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Diss Factsheets
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EC number: - | 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 July 2014 to 20 Oct 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant with GLP and testing guideline, coherence among data, results and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial gene mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Brown DYHY 0331/0334
Constituent 1
Method
- Target gene:
- The test item Reactive Brown DYHY0331/0334 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) or uninduced Syrian hamster (Prival modification)
- Test concentrations with justification for top dose:
- In Main Assay I and II: 5000, 2500, 1250, 625 and 313 µg/plate.
- Vehicle / solvent:
- sterile water for injection
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, Trypan Blue
- Details on test system and experimental conditions:
- Toxicity and Main Assay I were performed using the plate incorporatin method; Main assay II using the pre-incubaton 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
- 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
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No relevant increase in the number of revertant colonies was observed in the plate incorporation or pre-incubation assay, at any dose level, with any tester strain, in the absence or presence of any S9 metabolic activation system.
- 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
It is concluded that the test item, Reactive Brown DYHY0331/0334, 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 Reactive Brown DYHY0331/0334 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. In the preliminary toxicity test and in Main Assay I, treatments were performed using the plate incorporation method in the absence and presence of a cofactor-supplemented S9 metabolic fraction prepared from the livers of rats treated with phenobarbitone and b-naphthoflavone. Based on the chemical structure of the test item (azodyes), Main Assay II was performed using the preincubation method and a reductive metabolic activation system (Prival modification).
The test item was used as a solution in sterile water for injection.
The test item Reactive Brown DYHY0331/0334 was assayed in the toxicity test at a maximum concentration of 5000 μg/plate and at four lower concentrations spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 μg/plate. No toxicity was observed with any tester strain at any dose level, in the absence or presence of S9 metabolism. Plates treated with the test item presented a dose dependent black colour of the agar, which did not interfere with the scoring of colonies.
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: 5000, 2500, 1250, 625 and 313 μg/plate.
No toxicity was observed with any tester strain at any dose level, in the absence or presence of S9 metabolism. Plates treated with the test item presented a dose dependent black colour of the agar, which did not interfere with the scoring of colonies.
As no relevant increase in revertant numbers was observed at any concentration tested, a Main Assy II was performed using the pre-incubation method in the presence of flavin mononucleotide and uninduced hamster liver S9.
The dose-range used was the same as in Main Assay I.
No toxicity was observed with any tester strain at any dose level, in the absence or presence of S9 metabolism. Plates treated with the test item presented a dose dependent black colour of the agar, which did not interfere with the scoring of colonies.
The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of any metabolic activation system metabolism.
It is concluded that, under the reported experimental conditions, the test item Reactive Brown DYHY0331/0334 does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of the standard S9 metabolic activation or using a reductive metabolic activation, as described by Prival and Mitchell for azo-dyes.
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.
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