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EC number: 473-730-4 | CAS number: 928768-73-4
- 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:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 473-730-4
- EC Name:
- -
- Cas Number:
- 928768-73-4
- Molecular formula:
- C13H28SO3
- IUPAC Name:
- 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol
- Test material form:
- liquid: viscous
- Details on test material:
- Batch number: 20074-10142005
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Test concentrations with justification for top dose:
- Short Term Treatment Test - Experiment 1
Group Final Concentration of Test Material (µg/ml)
6(18)-hour without S9 0*, 10.31 ,20.63*, 41.25*, 82.5*, 123.75, 165, MMC 0.1 *
6(18)-hour with S9 0*, 20.63,41.25*, 82.5*, 165*, 247.5, 330, CP 5.0*
Continuous Treatment Test - Experiment 2 and Short Term
Group Final Concentration of Test Material (µg/ml)
24-hour 0*, 5.15, 10.31*, 20.63*, 30.94*, 41.25*, 82.5 MMC 0.05*
6(18)-hour with S9 0*, 10.31,20.63*, 41.25*, 82.5*, 165,247.5, CP 5.0*
* Dose levels selected for metaphase analysis
MMC = mitomycin C
CP = cyclophosphamide
- Details on test system and experimental conditions:
- The Chinese Hamster Lung (CHL, also known as CHL/IU) cell line, isolated by Koyama et al (1970) and cloned by Ishidate and Sofbni (1985), was used. The CHL cell line has an average generation time of approximately 17 hours when growing under normal experimental conditions.
Cells were grown in Eagle's Minimal Essential Medium (MEM) with HEPES buffer and Earle's Salts and supplemented "in-house" with 10% foetal bovine serum and antibiotics, at 37°C with 5% C02 in air.
Cultures were established 16 to 72 hours prior to treatment using the appropriate number of cells per flask depending on the pre-exposure culture period. The cells were exposed to at least three doses of the test material, vehicle and positive controls both with and without metabolic activation. All exposures were performed in duplicate (A + B) and cultures were maintained at 37°C in a humidified atmosphere of 5% C02 in air. - Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Key result
- Species / strain:
- mammalian cell line, other: Chinese Hamster Lung (CHL, also known as CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material did not induce any statistically significant, dose-related increases in the frequency of cells with structural or numerical chromosome aberrations either in the presence or absence of a liver enzyme metabolising system or after various exposure times. The test material was therefore considered to be non-clastogenic to CHL cells in vitro. - Executive summary:
The test material did not induce any statistically significant, dose-related increases in the frequency of cells with structural or numerical chromosome aberrations either in the presence or absence of a liver enzyme metabolising system or after various exposure times. The test material was therefore considered to be non-clastogenic to CHL cells in vitro.
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