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EC number: 212-782-2 | CAS number: 868-77-9
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study, carried out by the Hatano research Institute, Food and Drug Safety Center (Japan), Guideline study, GLP; german translation available, only study summary is written English.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- publication
- Title:
- Relevance of chemical structure and cytotoxicity to the induction of chromosome aberrations based on the testing results of 98 high production volume industrial chemicals.
- Author:
- Kusakabe H, Yamakage K, Wakuri S, Sasaki K, Nakagawa Y, Watanabe M, Hayashi M, Sofuni T, Ono H, Tanaka N
- Year:
- 2 002
- Bibliographic source:
- Mutation Research 517 (1-2): 187-198
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-hydroxyethyl methacrylate
- EC Number:
- 212-782-2
- EC Name:
- 2-hydroxyethyl methacrylate
- Cas Number:
- 868-77-9
- Molecular formula:
- C6H10O3
- IUPAC Name:
- 2-hydroxyethyl methacrylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Supplier: Nippon Shokubai
Batch No. 5P05LA
Purity: 97.6 %
Ethylenglycol dimethacrylate: 0.2 - 0.3 %
Diethylenglycol monomethacrylate: 2.0 -2.5%
Stabilzer: 50 ppm Hydrochinon monomethylether
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung (CHL/IU) cells
- Cytokinesis block (if used):
- The cytotoxic effect of the test substance on CHL/IU cells was determined using a monolayer cell density meter (Monocellater TM, manufactured by Olympus Kogaku Kogyo (AG)) by determining the growth rate for each group.
The cell growth was compared control group with /neutral/ medium. It was found that with both continuous and short-term medication, the cytotoxic did not exceed 50% at all concentrations used. - Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix
- Test concentrations with justification for top dose:
- -S9 mix (continuous treatment): 0, 0.16, 0.33, 0.65, 1.3 mg/ml; -S9-mix and +S9-mix(short-term treatment): 0, 0.33, 0.65 and 1.3 mg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: solubility tests
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix, Mitomycin C; +S9 mix, Cyclophosphamide S-9: Rat liver, induced with phenobarbital and 5,6-benzoflavone
- Details on test system and experimental conditions:
- Test duration: continous treatment: 24-hours
short-term treatment: 6-hours
Plates/test: 2 - Evaluation criteria:
- A substance is considered clastogenic if: - any dose level shows
a statistically signicant increase in aberration-bearing
cells - the increase is over historical controls - the increase is present in both replicates - Statistics:
- yes
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster lung (CHL/IU) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: Toxicity was not observed up to 0.65 mg/ml in continuous and short-term treatment with or without S9-mix.
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Structural chromosomal aberrations (including gap) were induced under the following conditions:
24 h continuous treatment (0.65 and 1.3 mg/ml: mid and high concentrations, 10.0 and 70.6 %, respectively);
48 h continuous treatment (0.16 - 0.65 mg/ml: all concentrations, 6.0 - 84.0 %);
short-term treatment with an exogenous metabolic activation system (1.3 mg/ml: high concentration, 13.0 %).
Polyploidy was induced under the following conditions: the 48 h continuous treatment (0.65 mg/ml, 3.25 %);
short-term treatment with an exogenous metabolic activation system (0.65 mg/ml: mid concentration, 1.25 %);
short-term treatment without the metabolic activation system (0.33 and 1.3 mg/ml: low and high concentrations, 0.88 and 6.13 %, respectively).
However, a trend test showed no dose-dependency for the polyploidy with short-term treatment and the metabolic activation system.
Lowest concentration producing cytogenetic effects in vitro:
Without metabolic activation (continuous treatment): 0.16 mg/ml (clastogenicity)
0.65 mg/ml (polyploidy)
Without metabolic activation (short-term treatment): 0.33 mg/ml (polyploidy)
With metabolic activation (short-term treatment): 1.3 mg/ml (clastogenicity)
0.65 mg/ml (polyploidy)
Any other information on results incl. tables
Result table see under attachments
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive
Structural chromosomal aberrations (including gap) were induced under the conditions of the study. - Executive summary:
HEMA has been evaluated for its ability to induce chromosomal aberrations in mammalian cells in culture (MHW 1997). Kusakabe et al. (2002) evaluated the clastogenic potential of HEMA along with a large number of other substances in Chinese hamster lung cells in culture, exposed to concentrations up to 1.3 mg/ml. HEMA was reported to induce structural chromosome aberrations following 6-hour exposure of cells but only in the presence of S9 at 1.3 mg/ml. Continuous exposure of cells for 24 or 48 hours without S9 also caused an elevated incidence of chromosome aberrations (from 0.16 mg/ml for the 48-hour exposure and from 0.65 mg/ml for the 24-hour exposure). Polyploidy was reported after both short-term treatment and 48-hour continuous treatment exposures. However, no dose-dependency was observed for polyploidy in the short-term treatment with metabolic activation. These effects were found at exposure levels without cytotoxicity or at concentrations which caused <50% cell death (no toxicity up to 0.65 mg/ml). For careful interpretation of these results two publications by Fujita et al (2016) should be considered. If the cytotoxicity index relative cell count (RCC) is replaced with a new index, RICC or RPD (relative increase in cell count/relative population doubling), the result was identified as being possibly false positive.
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