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EC number: 238-518-6 | CAS number: 14513-34-9
- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28th Jan 2003 to 17th Feb 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 121177-93-3
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: The test item was dissolved in DMSO. The solvent was compatible with the survival of the bacteria and S9 activity.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was dissolved in DMSO
- Preliminary purification step (if any): not performed
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicabl
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital (80 mg/kg b.w.) and ß-Naphtoflavone (100 mg/kg b.w.) induced rat liver S9
- Test concentrations with justification for top dose:
- pre-experiment: 3.2, 10.2, 32.1, 101.5, 320.8, 1015.2, 2538, 5076 µg/plate. To determine the toxicity of the test item in TA98 and TA100
exposure concentrations: 32.1, 101.5, 320.8, 1015.2, 2538 and 5076 µg/plate. Concentrations based on results from the pre-experiment. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- without metabolic activation, TA 97a, TA 98
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation, TA 102
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation, TA 1535, TA 100
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- with metabolic activation, TA 1535, TA 97a, TA 98, TA 100 and TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding (if applicable): not specified
ACTIVATION: The protein concentration in the S9 preparation was 44.5 mg/ml. 100 mM sodium-ortho-phosphat-buffer, pH 7.4 were ice-cold added to the following pre-weighed reagents to give final concentrations in the S9 mix of: 8 mM MgC12, 33 mM KCI, 5 mM Glucose-6-phosphate, 5 mM NADP.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells):
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED: not specified
DETERMINATION OF CYTOTOXICITY
- Method: background lawn growth; number of revertants; mutation factor
- Any supplementary information relevant to cytotoxicity: not applicable
OTHER EXAMINATIONS:
- Determination of polyploidy: not applicable
- Determination of endoreplication: not applicable - Rationale for test conditions:
- Concentrations based on results from the pre-experiment.
- Evaluation criteria:
- A test item was considered mutagenic when:
- a dose-related increase in the number of revertants occured and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation - Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA97a, TA100, TA98 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA1535 and TA100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2538 µg/plate and 5076 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA1535 and TA100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5076 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA97a and TA102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5076 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2538 and 5076 µg/plate
- 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: not specified
- Definition of acceptable cells for analysis: not specified
- Other confounding effects: not specified
RANGE-FINDING/SCREENING STUDIES: No mutagenic or cytotoxic effects were observed.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: Results within historical control data ranges.
- Negative (solvent/vehicle) historical control data: Results within historical control data ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: background lawn
- Other observations when applicable: not applicable - Remarks on result:
- other:
- Remarks:
- Pre-experiment
Any other information on results incl. tables
Table 1: Experiment I, plate incorporation test
Concentration μg/plate |
TA1535 |
|
TA98 |
|
TA97a |
|
TA100 |
|
TA102 |
|
|
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
A dest. |
24 |
25 |
23 |
20 |
105 |
130 |
117 |
103 |
274 |
263 |
DMSO |
23 |
23 |
24 |
21 |
106 |
97 |
101 |
101 |
269 |
277 |
32.1 |
25 |
27 |
22 |
18 |
111 |
112 |
117 |
88 |
405 |
333 |
101.5 |
23 |
26 |
23 |
14 |
124 |
108 |
101 |
82 |
319 |
355 |
320.8 |
22 |
26 |
21 |
21 |
105 |
105 |
117 |
95 |
413 |
219 |
1015.2 |
22 |
23 |
19 |
15 |
140 |
123 |
114 |
85 |
431 |
396 |
2538 |
26 |
26 |
16 |
15 |
115 |
101 |
93 |
89 |
436 |
434 |
5076 |
25 |
25 |
17 |
20 |
103 |
107 |
101 |
90 |
286 |
280 |
NaN3 10 |
/ |
519 |
/ |
/ |
1364 |
/ |
/ |
1166 |
/ |
/ |
2-AA 2.5 |
261 |
/ |
2055 |
/ |
/ |
/ |
2297 |
/ |
669 |
/ |
4-NOPD 40 |
/ |
/ |
/ |
/ |
/ |
1036 |
/ |
/ |
/ |
/ |
4-NOPD 10 |
/ |
/ |
/ |
863 |
/ |
|
/ |
/ |
/ |
/ |
MMS 1200 |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
1035 |
Table 2: Experiment II, pre-incubation test
Concentration μg/plate |
TA1535 |
|
TA98 |
|
TA97a |
|
TA100 |
|
TA102 |
|
|
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
A dest. |
10 |
12 |
31 |
26 |
140 |
91 |
120 |
106 |
384 |
364 |
DMSO |
11 |
10 |
26 |
23 |
166 |
118 |
104 |
96 |
346 |
361 |
32.1 |
9 |
18 |
33 |
20 |
89 |
93 |
109 |
123 |
309 |
227 |
101.5 |
11 |
20 |
27 |
20 |
117 |
112 |
119 |
113 |
323 |
272 |
320.8 |
11 |
15 |
29 |
23 |
135 |
113 |
107 |
122 |
348 |
295 |
1015.2 |
12 |
14 |
27 |
26 |
163 |
140 |
112 |
100 |
327 |
283 |
2538 |
9 |
14 |
21 |
32 |
167 |
137 |
101 |
88 |
268 |
269 |
5076 |
11 |
12 |
33 |
22 |
133 |
99 |
119 |
177 |
357 |
209 |
NaN3 10 |
/ |
1185 |
/ |
/ |
/ |
/ |
/ |
730 |
/ |
/ |
2-AA 2.5 |
193 |
/ |
2783 |
/ |
1459 |
/ |
1632 |
/ |
742 |
/ |
4-NOPD 40 |
/ |
/ |
/ |
/ |
/ |
1261 |
/ |
/ |
/ |
/ |
4-NOPD 10 |
/ |
/ |
/ |
1165 |
/ |
/ |
/ |
/ |
/ |
/ |
MMS 1200 |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
2422 |
Applicant's summary and conclusion
- Conclusions:
- [Dimethoxy(methyl)silyl]methyl methacrylate has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471 (1989), and under GLP, using Salmonella typhimurium strains TA 1535, TA 97a, TA 98, TA 100 and TA 102. No increase in the number of revertants was observed in any test strain, with or without metabolic activation. Appropriate positive, negative and solvent controls were added and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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