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EC number: 269-941-4 | CAS number: 68391-30-0
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON Basic Red 76
- Author:
- Scientific Committee on Consumer Safety SCCS
- Year:
- 2 011
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS - adopted at its 10th plenary meeting of 22 March 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- [7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride
- EC Number:
- 269-941-4
- EC Name:
- [7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 68391-30-0
- Molecular formula:
- C20H22ClN3O2
- IUPAC Name:
- 7-hydroxy-8-[(2-methoxyphenyl)diazenyl]-N,N,N-trimethylnaphthalen-2-aminium chloride
- Reference substance name:
- Basic Red 76
- IUPAC Name:
- Basic Red 76
- Details on test material:
- Details on test materialName of test material (as cited in study report): Basic Red 76Molecular formula (if other than submission substance): C20H22N3O2 ClMolecular weight (if other than submission substance): 371.86g/molSubstance type: Organic Physical state: SolidPurity: 98.6% HPLC Impurities (identity and concentrations): water content = 4.1%(w/w); Monomethyl sulphate 15.9% (w/w); o-anisidine = 19ppm; Chloromethane = 0.3% (w/w); Methyl acetate = 0.1% (w/w); Methyl formate = 0.4% (w/w); 7-Hydroxy-N,N,N-trimethyl-napthalen-2-aminium chloride = <500 ppm (detection limit); Sulphated ash 0.3% (w/w); Chloride 2.7% (w/w); Sodium = 190 ppm
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9-fraction from phenobarbital/β-naphthoflavone-induced rats was used as exogenous metabolic activation system.
- Test concentrations with justification for top dose:
- experiment I: 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate without and with S9-mixexperiment II: 33, 100, 333, 1000, 2500 and 5000 μg/plate without and with S9-mix
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: in accordance with the OECD guideline
- Details on test system and experimental conditions:
- Details on test system and conditionsMETHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper diskExperiment I was performed according to the direct plate incorporation test, experiment II with the pre-incubation method.DURATIONPreincubation period: 60 minutes Exposure duration: 48 hours incubation with and without S9 mixNUMBER OF REPLICATIONS: triplicates in 2 individual experimentsNUMBER OF CELLS EVALUATED: No dataDETERMINATION OF CYTOTOXICITYMethod: mitotic index; cloning efficiency; relative total growth; other: No dataOTHER EXAMINATIONS:Determination of polyploidy: No dataDetermination of endoreplication: No dataOther:experiment I: direct plate incorporation with 48 h incubation without and with S9-mixexperiment II: pre-incubation method with 60 minutes pre-incubation and at least 48 h incubation without and with S9-mixTest concentrations were based on the results of a pre-experiment with strains TA98 and TA100 for toxicity and mutation induction both without and with S9-mix. Toxicity was evaluated for 8 concentrations up to the prescribed maximum concentration of 5000 μg/plate on the basis of a reduction in the number of revertant colonies and/or clearing of the bacterial background lawn. Becauserelevant toxic effects were not observed in any of the strains at the maximal concentration, 5000 μg/plate was used as the top concentration. Since in this pre-experiment evaluable plates were obtained for five concentrations or more in the strains used, the pre-experiment is reported in experiment I.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:Test concentrations were based on the results of a pre-experiment with strains TA98 and TA100 for toxicity and mutation induction both without and with S9-mix. Toxicity was evaluated for 8 concentrations up to the prescribed maximum concentration of 5000 μg/plate on the basis of a reduction in the number of revertant colonies and/or clearing of the bacterial background lawn. Because relevant toxic effects were not observed in any of the strains at the maximal concentration, 5000 μg/plate was used as the top concentration.
- 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):negativeBasic Red 76 was investigated for the induction of gene mutations in strains of Salmonella typhimurium (Ames test).In the main tests toxic effects evident as clearing of the bacterial background lawn were observed in experiment I in TA98 and TA100 and in experiment II in all strains predominantly at higher concentrations. Toxic effects evident as a reduction in the number of revertants were observed at higher concentrations without and with metabolic activationin nearly all strains tested. A biologically relevant increase in revertant colonies was not observed in any of the strains tested at any dose level in the absence or presence of S9-mix in both experiments.Under the experimental conditions used, Basic Red 76 was not mutagenic in this gene mutation tests in bacteria both in the absence and the presence of S9 metabolic activation.
- Executive summary:
Basic Red 76 was investigated for the induction of gene mutations in strains ofSalmonella typhimurium(Ames test).
Salmonella typhimuriumTA98, TA100, TA102, TA1535 and TA1537 were used for the AMES assay. DMSO was used as a vehicle.
Concentration: experiment I: 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate without and with S9-mix
experiment II: 33, 100, 333, 1000, 2500 and 5000 μg/plate without
and with S9-mix
Treatment: experiment I: direct plate incorporation with 48 h incubation without and with S9-mix
experiment II: pre-incubation method with 60 minutes pre-incubation
and at least 48 h incubation without and with S9-mix
Liver S9-fraction from phenobarbital/β-naphthoflavone-induced
rats was used as exogenous metabolic activation system. Test concentrations were based on the results of a pre-experiment with strains TA98 and TA100 for toxicity and mutation induction both without and with S9-mix. Toxicity was evaluated for 8 concentrations up to the prescribed maximum concentration of 5000 μg/plate on the basis of a reduction in the number of revertant colonies and/or clearing of the bacterial background lawn. Because relevant toxic effects were not observed in any of the strains at the maximal concentration, 5000 μg/plate was used as the top concentration. Since in this pre-experiment evaluable plates were obtained for five concentrations or more in the strains used, the pre-experiment is reported in experiment I. Experiment I was performed according to the direct plate incorporation test, experiment II with the pre-incubation method. Negative and positive controls were in accordance with the OECD guideline.
In the main tests toxic effects evident as clearing of the bacterial background lawn were observed in experiment I in TA98 and TA100 and in experiment II in all strains predominantly at higher concentrations. Toxic effects evident as a reduction in the number of revertants were observed at higher concentrations without and with metabolic activation
in nearly all strains tested. A biologically relevant increase in revertant colonies was not observed in any of the strains tested at any dose level in the absence or presence of S9-mix in both experiments.
Under the experimental conditions used, Basic Red 76 was not mutagenic in this gene mutation tests in bacteria both in the absence and the presence of S9 metabolic activation
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