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EC number: 219-674-4 | CAS number: 2495-37-6
- 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:
- 2011-08-23 to 2011-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP.
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:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- dated May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate dated 30 March 2009
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Benzyl methacrylate
- EC Number:
- 219-674-4
- EC Name:
- Benzyl methacrylate
- Cas Number:
- 2495-37-6
- Molecular formula:
- C11H12O2
- IUPAC Name:
- benzyl methacrylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Benzyl methacrylate
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM containing Hank’s salts supplemented with 10% FBS, 5 µg/mL neomycin, 1% amphotericin B
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Other: each batch screened for spontaneous mutant frequency - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sß mix
- Test concentrations with justification for top dose:
- range finding pre-experiment: 13.8 to 1760 mg/L (approx. 10 mM, the guideline limit concentration)
Doses applied:
Experiment I:
13.8, 27.5, 55, 110, 220, 330, 440 mg/L without S9 mix, exposure period 4 h; 13.8, 27.5, 55, 110 mg/L chosen for mutation rate analysis
55, 110, 220, 440, 880, 1760 mg/L with S9 mix, exposure period 4 h; 55, 110, 220, 440, 880 mg/L chosen for mutation rate analysis
Experiment II:
13.8, 27.5, 55, 110, 165, 220 mg/L without S9 mix, exposure period 24 h; 13.8, 27.5, 55, 110, 165 mg/L chosen for mutation rate analysis
27.5, 55, 110, 220, 440, 880 mg/L with S9 mix, exposure period 4 h; 27.5, 55, 110, 220, 440 mg/L chosen for mutation rate analysis - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (final concentration in medium: 0.5%)
- Justification for choice of solvent/vehicle: solubility properties, relative non-toxicity to cell cultures
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- other: (without metabolic activation)
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- other: (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Experiment I: 4 h with and without metabolic activation
Experiment II: 4 h with metabolic activation, 24 h without metabolic activation
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 8 days
- Fixation time (start of exposure up to fixation or harvest of cells): 15 days
SELECTION AGENT (mutation assays): 11 mg/L 6-thioguanine (6-TG)
NUMBER OF REPLICATIONS: 2 replicates per experiment
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
OTHER:
- colonies used to determine the cloning efficiency (survival) were fixed and stained approx. 7 days after treatment
- the colonies were stained with 10 % methylene blue in 0.01 % KOH solution; colonies with more than 50 cells were counted.
- Following the expression time of 7 days five cell culture flasks were seeded with about 3 - 5x10E05 cells each in medium containing 6-TG; 2 additional flasks were seeded with approx. 500 cells each in non-selective medium to determine the viability. - Evaluation criteria:
- The assay is considered acceptable if it meets the following criteria:
- the numbers of mutant colonies per 10E06 cells found in the solvent controls fall within the laboratory historical control data range
- the positive control substances must produce a significant increase in mutant colony frequencies
- the cloning efficiency (absolute value) of the solvent controls must exceed 50%
A positive response is described as follows:
- reproducible induction of a mutation frequency that is three times above the spontaneous mutation frequency at least at one of the concentrations in the experiment
- reproducible concentration-related increase of the mutation frequency; such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05.
Biological and statistical significance were considered together.
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
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: solvent control: 7.33; 1760 mg/L BNMA: 7.31 -> no relevant shift
- Effects of osmolality: solvent control: 365 mOsm; 1760 mg/L BNMA: 344 -> no relevant shift
- Water solubility:
Phase separation was observed in the first experiment at 220 mg/L and above with metabolic activation and at 110 mg/L and above without metabolic activation. In the second experiment phase separation was observed at 110 mg/L and above with and without metabolic activation.
