Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-617-2 | CAS number: 97-90-5
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 473 (1983)
- Deviations:
- yes
- Remarks:
- the stability of the test substance has not been reported; the stability and achieved concentration of the test substance in the vehicle used were not determined by analysis
- Principles of method if other than guideline:
- Method: according to OECD Guide-line 473 (1983) and UKEMS Recommended Procedure for Basic Mutagenicity Tests (Kirkland, 1990)
- GLP compliance:
- yes
- Type of assay:
- other: cultured human lymphocytes
Test material
- Reference substance name:
- Ethylene dimethacrylate
- EC Number:
- 202-617-2
- EC Name:
- Ethylene dimethacrylate
- Cas Number:
- 97-90-5
- Molecular formula:
- C10H14O4
- IUPAC Name:
- 2-[(2-methylprop-2-enoyl)oxy]ethyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Supplier: ICI Chemicals & Polymers Limited, Runcorn, UK
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: in the fridge, in the dark
Method
Species / strain
- Species / strain / cell type:
- other: human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- AROCLOR 1254 induced rat liver microsomal fraction S9 mix
- Test concentrations with justification for top dose:
- Range-finding cytotoxicity test:
8, 40, 200, 1000 and 5000 µg/mL
Main cytogenetic tests:
-S9-mix: 25, 100, 200, 400, 600, and 800 µg/mL
+S9-mix: 100, 500, 1000, 2000, 3500 and 5000 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO, Dimethylsulphoxide
- Justification for choice of solvent/vehicle: The solvent was chosen according to its solubility properties.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Dosing solutions prepared in sterile double deionised water. Migrated to IUCLID6: Final concentration: 1.0 µg/mL
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Dosing solutions prepared in sterile double deionised water. Migrated to IUCLID6: Final concentration: 50 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration: 72 and 96 hours
- Expression time (cells in growth medium): 3 hours
- Fixation time (start of exposure up to fixation or harvest of cells): at 72 or 96 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemid (0.4 µg/mL)
STAIN (for cytogenetic assays): Giemsa and mounted in DPX
NUMBER OF REPLICATIONS:2
NUMBER OF CELLS EVALUATED: 100 cells per culture were evaluated (examination of cells with abberations); 1000 lymphocytes per culture (examination of mitose index)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Statistics:
- Evaluation was performed only for cells carrying aberrations exclusive gaps. The cells for each of the treatment groups were compared to the solvent control values using the Fisher's Exact Test (one sided).
Results and discussion
Test results
- Species / strain:
- lymphocytes: human lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- at 600 µg/mL
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1000 and 5000 µg/mL in the absence of S9 or at 5000 µg/mL in the presence of S9-mix.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results:
Increases in the percentage of aberrant cells were
observed at 100, 400, and 600 mg/l in male donor cultures at
72 h sampling time and in female donor cultures at 600 mg/l harvested after 72 h; no significant increases were observed
at 96 h sampling time.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive in vitro in the absence of S9-mix
In the Chromosomal aberration test with human lymphocytes according to OECD 473 in the absence of mammalian activation S9-mix structural chromosomal aberrations were observed. Therefore, Ethyleneglycol dimethacrylate is considered to be clastogenic (in vitro in the absence of S9-mix) at 600 µg/mL under the experimental conditions reported. - Executive summary:
In a cytogenetic assay (Chromosome aberration test with human lymhocytes from two donors (1 f, 1 m) according to OECD 473) human lymphocytes were exposed to Ethylene glycol dimethacrylate (purity: 98 % w/w, solvent: DMSO) at concentrations in the range of 25 to 5000 µg/mL
in the presence and absence of mammalian metabolic activation S9 -mix (Aroclor 1254 induced rat liver homogenate).
The assay was performed in two independent experiments using Ethylene glycol dimethacrylate (EGDMA) concentrations of 25, 100, 200, 400, 600 and 800 µg/mL in the presence of S9 -mix and concentrations of 100, 500, 1000, 2000 , 3500 and 5000 µg/mL in the absence of S9 -mix. Dose related reductions in mitotic activity were observed in cultures from both donors in the presence and absence of S9 -mix at the 72 hour sampling time.
Cultures treated with higher concentrations of EGDMA (600 µg/mL -S9 -mix and 1000 µg/mL +S9 -mix) in the main cytogenetic tests were considered not to be suitable for chromosomal aberration analysis due to lack of metaphases as a result of toxicity or due to cytotoxic effects on the chromosome structure.
Cultures from both donors exposed with EGDMA at concentrations of 100, 400 and 600 µg/mL in the absence of S9 -mix and 100, 500 and 1000 µg/mL in the presence of S9 -mix were choosen for chromosomal aberration analysis at 72 hours sampling time. Additionally, cultures from the female donor treated at 400 µg/mL in the absence of S9 -mix and 1000 µg/mL in the presence of S9 -mix were selected for analysis at 96 hour sampling time.
No statistically or biologically significant increases in percentage of aberrant cells, compared to the solvent control values, were seen at any of the EGDMA concentrations tested in either donor, in the presence of S9 -mix at the 72 hour sampling time or in the presence or absence of S9 -mix at 96 hour sampling time. Statistically significant increases of chromosomal aberrations were seen in cultures from both donors treated with EGDMA at 600 µg/mL in the absence of S9 -mix and examined at 72 hours sampling time.
No significant increases were observed at the 96-hours.
Positive controls (mitomycin C and cyclophosphamide) induced the appropriate response confirming the sensitivity of the test system.
Therefore EGDMA showed under the experimental conditions reported reproducibly induced chromosomal damage in human peripheral blood lymphocytes in vitro in the absence of auxiliary mammalian metabolic activation S9 -mix.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 473 for in vitro cytogenetic mutagenicity data.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.