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EC number: 813-349-6 | CAS number: 56289-56-6
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 October 2016 - 17 November 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- prop-2-en-1-yl (2E)-3-phenylprop-2-enoate
- EC Number:
- 813-349-6
- Cas Number:
- 56289-56-6
- Molecular formula:
- C12H12O2
- IUPAC Name:
- prop-2-en-1-yl (2E)-3-phenylprop-2-enoate
- Test material form:
- liquid
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced with Phenobarbitone/β-Naphthoflavone at 80/100 mg/kg/day.
- Test concentrations with justification for top dose:
- - Experiment 1:
TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA (without and with S9): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
- Experiment 2, without S9:
TA 100 and TA 1535: 1.5, 5, 15, 50, 150, 300, 500 and 1500 μg/plate
TA 98: 1.5, 5, 15, 50, 150, 200, 250 and 500 μg/plate
TA 1537: 15, 50, 150, 250, 500, 750, 1500 and 5000 μg/plate
WP2uvrA: 5, 15, 50, 150, 500, 750, 1500 and 5000 μg/plate
- Experiment 2, with S9:
TA 100 and TA 1535: 1.5, 5, 15, 50, 150, 300, 500 and 1500 μg/plate
TA 98 and TA 1537: 15, 50, 150, 200, 250, 500, 750, 1500 and 5000 μg/plate
WP2uvrA: 5, 15, 50, 150, 500, 750, 1500 and 5000 μg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: The test item was immiscible in sterile distilled water at 50 mg/mL but was fully miscible in dimethyl sulphoxide at the same concentration in solubility checks performed in-house. Dimethyl sulphoxide was therefore selected as the vehicle.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 100 μL/plate DMSO
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene (2AA) in the presence of S9-mix, 1 μg/plate in DMSO for TA100, 2 μg/plate in DMSO for TA1535 and TA1537, 10 μg/plate in DMSO for WP2uvrA.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION:
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: Doses of the test substance were tested in triplicate in each strain.
NUMBER OF CELLS EVALUATED: 0.9 to 9 x 10^9 bacteria per mL
DETERMINATION OF CYTOTOXICITY
- Method: The plates were viewed microscopically for evidence of thinning (toxicity). - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- In experiment 1 only
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies in excess of the minimum positive control values over the previous two years, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
- Negative (solvent/vehicle) historical control data:
TA1535: 7 to 40
TA100: 60 to 200
TA1537: 2 to 30
TA98: 8 to 60
WP2uvrA: 10 to 60
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In the first mutation test, the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains initially from 500 μg/plate in both the absence and presence S9-mix.
- In the second mutation test, the test item again induced a toxic response with weakened bacterial background lawns noted in the absence of S9-mix from 300 μg/plate (TA1535), 500 μg/plate (TA100 and TA98), 750 μg/plate (TA1537) and at 5000 μg/plate (WP2uvrA). In the presence of S9-mix, weakened bacterial background lawns were noted from 500 μg/plate (TA100 and TA1535), 1500 μg/plate (TA98 and TA1537) and at 5000 μg/plate (WP2uvrA).
Applicant's summary and conclusion
- Conclusions:
- The substance is mutagenic (in the absence of S9-mix only) in the Salmonella typhimurium reverse mutation assay and not mutagenic in the Escherichia coli reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent direct plate experiments in the absence and presence of S9 -mix. Adequate negative and positive controls were included. No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate. The test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains initially from 500 μg/plate in both the absence and presence S9-mix. Consequently, the maximum recommended dose level of 5000 μg/plate or the toxic limit of the test item was employed as the maximum dose in the second mutation test, depending on bacterial strain type and presence or absence of S9-mix. In the first mutation test, the test item induced statistically significant increases in the revertant colony frequency of tester strains TA100, WP2uvrA, TA98 and TA1537 at sub-toxic dose levels in the absence of S9-mix only. There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains dosed in the presence of metabolic activation (S9-mix) or for TA1535 dosed in the absence of S9-mix. Results for the second mutation test showed that the test item again induced statistically significant increases in the revertant colony frequency of tester strains TA100, TA98 and TA1537 at sub-toxic dose levels in the absence of S9-mix only. Once again, there were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains dosed in the presence of metabolic activation (S9-mix) or for TA1535 (and WP2uvrA in this experiment) dosed in the absence of S9-mix.
The test item was considered, therefore, to have induced substantial, dose-related and reproducible increases in the frequency of revertant colonies for Salmonella strains TA100, TA1537 and TA98 dosed in the absence of S9-mix at sub-toxic dose levels of the test item. The individual revertant counts at the non-toxic, statistically significant dose levels for TA98 and TA1537 in particular, exceeded the in-house untreated/vehicle control counts for the strains. Based on the results, it is concluded that the substance is mutagenic (in the absence of S9-mix only) in the Salmonella typhimurium reverse mutation assay and not mutagenic in the Escherichia coli reverse mutation assay.
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