Registration Dossier
Registration Dossier
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: 700-261-7 | CAS number: 4427-96-7
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2019-05-07 to 2019-05-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed to current OECD guidelines with no significant deviations and run in OECD GLP certified lab.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (4R)-4-ethenyl-1,3-dioxolan-2-one; (4S)-4-ethenyl-1,3-dioxolan-2-one
- EC Number:
- 700-261-7
- Cas Number:
- 4427-96-7
- Molecular formula:
- C5H6O3
- IUPAC Name:
- (4R)-4-ethenyl-1,3-dioxolan-2-one; (4S)-4-ethenyl-1,3-dioxolan-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: A03-18-0081
Purity: ≥99.9%
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : The S9 was prepared from the livers of the rats induced with Aroclor1254, and the details are shown below: Male SD (Sprague-Dawley) rats were treated by a single intraperitoneal injection of Aroclor 1254 at the dose of 500 mg/kg body weight five days prior to the S9 preparation. The livers of the rats were taken out under aseptic conditions, homogenized in a 0.15 mol/L KCl solution (1g liver: 3 mL KCl solution) and centrifuged at 11000 rpm for 10 min with AllegraTM 64R Auto Freeze Centrifuge. The supernatant of S9 was stored in liquid nitrogen (-196 °C) not more than two years.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Before being used, this batch of S9 was tested for its sterility, its protein content (not higher than 40 mg/mL), and its capability to activate known mutagens in Ames test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water (H2O)
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: Dexon; 2-Aminofluorene; 1, 8-Dihydroxyanthraquinone; 2-Aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : two, the first and validation experiment
METHOD OF TREATMENT/ EXPOSURE:
- Plate-incorporation in the first test, pre-incubation method in the validation test.
TREATMENT AND HARVEST SCHEDULE:
- Plate-incorporation
- In the absence of S9 mix: 200 μL of histidine-biotin solution, 100 μL of fresh cultures of bacteria, 500 μl of PBS, 100 μL of the test item formulation or H2O or positive control solution and 2000 μL of molten top-layer agar medium kept in a water bath at 42.7 °C - 47.5 °C were added to a sterile test tube under aseptic conditions. After vortexing, the mixture was evenly overlaid on the surface of MGA plate, all dose levels and the controls were performed in triplicate. After the top-layer agar was solidified, the plates were inverted and incubated for about 48 hours at 36.0 - 38.7 °C. The test item precipitate was observed by naked eyes in three parallel plates of each dose group of TA98 before and after incubation. After incubation, the number of revertant colonies in each plate was counted. As counting the plates of the positive controls (except for TA1535), the back of a plate was divided into eight sectors on back, and two diagonal sectors were chosen randomly and counted, then the result was multiplied by 4 as the number of revertant colonies, and the signs of background lawn were observed microscopically.
- In the presence of S9 mix: All procedures were the same as those in the absence of S9 mix except for PBS replaced with S9 mix.
- Pre-incubation
- Preincubation period, if applicable: Fresh cultures of bacteria, PBS or S9 mix, and working solution of the test item or solvent or positive control solution were mixed in a sterile test tube and pre-incubated at 35.5 - 36.9 °C for a minimum of 20 min firstly.
- Exposure duration/duration of treatment: All tested plates were inverted and incubated for about 69 hours at 35.0 - 38.4 °C.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: the number of revertant colonies, the data on the background lawn and precipitate of the test item - Evaluation criteria:
- CRITERIA OF CYTOTOXICITY
The test item is evaluated as cytotoxicity if one of the below criteria is met.
- Compared with the concurrent solvent control, the number of the revertant colonies has significant decrease or none;
- Compared with the concurrent solvent control, the sign of the background lawn has obvious thinning or clearing.
CRITERIA OF POSITIVE RESULT
- When there is a concentration-related increase over the range (equal to or greater than two times that of the concurrent solvent control in TA97a, TA98, TA100, TA102 and equal to or greater than three times that of the concurrent solvent control in TA1535) in the mean number of revertant colonies in at least one strain with or without metabolic activation system, the test item should be evaluated as positive.
- When there is a reproducible increase (equal to or greater than two times that of the concurrent solvent control in TA97a, TA98, TA100, TA102 and equal to or greater than three times that of the concurrent solvent control in TA1535) at one or more concentrations in the mean number of revertant colonies in at least one strain with or without metabolic activation system, the test item should be evaluated as positive.
CRITERIA OF NEGATIVE RESULT
The test item should be evaluated as negative if none of the above criteria is met.
