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EC number: 264-036-0 | CAS number: 63225-53-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 Dec 2014 - 13 Jan 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Version / remarks:
- adopted in 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Gyógyszerészeti és Egészségügyi Minőség- és Szervezetfejlesztési Intézet (National Institute for Quality- and Organizational Development in Healthcare and Medicines), Budapest, Hungary
- Type of assay:
- other: in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-[[(butylamino)carbonyl]oxy]ethyl acrylate
- EC Number:
- 264-036-0
- EC Name:
- 2-[[(butylamino)carbonyl]oxy]ethyl acrylate
- Cas Number:
- 63225-53-6
- Molecular formula:
- C10H17NO4
- IUPAC Name:
- 2-[[(butylamino)carbonyl]oxy]ethyl acrylate
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Cell proliferation: doubling time 12 - 14 h
- Type and identity of media:
DME medium supplemented with:
- L-glutamine (2mM)
- 1% of Antibiotic-antimycotic solution (containing 10000 U/mL penicillin, 10 mg/mL streptomycin and 25 µg/mL amphoptericin-B)
- heat-inactivated bovine serum (final concentration 10 %)
During the 3 and 20 h treatments the serum content was reduced to 5%.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone
- Test concentrations with justification for top dose:
- Dose range finding study:
3 h treatment: 0.5, 1, 2, 4, 8, 16 and 32 µg/mL without S9 mix
3 h treatment: 5, 10, 15, 30, 60, 120 and 240 µg/mL with S9 mix
20 h treatment: 0.5, 1, 2, 4, 8, 16 and 32 µg/mL without S9 mix
Experiment 1:
3 h treatment: 0.5, 1, 2, 4 and 4.5 µg/mL without S9 mix
3 h treatment: 10, 20, 40, 80 and 90 µg/mL with S9 mix
Experiment 2:
3 h treatment: 10, 20, 40, 80 and 90 µg/mL with S9 mix
20 h treatment: 0.5, 1, 2, 4 and 4.5 µg/mL without S9 mix
4.5 µg/mL was tested but not evaluated due to sufficient cytotoxicity at the next lower concentration and sufficient number of concentrations. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 h and 20 h
- Fixation time (start of exposure up to fixation or harvest of cells): 3 h treatment: 20 h and 28 h; 20 h treatment: 20 h and 28 h
SPINDLE INHIBITOR (cytogenetic assays): colchicine, 0.2 µg/mL
STAIN (for cytogenetic assays): 5% Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: Relative Increase in Cell Counts (RICC)
OTHER EXAMINATIONS
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- Validity criteria for the test:
The chromosome aberration assay is considered acceptable if it meets the following criteria:
- the number of aberrations found in the negative and/or solvent controls falls within the range of historical laboratory control data.
- the positive control items produce biologically relevant increases in the number of cells with structural chromosome aberrations.
Evaluation of test results:
The test item is regarded as non-clastogenic if:
- the number of metaphases with structural chromosome aberrations in all evaluated dose groups is in the range of our historical control data
- and/or no significant increase in the number of metaphases with structural chromosome aberration is observed.
A test item is classified as clastogenic if it meets the following criteria:
- increase in the frequency of metaphases with aberrant chromosomes are observed at one or more test concentrations (above the range of our historical control data).
- the increase is reproducible between replicate cultures and between tests (when the treatment conditions are the same).
- the increase is statistically significant.
Both, biological and statistical significance should be considered together. - Statistics:
- For statistical analysis, Fisher exact and CHI2 tests were utilized. The parameters evaluated for statistical analysis were as follows: number of aberration and number of cells with aberration (with and without gaps).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 80 µg/mL and higher following the 3 h treatment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 4 µg/mL following the 3 h and 20 h treatment
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No significant differences between test item treatment and control groups were observed.
- Effects of osmolality: No significant differences between test item treatment and control groups were observed.
