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EC number: 810-760-2 | CAS number: 149855-64-1
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 17, 2008 to August 20, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-ethylhexyl methacrylate
- EC Number:
- 211-708-6
- EC Name:
- 2-ethylhexyl methacrylate
- Cas Number:
- 688-84-6
- IUPAC Name:
- 2-ethylhexyl methacrylate
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexyl methacrylate
- Physical state: liquid
- Analytical purity: 99.08 %
- Purity test date: 2008-04-16
- Lot/batch No.: 2027090327
- Expiration date of the lot/batch: October 21, 2008
- Storage condition of test material: At room temperature (+15 to +25 °C), protected from light
Constituent 1
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 (minimal essential medium; SEROMED, 12247 Berlin, Germany) supplemented with 10 % fetal calf serum (FCS; PAA Laboratories GmbH, 35091 Cölbe, Germany).
- 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:
- Experiment I:
without S9 mix: 0.3; 0.5; 1.0; 2.0; and 4.0 μg/mL
with S9 mix: 62.5; 125; 250; 500; and 1000 μg/mL
Experiment II:
without S9 mix: 3.8; 7.5; 15.0; 30.0; and 45.0 μg/mL
with S9 mix: 62.5; 125; 250; 500; and 1000 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The solvent was chosen according to its solubility properties and its non-toxicity to the cells. The final concentration of ethanol in the culture medium did not exceed 0.5 % v/v.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9 activation: Ethyl methanefulfonate (EMS); With S9 activation: 7,12-dimethylbenz(a)anthracene (DMBA)
- Evaluation criteria:
- The gene mutation assay is considered acceptable if it meets the following criteria:
- the numbers of mutant colonies per 106 cells found in the negative and/or solvent con-trols fall within the laboratory historical control data range of 2001 – 2007).
- the positive control substances must produce a significant increase in mutant colony frequencies.
- the cloning efficiency II (absolute value) of the negative and/or solvent controls must exceed 50 %. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT®11 (SYSTAT Software, Inc., 501, Canal Boulevard, Suite C, Richmond, CA 94804, USA) statistics software. 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. However, both, biological and statistical significance were considered together.
Results and discussion
Test results
- 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:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiments up to the maximum concentration.
Appropriate reference mutagens were used as positive controls and showed a distinct in-crease in induced mutant colonies and thus showed the sensitivity of the test system and the activity of the S9 mix.
The evaluated experimental points and the results are summarized in Table 2
Table 2: Summary of results
relative |
relative |
mutant |
relative |
relative |
mutant |
|||||
Conc. ug/mL |
S9 mix |
Cloning eff. I % |
Cloning eff. II % |
Colonies per 10E5 cells |
Induction factor |
Cloning eff. I % |
Cloning eff. II % |
Colonies per 10E5 cells |
Induction factor |
|
EXP I 4 hr |
CULTURE I |
CULTURE II |
||||||||
Solvent control (EtOH) |
150 |
- |
100.0 |
100.0 |
11.6 |
1.0 |
100.0 |
100.0 |
23.3 |
1.0 |
Pos control |
0.1 |
- |
14.2 |
71.7 |
133.0 |
11.5 |
51.9 |
58.5 |
162.7 |
7.0 |
Test item |
0.3 |
- |
116.3 |
Culture was not continued* |
108.4 |
Culture was not continued* |
||||
Test item |
0.5 |
- |
95.8 |
104.4 |
4.3 |
0.4 |
100.4 |
54.1 |
12.3 |
0.5 |
Test item |
1.0 |
- |
110.4 |
104.6 |
2.0 |
0.2 |
103.3 |
67.9 |
9.5 |
0.4 |
Test item |
2.0 |
- |
90.3 |
99.6 |
26.7 |
2.3 |
90.8 |
61.2 |
3.0 |
0.1 |
Test item |
4.0 |
- |
67.4 |
66.7 |
15.4 |
1.3 |
20.0 |
65.1 |
28.2 |
1.2 |
Test item |
8.0 |
- |
17.4 |
87.4 |
1.3 |
0.1 |
4.5 |
64.9 |
8.0 |
0.3 |
Test item |
16.0 |
- |
0.0 |
Culture was not continued** |
0.0 |
Culture was not continued** |
||||
Test item |
0.0 |
Culture was not continued** |
0.0 |
Culture was not continued** |
||||||
Solvent control (EtOH) |
+ |
100.0 |
100.0 |
10.2 |
0.9 |
100.0 |
100.0 |
14.4 |
