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Reaction mass of copper complex of [(2,6-difluoroheterocycl-4-yl)amino]hydroxy{[2-hydroxy-3-sulfonato-5-(vinylsulfonyl)phenyl]diazenyl}naphthalene sulfonic acid, dialkali salt and copper complex of [(2,6-difluoroheterocycl-4-yl)amino]-hydroxy{[2-hydroxy-3-sulfonato-5-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl]diazenyl}naphthalene sulfonic acid, trialkali salt
EC number: 479-550-2 | 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 DNA damage and/or repair study
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 20-Mar-2001 to 27-May-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study on structural analogue
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.18 (DNA Damage and Repair - Unscheduled DNA Synthesis - Mammalian Cells In Vitro)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5550 - Unscheduled DNA Synthesis in Mammalian Cells in Culture
- GLP compliance:
- yes
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
Test material
- Test material form:
- other: solid
- Details on test material:
- see below
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- hepatocytes: primary, male rats
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 5000.0,3000.0, 1000.0, 300.0, 100.0,30.0, 10.0, 3.0, 1.0, 0.3 and 0.1 ug/ml
- Vehicle / solvent:
- not necessary because the test substance was dissolved/suspended directly into the test system (cell culture medium)
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated control
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: Approximately 5 x 105 cells were seeded in a 35 mm culture dish, allowed to attach for approx. 2 hours and exposed to the test and control compound for 16 - 20 hours at 37 degrees C.
- Selection time (if incubation with a selection agent): After incubation the test substance was replaced by a 0.5 % neutral red solution, which was allowed to incubate for approx. four hours.
Survival was determined by photometric measurement of the neutral red extinction. - Evaluation criteria:
- Criteria for a positive response:
-If the net nuclear grain number was at least five grains higher than the corresponding solvent control value, the results for that dose were considered significant.
-The test compound is classified as genotoxic if it reproducibly induces with one of the test compound concentrations a significant increase in ['H] thymidine incorporation in comparision with the solvent control.
- The test compound is classified as genotoxic if there is a reproducible significant concentration related increase in ['H] thymidine incorporation in cornparision with the solvent control.
-In the final instance, however the interpretation of the results were based on scientific judgement.
Results and discussion
Test results
- Species / strain:
- hepatocytes: primary male rat
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 300 µg/ml
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- In a preliminary experiment for solubility, the test was studied with respect to its solubility in hepatocyte attachment medium. The highest concentration at which no visible precipitation was observed, was 5000.0 ug/ml. Based on these results 5000.0 ug/ml was determined as maximum dose level for the main assays and ten lower concentrations were included in the treatment series. In both experiments cytotoxicity could not be determined with the neutral red assay, as death cells incorporated the dark blue test compound which disturbed the photometric measurement of neutral red. Microscopic examination of the hepatocyte cultures showed dark blue incorporation of the test substance in all hepatocyte nuclei at the concentrations of 5000.0, 3000.0, 1000.0 and 300.0 ug/ml as a sign of heavy cytotoxicity and a very low survival rate. Therefore these concentrations were excluded from the evaluation of genotoxicity. A dose range of seven concentrations from 0.1 to 100.0 ug/ml was used.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Teh test item is not genotoxic as determined by the in vitro UDS test in primary rat hepatocytes. - Executive summary:
In an unscheduled DNA synthesis assay, primary rat hepatocyte cultures were exposed to the test item in cell culture medium at concentrations of 5000.0, 3000.0, 1000.0, 300.0, 100.0,30.0, 10.0, 3.0, 1.0, 0.3 and 0.1 ug/ml for 16-20 hours.
The test item was tested up to the limit concentration, 5000 ug/ml. However, microscopic examination of the hepatocyte cultures in a preliminary range finding experiment showed dark blue incorporation of the test substance in all hepatocyte nuclei at the concentrations of 5000.0, 3000.0, 1000.0 and 300.0 ug/ml as a sign of heavy cytotoxicity and a very low survival rate. Therefore these concentrations were excluded from the evaluation of genotoxicity. A dose range of seven concentrations from 0.1 to 100.0 ug/ml was used. The positive controls induced the appropriate response. There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures was induced.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 482 for DNA damage and/or repair.
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