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Diss Factsheets
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EC number: 203-311-1 | CAS number: 105-58-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his+
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0-6666ug/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine & 2-aminoanthracene
- Details on test system and experimental conditions:
- The test substance was assayed for mutagenicity in the preincubation assay. Concurrent solvent and positive controls were tested with and without the metabolic activation systems (S9 mix [hamster and rat]). At least five dose levels were tested, with three plates per dose level.
- Evaluation criteria:
- -Mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold
-Nonmutagenic response: when no increase in the number of revertants was elicited by the chemical
-Questionable response: when there was an absence of a clear-cut dose-related increase in revertants, when the dose-related increases in the number of revertants were not reproducible, or when the response was of insufficient magnitude to support a determination of mutagenicity - Statistics:
- yes (not further specified)
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Diethyl carbonate was tested negative in an Ames test with Salmonella typhimurium strains TA 100, TA 1535, TA 1537 and TA 98, with and without metabolic activation, at doses up to 6666 ug/plate. - Executive summary:
Diethyl carbonate was tested negative in an Ames test with Salmonella typhimurium strains TA 100, TA 1535, TA 1537 and TA 98, with and without metabolic activation, at doses up to 6666 ug/plate.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Concerning genotoxicity, the database for diethyl carbonate (DEC) is limited as only one negative Ames test with S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 is available. Therefore, data for dimethyl carbonate (DMC) are taken into further consideration (read across). The two compounds differ with regard to the length of their ester side chain. DEC contains two ethyl and DMC contains two methyl groups. Structural similarity can be calculated by using different models/algorithms and will then result in a percentage of similarity. Using the mathematical model “Yule” from the OECD toolbox (v 2.3) a structural similarity of 88.89% is calculated (15 out of 28 possible atom pairs match to DEC, 4 out of 6 topological torsions and 4 out of 8 atom centred fragments). Although the calculated value has only an indicative character, it confirms the high structural similarity of both compounds.
In a Comet assay with L 929 mice fibroblasts, dimethyl carbonate gave no indications for a DNA damage at concentrations of up to 150 mg/mL.
In an in vivo cytogenetic test for detection of chromosome aberrations in spermatogonial mitoses (study design comparable to OECD Guideline 483), male mice were dosed once orally with 0, 0.99, 1.99 or 3.97 g/kg bw of dimethyl carbonate. The results of this study gave no indications for an increase in chromosome aberrations.
Also the main metabolite ethanol gave no indications for a genotoxic/mutagenic potential. In the OECD SIDS for Ethanol (http://www.inchem.org/documents/sids/sids/64175.pdf) it was stated:
“The balance of evidence is that ethanol is not genotoxic. Negative results from a number of bacterial mutation assays appear to be reliable. Of the mammalian cell mutation assays a weak mutagenic effect in mouse lymphoma cells occurred only at very high ethanol concentrations. In vivo tests for chromosome aberrations in both rats and Chinese hamsters have given negative results. There is very little evidence to suggest that ethanol is genotoxic in somatic cells and it may have a very limited capacity to induce genetic changes in vivo but under very specific circumstances and at very high doses achievable in humans only by deliberate oral ingestion.”
Justification for classification or non-classification
Although the database concerning genotoxicity/mutagenicity for diethyl carbonate is limited, the read across with data from dimethyl carbonate (high structural similarity of both compounds) and also from the main metabolite ethanol is not indicating a significant genotoxic/mutagenic potential for diethyl carbonate. Therefore, no classification according to EU and GHS criteria is required.
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