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EC number: 250-284-7 | CAS number: 30674-80-7
- 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 DNA damage and/or repair study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 September 1979 to 17 November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study predates the appropriate OECD test guideline, but was conducted in compliance with GLP. Nevertheless, the study was conducted similar to the OECD TG 482 with acceptable restrictions. The restrictions were that less cells were evaluated than demanded in the guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- Version / remarks:
- (1986)
- Deviations:
- yes
- Remarks:
- (only 30 cells evaluated)
- GLP compliance:
- yes
- Type of assay:
- other: DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
Test material
- Reference substance name:
- 2-isocyanatoethyl methacrylate
- EC Number:
- 250-284-7
- EC Name:
- 2-isocyanatoethyl methacrylate
- Cas Number:
- 30674-80-7
- Molecular formula:
- C7H9NO3
- IUPAC Name:
- 2-isocyanatoethyl methacrylate
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- hepatocytes: primary hepatocytes from one male Sprague Dawley rat (8-12 weeks of age; approximately 221 g bw)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Williams Medium E supplemented with 10% foetal calf serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not applicable
- Periodically checked for karyotype stability: not applicable
- Periodically "cleansed" against high spontaneous background: not applicable - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- not applicable
- Metabolic activation system:
- primary hepatocyte cultures have sufficient metabolic capacity
- Test concentrations with justification for top dose:
- 10 and 1 mM, 100, 10, and 1 µM, and 100, 10, and 1 nM
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: cell culture medium
- Due to limited solubility of the positive control substance, cell culture medium additional supplemented with 0.1% (v/v) DMSO was used for the positive control.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (cell culture medium with 0.1% DMSO with respect to the positive control)
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- diluted in cell culture medium with 0.1% DMSO
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- 10, 1, and 0.1 µM
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium containing 3H-Thymidine (10 µCi/mL) and dexamethasone (1 µM in 0.1% ethanol final concentration)
DURATION
- Exposure duration: 18 h
- Fixation time (start of exposure up to fixation of cells): 20 h
NUMBER OF REPLICATIONS: 1
NUMBER OF CELLS EVALUATED: 30
DETERMINATION OF CYTOTOXICITY
- Method: morphological examination (detachment and/or rounded granular appearence of the cells) - Evaluation criteria:
- The net number of grains in treated cells were compared to the appropriate control. Net nuclear labelling is often observed in control cells, but rarely exceeds a mean of 5 grains per nucleus. Therefore, a mean of 6 or more grains per nucleus (this may vary with experimental conditions) and statistical significance from control is required for an unequivocal positive result.
In cases where nuclear labelling is very intense (approximately greater than 75 grains per nucleus) the results are reported as the best approximation of the number of grains present. In addition to statistical significance from control, a dose response relationship should exist. - Statistics:
- The net number of grains in treated cells were compared to the appropriate control by analysis of variance and Dunnett's t-test, with statistical significance from control at p ≤ 0.05.
Results and discussion
Test results
- Species / strain:
- hepatocytes: primary hepatocytes from one male Sprague Dawley rat
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1 mM and above clearly cytotoxic
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- none stated in the study report
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- The test item was cytotoxic to the rat hepatocyte cultures at concentrations of 10 and 1 mM as indicated by the detachment and/or rounded granular appearence of the cells after chemical treatment, however, enough cells were present after processing for UDS evaluation. The appearence of the cultures improved with decreasing concentration of the test material so that cultures treated with 0.1 mM to 1 nM approached and matched the appearence of control cultures.
Any other information on results incl. tables
Tab. 1: The effects of the test item in the Rat Hepatocyte Unscheduled DNA Synthesis (UDS) Assay
Treatment |
Concentration |
Net nuclear grains* (mean±SD) |
|
Negative control |
- |
- |
-2±3 |
Test item |
10 mM |
1550 µg/mL |
0±1 # |
1 mM |
155 µg/mL |
1±2 # |
|
100 µM |
15.5 µg/mL |
-3±4 |
|
10µM |
1.55 µg/mL |
-2±3 |
|
1 µM |
0.155 µg/mL |
-2±3 |
|
100 nM |
0.0155 µg/mL |
-2±2 |
|
10 nM |
0.00155 µg/mL |
-2±3 |
|
1 nM |
0.000155 µg/mL |
-3±3 |
|
Positive control (2-AAF)** |
10 µM |
2.2 µg/mL |
40±10*** |
1 µM |
0.22 µg/mL |
40±12*** |
|
100 nM |
0.022 µg/mL |
33±12*** |
|
Solvent control (with 0.1% DMSO) |
- |
- |
-3±4 |
* net nuclear grains = nuclear grains-background cytoplasm grains
**2 -AAF = acetylaminofluorene
*** positive responses, 6 or more net nuclear grains and p ≤ 0.05
# treatment related cytotoxicity was observed
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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