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EC number: 423-270-5 | CAS number: 164462-16-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM supplemented with 10 % FCS
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically checked for plating efficiency: yes
- Cell cycle duration: 13-14 h
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix extracted from Aroclor activated rat livers
- Test concentrations with justification for top dose:
- Pretest: 1; 5; 10; 50; 100; 500; 1000; 3000 µg/ml with and without S-9 mix
1. experiment: 900; 1800; 2700 µg/ml with and without S-9 mix
2. experiment: 1800; 2250; 2700 µg/ml without S-9 mix - Vehicle / solvent:
- Due to the good solubility of the test substance in water, the aqueous culture medium (MEM) was selected as the vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without S-9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S-9 mix
- Details on test system and experimental conditions:
- DETAILS OF 1. and 2. EXPERIMENT:
METHOD OF APPLICATION: in medium
DURATION
- Attachment period: 24-30 h
- Exposure duration: 4 h with or without S-9 mix
- Expression time (cells in growth medium): 14 h
- Fixation time (start of exposure up to fixation or harvest of cells): ~ 18 h
The 2nd harvest time of 28 hours generally conducted was omitted due to the clear clastogenic effect of the pretest.
SPINDLE INHIBITOR (cytogenetic assays): Colcemid dissolved in PBS
STAIN (for cytogenetic assays): Giemsa and Titrisol pH 7.2
NUMBER OF REPLICATIONS: 2 per dose
NUMBER OF CELLS EVALUATED: 50-200 metaphase cells depending on the incidence of chromosomally damaged cells
CHROMOSOMAL ANALYSIS
- Method: Structural and numerical chromosomal aberrations
DETERMINATION OF CYTOTOXICITY
-Method: cell counts, morphology, mitotic index
OTHER EXAMINATIONS:
- Treatment conditions: pH, osmolality, solubility of test substance (microscopically)
TEST SUBSTANCE ANALYSIS
The stability of the test substance throughout the study period will be proven by reanalysis at a later date. The homogeneity of the test substance was guaranteed by mixing before preparation of the test substance formulations. The stability of the test substance in water was determined analytically. - Statistics:
- - statistical evaluation: MUCHAN program system (BASF AG).
- comparison of dose groups with control data: Fisher's exact test; correction using one-sided Bonferri-Holm test
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Remarks:
- chelating properties of test substance may be causative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S-9 mix at 2700 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH remained unchanged during the experiments (pH 7.4 - 7.8)
- Effects of osmolality: Osmolality remained unchanged.
- Water solubility: test substance completely soluble
- Precipitation: not observed.
RANGE-FINDING/SCREENING STUDIES:
Only the highest dose of 3,000 µg/mL exhibited chromosomal aberrations with a high proportion and a weakly toxic effect (weak suppression of the mitotic activity, decrease in the cell count, reduced cell attachment). Thus, according to the findings of the pretests and in agreement with current guidelines, 2,700 µg/mL (both with and without S-9 mix) were selected as top doses. Higher doses were not tested to avoid concentrations which may lead to artefactual chromosome breakage.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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