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EC number: 807-159-2 | CAS number: 69701-99-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
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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:
- 26 Jun 2006 - 20 Jul 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- EC Number:
- 807-159-2
- Cas Number:
- 69701-99-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 19892501
- Purity: 97.5%
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 applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Source: Dr. T. Matsushima, Japan Bioassay Laboratory, Japan Industrial Safety and Health Association, Hadano-city, Kanagawa.
Bacterial cultures were freshly prepared in Oxoid nutrient broth #2 (248458), by inoculating bacteria from frozen stock cultures (kept at -80 °C). 30µL stock solution was inoculated into the 15 mL broth and incubated for 10 hours at 37 °C and 120 rpm using rotary shaker.
S9 and S9 mix:
- Lot No: 06051202
- Source: Oriental Yeast Corporation, Tokyo, Japan.
- Date of preparation: 12 May 2006
- Preparation: prepared by a slight modification of the method described by Ames, McCann, and Yamazaki: 5,6-Benzoflavone (BF) and phenobarbital (PB) were used as an incuder of drug-metabolising enzyme system.
Animals:
- Species/ Strain: Rat/ Sprague-Dawley
- Sex: Male
- Age: 7 weeks
- Body weight: 217.5 ± 10.9 g
- Amount of inducing substance (g/kg bw): PB – 4 times, 0.03-0.06; BF – 1 time, 0.08
The S9 mix contained 4mM NADPH, 4mM NADH, 5mM Glucose-6-Phosphate, 8mM MgCl2, 33 mM KCl, 100mM sodium phosohate buffer (pH 7.4) and 10% (50µL S9 per plate). - Test concentrations with justification for top dose:
- Range finder test (µg/ plate): 0, 4.88, 19.5. 78.1. 313, 1250 and 5000
Mutgenicity test (µg/ plate): 0, 156, 313, 625, 1250, 2500 and 5000 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide); 2-aminoamthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The mutagenicity was assayed from a maximum level of 5000 µg test substance/ plate by the pre-incubation method (37 °C, 20 min) with and without metabolic activation system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- MEDOL-10 did not increase revertant colonies when tested up to 5000 µg/plate with or without metabolic activation.
Toxicity was observed at 5000µg/plate with or without metabolic activation for all bacteria tested.
Toxicity was also observed at 2500 µg/plate without metabolic activation for Salmonella Typhimurium TA100.
No test item precipitation was observed. - Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- Test item did not show mutagenicity in any bacteria strain by the preincubation method with or without metabilic activation system.
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