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EC number: 939-518-5 | CAS number: 68439-49-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Jan - 3 Nov 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted in 1983
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- Version / remarks:
- adopted in 2016
- Deviations:
- yes
- Remarks:
- pleaser refer to "Principles of method if other than guideline".
- Principles of method if other than guideline:
- Deviations to OECD guideline 473 (2016): only 200 metaphases evaluated per condition, cytotoxicity measured by counting the number of cells at the end of the culture period relative to control, instead of RPD or RICC; no information on karyotype stability or mycoplasma contamination check, acceptability and evaluation criteria differ from those specified in guideline
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Hexadecan-1-ol
- EC Number:
- 253-149-0
- EC Name:
- Hexadecan-1-ol
- Cas Number:
- 36653-82-4
- Molecular formula:
- C16H34O
- IUPAC Name:
- hexadecan-1-ol
- Reference substance name:
- 2-(hexadecyloxy)ethanol
- EC Number:
- 218-373-5
- EC Name:
- 2-(hexadecyloxy)ethanol
- Cas Number:
- 2136-71-2
- Molecular formula:
- C18H38O2
- IUPAC Name:
- 2-(hexadecyloxy)ethanol
- Reference substance name:
- 2-[2-(Hexadecyloxy)ethoxy]ethanol
- EC Number:
- 610-892-9
- Cas Number:
- 5274-61-3
- Molecular formula:
- C20H42O3
- IUPAC Name:
- 2-[2-(Hexadecyloxy)ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(Hexadecyloxy)ethoxy]ethoxy]ethanol
- Cas Number:
- 4484-59-7
- Molecular formula:
- C22H46O
- IUPAC Name:
- 2-[2-[2-(Hexadecyloxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(2-hexadecoxyethoxy)ethoxy]ethoxy]ethanol
- Cas Number:
- 5274-63-5
- Molecular formula:
- C24H50O5
- IUPAC Name:
- 2-[2-[2-(2-hexadecoxyethoxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- CH3(CH2)17OH
- IUPAC Name:
- octadecan-1-ol
- Reference substance name:
- 2-(octadecyloxy)ethanol
- EC Number:
- 218-374-0
- EC Name:
- 2-(octadecyloxy)ethanol
- Cas Number:
- 2136-72-3
- Molecular formula:
- C20H42O2
- IUPAC Name:
- 2-(octadecyloxy)ethanol
- Reference substance name:
- 2-[2-(Octadecyloxy)ethoxy]ethanol
- EC Number:
- 605-213-8
- Cas Number:
- 16057-43-5
- Molecular formula:
- C22H46O3
- IUPAC Name:
- 2-[2-(Octadecyloxy)ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(Octadecyloxy)ethoxy]ethoxy]ethanol
- EC Number:
- 610-180-8
- Cas Number:
- 4439-32-1
- Molecular formula:
- C24H50O
- IUPAC Name:
- 2-[2-[2-(Octadecyloxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethanol
- Cas Number:
- 59970-10-4
- Molecular formula:
- C26H54O5
- IUPAC Name:
- 2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
- Cas Number:
- 71093-13-5
- Molecular formula:
- C28H58O6
- IUPAC Name:
- 2-[2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: The cell line used was obtained from the University of Leiden in 1987.
- Suitability of cells: Cell type selected is listed as one of the recommended cell types in OECD guideline 473.
- Normal cell cycle time: The cells have a generation time of approx. 12 h.
- Methods for maintenance in cell culture: The cells were grown as monolayers. Cells were trypsinised from stock flasks and resuspended in fresh culture medium at densities of 0. I x 10E6 or 0.05 x 10E6 cells/mL. These cells, in 5 mL volumes, were dispensed into tissue culture flasks. The high and low cell densities were for cultures harvested at 24 or 48 h post treatment respectively. The cultures were established approx. 20 h before testing.
