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EC number: 310-080-1 | CAS number: 102242-49-9 The complex residue resulting from the vacuum distillation of C6-24 fatty alcohols which is derived from hydrogenation of C6-24 fatty acids methyl esters. It consists predominantly of satd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
- 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 / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline 487 under GLP
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:
- other: OECD Guideline 487 (In Vitro Mammalian Cell Micronucleus Test )
- Deviations:
- yes
- Remarks:
- minor changes to culture conditions with no impact on study outcome
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Alcohols, C6-24, distn. residues
- EC Number:
- 310-080-1
- EC Name:
- Alcohols, C6-24, distn. residues
- Cas Number:
- 102242-49-9
- Molecular formula:
- Not available for this UVCB (see Remarks)
- IUPAC Name:
- Alcohols, C6-24, distn. residues
- Details on test material:
- - Name of test material (as cited in study report): C-SAT 100018
- Analytical purity: 100%
- Lot/batch No.: CF00460029
- Expiration date of the lot/batch: February 26, 2011
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- without S9 mix: 4.5, 7.8, 13.6, 23.9, 41.8, 73.1, 127.9, 223.9, 391.8, 685.7, 1200, 2100 µg/ml
with S9 mix: 13.6, 23.9, 41.8, 73.1, 127.9, 223.9, 391.8, 685.7, 1200, 2100 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: THF (tertahydrofuran)
- Justification for choice of solvent/vehicle: solubility properties and its relative non-toxicity to the cell cultures
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without S9: Demecolcin and Mitomycin C; with S9: cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 and 20h
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 1000
DETERMINATION OF CYTOTOXICITY
- Method: Cytokinesis-block proliferation index - Evaluation criteria:
- A test item can be classified as non-mutagenic if:
- the number of micronucleated cells in all evaluated dose groups is in the range of the laboratory’s historical control data and
- no statistically significant or concentration-related increase in the number of micronucleated cells is observed.
A test item can be classified as mutagenic if:
- the number of micronucleated cells is not in the range of the historical laboratory control data and
- either a concentration-related increase of micronucleated cells in three test groups or a statistically significant increase of the number of micronucleated cells is observed. - Statistics:
- Chi-square test
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In a test according to OECD Guideline 487 under GLP, the test substance was negative (with and without metabolic activation) as it did not induce micronuclei in human lymphocytes in vitro. - Executive summary:
The test substance, dissolved in THF, was assessed for its potential to induce micronuclei in human lymphocytes in vitro in the absence and presence of metabolic activation by S9 mix acc. to OECD guideline 487 under GLP.
Two independent experiments were performed. In Experiment I, the exposure period was 4 hours with and without S9 mix. In Experiment II, the exposure periods were 4 hours with S9 mix and 20 hours without S9 mix. The chromosomes were prepared 40 hours after start of treatment with the test item.
In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were scored for cytogenetic damage on coded slides. To determine a cytotoxic effect the CBPI was determined in approximately 500 cells per culture and cytotoxicity is described as % cytostasis.
The highest treatment concentration in this study, 2100.0 µg/mL was chosen with regard to the solubility properties of the test item and with respect to the current OECD Draft Guideline 487 for the in vitro mammalian cell micronucleus test.
In Experiment I, visible precipitation of the test item in the culture medium was observed at 13.6 µg/mL and above in the absence of S9 mix and at 73.1 µg/mL and above in the presence of S9 mix at the end of treatment. In addition, precipitation occurred in Experiment II, in the absence of S9 mix, at 23.9 µg/mL and above and in the presence of S9 mix at 73.1 µg/mL and above at the end of treatment. No relevant influence in the osmolarity or pH value was observed.
In this study, at both preparation intervals, in the absence as well as in the presence of S9 mix, no biologically relevant cytotoxicity indicated by a clearly CBPI expressed as cytostasis could be observed.
In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying micronuclei was observed. The micronucleus rates of the cells after treatment with the test item (0.2 -1.0 % micronucleated cells) were close to the range of the solvent control values (0.55 - 0.9 % micronucleated cells) and within the range of the laboratory´s historical control data. In Experiment II in the absence of S9 mix, one single value slightly exceeded this range (0.45 % micronucleated cells), but since no statistical significance is observed this finding is considered as being biologically irrelevant.
In both experiments, either Demecolcin (100 ng/mL), MMC (1.0 µg/mL) or CPA (12.5 µg/mL) were used as positive controls and showed distinct increases in cells with micronuclei.
In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce micronuclei in human lymphocytesin vitro,when tested up to precipitating concentrations.
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