 | 2 | 0 | 1 | 1 | 0 | 2 | 0 | 87 | 99 | 3 | 4.0 | 2.5 |
6.0 mM | 200 | yes | 7 | 3 | 0 | 1 | 1 | 0 | 1 | 0 | 46 | 80 | 2 | 6.5 | 2.5 |
8.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 10 | n.d. | n.d. | n.d. | n.d. |
10.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 3 | n.d. | n.d. | n.d. | n.d. |
CPA 0.83 µg/mL | 200 | - | 0 | 10 | 5 | 1 | 1 | 0 | 0 | 2 | 88 | 98 | 1 | 9.0 | 8.5 |
n.d. not determined
Applicant's summary and conclusion
- Conclusions:
- Dichloromethyl(3,3,3-trifluoropropyl)silane was tested for in vitro cytogenicity to mammalian cells according to the OECD TG 473 and in compliance with GLP. The test item did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line with and without metabolic activation up to cytotoxic concentrations. Appropriate positive and solvent controls were included into the study and gave the expected results. The test item is therefore considered to be non-clastogenic under the conditions of the test.
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