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EC number: 209-053-6 | CAS number: 553-90-2
- 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:
- 6 May 1997 - 25 June 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Notification No. 700 of the Planning and Coordination Bureau, EA, No.1039 of the Pharmaceutical Affairs Bureau, MHW & No.1014 (1986) of the Basic Industries Bureau, MITI, the Notification of Ministry of the Labor, Japan, No. 77.
- GLP compliance:
- yes
- Remarks:
- GLP statement not singed by study director
- Type of assay:
- other: Mutagenic potential assey using a bacterial/microsome test system
Test material
- Reference substance name:
- Dimethyl oxalate
- EC Number:
- 209-053-6
- EC Name:
- Dimethyl oxalate
- Cas Number:
- 553-90-2
- Molecular formula:
- C4H6O4
- IUPAC Name:
- dimethyl oxalate
1
- Specific details on test material used for the study:
- Name: Dimethyl oxalate
Description: white solid
Purity of the substance 99.9%
Method
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:
- 10% liver S9
- Test concentrations with justification for top dose:
- Concentration-determination test:
With and without S9 mix: 4.88; 19.5; 78.1; 313; 1250 and 5000 µg/plate, for all tester strains
Mutagenicity test:
With and without S9 mix: six concentrations between 156 and 10000 µg/plate, for all tester strains
Mutagenicity confirmation test 1:
With S9 mix: 1250, 2500, 3750, 5000, 6250, 7500, 8750 and 10000 µg/plate, tester strain TA100
Mutagenicity confirmation test 2:
With and without S9 mix: 1250, 2500, 3750, 5000, 6250, 7500, 8750 and 10000 µg/plate, tester strain TA100
Mutagenicity confirmation test 3 and 4:
With and without S9 mix: 1000, 2000, 3000, 4000, 5000, 6000, 7000 and 8000 µg/plate, tester strain TA100 - Vehicle / solvent:
- Concentration-determination test and Mutagenicity test: water
Mutagenicity confirmation tests 1-4: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, 9-Aminoacridine
- Details on test system and experimental conditions:
- The bacterial strains were stored in -80 °C. Overnight sub-cultures of the appropriate coded stock cultures were prepared in nutrient broth and incubated at 37 °C for approximately 10 h.
The test item was tested in a concentration-determination test, mutagenicity test and four mutagenicity confirmation tests. The concentration-determination test, mutagenicity test and mutagenicity confirmation tests 1, 3 and 4 were performed according to the pre-incubation method. The mutagenicity confirmation test 2 was performed according to the plate incorporation method. - Evaluation criteria:
- The response was regarded positive in principle if the maximum number or revertant colonies in the test material group increased 2-fold relative to the vehicle control group and dose-response and reproducibility were confirmed.
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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
The concentration-determination test:
The number of revertant colonies increased at 5000 µg/plate for TA100 with or without metabolic activation, which was below 2 fold value compared to that of the vehicle control. No significant increases of revertant colonies were recorded for other strains.
Mutagenicity test:
The test material induced less than 2 fold increases in the number of revertant colonies of TA100 with or without metobolic activation to the vehicle control at the concentration range in which no toxicity was observed.
Mutagenicity test, Mutagenicity confirmation tests 3 and 4
The test material induced 1.5~1.8 fold increses in the number of revertant colonies of TA100 to the vehicle control at the concentration range in which no toxicity was observed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
Negative
The test material was judged to be non-mutagenic because it did not induce any increases in the number of revertant colonies to at least twice as many as that of vehicle control the concentration range in which no toxicity was observed. - Executive summary:
The potential of test item Dimethyl oxalate to induce mutagenicity in Salmonella typhimurium and Escherichia coli was evaluated in experimental study by using a bacterial/microsome test system in accordance with national guidelines of Japan. The test was performed in the absence and presence of a rat liver metabolizing system (S9 mix). The validity criteria of test were fulfilled. Under experimental conditions, the test substance was judged to be non-mutagenic.
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