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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 943-382-2 | CAS number: -
- 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:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- Since January 27, 1992 to May 29, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Similar substance 2
- IUPAC Name:
- Similar substance 2
Constituent 1
Method
- Target gene:
- no data
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- without S9 mix:
0.30; 1.00; 2.50 mg/ml
with S9 mix:
0.10; 0.30; 1.00 mg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
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 S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: MEM medium supplemented with 10 % fetal calf serum
DURATION
- Exposure duration: 18h, 28h
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 5 x 10^4 - 1x 10^5 - Evaluation criteria:
- A test article is classified as mutagenic if it induces either a concentration-related increase in the number of structural chromosomal aberrations or a significant positive response for at least one of the test points.
A test article producing neither a concentration-related increase in the number of structural chromosomal aberrations nor a significant positive response at any one of the test points is considered non-mutagenic in this system.
This can be confirmed by means of the chi-square test. However, both biological and statistical significance should be considered together.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
The test article precipitated in the culture medium (macroscopically visible) with concentrations of 1.00 mg/ml and higher (with and without S9 mix). A precipitation (microscopically visible) could be observed at concentrations of 0.10 mg/ml and higher (fixation interval 18 h, with and without S9 mix) and did not allow appropriate evaluating of metaphases after treatment with the highest concentration used (5.00 mg/ml). At fixation interval 28 h precipitation was found at concentrations of 0.30 mg/ml and higher (without S9 mix) and 1.00 mg/ml and higher (with S9 mix). - 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 conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article did not induce structural chromosome aberrations as determined by the chromosomal aberration test in the V79 Chinese hamster cell line. Therefore, the substance is considered to be non-mutagenic in this chromosomal aberration test. - Executive summary:
The test article was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro. Preparation of chromosomes was done 18 h (low, medium and high concentration rate), and 28 h (high concentration rate) after start of treatment with the test article which was dissolved in distilled water. The treatment interval was 4 h.
In each experimental group two parallel cultures were used. Per culture 100 metaphases were scored for structural chromosomal aberrations except for the positive control culture where 25 metaphases were scored. The following concentrations were evaluated:
without S9 mix:
18 h: 0.30; 1.00; 2.50 mg/ml
28 h: 2.50 mg/ml
with S9 mix:
18 h: 0.10; 0.30; 1.00 mg/ml
28 h: 1.00 mg/ml
As requested by the sponsor and according to recommendations in several guidelines the highest concentration of the test article administered was 5.00 mg/ml. A plating efficiency assay as indicator for toxicity response was performed in a former study of CCR (Project no: 131523).
A precipitation of the test article occured from concentrations of 0.10 mg/ml and did not allow appropriate evaluation of the highest concentration used (5.00 mg/ml). In the absence of S9 mix the mitotic index was reduced at both fixation intervals at the highest concentration scored (2.50 mg/ml). In presence of S9 mix at fixation interval 18 h a concentration dependend decrease of mitotic index was found at concentrations higher than 0.10 mg/ml. A steep increase in toxicity of the test article in the concentration range 1.00 - 2.50 mg/ml at both fixation intervals and in presence of S9 mix prevented the evaluation of cultures treated with concentrations higher than 1.00 mg/ml. There was no relevant increase in cells with structural aberrations after treatment with the test article at each fixation interval either without or with metabolic activation by S9 mix. Appropriate reference mutagens were used as positive controls and showed distinct increases in cells with structural chromosome aberrations.
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