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Diss Factsheets
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EC number: 205-500-4 | CAS number: 141-78-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is well reported. The lack of replicates is compensated for by the fact that this is s screening test of 46 chemicals, all with individual controls and all reported in detail. Only significant shortcoming is that it is not to GLP and deviates from the OECD 473 protocol.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- single doses used and not all doses in duplicate
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Supplier: Litton Bionetics, Kentucky, MD. Used at 5th pasage level after cloning
- Periodically checked for karyotype stability: yes, by not using after 15th passage.
- Periodically checked for Mycoplasma contamination: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 from SD rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 500, 1510, 5000ug/ml without activation. 500, 1510, 5010ug/ml and 3010, 4020, 5020ug/ml with activation.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2115 (without metabolic activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1831 (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: Cultures initiated for 24hrs prior to substance addition. With metabolic activation, substance pretreated for 2hrs with S9 before exposure with cells.
- Exposure duration: 8hrs.
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time with spindle inhibitor up to harvest of cells: 2hrs
SPINDLE INHIBITOR (cytogenetic assays): colecemid
STAIN (for cytogenetic assays): Slides were stained with 5% Giesma for 5 minutes.
NUMBER OF REPLICATIONS: no data
NUMBER OF CELLS EVALUATED: Selection of cells for scoring was based on well spread chromosomes with good morphology and a chromosome number of 21±2. All cells except the positive control were scored by a single technician. 200 metaphase cells per dose were scored.
DETERMINATION OF CYTOTOXICITY
- Cytotoxicity not observed. - Evaluation criteria:
- Abberations scored included chromatid gap, break, fragment, deletions, double minutes, all defined as 'simple', and interstitial deletions
- Statistics:
- All categories of aberrations combined for statistical analysis. The percent of cells with aberrations was used for analysis rather than the
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Ethyl acetate was not toxic at the highest dose tested
- 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 with metabolic activation
negative without metabolic activation
Ethyl acetate was not toxic at the highest dose tested, with and without activation. Test with activation was negative even at delayed harvest time (> 14 h); S9 from Aroclor -1254 induced rats. - Executive summary:
The frequency of chromosome aberrations was evaluated in Chinese Hamster Ovary cells exposed to ethyl acetate concentrations up to 1500 ug/ml in a well reported study that was similar to guideline. Results were negative with and without metabolic activation up to the highest dose tested of 15mg/ml.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for selection of genetic toxicity endpoint
best available data
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.