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EC number: 819-688-6 | CAS number: 219828-90-7
- 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:
- 25 Jul 2008 - 25 Aug 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ministry of Labor Ordinance No. 76, 1988 and Ordinance No.13, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- methyl 2-[(prop-2-en-1-yloxy)methyl]prop-2-enoate
- EC Number:
- 819-688-6
- Cas Number:
- 219828-90-7
- Molecular formula:
- C8H12O3
- IUPAC Name:
- methyl 2-[(prop-2-en-1-yloxy)methyl]prop-2-enoate
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Dose-finding study:
Test substance groups: Selected in accordance with the “Guidelines”.
Positive control groups: Selected in accordance with the concentrations for positive control substances in “Guide to Mutagenicity Studies under the Industrial Safety and Health Act”
Concentrations: 0.00305, 0.0122, 0.00488, 0.195, 0781, 3.13, 12.5 and 50 mg/mL.
Main study:
In the dose-finding study, growth inhibitions were observed at 5000μg/plate for five tester strains in the absence and presence of the metabolic activity system. Therefore, the composition of groups in the main study included 6 dose levels by a common ratio of 2 both in the absence and presence of the metabolic activity system; from the highest dose of 5000 μg/plate to the lowest dose of 156 μg/plate.
Concentrations: 1.56, 3.13, 6.25, 12.5 and 50 mg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance is insoluble in water, but soluble at 50 mg/mL or more in DMSO. Therefore, DMSO was selected as the solvent.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Additive volume of the prepared solution 100 μL per plate. Reason for the additive volume of the prepared solution 100 µL, which is the maximal possible volume without inhibition of bacterial growth by DMSO, was selected for positive control substances. Also, the same volume was selected for the test substance and negative control solutions.
45 μL of each tester strain were directly inoculated into 20 mL of 2.5% nutrient broth. The resulting mixture was cultured with shaking at 50 rpm for 9 hr at 37°C.
After incubation, the optical density of bacterial suspensions was measured to confirm that the viable bacterial count was not less than 1.0 × 10E9/mL.
In the absence of the metabolic activation system (without S9 mix):
500 μL of 100 mM Na-phosphate buffer (pH 7.4) and 100 μL of bacterial suspension were added to 100 μL of the test solution in each culture tube and the suspending solution was pre-incubated with shaking for 20 minutes at 37°C. Subsequently, 2 mL of a mixture of 0.5 mM biotin-0.5 mM histidine solution (in case of E. coli: 0.5 mM tryptophan solution) and 0.6% soft agar fluid (volume ratio 1:10) was added to each of the suspending solutions, and then poured onto the minimal glucose agar plate (Tesmedia AN Medium, Oriental Yeast Co., Ltd.,). All the plates were incubated for 48 hours at 37°C.
In the presence of metabolic activation system (With S9 mix):
500 µL of S9 mix and 100 µL of bacterial suspension were added to 100 µL of the test solution in each culture tube and the suspending solution was pre-incubated with shaking for 20 minutes at 37°C. Subsequently, 2 mL of a mixture of 0.5 mM biotin-0.5 mM histidine solution (in case of E. coli: 0.5 mM tryptophan solution) and 0.6% soft agar fluid (volume ratio 1:10) was added to each of the suspending solutions, and then poured onto the minimal glucose agar plate. All the plates were incubated for 48 hours at 37°C.
After incubation, the presence or absence of precipitation was checked visually for all dose levels. Moreover, the background lawn was observed using a microscope to confirm the presence or absence of bacterial growth inhibition. Thereafter, the numbers of revertant colonies were counted, twice for each plate, using a colony counter (PC-10NII, Toyo Sokki Co., Ltd.). The number of colonies was corrected and the mean of the corrected values was the number of revertant colonies for each plate. - Rationale for test conditions:
- Guidelines
- Evaluation criteria:
- Acceptance criteria
From the number of revertant colonies on each plate, the mean values (rounded to integers) are obtained. If all of the following criteria are met, the results are considered positive.
1) The number of revertant colonies in the test substance group is equal to or greater than twice the mean negative control value.
2) Dose-dependency is observed.
3) Reproducibility is observed when comparing the dose-finding study and main study results. - Statistics:
- not specified
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- For five tester strains, the number of revertant colonies in the test substance groups did not increase greater than twice that in the negative control group in the absence or presence of the metabolic activation system.
Bacterial growth inhibition was observed at 2500 µg/plate and more for five tester strains in the absence and presence of the metabolic activation system.
Precipitation of the test substance on the plates was not observed in five tester strains in the absence or presence of the metabolic activation system.
Applicant's summary and conclusion
- Conclusions:
- In the results of the dose-finding study and main study, Methyl α-(Allyloxymethyl)acrylate did not induce increases in the number of revertant colonies for five tester strains in the absence or presence of the metabolic activation system, and the number did not reach more than twice that of the negative control group.
Therefore, Methyl α-(Allyloxymethyl)acrylate was judged not to be mutagenic agent, under the conditions of this study.
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