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EC number: 451-690-9 | CAS number: 86273-46-3
- 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
- Study period:
- Between Feb. 23rd and May 25, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- see priniciples of method
- Principles of method if other than guideline:
- The wells were not washed after 4 hours in culture in the growth inhibition test. In this study, it was found that the test substance was dissolved into the vehicle and not precipitated. Moreover, the results of the absorbance of negative control were within the range of the standard deviation of the historical control dtaa in our laboratory. Therefore protocol deviation noted above was not considered to give an effect on the integrity and interpretation of the data or outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: not stated Date of Signature: 25th May 2006
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 451-690-9
- EC Name:
- -
- Cas Number:
- 86273-46-3
- Molecular formula:
- C9H14O4
- IUPAC Name:
- 2-[2-(ethenyloxy)ethoxy]ethyl prop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- Name of test material (as cited in study report): 2-(2-Vinyloxyethoxy) ethyl acrylate
- Molecular formula (if other than submission substance): C9H1404
- Molecular weight (if other than submission substance): 186.20
- Substance type: Transparent liquid
- Physical state: liquid
- Analytical purity: 99,3%
- Lot/batch No.: 5B25
- Expiration date of the lot/batch: Dec. 31 , 2007
- Storage condition of test material: Light tight, Refrigerate
- Handling & notice: Mask and gloves should be worn
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):
- Model chromosome number of Chinese hamster lung (CHL/IU) cells is 25, and cell-cycle is 15-17 hours. Cells were cultured with EMEM in the C02 incubator.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat induced liver PB + BF)
- Test concentrations with justification for top dose:
- A growth inhibition test was conducted in 9 dose levels, in which the highest dose of 5000 µg/mL was sequentially diluted to 8 additional lower doses (2.5, 5, 10, 105, 210, 420µg/mL) with the negative control groups.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO, Lot No. : K33960231 504, Merck, USA)
- Justification for choice of solvent/vehicle: Dimethyl sulfoxide (DMSO) was used as a vehicle since the test substance was dissolved through the pre-preparation of the test substance.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- In the presence of S9 Migrated to IUCLID6: (CP)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- In the absence of S9 Migrated to IUCLID6: (MMC)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in medium
DURATION
- Preincubation period:
48 hrs
- Exposure duration:
Short term exposure = 6 hours Continuous treatment = 24 hours
- Expression time (cells in growth medium):
18 hrs for 6 hrs exposure.
- Selection time (if incubation with a selection agent):
Not applicable.
- Fixation time (start of exposure up to fixation or harvest of cells):
24 hrs.
SELECTION AGENT (mutation assays):
No selection agent.
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays):
Stained with 5% Giemsa solution
NUMBER OF REPLICATIONS:
Duplicate cultures
NUMBER OF CELLS EVALUATED:
200/metaphases/dose
DETERMINATION OF CYTOTOXICITY
- Method:
-Scoring of Chromosome Damage:
In each slide, 100 metaphases (200 metaphases/dose) were examined using the biological microscope of differential interference type (BX51, Olympus, Japan) of 1 ODD-fold magnification. Structural aberration was classified as follows; chromatid break (ctb), chromatid exchange (cte), chromosome break (csb), chromosome exchange (cse) and other (0). Numerical aberration was classified as follows polyploidy (pol). Two types aberration such as chromatid and chromosome gap (g) were recorded separately. In the meta phase, if there are several gap or cuttings, it was recorded as a fragment (frg). For a numerical aberration, any cell with 1 or more aberration was counted as 1 aberrant cell. Evaluation of results did not include gaps while the gaps were recorded in raw data of structural aberration. For numerical aberration, any cell with 1 or more polyploidy (pol) aberration was counted as 1 aberrant cell.
OTHER EXAMINATIONS:
- Determination of polyploidy:
Frequency of polyploid cells - Evaluation criteria:
- The final decision of chromosome aberration in relation to the test substance was carried out in accordance with Toshio Sofuni and et al. [4]. If an an appearance rate was below 5% between 5 and 10% and over 10%, it was judged as a negative, equivocal, and positive, respectively
- Statistics:
- Statistical analysis was not performed. The mean value and standard deviation were calculated using the values measured from the test.
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
- Remarks:
- Refer to information on results and attached tables.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Range finding studies:
Growth inhibition test (Table 1)
A growth inhibition test was conducted in 9 dose levels, in which the highest dose of 5000 µg/mL is sequentially diluted to 8 additional lower doses (5, 10, 50, 100,250,500, 1000,2500 µg/mL) with the negative control groups. As the result of the growth inhibition test, the ICso was calculated as 9.2 µg/mL and 422.1 µg/mL for the short time treatment without and with metabolic activation system and 8.9 µg/mL for the continuous treatment.
