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EC number: 228-536-2 | CAS number: 6290-17-1
- 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:
- 13 March 2002 - 28 March 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd 11 March 2002
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
- EC Number:
- 228-536-2
- EC Name:
- Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
- Cas Number:
- 6290-17-1
- Molecular formula:
- C9H16O4
- IUPAC Name:
- ethyl 2-(2,4-dimethyl-1,3-dioxolan-2-yl)acetate
- Test material form:
- liquid
1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from livers of male Wistar rats, induced with phenobarbital and ß-naphtoflavone
- Test concentrations with justification for top dose:
- 0.05, 0.16, 0.5, 1.6 and 5 mg/plate
The top dose was selected according to OECD guideline 471. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water (aqua bidest)
- Justification for choice of solvent/vehicle: according to OECD guideline 471.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- other: ICR 191, 4-nitro-o-phenylendiamine, nitrofurantoine, 2-aminoanthracen, danthron
- Remarks:
- See table 1 for details on positive control substances
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
- Medium used: 25 mL Vogel-Bonner minimal medium; for strain TA97a with 0.4% D+ glucose, for all other strains with 2% D+ glucose
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 per concentration and control (titer control replicates were prepared 2-fold).
DETERMINATION OF CYTOTOXICITY
- Method: plates were inspected for present and reduced background lawn; colonies were counted, if no reduced background lawn was observed, with a colony counter (BZG 30; WTW)
- Any supplementary information relevant to cytotoxicity:
- OTHER: The test item is to be interpretated mutagenic if there is a concentration effect relationship and the induction rate is ≥ 2. - Evaluation criteria:
- Since no validity criteria are described in OECD and EC guidelines, the following validity criteria from the literature and DIN guideline were used:
- The following genotypes of the tested strains had to be confirmed:
- Histidine auxotrophy
- Ampicillin resistance
- Tetracycline resistance (only TA 102)
- UV-sensitivity (except TA 102)
- Growth inhibition with crystal violet (rfa-mutation)
- Titer of the overnight culture had to be ≥ 1 x 10^8 cells/mL.
- Spontaneous revertants/plate (negative controls) had to be within the following ranges:
- TA 97 a ± S9 : 150 - 450
- TA 98 ± S9 : 15- 50
- TA 100 ± S9 : 60 - 200
- TA 102 ± S9 : 300 - 600
-TA 1535 ± S9 : 5- 30
- The induction rates of the positve controls had to be ≥ 2.
The validity criteria were met.
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 applicable
- 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 applicable
- 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 applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium 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 experiments in the absence and presence of S9 -mix. Adequate negative and positive controls were included.
The maximum dose level of the test item in both experiments was selected as the maximum recommended dose level of 5000 μg/plate. There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix) in both experiments. The substance did not induce a significant dose related increase in the number of revertant (His+) colonies in each of the five S.typhimurium tester strains (TA97a, TA1535, TA102, TA98 and TA100) both in the absence and presence of S9-metabolic activation. These results were confirmed in the independently repeated experiment. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
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