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EC number: 211-854-0 | CAS number: 701-35-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Version / remarks:
- July 29, 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- Trichloro-p-tolylsilane
- EC Number:
- 211-854-0
- EC Name:
- Trichloro-p-tolylsilane
- Cas Number:
- 701-35-9
- Molecular formula:
- C7H7Cl3Si
- IUPAC Name:
- trichloro(4-methylphenyl)silane
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- TK locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Cell cycle length, doubling time or proliferation index: 10-12 h
- Modal number of chromosomes: 40 ± 2
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: RPMI 1640 complete
medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically 'cleansed' against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix
- Test concentrations with justification for top dose:
- Experiment I:
- 0.225, 0.250, 0.275, 0.300, 0.325, 0.350, 0.375, 0.400 μL/mL (without metabolic activation)
- 0.300, 0.325, 0.350, 0.375, 0.400, 0.425, 0.450, 0.475, 0.500 μL/mL (with metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran
- Justification for choice of solvent/vehicle: THF was selected based on the solubility test of the test item; the solvent was compatible with the survival of the cells and S9 activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- ethylmethanesulphonate
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in RPMI medium with 5% horse serum
- Cell density at seeding: adjusted daily to 3 x 10E5
DURATION
- Exposure duration: 4 h
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 12 days
SELECTION AGENT (mutation assays): trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: only negative and solvent controls were plated in duplicate; mutant frequency was counted in 4 plates for all treatment groups.
NUMBER OF CELLS EVALUATED: four 96-well plates at a density of approximately 2000 cells/well
DETERMINATION OF CYTOTOXICITY
- Method: suspension growth (SG; the number of times the cell number increased from the starting cell density); relative total growth (RTG; the product of the relative suspension growth [RTG] and the relative cloning efficiency [RCE]) - Rationale for test conditions:
- The assay was considered acceptable if the following criteria were met:
1. At least 3 out of 4 of the 96-well plates were scorable;
2. The cloning efficiency of the negative and/or solvent controls was between 65-120%;
3. The spontaneous mutant frequency in the negative and/or solvent controls was between 50 to 170 mutant per 10E6 cells;
4. The cell number of negative and/or solvent controls increased between 8 to 32 fold during the 2-day growth period; and
5. Positive controls responded appropriately and produced either at least 300 mutants per 10E6 cells with at least 40% of the colonies being small OR indcued a small colony mutant frequency of at least 150 mutants per 10E6 cells. The RTG for positive controls also must be greater than 10%. - Evaluation criteria:
- The test item is considered mutagenic if the following criteria are met:
- The induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 mutants per 10E6 cells
- A dose-dependent increase in mutant frequency is detected.
Besides, combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (≥ 40% of total colonies) is an indication for potential clastogenic effects and/or chromosomal aberrations.
According to the OECD guideline, the biological relevance is considered first for the interpretation of results. Statistical methods might be used as an aid in evaluation of the test result.
A test item is considered to be negative if the induced mutant frequency is below the GEF and the trend of the test is negative. - Statistics:
- Statistical significance at the 5% level (p < 0.05) was evaluated for mutant frequency by means of the non-parametric Mann-Whitney test.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- RTG was 10.1% for 0.400 mg/mL, -S9, and 9.6% at 0.500 mg/mL, +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Mutant frequencies without metabolic activation were not statistically significantly increased over the solvent controls. With metabolic activation, there was a statically significant increase in mutant frequencies over the solvent controls at 0.350, 0.375, and 0.475 mg/mL; however, these increases were not considered treatment related because there was no evidence of a dose-relationship.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: The pH dectected was within the normal physiological range.
- Effects of osmolality: not reported
- Evaporation from medium: not reported
- Water solubility: test item is water-reactive
- Precipitation: No precipitation was observed in the main experiment; precipitation was observed in the pre-experiment at a concentration of 2 mg/mL.
