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EC number: 271-832-1 | CAS number: 68609-68-7 The complex combination of products produced by the distillation of products from a 2-ethyl-1-hexanol manufacturing process. It consists predominantly of organic compounds such as alcohols, aldehydes, esters, carboxylic acids and acetals having carbon numbers predominantly in the range of C4 through C16 and boiling in the range of 150°C to 308°C (302°F to 586°F).
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues
- EC Number:
- 271-832-1
- EC Name:
- 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues
- Cas Number:
- 68609-68-7
- Molecular formula:
- UVCB, not applicable, see section 1.2 for information on constituents
- IUPAC Name:
- 2,4-diethyl-3-propylpentane-1,5-diol; 2,4-diethyloctan-1-ol; 2-ethylhexan-1-ol; 2-ethylhexane-1,3-diol
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- No target gene
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: DME
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian microsomal fraction (S9 mix)
- Test concentrations with justification for top dose:
- Experiment A:
3/20 hours treatment/sampling time
without S9 mix: 61.73, 20.58, 6.86, 2.29, 0.76 μg/mL
with S9 mix: 185.18, 61.73, 20.58, 6.86, 2.29 μg/mL
Experiment B:
20/28 hours treatment/sampling time
without S9 mix: 20.58, 6.86, 0.76, 0.25 μg/mL
Experiment B:
3/28 hours treatment/sampling time
with S9 mix: 185.18, 61.73, 20.58, 6.86, 2.29 μg/mL - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: no data; however, DMSO is a standard solvent used in studies of this type and a concurrent solvent control was included.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Dulbecco's Modified Eagle's (DME) medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (1 % in DME medium)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DME medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (1 % in DME medium)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 hours
- Exposure duration: 3 or 20 hours
- Expression time (cells in growth medium): 20 or 28 hours
- Fixation time (start of exposure up to fixation or harvest of cells): after 20 or 28 hours (after expression time)
SPINDLE INHIBITOR (cytogenetic assays): colchicine
STAIN (for cytogenetic assays): Giemsa stain (5 %)
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: at least 200 metaphase cells containing 2 N ± 2 centromeres
DETERMINATION OF CYTOTOXICITY
- Method: the viable cells were distinguished from non-viable cells on the basis of their appearance and shape
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- – the number of aberrations found in the negative and /or solvent controls falls within the range of historical laboratory control data.
– the positive control items produce biologically relevant increases in the number of cells with structural chromosome aberrations. - Statistics:
- A Chi square test was performed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no effects
- Effects of osmolality: no effects
- Precipitation: no precipitation was noted for examined test concentrations
RANGE-FINDING/SCREENING STUDIES:
Based on the results of a pre-test (cytotoxicity) the concentration indicated in section "Test concentrations" were selected
COMPARISON WITH HISTORICAL CONTROL DATA:
In the presence of metabolic activation, although the chromosomal aberration numbers were not statistically significantly higher than solvent control, the mean values at 61.73 μg/mL (3 hours treatment and 20 hours sampling time) were slightly above the historical control range. The frequency of the cells with structural chromosome aberrations without gaps was within the historical control range in a second experiment with 3 hours treatment and 28 hours sampling time.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The cytotoxicity observed at a test item concentration of 185.18 µg/mL was too pronounced for a reliable analysis due to a limited number of available metaphases. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
There were no biologically relevant increases in the rate of polyploid or endoreduplicated metaphases in either experiment in the presence or absence of metabolic activation. The validity of the test was shown using ethyl methanesulphonate (0.4 and1.0 μL/mL) and cyclophosphamide (6.0 μg/mL) as positive controls. The test item tested up to cytotoxic concentrations, both with and without metabolic activation, did not induce significant structural chromosome aberrations in this test in Chinese Hamster lung cells.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item was non-clastogenic in this system. - Executive summary:
In a mammalian cell cytogenetics assay for chromosome aberration (Al-Sabti, 2010), V79 cell cultures were exposed to 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues in 1 % DMSO at (i) 0.76, 2.29, 6.86, 20.58, and 61.73 µg/mL (without S9 mix), 2.29, 6.86, 20.58, 61.73 and 185.18 µg/mL (with S9 mix) with 3 hours treatment and 20 hours harvest and at (ii) 0.25, 0.76, 6.86 and 20.58 µg/mL (without S9 mix) with 20 hours treatment and 28 hours harvest as well as at (iii) 2.29, 6.86, 20.58, 61.73 and 185.18 µg/mL (with S9 mix) with 3 hours treatment and 28 hours harvest. The results of a pretest on cytotoxicity were used as basis for dose level selection. Montanol 800 was tested up to cytotoxic concentrations with and without metabolic activation. Positive controls induced the appropriate responses. There was no evidence of chromosome aberration induced over background.
This study is classified as acceptable. This study satisfies the requirement for test guideline OECD 473 for in vitro cytogenetic mutagenicity data.
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