RANGE-FINDING/SCREENING STUDIES: pre-test for cytotoxicity, cytotoxicity at 110 mg/L and above without metabolic activation, and 880 mg/L and above with metabolic activation
COMPARISON WITH HISTORICAL CONTROL DATA: mutant frequencies were within the historical range of solvent controls
Any other information on results incl. tables
Conc. [mg/L] |
S9 mix |
Rel. CE [%] |
Mutant colonies /10E06 cells |
Induction factor |
Rel. CE [%] |
Mutant colonies /10E06 cells |
Induction factor |
|
Experiment I, 4 h treatment |
Culture I |
Culture II |
||||||
Solvent control |
- |
100.0 |
16.9 |
1.0 |
100.0 |
18.3 |
1.0 |
|
P.C. (EMS) |
- |
97.9 |
132.8 |
7.0 |
102.5 |
147.1 |
8.0 |
|
Test item |
13.8 |
- |
99.3 |
8.1 |
0.4 |
104.0 |
20.9 |
1.1 |
Test item |
27.5 |
- |
99.9 |
10.4 |
0.6 |
104.3 |
9.7 |
0.5 |
Test item |
55 |
- |
97.9 |
12.4 |
0.7 |
111.0 |
14.5 |
0.8 |
Test item |
110 |
- |
89.5 |
8.0 |
0.4 |
72.8 |
10.4 |
0.6 |
Test item |
220 |
- |
0.0 |
not continued |
0.0 |
not continued |
||
Test item |
330 |
- |
0.0 |
not continued |
0.0 |
not continued |
||
Test item |
440 |
- |
0.0 |
not continued |
0.0 |
not continued |
||
Experiment I, 4 h treatment |
Culture I |
Culture II |
||||||
Solvent control |
+ |
100.0 |
29.1 |
1.0 |
100.0 |
14.6 |
1.0 |
|
P.C. (DMBA) |
+ |
45.5 |
983.2 |
33.7 |
60.0 |
675.1 |
46.1 |
|
Test item |
55 |
+ |
95.9 |
47.4 |
1.6 |
96.0 |
29.9 |
2.0 |
Test item |
110 |
+ |
97.3 |
21.0 |
0.7 |
99.5 |
26.1 |
1.8 |
Test item |
220 |
+ |
94.0 |
17.5 |
0.6 |
97.3 |
8.6 |
0.6 |
Test item |
440 |
+ |
90.9 |
10.1 |
0.3 |
94.5 |
16.9 |
1.2 |
Test item |
880 |
+ |
61.0 |
16.8 |
0.6 |
75.3 |
14.1 |
1.0 |
Test item |
1760 |
+ |
31.3 |
not continued |
55.2 |
not continued |
||
Experiment II, 24 h treatment |
Culture I |
Culture II |
||||||
Solvent control |
- |
100.0 |
4.6 |
1.0 |
100.0 |
20.4 |
1.0 |
|
P.C. (EMS) |
- |
99.4 |
136.3 |
29.7 |
87.6 |
153.1 |
7.5 |
|
Test item |
13.8 |
- |
95.3 |
5.6 |
1.2 |
84.6 |
10.1 |
0.5 |
Test item |
27.5 |
- |
102.8 |
6.1 |
1.3 |
79.6 |
8.8 |
0.4 |
Test item |
55 |
- |
99.0 |
8.4 |
1.8 |
82.3 |
7.7 |
0.4 |
Test item |
110 |
- |
84.0 |
7.5 |
1.6 |
79.9 |
18.6 |
0.9 |
Test item |
165 |
- |
40.2 |
13.8 |
3.0 |
55.9 |
6.8 |
0.3 |
Test item |
220 |
- |
5.2 |
not continued |
11.3 |
not continued |
||
Experiment II, 4 h treatment |
Culture I |
Culture II |
||||||
Solvent control |
+ |
100.0 |
7.0 |
1.0 |
100.0 |
3.6 |
1.0 |
|
P.C. (DMBA) |
+ |
48.5 |
487.9 |
70.1 |
38.2 |
444.0 |
125.1 |
|
Test item |
27.5 |
+ |
100.4 |
6.8 |
1.0 |
101.3 |
5.3 |
1.5 |
Test item |
55 |
+ |
97.8 |
12.6 |
1.8 |
99.5 |
6.8 |
1.9 |
Test item |
110 |
+ |
96.9 |
10.9 |
1.6 |
98.8 |
9.0 |
2.5 |
Test item |
220 |
+ |
100.0 |
11.0 |
1.6 |
102.2 |
7.0 |
2.0 |
Test item |
440 |
+ |
101.1 |
13.8 |
2.0 |
100.4 |
5.8 |
1.6 |
Test item |
880 |
+ |
71.6 |
not continued |
86.2 |
not continued |
P.C. = positive control
CE = cloning efficiency
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, BNMA is considered to be non-mutagenic in this HPRT assay. - Executive summary:
In a mammalian cell gene mutation assay according to OECD guideline 476, adopted 21 July 1997 (HPRT test), V79 cells cultured in vitro were exposed to BNMA (98.37% a.i.) at the following concentrations in the presence and absence of mammalian metabolic activation (S9 mix).
Experiment I:
Without metabolic activation: 0 (control), 13.8, 27.5, 55, 110 mg/L
With metabolic activation: 0 (control), 55, 110, 220, 440, 880 mg/L
Experiment II:
Without metabolic activation: 0 (control), 13.8, 27.5, 55, 110, 165 mg/L
With metabolic activation: 0 (control), 27.5, 55, 110, 220, 440 mg/L
BNMA was tested up to cytotoxic or phase-separation concentrations. The positive controls induced the appropriate response. There was no evidence of induced mutant colonies over background.
In this HPRT test, BNMA was found to be not mutagenic.
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