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EC number: 251-807-1 | CAS number: 34041-09-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-08-30 till 2007-09-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no rescrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-ethylhexanoic acid
- EC Number:
- 205-743-6
- EC Name:
- 2-ethylhexanoic acid
- Cas Number:
- 149-57-5
- Molecular formula:
- C8H16O2
- IUPAC Name:
- 2-ethylhexanoic acid
- Details on test material:
- Test substance No.: 07/0323-1
Batch identification: B 561 laufender Betrieb
Purity: 99.8 area-%
Homogeneity: The homogeneity of the test substance was guaranteed on account of the high purity.
Storage stability: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Date of production: 08 Jun 2007
Molecular weight: 144.21 g/mol
Physical state, appearance: Liquid, colorless to yellow
Storage conditions: Room temperature
Constituent 1
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- The CHO (Chinese hamster ovary) cell line (substrain K3) (1, 2) is a permanent cell line derived from the Chinese hamster and has a
- high proliferation rate (doubling time of about 12 - 16 hours)
- high plating efficiency (about 90%)
- karyotype with a modal number of 20 chromosomes.
Stocks of the CHO cell line (1-mL portions) were maintained at -196°C in liquid nitrogen using 7% DMSO in culture medium as a cryoprotectant. Each batch used for mutagenicity testing was checked for mycoplasma contamination. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254
- Test concentrations with justification for top dose:
- 1 - 10 - 50 - 100 - 250 - 500 - 750 - 1000 - 1500 μg/mL
- Vehicle / solvent:
- Due to the limited solubility of the test substance in water, dimethylsulfoxide (DMSO) was selected as the vehicle, which had been demonstrated to be suitable in the CHO/HPRT test and for which historical data are available.
The final concentration of the vehicle DMSO in the culture medium was 1% (v/v).
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- without metabolic activation: positive control substance; ethylmethanesulphonate. With metabolic activation: positive control substance: methylcholanthrene.
- Details on test system and experimental conditions:
- Day 1: Seeding of the cells pretreated with "HAT" medium: in 175 cm² flasks (1x106 cells in 20 mL) and in 25 cm² flasks (200 cells in 5 mL)
Day 2: Test substance incubation (20 – 24 hours after seeding); exposure period (4-hour and 24-hour); washing of the cultures (4-hour exposure);
1st cytotoxicity determination (cloning efficiency 1: survival)
Day 3: Washing of the cultures (24-hour exposure)
Day 5: 1st passage of the treated cells
Day 9: 2nd passage of the treated cells with seeding in the selection medium ("TG" medium); 2nd cytotoxicity determination (cloning efficiency 2: viability)
From day 16: Drying, fixation, staining and counting of the selected colonies
In this study all incubations were performed at 37°C with a relative humidity of > 90% in a 5% (v/v) CO2 atmosphere. - Evaluation criteria:
- • The absolute cloning efficiencies of the negative controls should not be less than 50% (with and without S9 mix).
• The background mutant frequency in the negative controls should fall within our historical negative control data range of 0 – 15 mutants per 106 clonable cells.
• The positive controls both with and without S9 mix must induce distinctly increased mutant frequencies.
• At least 4 dose levels ranging up to a toxic concentration or up to or beyond the limit of solubility under culture conditions should be tested. Freely soluble and apparently non-toxic substances are not tested at concentrations higher than 5 mg/mL or 10 mM. - Statistics:
- no
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The positive control substances EMS (without S9 mix; 300 μg/mL) and MCA (with S9 mix; 10 μg/mL) induced clearly increased mutant frequencies as expected. The values of the corrected mutant frequencies (MFcorr.: 91.24 – 553.18 per 106 cells) were clearly within our historical positive control data range (without S9 mix 4 hours treatment: MFcorr.: 48.83 –587.77 per 106 cells; without S9 mix 24 hours treatment: MFcorr.: 272.94 – 331.63 per 106 cells; with S9 mix: MFcorr.: 29.06 – 413.54 per 106 cells.
The osmolarity was not influenced by test substance treatment. The pH of the stock solutions were adjusted to physiological values using small amounts of 2 N NaOH.
In this study, in the absence and the presence of S9 mix no precipitation of the test substance in culture medium was observed up to the highest applied test substance concentration. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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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