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EC number: 229-186-3 | CAS number: 6424-76-6
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jan 2016-19 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- EC Number:
- 229-186-3
- EC Name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- Cas Number:
- 6424-76-6
- Molecular formula:
- C36H18O4
- IUPAC Name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Vat Blue 16
Constituent 1
Method
- Target gene:
- The test item Vat Blue 16 was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured
by reversion of auxotrophic strains to prototrophy.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver homogenate from induced rat ( rat mixed induction).
- Test concentrations with justification for top dose:
- In Main Assay I : 1250, 625, 313, 156 and 78.1 µg/plate.
In Main Assay II : 625, 313, 156, 78.1 and 39.1 µg/plate. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Toxicity and Main Assay I were perfomed using the plate incorporation method.
Main Assay II was perfomed using pre-incubation method. - Evaluation criteria:
- For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at
the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies
with increasing dose levels. - Statistics:
- Doubling rate (Chu et al. 1981).
Regression line.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test item did not induce two-fold increases in the number of revertant colonies, at any dose level, in any tester strain, in the absence or presence of S9 metabolism.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the test item Vat Blue 16 does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
- Executive summary:
The test item Vat Blue 16 was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy. The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with Phenobarbital and 5,6-Benzoflavone. The test item was used as a solution in dimethylsulfoxide (DMSO).
Toxicity test : Based on results obtained in a preliminary solubility trial, the test item Vat Blue 16 was assayed in the toxicity test at a maximum concentration of 1250 µg/plate and at four lower concentrations spaced at approximately half-log intervals: 395, 125, 39.5 and 12.5 µg/plate. No toxicity nor increases in revertant colonies were observed with any tester strain, at any dose level, in the absence or presence of S9 metabolic activation. Precipitation of the test item was observed at the end of the incubation period, with all tester strains, at the highest dose level tested, both in the absence and presence of S9 metabolism.
Main Assay I : On the basis of toxicity test results, in Main Assay I, using the plate incorporation method, the test item was assayed at the following dose levels: 1250, 625, 313, 156 and 78.1 µg/plate in the absence or presence of S9 metabolism. No toxicity was observed with any tester strain at any dose level, in the absence or presence of S9 metabolism. Precipitation of the test item was observed at the end of the incubation period, with all tester strains, at the highest dose level tested, both in the absence and presence of S9 metabolism.
Main Assay II : As no relevant increase in revertant numbers was observed at any concentration tested, a pre-incubation step was included for all treatments of Main Assay II. As limited by the maximum feasible concentration in DMSO, the test item was assayed at the following dose levels: 625, 313, 156, 78.1 and 39.1 µg/plate. No toxicity was observed with any tester strain, at any dose level, in the absence or presence of S9 metabolism. No precipitation of the test item was observed at the end of the incubation period at any concentration.
Conclusion : It is concluded that the test item Vat Blue 16 does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
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