RANGE-FINDING/SCREENING STUDIES: A pre-experiment was conducted at concentrations up to 2 mg/mL.
HISTORICAL CONTROL DATA
- Positive historical control data: EMS (300 μL/mL): 726.5±203.5; MMS (10 μL/mL): 763.4±421.6; B[a]P (1.5 μL/mL): 535.5±152.5
- Negative (solvent/vehicle) historical control data: Negative control, -S9: 87.9±25.5; Negative control, +S9: 85.1±24.3; THF, -S9: 105.9±30.0; THG, +S: 10.6±23.5
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: relative total growth (RTG)
- Other observations when applicable: Growth inhibition was observed both with and without metabolic activation. Without metabolic activation, the relative total growth (RTG) was 10.1% for the highest concentration (0.400 mg/mL); with metabolic activation, the RTG was 9.6% at 0.500 mg/L.
Any other information on results incl. tables
Table 1: Experiment I - 4 h exposure - With Metabolic Activation
Concentration |
Relative cloning efficiency [%] |
Relative Total Growth [%] |
Mutants per 10E+06 surviving cells |
Mutation factor |
Negative 1 |
96.5 |
87.7 |
90.4 |
/ |
Negative 2 |
77.0 |
71.7 |
113.2 |
/ |
Solvent (THF) 1 |
100.0 |
100.0 |
70.1 |
/ |
Solvent (THF) 2 |
65.6 |
/ |
||
0.300 |
101.3 |
95.9 |
82.9 |
15.1 |
0.325 |
103.0 |
98.5 |
96.6 |
28.8 |
0.350 |
93.6 |
83.9 |
114.8* |
47.0 |
0.375 |
90.7 |
82.2 |
115.7* |
47.9 |
0.400 |
101.3 |
72.2 |
60.4 |
-7.4 |
0.425 |
103.0 |
18.9 |
65.0 |
-2.9 |
0.450 |
104.7 |
33.3 |
66.8 |
-1.0 |
0.475 |
88.0 |
25.1 |
102.0* |
34.2 |
0.500 |
96.5 |
9.6 |
54.1 |
-13.7 |
B[a]P, 3.5 µg/mL |
90.7 |
61.3 |
537.1* |
469.2 |
B[a]P Benzo[a]pyrene
* Statistically significant
Table 2: Experiment I - 4 h exposure - Without Metabolic Activation
Concentration |
Relative cloning efficiency [%] |
Relative Total Growth [%] |
Mutants per 10E+06 surviving cells |
Mutation factor |
Negative 1 |
93.0 |
91.2 |
91.8 |
/ |
Negative 2 |
99.2 |
106.1 |
72.6 |
/ |
Solvent (THF) 1 |
100.0 |
100.0 |
114.7 |
/ |
Solvent (THF) 2 |
82.8 |
/ |
||
0.225 |
93.0 |
78.0 |
86.5 |
-12.2 |
0.250 |
104.3 |
92.4 |
52.6*a |
-46.2 |
0.275 |
87.4 |
68.1 |
90.5 |
-8.2 |
0.300 |
113.9 |
93.6 |
85.9 |
-12.9 |
0.325 |
94.5 |
67.4 |
88.9 |
-9.9 |
0.350 |
81.1 |
40.9 |
84.8 |
-14.0 |
0.375 |
84.8 |
34.6 |
109.4 |
10.7 |
0.400 |
73.2 |
10.1 |
99.0 |
0.3 |
EMS, 300 µg/mL |
90.2 |
71.3 |
595.3* |
496.5 |
MMS, 10 µg/mL |
70.1 |
55.5 |
690.4* |
591.7 |
EMS Ethylmethanesulfonate
MMS Methylmethanesulfonate
* Statistically significant
a Significantly decreased compared to the solvent control, therefore not relevant for interpretationof results
Applicant's summary and conclusion
- Conclusions:
- In an OECD 490 study, the test material is not considered to be mutagenic in an in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells both with and without metabolic activation.
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