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EC number: 257-407-3 | CAS number: 51772-85-1
- 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
- Study period:
- 07 February 2018 to 25 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: gene mutation in mammalian cells using the thymidine kinase locus
Test material
- Reference substance name:
- 3-[tris(acetoxy)silyl]propyl methacrylate
- EC Number:
- 257-407-3
- EC Name:
- 3-[tris(acetoxy)silyl]propyl methacrylate
- Cas Number:
- 51772-85-1
- Molecular formula:
- C13H20O8Si
- IUPAC Name:
- 3-[tris(acetoxy)silyl]propyl methacrylate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- thymidine kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Eurofins Munich stock cultures
- Suitability of cells: Mouse Lymphoma L5178Y cells (clone TK+/- -3.7.2C) have been used successfully in in vitro experiments for many years.
- Cell cycle length, doubling time or proliferation index: 10-12 hours
- ff Sex, age and number of blood donors if applicable: not applicable
- Whether whole blood or separated lymphocytes were used if applicable: not applicable
- Number of passages if applicable: not applicable
- Methods for maintenance in cell culture if applicable: Large stock cultures of the cleansed L5178Y cell line are stored over liquid nitrogen (vapour phase) in the cell bank of Eurofins Munich.
- Modal number of chromosomes: near diploid karyotype (40 +/- 2 chromosomes)
- Normal (negative control) cell cycle time: 10-12 hours
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: not applicable
- 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:
- phenobarbital / β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- The selection of the concentrations used in the main experiment was based on data from the pre-experiment. The test item was investigated at the following concentrations:
without metabolic activation:
50, 100, 150, 200, 250 and 300 µg/mL
and with metabolic activation:
20, 50, 100, 200, 400 and 600 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Based on a pre-experiment for solubility. DMSO was used as solvent and 2 mg/mL was used as the highest concentration. The test item was dissolved in anhydrous DMSO shortly (less than 1 hour) before treatment. From the highest test item stock solution of 200 mg/mL separate dosing solutions were prepared for each of the concentrations by serial dilution with DMSO. 1% (v/v) of each dosing solution will be added directly to the cell culture medium. The pH-value detected with the test item was within the physiological range (pH 7.0 ± 0.4). Osmolality of the highest test item concentration was 469 mOsm/kg. The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: An appropriate quantity of the S9 supernatant was thawed and mixed with S9 cofactor solution to result in a final protein concentration of 0.75 mg/mL in the cultures. Cofactors were added to the S9 mix to reach the concentrations below: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-phosphate-buffer pH 7.4.
METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): 1 x 10⁷ cells
DURATION
- Exposure duration: short-term 4-hour exposure
- Expression time (cells in growth medium): 2 days following 4-hour exposure
- Selection time (if incubation with a selection agent): 12 days
SELECTION AGENT (mutation assays): selective medium
NUMBER OF REPLICATIONS: Single cultures. Negative and solvent controls are tested in duplicate.
NUMBER OF CELLS EVALUATED: 2000 cells/well in 200 µL selective medium
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; Relative Total Growth, RTG
- Any supplementary information relevant to cytotoxicity: not specified
OTHER EXAMINATIONS:
- Determination of polyploidy: no
- Determination of endoreplication: no
- Colony sizing colony characterization by colony sizing was carried out in case the test was positive - Rationale for test conditions:
- Based on pre-experiment.
- 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 106 cells and
- 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
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- RTG: 10.6% at 300 µg/mL without metabolic activation; 11.5% at 600 µg/mL with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not specified
- Effects of osmolality: not specified
- Evaporation from medium: not specified
- Water solubility: not specified
- Precipitation: No precipitation of the test item was noted in the pre-experiment / main experiment.
- Definition of acceptable cells for analysis: not specified
- Other confounding effects: not specified
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determined in a pre-experiment up to a maximum concentration of 2 mg/mL. Six concentrations [25, 50, 150, 450, 1000 and 2000 µg/mL] were tested without and with metabolic activation. The experimental conditions in these pre-experiment were the same as described below in the paragraph experimental performance. After a 2-day growth period the relative suspension growth (RSG) of the treated cell cultures was calculated according to the method of Clive and Spector.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: All mutant frequencies for negative, solvent and positive controls were found within the historical range of the test facility Eurofins Munich.
