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EC number: 610-949-8 | CAS number: 53045-70-8
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 04, 2006 - April 17, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 07-1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 06-2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- 2-ethylbut-3-en-1-ol
- EC Number:
- 610-949-8
- Cas Number:
- 53045-70-8
- Molecular formula:
- C6H12O
- IUPAC Name:
- 2-ethylbut-3-en-1-ol
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 mix of Aroclor 1254 induced animals
- Test concentrations with justification for top dose:
- Experiment 1: 0, 15.8, 50, 158, 500, 1580 and 5000 µg/ml
(+/- S9 mix)
Experiment 2: 0, 158, 500, 1580 and 5000 (+/- S9 mix) - Vehicle / solvent:
- Ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 7,12-dimethylbenzanthracene
- Remarks:
- Positive control for experiments without S9 mix: NQO Positive control for experiments with S9 mix: DMBA
- Details on test system and experimental conditions:
- In a preceding range finding test, the relative survival was determined after exposure to various test material concentrations ranging between 5 and 5000 μg/mL. A clear reduction in the relative survival of the cells occurred at the concentration of 5000 μg/mL in the absence and presence of S9 mix, respectively. Precipitation of the test item in the cell culture medium was not seen. A relevant change in the pH and the osmolarity of the culture medium was not detected in the concentration range tested in the main study.
- Evaluation criteria:
- see below
- Statistics:
- All calculations such as determination of survival or viability, determination of mutant frequency or assessment of statistical significance of mutant frequency were performed by computer using validated software.
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 ug/mL in the 1st series without S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In this GLP study performed according to OECD GL 476, the test item was assessed for its ability to induce mutation at the tk locus (5-trifluorothymidine resistance) in mouse lymphoma cells using a fluctuation protocol. Based on the obtained results and under the conditions employed in this study, the test item was not mutagenic in this test system both in the absence or presence of S9 mix.
- Executive summary:
Study design
In this GLP study performed according to OECD GL 476 the test item was assayed for its ability to induce mutations at the TK locus (5-trifluorothymidine resistance) in L5178Y mouse lymphoma cells using a fluctuation protocol. The study consisted of two independent experimental series, each conducted in the absence and presence of an exogenous metabolizing system (S9 mix from livers of rats pre-treated with Aroclor 1254). Ethanol was used as the solvent. The exposure times were 3 and 24 hours in the absence and 3 hours in the presence of S9 mix, respectively. Test item concentrations ranging from 15.8 to 5000 μg/mL were tested in the absence or presence of S9 mix.
Results
No precipitation of the test material in the incubation medium was observed. Clear cytotoxic effects, i.e. a relevant decrease in either the % relative survival or % total growth of the test cells, occurred at the highest concentration tested in the 1st experiment in the absence of S9, i.e. at 5000 μg/mL. The doses tested were selected to determine viability and mutagenicity (5 -trifluorothymidine (TFT) resistance) 2 days after treatment. Negative (solvent) and positive control treatments were included in each mutation experiment in the absence and presence of S9 mix. Mutant frequencies in negative control cultures fell within normal ranges, and clear increases in mutation were induced by the positive control chemicals 4-nitroquinoline N-oxide (without S9 mix) and 7, 12-dimethylbenz[a]anthracene (with S9 mix). Therefore, the study was accepted as valid.
Conclusion
No relevant increases in mutant frequency were observed following treatment with test item in the two experimental series in the absence and presence of S9 mix. It is therefore concluded that the test item is non-mutagenic in this test system under conditions where the positive controls exerted potent mutagenic effects.
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