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EC number: 271-234-0 | CAS number: 68526-85-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 473: GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- isodecanol
- IUPAC Name:
- isodecanol
- Reference substance name:
- Alcohols, C9-11-branched and linear, C10-rich
- EC Number:
- 298-696-6
- EC Name:
- Alcohols, C9-11-branched and linear, C10-rich
- Cas Number:
- 93821-11-5
- IUPAC Name:
- C9-11, C10-rich branched alkyl alcohol
- Details on test material:
- - Name of test material (as cited in study report): Isodecanol Test results for CAS number 93821 -11 -5 are reported as the source substance. This is the previous CAS number for the Alcohols C9 -C11 -iso, C10 rich: isodecanol (Exxal 10) before harmonization of the CAS numbers. CAS number 68526 -85 -2 and 93821 -11 -5 refer to the same substance (i. e. Exxal 10).
- Substance type: colorless liquid
- Physical state: liquid
- Analytical purity: >99% wt total alcohol
- Lot/batch No.: 60917T1602
- Stability under test conditions:
- Storage condition of test material: ambient temperature, protected from light
- Specific gravity: 0.836-0.840 kg/l at 20C
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham’s F-12 with Glutamax-I supplemented with heat-inactivated fetal calf serum (10%), penicillin (100 IU/ml) and streptomycin (100 ug/ml)
- Properly maintained: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of Aroclor induced male rat liver
- Test concentrations with justification for top dose:
- Test 1 (5, 10, 20, 30, 40, 80, or 160 ug/ml)
Test 2 (5, 10, 20, 30, 40, 50, 60, 70, 80, 100 ug/ml) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Substrate soluble
- Stock solution – 50 mg/ml
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO alone
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C (without S9) or cyclophosphamide (with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Cells were seeded in sterile, screw-capped tissue culture flasks (surface area 25 cm2; 120,000 cells per flask). Test substance was added to the flask with or without S9 fraction.
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 14 hours
NUMBER OF REPLICATIONS:
- 2 replicate flasks
NUMBER OF CELLS EVALUATED:
- At least 1000 nuclei
STAIN
- Giemsa
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- The study was considered valid if the positive controls give a statistically significant increase in the number of aberrant cells and the negative controls are within the historical range.
A response is considered to be positive if a concentration-related increase or a reproducible increase in the number of cells with structural chromosomal aberrations is observed.
A response is considered to be equivocal if the percentage of cells with structural chromosomal aberrations is statistically higher than that of the negative control.
A test substance is considered clastogenic if a concentration-related increase in the percentage of cells with structural chromosomal aberrations over the concurrent control frequencies is observed, or if a single positive test point is observed in both tests at approximately the same dose level.
A test substance is considered to be negative in the chromosomal aberrations test if it produces neither a dose-related increase in the number of structural chromosomal aberrations nor a reproducible positive response at any of the test points. - Statistics:
- Data were analyzed by the Fisher’s exact probability test (two-sided) to determine significant differences between treated and control cultures.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Test #1 (80 and 160 ug/ml) Test #2 (80 and 100 ug/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Test #1 - The test substance did not induce a statistically significant increase in the number of aberrant cells at any of the dose levels tested; with or without metabolic activation.
Test #2 - The test substance did not induce a statistically significant increase in the number of aberrant cells at any of the dose levels tested; with or without metabolic activation. The mitotic indices of 50 and 60 ug/ml were clearly reduced to 38% and 52%, respectively of that of the concurrent control. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
The mammalian chromosomal aberration test to assess the genotoxicity of isodecanol was negative. - Executive summary:
Isodecanol was examined for its potential to induce structural chromosomal aberrations in Chinese Hamster Ovary (CHO) cells, in both the presence and absence of an S9 metabolic activation system. Two separate chromosomal aberration tests were performed and only differed by the maximum dose tested. The doses were: Test 1 (5, 10, 20, 30, 40, 80, or 160 ug/ml), Test 2 (5, 10, 20, 30, 40, 50, 60, 70, 80, 100 ug/ml). Isodecanol did not induce a statistically significant increase in the number of cells with structural chromosomal aberrations at any of the doses chosen with or without metabolic activation; significant cytotoxicity was noted above 80 ug/ml. Under the conditions in this study, isodecanol was cytotoxic but not a clastogenic agent for CHO cells.
The mammalian chromosomal aberration test to assess the genotoxicity of isodecanol was negative.
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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