CRITERIA OF EQUIVOCAL RESULT
Although most tests give clear positive or negative results, in some instances the data generated prohibit making a definite judgment about test item. Results of this type should be reported as equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed only at 5000 μg/plate dose level.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed only at 5000 μg/plate dose level.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH:
- Data on osmolality:
- Possibility of evaporation from medium:
- Water solubility:
- Precipitation and time of the determination:
- Definition of acceptable cells for analysis:
- Other confounding effects:
RANGE-FINDING/SCREENING STUDIES:
- Preliminary test: The standard plate incorporation method was performed at 3 dose levels, including 5000, 1000 and 200 μg/plate, in five tester strains of TA97a, TA98, TA100, TA102 and TA1535, with and without metabolic activation system. Solvent control (H2O) in each tester strain was performed at the same time. The dose volume of each dose group and solvent control group were 0.1ml/plate, in duplicate.
- Preliminary test results: About the precipitation of the test item, monitoring of TA98 showed that there was no precipitate at any designed dose level before and after incubation with and without metabolic activation system. Moreover, compared to the concurrent solvent controls, the test item was considered to be no cytotoxicity to all tester strain at all designed dose levels with and without metabolic activation.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : In the first test and the validation test, the mean number of revertant colonies in the solvent controls and positive controls were within the range of historical control data in this lab. In addition, the background lawn in the solvent controls and positive controls had grown as densely packed microcolonies which form a uniform layer observed with microscope. So the sensitivity of the assay and the efficacy of the S9 mix were validated.
Ames test:
In two tests, the results of the viable count showed that the density of living bacteria in the cultures of each tester strain was within the acceptable range of 0.9 - 9×10^9 colony forming units (CFU)/mL.
In the first test, there was no precipitate at any dose level before and after the incubation, with and without metabolic activation system. In the validation test, the same result was obtained as in the first test.
In the first test, cytotoxicity was observed only at 5000 μg/plate dose level in some tester strains in two treatment conditions, including TA102 with S9mix and TA98 with and without S9mix. It was showed that the number of revertant colonies was significant decrease and/or the background lawn was thinner than the concurrent solvent controls. In the validation test, the same cytotoxicity results were observed as in the first test.
In the first test, with and without metabolic activation, the mean number of revertant colonies at each dose level in all tester strains was less than two times that of the concurrent solvent controls in TA97a, TA98, TA100, TA102 and less than three times that of the concurrent solvent controls in TA1535. In the validation experiment, the same mutagenic result was obtained as in the first test.
Applicant's summary and conclusion
- Conclusions:
- The results both in the first test and the validation test were negative. The test item considered to be non-mutagenic in the bacterial reverse mutation test using the histidine requiring tester strains of Salmonella typhimurium.
- Executive summary:
The study was performed to evaluate the ability of the test item to induce reverse mutations in the genome of the histidine requiring tester strains of Salmonella typhimurium according to OECD Guideline 471 (Bacterial Reverse Mutation Assay).
Five histidine requiring (his-) mutant tester strains of Salmonella typhimurium including TA97a, TA98, TA100, TA102 and TA1535 were treated with Vinyl ethylene carbonate using the standard plate incorporation method and the pre-incubation method at six dose levels, in triplicate, with the solvent controls and positive controls, both in the presence and absence of the cofactor-supplemented S9 (S9 mix).Based on the results of the preliminary test (initial toxicity test) that had been performed in this lab before, six dose levels were selected in the first experiment, including 1500, 500, 150, 50, 15 and 5 g/plate with and without metabolic activation. Distilled water (H2O) was used as solvent. The validation experiment was conducted using the same dose levels and solvent as the first experiment.
In two tests, the results of the viable count showed that the density of living bacteria in the cultures of each tester strain was within the acceptable range of 0.9 - 9×10^9 colony forming units (CFU)/mL. At the same time, all results of positive and solvent controls met the requirements of this test, so the sensitivity of the test system and the efficacy of the S9 mix were validated.
In the first test, there was no precipitate at any dose level before and after the incubation, with and without metabolic activation system. In the validation test, the same result was obtained as in the first test.
In the first test, cytotoxicity was observed only at 5000 μg/plate dose level in some tester strains in two treatment conditions, including TA102 with S9mix and TA98 with and without S9mix. It was showed that the number of revertant colonies was significant decrease and/or the background lawn was thinner than the concurrent solvent controls. In the validation test, the same cytotoxicity results were observed as in the first test.
In the first test,with and without metabolic activation, the mean number of revertant colonies at each dose level in all tester strains was less than two times that of the concurrent solvent controls in TA97a, TA98, TA100, TA102 and less than three times that of the concurrent solvent controls in TA1535. In the validation experiment, the same mutagenic result was obtained as in the first test.
Under the conditions of this study, the results both in the first test and the validation test were negative. The test item considered to be non-mutagenic in the bacterial reverse mutation test using the histidine requiring tester strains of Salmonella typhimurium.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.