- Precipitation: A clear solution was obtained up to a concentration of 10 mg/mL. There was no precipitation in the medium at any concentration tested.
RANGE-FINDING/SCREENING STUDIES: In order to determine the treatment concentrations of test item in the cytogenetic study a dose selection was performed. The cells were treated using increasing concentrations of test item in the absence or presence of S9 mix and were incubated at 37 °C for 3 h. Cell counts were performed after 20 h. Additional groups of cells were treated for 20 h without metabolic and for 3 h with metabolic activation, with cell counts conducted after 20 h (without S9 mix only) and 28 h (without and with S9 mix).
COMPARISON WITH HISTORICAL CONTROL DATA: In the concurrent negative control group the percentage of cells with structural aberration(s) without gap was equal or less than 5 %, confirming the suitability of the cell line used.
Any other information on results incl. tables
Table 1. Results of chromosomal aberration test.
Test item |
Concentration |
RICC |
Aberrant cells per 200 metaphase chromosome spreads |
|
|
in µg/mL |
in % |
No. of cells with aberrations |
No. of cells with aberrations |
Exposure period 3 h, sampling time 20 h, without S9 mix |
||||
DMSO |
0.45 µL |
100 |
4 |
2 |
EMS |
1.0 µL |
- |
26** |
21** |
Test substance |
0.5 |
97 |
6 |
2 |
1 |
86 |
5 |
2 |
|
2 |
77 |
5 |
2 |
|
4 |
50 |
7 |
2 |
|
Exposure period 3 h, sampling time 20 h, with S9 mix |
||||
DMSO |
9 µL |
100 |
6 |
3 |
CP |
5.0 |
- |
35** |
30** |
Test substance |
10 |
99 |
6 |
3 |
20 |
86 |
7 |
4 |
|
40 |
80 |
10 |
4 |
|
80 |
50 |
9 |
6 |
|
90 |
44 |
11 |
7 |
|
Exposure period 20 h, sampling time 20 h, without S9 mix |
||||
DMSO |
0.45 µL |
100 |
4 |
2 |
EMS |
0.4 µL |
|
32** |
26** |
Test substance |
0.5 |
94 |
5 |
3 |
1 |
82 |
4 |
2 |
|
2 |
67 |
4 |
2 |
|
4 |
49 |
6 |
3 |
|
Exposure period 20 h, sampling time 28 h, without S9 mix |
||||
DMSO |
0.45 µL |
100 |
4 |
2 |
EMS |
0.4 µL |
- |
33** |
27** |
Test substance |
0.5 |
98 |
4 |
2 |
1 |
81 |
4 |
2 |
|
2 |
74 |
4 |
2 |
|
4 |
50 |
5 |
2 |
|
Exposure period 3 h, sampling time 28 h, with S9 mix |
||||
DMSO |
9 µL |
100 |
3 |
1 |
CP |
5.0 |
- |
34** |
29** |
Test substance |
10 |
97 |
4 |
2 |
20 |
92 |
4 |
2 |
|
40 |
79 |
5 |
3 |
|
80 |
49 |
7 |
4 |
|
90 |
43 |
11* |
7* |
* (p ≤ 0.05); ** (p ≤ 0.01)
DMSO: Dimethyl sulfoxide
EMS: Ethylmethane sulphonate
CP: Cyclophosphamide
RICC: Relative Increase in Cell Counts
In Experiment 1, the test item caused a moderate increase in the number of cells with structural chromosome aberrations in the presence of metabolic activation, up to and including cytotoxic concentrations. This increase was dose associated and biologically important.
In Experiment 2, the test item caused an increase in the number of cells with structural chromosome aberrations without gaps in the presence of S9 mix at concentration of 90 µg/mL following 3 h treatment. This increase was biologically and statistically significant.
No increase in the rate of polyploid and endoreduplicated metaphases was found after treatment with the different concentrations of the test item.
Applicant's summary and conclusion
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