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EC number: 219-834-3 | CAS number: 2549-51-1
- 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:
- weight of evidence
- Study period:
- From 9 August 2016 to 11 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Vinyl chloroacetate
- EC Number:
- 219-834-3
- EC Name:
- Vinyl chloroacetate
- Cas Number:
- 2549-51-1
- Molecular formula:
- C4H5ClO2
- IUPAC Name:
- ethenyl 2-chloroacetate
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: peripheral blood lymphocytes
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: human donor
- Sex, age and number of blood donors if applicable: non-smoking male aged 30 years (preliminary testing), non-smoking male aged 26 years (main experiment).
- Whether whole blood or separated lymphocytes were used if applicable: whole blood
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Eagle's minimal essential medium with HEPES buffer (MEM), supplemented with L-glutamine, penicillin/streptomycin, amphotericin B and 10% fetal bovine serum (FBS), at approximately 37°C with 5% CO2 in humidified air.
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 4-hour exposure experiments: 37.5, 75, 150, 200, 300, 450 and 600 μg/mL.
24-hour exposure experiment: 9.38, 18.75, 37.5, 50, 75, 100 and 150 μg/mL.
Based on the outcome the preliminary toxicity testing. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test item was insoluble in culture media but soluble in DMSO.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- other: Demecolcine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 4 or 24 hours
SPINDLE INHIBITOR: Cytochalasin B
STAIN: 5% Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: A minimum of 500 cells per dose level for the CBPI, 2000 binucleated cells per dose level for the presence of micronuclei
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: The criteria for identifying micronuclei were that they were round or oval in shape, non-refractile, not linked to the main nuclei and with a diameter that was approximately less than a third of the mean diameter of the main nuclei. Binucleate cells were selected for scoring if they had two nuclei of similar size with intact nuclear membranes situated in the same cytoplasmic boundary. The two nuclei could be attached by a fine nucleoplasmic bridge which was approximately no greater than one quarter of the nuclear diameter.
DETERMINATION OF CYTOTOXICITY
- Method: Cytokinesis-Block Proliferation Index (CBPI) - Evaluation criteria:
- Providing that all of the acceptability criteria are fulfilled, a test item is considered to be clearly negative if, in most/all of the experimental conditions examined:
1. None of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control.
2. There is no dose-related increase.
3. The results in all evaluated dose groups should be within the range of the laboratory historical control data.
Providing that all of the acceptability criteria are fulfilled, a test item may be considered to be clearly positive, if in any of the experimental conditions examined, there is one or more of the following applicable:
1. At least one of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control.
2. There is an increase which can be considered to be dose-related.
3. The results are substantially outside the range of the laboratory historical negative control data.
When all the criteria are met, the test item is considered able to induce chromosome breaks and/or gain or loss in this test system. - Statistics:
- The frequency of cells with micronuclei was compared, where necessary, with the concurrent vehicle control value using the Chi-squared Test on observed numbers of cells with micronuclei. Other statistical analyses may be used if appropriate. A toxicologically significant response was recorded when the p value calculated from the statistical analysis of the frequency of cells with micronuclei was less than 0.05 and there was a dose-related increase in the frequency of cells with micronuclei which was reproducible.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: dose-related inhibition of CBPI
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No significant change in pH.
- Effects of osmolality: The osmolality did not increase by more than 50 mOsm.
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: see attached background documents
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: see attached background documents
- Indication whether binucleate or mononucleate where appropriate: see attached background documents
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: see attached background documents
- Negative (solvent/vehicle) historical control data: see attached background documents
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: CBPI
Any other information on results incl. tables
See attached background material.
Applicant's summary and conclusion
- Conclusions:
- The test substance was markedly toxic and induced statistically significant increases in the frequency of binucleate cells with micronuclei, using a dose range that included a dose level that induced approximately 50% cytostasis. As a result of the positive response further scoring was performed on the mononucleate cells to indicate whether it was due to an aneugenic or clastogenic mechanism. Since there was no marked increase in the number of mononucleate cells with micronuclei it was considered that the response was likely to be due to clastogenic activity. The substance was mutagenic under the conditions of the test.
- Executive summary:
The potential of vinyl chloroacetate to induce structural chromosomal aberration in vitro was determined in accordance with the OECD Guideline for Testing of Chemicals 487.
Duplicate cultures of human lymphocytes, treated with the test item, were evaluated for micronuclei in binucleate cells at four dose levels, together with vehicle and positive controls. Three conditions were used for the study: a 4-hour exposure in the absence or presence of a standard metabolizing system (S9) at a 2% final concentration and a 24-hour exposure in the absence of metabolic activation. At the end of the exposure period, the cell cultures were washed and then incubated for a further 24 hours in the presence of Cytochalasin B. The dose levels used in the Main Experiment were selected using data from the preliminary toxicity test where the results indicated that the maximum concentration should be limited by toxicity.
The test substance was markedly toxic and did induce statistically significant increases in the frequency of binucleate cells with micronuclei, using a dose range that included a dose level that induced approximately 50% cytostasis. As a result of the positive response further scoring was performed on the mononucleate cells to indicate whether it was due to an aneugenic or clastogenic mechanism. Since there was no marked increase in the number of mononucleate cells with micronuclei it was considered that the response was likely to be due to clastogenic activity. The substance was mutagenic under the conditions of the test.
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