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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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented publication which meets basic scientific principles. No data on replicates. No data on necropsy, slide preparation or clinical observations.
Data source
Reference
- Reference Type:
- publication
- Title:
- Aneuploidy inducing chemicals in yeast evaluated by the micronucleus test.
- Author:
- Basler, A.
- Year:
- 1 986
- Bibliographic source:
- Mutat. Res. 174: 11 - 13
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Remarks:
- , no significant deviations based on the information available
- Principles of method if other than guideline:
- Method: other: Micronucleus Test according to Schmid (Mut Res, 31, 9-15, 1975).
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 141-76-8
- IUPAC Name:
- 141-76-8
- Reference substance name:
- Ethyl acetate
- EC Number:
- 205-500-4
- EC Name:
- Ethyl acetate
- Cas Number:
- 141-78-6
- Molecular formula:
- C4H8O2
- IUPAC Name:
- ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): ethyl acetate in corn oil.
- Supplier: Merck.
Constituent 1
Constituent 2
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-15 weeks old
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Corn oil
- Duration of treatment / exposure:
- Single dose.
- Frequency of treatment:
- Single dose.
Doses / concentrations
- Dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
- Remarks:
- Dose approximately 66% of LD50.
- No. of animals per sex per dose:
- 10 animals/time point group
- Control animals:
- yes
- Positive control(s):
- vandesine administered by i.p.
Examinations
- Tissues and cell types examined:
- The number of micronucleated erythrocytes was counted, scoring 1000 polychromatic erythrocytes per animal.
- Details of tissue and slide preparation:
- no data
- Evaluation criteria:
- non data
- Statistics:
- The differences between the frequencies of erythrocytes with micronuclei in each treated group and the controls were statistically estimated according to Kastenbaum and Bowman with a significance level of p<0.05.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No increase in the number of micronuclei in bone marrow polychromatic erythrocytes at any time relative to negative control. Positive control validated test system.
Any other information on results incl. tables
MICRONUCLEI IN POLYCHROMATIC ERYTHROCYTES IN BONE MARROW CELLS OF CHINESE HAMSTERS
|
Dose mg/kg |
Time of Preparation |
Number of Animals |
PCE with micronuclei (%) |
Ethyl Acetate p.o. |
2500.0 |
12 |
10 |
1.30 |
|
|
24 |
10 |
0.90 |
|
|
48 |
10 |
0.60 |
|
|
72 |
10 |
1.30 |
PE, polychromatic erythrocytes; *p<0.05; + cytotoxic, bone marrow without PE.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Ethyl acetate was negative in the hamster micronucleus assay (oral). - Executive summary:
Ethyl acetate did not induce increased frequency of micronucleated polychromatic erythrocytes in the bone marrow of hamsters treated with a single oral dose of 2500 mg/kg, approximately 2/3rds of the LD50 by this route.
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