MEDIA USED
- Type and composition: The basic medium (Ham's F-10) containing HEPES buffer, was supplemented with the antibiotic minocycline. For cell growth and treatment in the absence of S9 mix, foetal bovine serum (10% v/v) was added. The medium used for treatment in the presence of S9 mix and for washing cultures before or after treatment, was serum free.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats.
- method of preparation of S9 mix: S9 enzymes were prepared from the livers of adult, male Fischer rats. S9 was stored in sterile plastic tubes immersed in liquid nitrogen. To prepare S9 mix, Ham's F-10 was added to pre-weighed cofactors: nicotinamide adenine dinucleotide phosphate (NADP) disodium salt and glucose-6-phosphate (G-6-P) disodium salt, giving final concentrations in the S9 mix of NADP di-Na salt: 4 mM (3.150 mg/mL) and glucose-6-phosphate di-Na salt: 25 mM (7.605 mg/mL). This solution was immediately filter-sterilised by passage through a 0.2 pm disposable filter assembly and mixed 9:1 (v/v) with the S9.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Enzymic activity of each batch of S9 was characterised by testing selected pre-mutagens in an Ames test with S. typhimurium TA 1538. S9 batches used demonstrated, within each test, a satisfactory clastogenic response in cells treated with cyclophosphamide (CPI-I). - Test concentrations with justification for top dose:
- Test 1:
6 h exposure with metabolic activation, 24 h harvest: 313, 625, 1250*, 2500* and 5000* µg/mL
24 h exposure without metabolic activation, 24 h harvest: 1.25, 2.5, 5*, 10*, 20*, 39 and 78 µg/mL
Test 2:
6 h exposure with metabolic activation, 24 and 48 h harvest: 313, 625, 1250*, 2500* and 5000* µg/mL
24 h exposure without metabolic activation, 24 and 48 h harvest: 1.25, 2.5*, 5*, 10*, 20, 39 and 78 µg/mL
*: concentrations used for evaluation of chromosome aberrations
Justification for top dose: Dose levels were selected based on a preliminary experiment, in which the highest dose in the presence of S9 mix was 5000 µg/mL and the highest dose in the absence of S9 mix was 156 µg/mL- - Vehicle / solvent:
- - Vehicle/solvent: 1% ethanol
- Test formulation preparation: The test material was dissolved in ethanol and placed in a sonicating water bath for 30 min.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1% ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 6 and 24 h
- Harvest time: 24 and 48 h after beginning of treatment.
SPINDLE INHIBITOR:
0.1 µg/mL colcemid was added approx. 2 h prior to harvest.
SLIDE PREPRATION AND METAPHASE ANALYSIS:
- Methods of slide preparation and staining technique used including the stain used: Mitotic cells were harvested by gently tapping flasks to release these cells from the monolayer. Cells were sedimented by centrifugation (approx. 210 g) and treated with hypotonic solution (l% trisodium citrate) for 15 min at room temperature. The cells were then fixed using 4 mL of freshly prepared fixative (methanol:glacial acetic acid, 3:1). Two further changes of fixative were made. Slides were prepared by dropping the cell suspension on to clean, grease-free slides. For both experiments, 3 slides per culture were prepared.
- Number of cells spread and analysed per concentration: 200 (100 cells per culture)
- Criteria for scoring chromosome aberrations: Metaphases were assessed by light microscopy. The following structural aberrations were recorded: chromosome and chromatid breaks, gaps and fragments, complex structures such as exchanges, dicentric and rings, double minutes, uncondensed chromosomes, translocations, pulverised chromosomes, multiple aberrations. In addition, aneuploidy, endoreduplication and polyploidy were assessed.
