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EC number: 442-520-4 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 15th to July 31st, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- Version / remarks:
- Adopted July 21st, 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Yellow 6314-PPT
- IUPAC Name:
- Yellow 6314-PPT
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- On the day of the experiment (immediately before treatment), the test item was dissolved in DMSO. The fìnal concentration of DMSO in the culture medium was 0.5 % (vlv).
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fractions of rats, induced with phenobarbital/beta-naphthoflavone
- Test concentrations with justification for top dose:
- Concentration in the main test I (with metabolic activation): 6.3, 12.5, 25.0, 50.0, 75.0, 100.0 μg/ml – Precipitation interval: 18h, exposure: 4h.
Concentration in the main test II (with metabolic activation): 6.3, 12.5, 25.0, 50.0, 75.0, 100.0 μg/ml – Precipitation interval: 28h, exposure: 4h.
Concentration in the main test I (without metabolic activation): 1.3, 2.5, 5.0, 10.0, 20.0, 30.0 μg/ml – Precipitation interval: 18h, exposure: 4h.
Concentration in the main test II (without metabolic activation): 0.3, 0.6, 1.3, 2.5, 5.0, 10.0 μg/ml – Precipitation interval: 18h, exposure: 18h.
Concentration in the main test II (without metabolic activation): 1.3, 2.5, 5.0, 10.0 μg/ml – Precipitation interval: 28h, exposure: 28h. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- The test item, dissolved in DMSO, was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in two independent experiments. Following study design was performed:
- without metabolic activation:
experiment I with exposure period 4h, recovery 14h and preparation interval 18h.
experiment II with exposure period 18h and preparation interval 18h.
experiment II with exposure period 28h and preparation interval 28h.
- with metabolic activation:
experiment I with exposure period 4h, recovery 14h and preparation interval 18h.
experiment II with exposure period 4h, recovery 24h and preparation interval 28h.
ln each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations. The highest applied concentration in the pre-test on toxícity (250 μg/ml) was chosen with regard to the solubility properties of the test item in DMSO. Dose selection of the cytogenetic experiments was performed considering the toxicity data and the occurrence of precipitation.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Toxic effects indicated by reduced cell numbers of about and below 50 % of control were observed in experiment I and ll at preparation interval 18 hrs in the absence of S9 mix and in experiment ll at preparation interval 28 hrs in the presence of S9 mix.
Besides in experiment I after 4 hrs treatment in the presence of S9 mix and in experiment ll after 28 hrs continuous treatment in the absence of S9 mix, concentrations showing clearly reduced cell numbers were not evaluable for cytogenetic damage.
ln both independent experiments, neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No relevant increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls.
Appropriate mutagens were used as positive controls.
They induced statistically significant increases (p < 0.05) in cells with structural chromosome aberrations.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions reported, the test item did not induce structural chromosome aberrations in vitro. Therefore, the test item is considered to be non-clastogenic in this chromosome aberration test neither with nor without S9 mix.
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