2. In vitro chromosome aberration test (Table 2, 3)
On the basis of the growth inhibition test, the highest dose in chromosome aberration test was chosen as 10 µg/mL for the short time treatment without metabolic activation system and the continuous treatment, and 420 µg/mL for the short time treatment with metabolic activation system. Subsequently, the highest dose formulations were diluted by common ratio of 2 to produce 2 additional lower doses levels accompanied by a negative and positive control. Each dosing formulations were treated for 6 and 24 hours for the short time treatment regardless of metabolic activation and continuous treatment without metabolic activation, respectively; and specimens were prepared to examine chromosome aberration.
As a result, the structural and numerical chromosome aberrations were not observed in both the short time treatment with and without metabolic activation system and the continuous treatment as the negative control.
The cell proliferation rate in 0, 2.5, 5 and 10 µg/mL were calculated as 100.0, 102.7, 98.6 and 98.6 % for short time treatment without metabolic activation system, and in 0, 105, 210, 420 µg/mL were calculated as 100.0, 115.0, 115.0 and 82.5 % for short time treatment with metabolic activation system. In addition, the cell proliferation rate in 0, 2.5,5,10 µg/mL were calculated as 100.0,101.3,117.7, 72.2 % for continuous treatment system.
According to the chromosomal aberration test, the result was negative for the short time treatment with metabolic activation. In order to verify the result, the confirmation test was carry out in 6 hours after the cultivation, recovery time executed for 42 hours.
Result of confirmation test, the number of structural and numerical chromosome aberration was not increased as compared with that of a negative control.
Any other information on results incl. tables
This study was designed to examine the clastogenic potential of 2-(2-Vinyloxyethoxy) ethyl acrylate in the chromosome aberration test system using Chinese hamster lung cell.
The result of growth inhibition test showed that the IC50 was calculated as 9.2 µg/mL and 422.1 µg/mL for the short time treatment without and with metabolic activation system and 8.9 µg/mL for the continuous treatment. On the basis of the growth inhibition test, the highest dose in chromosome aberration test was chosen as 10 µg/mL for the short time treatment without metabolic activation system and the continuous treatment and 420 µg/mL for the short time treatment with metabolic activation system. Subsequently, the highest dose formulations were diluted by common ratio of 2 to produce 2 additional lower doses levels accompanied by a negative and positive control.
The structural and numerical chromosome aberrations were not observed in both the short time treatment with and without metabolic activation system and the continuous treatment as the negative control.
Form that the result showed negative for the short time treatment with metabolic activation, the confirmation test was performed to verify the negative result by 6 hours treatment and 42 hours recovery.
Through the confirmation test, it was also found that the number of structural and numerical chromosome aberration for the short time treatment with metabolic activation system was not increased as compared with that of a negative control.
It is confirmed that averages of chromosome aberration cells in negative and positive control group were within the range of the historical control data in our laboratory (Table 4).
In conclusion, 2-(2-Vinyloxyethoxy) ethyl acrylate did not show the chromosome aberrations regardless of application of metabolic activation system in the chromosome aberration test system using Chinese hamster lung cell (CHL/IU), under the conditions of this study. -
Applicant's summary and conclusion
- Conclusions:
- In conclusion, 2-(2-Vinyloxyethoxy) ethyl acrylate did not show the chromosome aberrations regardless of application of metabolic activation system in the chromosome aberration test system using Chinese hamster lung cell (CHL/IU), under the conditions of this study.
- Executive summary:
This study was designed to examine a clastogenic potential of 2-(2-Vinyloxyethoxy)ethyl acrylate in the chromosome aberration test system using Chinese hamster lung cell (CHL/IU).
The result of growth inhibition test showed that the IC50 (Inhibition concentration 50%) was calculated as 9.2 µg/mL and 422.1 µg/mL for the short time treatment without and with metabolic activation system and 8.9 µg/mL for the continuous treatment. On the basis of the growth inhibition test, the highest dose in chromosome aberration test was chosen as 1 0 µg/mL for the short time treatment without metabolic activation system and the continuous treatment, and 420 µg/mL for the short time treatment with metabolic activation system. Subsequently, the highest dose formulations were diluted by common ratio of 2 to produce 2 additional lower doses levels accompanied by a negative and positive control.
Each dosing formulations were treated for 6 and 24 hours for the short time treatment regardless of metabolic activation and continuous treatm~nt without metabolic activation, respectively; and specimens were prepared to examine chromosome aberration.
As the result of chromosome aberration test, the number of structural and numerical chromosome aberration cells of treatment groups was not increased as compared with that of a negative control group regardless of application of metabolic activation system in the short time treatment and continuous treatment.
From that the result showed negative for the short time treatment with metabolic activation, the confirmation test was performed to verify the negative result by 6 hours treatment and 42 hours recovery.
Through the confirmation test, it was also found that the number of structural and numerical chromosome aberration for the short time treatment with metabolic activation system was not increased as compared with that of a negative control. It is confirmed that averages of chromosome aberration cells in negative and positive control group were within the range of the historical control data in the laboratory.
In conclusion, 2-(2-Vinyloxyethoxy)ethyl acrylate did not show the chromosome aberrations regardless of application of metabolic activation system in the chromosome aberration test system using Chinese hamster lung cell (CHL/IU), under the conditions of this study.
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