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EC number: 203-721-0 | CAS number: 109-94-4
- 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
Description of key information
Data for test chemicals was reviewed to determine the mutagenic nature of ethyl formate (109-94-4). The studies are as mentioned below:
In Vitro Genetic Mutation study
AMES Assay
Mutagenicity potential of test substance was determined in bacterial strain by AMES assay. The test substance was exposed to salmonella strains TA98 and TA 100 with and without metabolic activation at concentrations of 0, 1000, 2500, 5000, 7500, 10000, µg/plate. No mutagenic effects were observed in the study both in the presence and absence of metabolic activation. Based on the results obtained the test substance was considered to be non-mutagenic with and without activation. Hence the substance cannot be classified as gene mutant in vitro.
In vitro Chromosomal abbreviation study in mammalian cell
The test chemical did not induce chromosomal aberration in the Chinese hamster fibroblast cell line CHL and hence is not likely to classify as a gene mutant 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from study report
- Qualifier:
- according to guideline
- Guideline:
- other: as per below mentioned
- Principles of method if other than guideline:
- Gene mutation assay was conducted to test the potential of test substance.
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: Salmonella strains TA 100 and TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% RLI
- Test concentrations with justification for top dose:
- 0, 1000,2500, 5000,7500, 10000µg/plate
- Vehicle / solvent:
- Dimethyl Sulfoxide
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; preincubation
- Evaluation criteria:
- No. of revertants
- Statistics:
- No data available
- Species / strain:
- S. typhimurium, other: Salmonella typhimurium strains TA-100 and TA-98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Test substace was considered to be non mutagenic in salmonella strains TA 100 and TA 98 with and without activation.
- Executive summary:
Mutagenecity potential of test substance was determined in bacterial strain by AMES assay. The test substance was exposed to salmonella strains TA98 and TA 100 with and without metabolic activation at concentrations of 0,1000,2500, 5000, 7500, 10000, µg/plate. No mutagenic effects were observed in the study both in the presence and absence of metabolic activation. Based on the results obtained the test substance was considered to be non mutagenic with and without activation. Hence the substance cannot be classified as gene mutant in vitro.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- A Chromosomal aberration tests in vitro was performed on the test substance to evaluate its mutagenic effect.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- No data available
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster fibroblast cell line
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Minimum Essential Medium (MEM; GIBCO) supplemented by 10% calf serum.
- Properly maintained: Yes, by 4 day passages
- Periodically checked for Mycoplasma contamination: No data available
- Periodically checked for karyotype stability: No data available
- Periodically "cleansed" against high spontaneous background: No data available - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data available
- Metabolic activation:
- not applicable
- Test concentrations with justification for top dose:
- 1,At three different doses with 2 mg/mL being the maximum dose concentration.
2,0.5, 1 and 2 mg/L - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO - Untreated negative controls:
- yes
- Remarks:
- Untreated cells served as negative controls.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium
DURATION
- Preincubation period: No data available
- Exposure duration: 24 and 48 hrs
- Expression time (cells in growth medium): 24 and 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): Giemsa solution (1.5%, pH 6.8)
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: 100 well spread metaphases
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes
- Determination of endoreplication: No data available
- Other: No data available - Rationale for test conditions:
- No data available
- Evaluation criteria:
- The incidence of polyploid cells as well as of cells with structural chromosomal aberrations such as chromatid or chromosome gaps, breaks, exchanges, ring formations, fragmentations and others, was recorded on each culture plate. In which the incidence of aberrations was usually less than 3.0%. The results were considered to be negative if the incidence was less than 4.9%, equivocal if it was between 5.0 and 9.9%,and positive if it was more than 10.0%.
- Statistics:
- No data available
- Species / strain:
- mammalian cell line, other: Chinese hamster fibroblast cell line
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not specified
- Species / strain:
- other: Chinese hamster fibroblast cell line
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: The maximum dose of each sample was selected by a preliminary test in which the dose needed for 50% cell-growth inhibition was estimated using a cell densitometer.
COMPARISON WITH HISTORICAL CONTROL DATA: No data available
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical did not induce chromosomal aberration in the Chinese hamster fibroblast cell line CHL and hence is not likely to classify as a gene mutant in vitro.