- Negative (solvent/vehicle) historical control data: All mutant frequencies for negative, solvent and positive controls were found within the historical range of the test facility Eurofins Munich.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Growth inhibition was observed in the experiment without and with metabolic activation. The relative total growth (RTG) was 10.6% (without metabolic activation) and 11.5% (with metabolic activation) for the highest concentration evaluated. - Remarks on result:
- other: See "Remarks"
- Remarks:
- The mutant frequencies induced by the test item did not show any biologically relevant increase. The GEF of 126 was not exceeded in any of the dose groups. A statistical analysis displayed that one of the mutant frequencies (with metabolic activation at a test concentration of 50µL/ML) was significantly increased over those of the solvent controls, but there was no evidence for a dose-response relationship. Therefore this effect was considered as not biologically relevant.
Any other information on results incl. tables
Table1: Summary: Main Experiment, without and with metabolic activation
Test Group |
Conc. [µg/mL] |
RCEa[%] |
RTGb[%] |
MFc[mutants/ 106cells] |
IMFd[mutants/ 106cells] |
GEFeexceeded |
Statistical Significant Increasef |
Precipitate |
|
Exp without S9
|
|
|
|
|
|
|
|
C1 |
0 |
114.4 |
112.8 |
117.5 |
/ |
/ |
- |
- |
C2 |
0 |
123.6 |
121.5 |
117.5 |
/ |
/ |
- |
- |
S1 |
0 |
100.0 |
100.0 |
126.8 |
/ |
/ |
/ |
- |
S2 |
0 |
100.0 |
100.0 |
126.8 |
/ |
/ |
/ |
- |
1 |
50 |
121.7 |
114.7 |
109.6 |
-17.1 |
- |
- |
- |
2 |
100 |
123.6 |
115.7 |
122.7 |
-4.1 |
- |
- |
- |
3 |
150 |
125.6 |
119.1 |
136.9 |
10.1 |
- |
- |
- |
4 |
200 |
123.6 |
75.7 |
99.9 |
-26.9 |
- |
- |
- |
5 |
250 |
127.7 |
39.1 |
80.9 |
-45.9 |
- |
- |
- |
6 |
300 |
98.5 |
10.6 |
122.9 |
-3.9 |
- |
- |
- |
EMS |
300 |
90.4 |
77.5 |
814.0 |
687.2 |
+ |
+ |
- |
MMS |
10 |
93.0 |
77.0 |
891.9 |
765.1 |
+ |
+ |
- |
|
Exp with S9
|
|
|
|
|
|
|
|
C1 |
0 |
93.1 |
99.8 |
113.8 |
/ |
/ |
- |
- |
C2 |
0 |
91.6 |
94.4 |
113.8 |
/ |
/ |
- |
- |
S1 |
0 |
100.0 |
100.0 |
108.2 |
/ |
/ |
/ |
- |
S2 |
0 |
100.0 |
100.0 |
108.2 |
/ |
/ |
/ |
- |
1 |
20 |
88.9 |
90.1 |
132.1 |
23.9 |
- |
- |
- |
2 |
50 |
90.3 |
96.5 |
158.5 |
50.4 |
- |
+ |
- |
3 |
100 |
93.1 |
97.3 |
111.8 |
3.6 |
- |
- |
- |
4 |
200 |
82.5 |
85.5 |
129.6 |
21.4 |
- |
- |
- |
5 |
400 |
79.0 |
30.6 |
121.3 |
13.1 |
- |
- |
- |
6 |
600 |
70.4 |
11.5 |
137.9 |
29.8 |
- |
- |
- |
B[a]P |
2.5 µg/mL |
52.2 |
25.3 |
560.9 |
452.7 |
+ |
+ |
- |
C: Negative controls
S: Solvent controls (1% DMSO; v/v)
a: Relative Cloning Efficiency, RCE = [(CEdose group/ CEof corresponding controls) x 100]
Cloning Efficiency, CE = ((-LN (((96 - (mean P1,P2)) / 96)) / 1.6) x 100)
b: Relative Total Growth, RTG = (RSG x RCE)/100
c: Mutant Frequency,
MF = {-ln [negative cultures/total wells (selective medium)] / -ln [negative cultures/total wells (non selective medium)]}x800
d: Induced Mutant Frequency, IMF = mutant frequency sample – mean value mutant frequency corresponding controls
e: Global Evaluation Factor, GEF (126); +: GEF exceeded, -: GEF not exceeded
f: statistical
significant increase in mutant frequency compared to solvent controls
(Mann Whitney test, p<0.05).
+: significant; -not significant
EMS: Ethylmethanesulfonate
MMS: Methylmethanesulfonate
B[a]P: Benzo[a]pyrene
Applicant's summary and conclusion
- Conclusions:
- 3-(Triacetoxysilyl)propyl methacrylate has been tested for mutagenicity to mammalian cells in a study conducted according to OECD TG 490, and in compliance with GLP using mouse lymphoma L5178Y cells. No test-substance induced increase in the number of mutations was observed when tested with and without metabolic activation. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study.
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