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Diss Factsheets
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EC number: 205-516-1 | CAS number: 141-97-9
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Molecular formula: C6H10O3
- Molecular weight: 130.14
- Physical state: liquid
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Source: Cell bank of "Genetic toxicology", HMR Germany, ProTox
Large stocks of the mycoplasma-free V79 cell line are stored in liquid nitrogen in the cell bank of "Genetic Toxicology", thus permitting repeated use of the same cell culture batch for numerous experiments. The identical characteristics of the cells ensure comparability of the experimental parameters. Thawed stock cultures were kept at approx. 37 "C and approx. 4 % CO, in 175 cm2 plastic flasks. About 5 x 1090 1 x lo6 cells were seeded into each flask in 30 ml of MEM-medium supplement with approx. 10 % (vlv) FCS (fetal calf serum) containing approx. 2 mM L-glutamine and approx. 0.1 % (wlv) neomycinsulfate. The cells were subcultured twice a week. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-liver fractions of Sprague-Dawley rats, induced with Aroclor 1254
- Test concentrations with justification for top dose:
- TREATMENT TIME 3h:
1. With S9-mix:
- Solvent control: 0.0 ug/ml
- Positive control: CPA 3.0 ug/ml
- Test group 1: 325.0 ug/ml
- Test group 2: 650.0 ug/ml
- Test group 3: 1301.4 ug/ml
2. Without S9-mix:
- Solvent control: 0.0 ug/ml
- Positive control: EMS 1500.0 ug/ml
- Test group 1: 325.0 ug/ml
- Test group 2: 650.0 ug/ml
- Test group 3: 1301.4 ug/ml
TREATMENT TIME 20h:
1. Without S9-mix:
- Solvent control: 0.0 ug/ml
- Positive control: EMS 400.0 ug/ml
- Test group 1: 325.0 ug/ml
- Test group 2: 650.0 ug/ml
- Test group 3: 1301.4 ug/ml - Vehicle / solvent:
- Cell culture medium
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- culture medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: EMS (Ethyl methane sulfonate) / With metabolic activation: CPA (Cyclophosphamide - Endoxan)
- Details on test system and experimental conditions:
- Details are given in thge report
- Evaluation criteria:
- The evaluation of the results was performed as follows:
- The test compound is classified as mutagenic if there is a concentration-related increase in the aberration rate (without gaps).
- The test compound is classified as non-mutagenic if the tests are negative both with and without metabolic activation.
- The test compound is classified as mutagenic if it induces a statistically significant increase in the aberration rate (without gaps) with one or more of the concentrations tested as compared with the solvent controls. - Statistics:
- Statistical evaluation was not necessary, because all dose groups were in the range of the solvent controls.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No precipitation observed.
- Remarks on result:
- other: strain/cell type: V79
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Solubility and preliminary toxicity testing:
Acetoacetic acid ethyl ester was dissolved in cell culture medium. Evaluation of the solubility in cell culture medium showed that 1301.4 ug/ml was the highest practicable concentration and produced no precipitate. This concentration corresponds to 10 mM, which is the highest dose level tolerated for the test system. Accordingly, the preliminary toxicity study was carried out using a maximum concentration of 1301.4 ug/ml and a range of lower dose levels down to 10 ug/ml.
Mutagenicity test:
In the main experiment no reduction of mitotic index was observed with and without metabolic activation at the 3 h treatment time. i In the repeat experiment at the 20 h treatment time in the absence of S9-mix the mitotic index was dose dependent reduced (indication of toxicity) reaching 33 % of the solvent control value at the highest dose level tested, 1301.4 ug/ml. After treatment with the test compound there was no relevant increase in the number of polyploid cells as compared with the solvent controls. The test compound Acetoacetic acid ethyl ester was assessed for its mutagenic potential in vitro in the chromosome aberration test in two independent experiments. No relevant reproducible enhancement of metaphases with aberrations over the range of the solvent control was found with any of the concentrations used, either with or without metabolic activation by S9-mix. The sensitivity of the test system was demonstrated by the enhanced mutation frequency in the cell cultures treated with the positive control compounds.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
EAA was not clastogenic in this chromosome aberration test system in vitro with cells of the V79 Chinese hamster cell line under the conditionsdescribed in this study. - Executive summary:
The assay was performed 1999 according to OECD-guideline no. 473. The test was performed with and without liver microsomal activation and used V79 cells of Chinese hamster lung fibroblasts. The test item was tested at the following concentrations: 325.0, 650.0 and 1301.4 ug/ml. Treatment time was 3 and 20 hours. In the main experiment, no reduction of mitotic index was observed with and without metabolic activation at the 3 h treatment time. In the repeat experiment at the 20 h treatment time in the absence of S9-mix the mitotic index was dose dependent reduced (indication of toxicity) reaching 33 % of the solvent control value at the highest dose level tested, 1301.4 ug/ml. EAA was found to be non-clastogenic in this test system.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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