1.0 |
|
Pos control DMBA |
1.3 |
+ |
33.3 |
103.5 |
617.6 |
53.2 |
6.2 |
105.1 |
515.8 |
35.9 |
Test item |
62.5 |
+ |
79.7 |
97.9 |
17.1 |
1.5 |
87.7 |
72.8 |
22.2 |
1.5 |
Test item |
125.0 |
+ |
54.7 |
100.4 |
13.1 |
1.1 |
76.5 |
84.3 |
9.6 |
0.7 |
Test item |
250.0 |
+ |
71.3 |
104.1 |
15.8 |
1.4 |
80.9 |
79.0 |
18.4 |
1.3 |
Test item |
500.0 |
+ |
70.4 |
104.6 |
8.8 |
0.8 |
75.6 |
91.4 |
31.5 |
2.2 |
Test item |
1000.0 |
+ |
21.8 |
92.4 |
11.2 |
1.0 |
9.0 |
99.7 |
19.2 |
1.3 |
Test item |
2000.0 |
+ |
3.6 |
Culture was not continued** |
1.5 |
Culture was not continued** |
||||
EXP II 24 hr |
CULTURE I |
CULTURE II |
||||||||
Solvent control (EtOH) |
- |
100.0 |
100.0 |
18.1 |
1.0 |
100.0 |
100.0 |
13.4 |
1.0 |
|
Pos control |
75.0 |
- |
80.1 |
104.5 |
118.3 |
6.5 |
75.6 |
82.6 |
261.8 |
19.6 |
Test item |
3.8 |
- |
91.3 |
118.8 |
18.9 |
1.0 |
90.0 |
102.1 |
26.0 |
1.9 |
Test item |
7.5 |
- |
81.0 |
122.1 |
5.7 |
0.3 |
86.0 |
86.2 |
10.7 |
0.8 |
Test item |
15.0 |
- |
76.1 |
118.4 |
13.9 |
0.8 |
80.2 |
116,6 |
17.6 |
1.3 |
Test item |
30.0 |
- |
79.8 |
111.2 |
8.8 |
0.5 |
71.7 |
100.8 |
10.3 |
0.8 |
Test item |
45.0 |
- |
35.7 |
125.9 |
8.9 |
0.5 |
0.0 |
74.5 |
6.9 |
0.5 |
Test item |
60.0 |
- |
0.0 |
Culture was not continued** |
0.0 |
Culture was not continued** |
||||
Exp II 4 hr |
CULTURE I |
CULTURE II |
||||||||
Solvent control (EtOH) |
+ |
100.0 |
100.0 |
29.4 |
1.0 |
100.0 |
100.0 |
29.3 |
1.0 |
|
Pos control DMBA |
1.3 |
+ |
25.3 |
61.3 |
1610.2 |
54.8 |
21,8 |
88.0 |
970.6 |
33.1 |
Test item |
62.5 |
+ |
99.5 |
81.8 |
47.5 |
1.6 |
90.3 |
82.2 |
21.0 |
0.7 |
Test item |
125.0 |
+ |
101.3 |
76.8 |
9.9 |
0.3 |
79.9 |
89.5 |
26.3 |
0.9 |
Test item |
250.0 |
+ |
70.6 |
62.9 |
20.7 |
0.7 |
69.1 |
89.4 |
20.4 |
0.7 |
Test item |
500.0 |
+ |
97.4 |
82.7 |
20.6 |
0.7 |
74.5 |
109.9 |
17.8 |
0.6 |
Test item |
1000.0 |
+ |
5.3 |
96.1 |
5.5 |
0.2 |
50.7 |
116.7 |
17.3 |
0.6 |
Test item |
2000.0 |
+ |
7.7 |
Culture was not continued** |
41.9 |
Culture was not continued** |
*Culture was not continued since a minimum of only four analyzable concentrations is required.
**Culture not continued due to exceedingly strong toxic effects
Statistical Analysis
Experimental Group |
P-value |
First experiment, culture 1 without S9 |
0.704 |
First experiment, culture 2 without S9 |
0.602 |
First experiment, culture 1 with S9 |
0.451 |
First experiment, culture 2 with S9 |
0.495 |
Second experiment, culture 1 without S9 |
0.241 |
Second experiment, culture 2 without S9 |
0.183 |
Second experiment, culture 1 with S9 |
0.174 |
Second experiment, culture 2 with S9 |
0.086 |
Applicant's summary and conclusion
- Conclusions:
- 2-Ethylhexyl methacrylate did not induce gene mutations at the HPRT locus in V79 cells with and without metabolic activation. Therefore, 2-Ethylhexyl methacrylate is considered to be non-mutagenic in this HPRT assay.
- Executive summary:
The potential of 2-Ethylhexyl methacrylate to induce gene mutations at the HPRT locus in V79 tells of the Chinese hamster was investigated in an OECD guideline 476 and GLP study (Harlan, 2008). The assay was performed in two independent experiments. The cells were exposed to the test item for 4 hours in the first experiment with and without metabolic activation. The second experiment was performed with a treatment period of 24 hours in the absence and 4 hours in the presence of metabolic activation. The maximum dose of the pre-test was 2000 µg/mL corresponding to a molar concentration of about 10 mM. The concentration range of the main experiments was limited by cytotoxic effects and was 0.1 - 16.0 (1stexperiment) and 3.8 – 60.0 (2ndexperiment) µg/ml without S9 and 62.5 – 2000 µg/ml with S9 (1stand 2ndexperiments). No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiments up to the maximum concentration. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies and thus showed the sensitivity of the test system and the activity of the S9 mix. In conclusion, 2-ethylhexyl methacrylate did not induce gene mutations at the HPRT locus in V79 cells.
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