- Determination of polyploidy: yes
- Determination of endoreplication: yes
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: From the cell counts, the number of cells recovered per culture, was calculated. This was compared with the number of cells (mean of 2 cultures) recovered from the vehicle control cultures. A dose level was considered to be toxic if die cell count was reduced to less dian 60% of the vehicle control cultures or if consistent evidence of changes to cell morphology was observed. - Evaluation criteria:
- Structural and numerical chromosomal aberrations were evaluated for lesions per cell, percentage of aberrant cells including cells with gaps only, percentage of aberrant cells excluding cells with gaps only, percentage of aneuploid cells and percentage of polyploid cells (normal and endoreduplicated) from additional assessment of ploidy.
A negative response was recorded if responses from the test material treated cultures are within the 95% confidence limits for historical negative controls. The response at a single dose was classified as significant if the percent of aberrant cells is consistently greater than the 99% confidence limits for a negative historical negative controls or greater than double the frequency of an elevated vehicle control or untreated culture if appropriate.
An experiment was positive if the response in at least the one acceptable dose level is significant by the criterion described above and is associated with an increase in aberrant cells in at least one other dose level. A test material was positive if both experiments were positive, as described above or if the second test was positive after the first test gave indications of activity. These indications may be suspicious levels of aberrant cells (benveen 95% and 99% confidence limits) at extreme or sub toxic dose levels.
An inconclusive response was recorded for experiments that met, in part or marginally, the criteria for a positive response.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the absence of S9 mix, cultures treated with 20-156 µg/mL (Test 1) and 10-78 µg/mL (Test 2) were judged to be toxic.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: The test substance did not change the colour of the culture medium, therefore no pH measurements were made.
- Data on osmolality: During the first test, the osmolality of selected concentrations of the test material was measured. The test substance did not affect the osmolality of the culture medium, therefore no further measurements were made.
- Precipitation and time of the determination: Observations of precipitation were made before cultures were washed out at the end of the treatment period. Cloudy solutions were noted in cultures treated with 78-156 µg/mL and lumps of precipitate were observed in cultures treated with 313-5000 µg/mL.
STUDY RESULTS:
STRUCTURAL CHROMOSOMAL ABERRATIONS RESULTS
In general, cultures treated with the test substance had levels of structural aberrations within the confidence limits of a negative response. There were 2 exceptions. In Test 2, with S9 mix, there were 2 cultures with suspicious levels of aberrant cells excluding gaps. As these responses were not reproduced in duplicate cultures or dose related, they were considered sporadic.
All vehicle and untreated control cultures had levels of structural aberrations within the 95% confidence limit of the historical negative control data. The positive control substances, CPH in the presence and MMS in the absence of S9 mix, induced structural aberrations. These results demonstrated the sensitivity of the test system.
NUMERICAL ABERRATIONS
An additional assessment of polyploidy was carried out in cultures harvested at 48 h. In the absence of S9 mix, both cultures treated with 10 µg/mL had positive responses and the cultures treated with 5 µg/mL had one positive and one suspicious response. There was an unusually high level of endoreduplicated cells in one of the cultures treated with 10 µg/mL. In the presence of S9 mix, one of the untreated control cultures had a slightly elevated incidence of polyploidy. A doubling over the elevated result was required to judge a culture as positive. There was no induction of polyploidy in the presence of S9 mix.
CYTOTOXICITY:
The test substance was found to be non-toxic to CHO cells in vitro when tested in the presence of S9 mix. In the absence of S9 mix, cultures treated with 20-156 µg/mL (Test 1) and 10-78 µg/mL (Test 2) were judged to be toxic. Toxicity was evident from reduced cell counts (< of vehicle control) and changes in the cell morphology. The toxicity in the absence of S9 mix may have been due to the longer exposure time.
HISTORICAL CONTROL DATA:
The solvent and the positive controls showed the expected results and the obtained values remained within the historical control data. For details on the historical control data please refer to the tables under “Attached background material”.
Any other information on results incl. tables
Detailed additional information is provided under 'Attached background material'.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the test item did not induce chromosomal aberrations in Chinese Hamster Ovary (CHO) cells in the presence or absence of metabolic activation.
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