- Executive summary:
Data for test chemicals was reviewed to determine the mutagenic nature of test chemical. The studies are as mentioned below:
In Chromosomal aberration tests in vitro for test substance in Chinese hamster fibroblast cell line CHL was observed. The cells were exposed to each sample at three different concentration 0.5, 1 and 2 mg/L for 24 and 48 hr. In the present studies, no metabolic activation systems were applied. As the incidence of aberrations 0.0% after 48 hr. The results were considered to be negative .Therefore test substance was considered to be negative in Chromosomal aberration tests in vitro.
In Chromosomal aberration tests in vitro for test substance in Chinese hamster fibroblast cell line CHL was observed. The cells were exposed to each sample at three different concentration 0.5, 1 and 2 mg/L for 24 and 48 hr. In the present studies, no metabolic activation systems were applied. As the incidence of aberrations 0.0% after 48 hr. The results were considered to be negative .Therefore test substance was considered to be negative in Chromosomal aberration tests in vitro.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data for test chemicals was reviewed to determine the mutagenic nature of ethyl formate (109-94-4). The studies are as mentioned below:
In Vitro Genetic Mutation study
AMES Assay
Mutagenicity potential of test substance was determined in bacterial strain by AMES assay. The test substance was exposed to salmonella strains TA98 and TA 100 with and without metabolic activation at concentrations of 0, 1000, 2500, 5000, 7500, 10000, µg/plate. No mutagenic effects were observed in the study both in the presence and absence of metabolic activation. Based on the results obtained the test substance was considered to be non-mutagenic with and without activation. Hence the substance cannot be classified as gene mutant in vitro.
Genetic toxicity of test chemical was tested in Salmonella typhimurium strains TA-1535, TA-1537 and TA-1538 by using plate test (overlay method). The compound was tested at concentration of 1.25, 2.50, and 5.00 % in presence and absence of metabolic activation. DMSO, water/ saline used as solvent control. Ethylmethanesulfonate, 2-Nitrofluorene, Quinacrine mustard used as positive control substance for non activation and 2 Acetylaminofluorene, 8-Aminoquinoline, 2-Aminoanthracene for activation. Rat liver, monkey liver and mouse liver was used as activation system. There were no increase in number of revertants/plate than control with and without Rat liver, monkey liver and mouse liver. Therefore, the test substance is considered to be non mutagenic in Salmonella typhimurium strains TA-1535, TA-1537 and TA-1538 in presence or absence of metabolic activation.
Genetic toxicity of test chemical was tested in Salmonella typhimurium strains TA-1535, TA-1537 and TA-1538 by using plate test (overlay method). The compound was tested at concentration of 1.25, 2.50, and 5.00 % in presence and absence of metabolic activation. DMSO, water/ saline used as solvent control. Ethylmethanesulfonate, 2-Nitrofluorene, Quinacrine mustard used as positive control substance for non activation and 2 Acetylaminofluorene, 8-Aminoquinoline, 2-Aminoanthracene for activation. Rat liver, monkey liver and mouse liver was used as activation system. There were no increase in number of revertants/plate than control with and without Rat liver, monkey liver and mouse liver. Therefore, the test chemical is considered to be non mutagenic in Salmonella typhimurium strains TA-1535, TA-1537 and TA-1538 in presence or absence of metabolic activation.
In vitro Chromosomal abbreviation study in mammalian cell
In Chromosomal aberration tests in vitro for test substance in Chinese hamster fibroblast cell line CHL was observed. The cells were exposed to each sample at three different concentration 0.5, 1 and 2 mg/L for 24 and 48 hr. In the present studies, no metabolic activation systems were applied. As the incidence of aberrations 0.0% after 48 hr. The results were considered to be negative .Therefore test substance was considered to be negative in Chromosomal aberration tests in vitro.
In Chromosomal aberration tests in vitro for test substance in Chinese hamster fibroblast cell line CHL was observed. The cells were exposed to each sample at three different concentration 0.5, 1 and 2 mg/L for 24 and 48 hr. In the present studies, no metabolic activation systems were applied. As the incidence of aberrations 0.0% after 48 hr. The results were considered to be negative .Therefore test substance was considered to be negative in Chromosomal aberration tests in vitro.
Based on the data summarized, ethyl formate (109-94-4)is expected to not induce gene mutation both In Vitro studies .Hence it is not likely to be mutagenic in vitro.
.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria for target substance ethyl formate (109-94-4) does not exhibit gene mutation in vitro . Hence the test chemical is not likely to classify as a gene mutant in vitro.
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