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EC number: 261-448-2 | CAS number: 58798-47-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 12 February to 15 March 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.14 (Mutagenicity - Salmonella Typhimurium Reverse Mutation Test)
- Principles of method if other than guideline:
- According to Ames et al. 1973 and 1975; Maron and Ames 1983
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- EC Number:
- 258-946-7
- EC Name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- Cas Number:
- 54060-92-3
- Molecular formula:
- C20H24N3O.CH3O4S C21H27N3O5S
- IUPAC Name:
- 2-{[2-(4-methoxyphenyl)-2-methylhydrazin-1-ylidene]methyl}-1,3,3-trimethyl-3H-indol-1-ium methyl sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): C. I. Basic Yellow 28 (Astrazon Goldgelb GLN)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine dependent
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9 mix
- Test concentrations with justification for top dose:
- First test: 8, 40, 200, 1000, 5000 µg/plate
Repeat tests: 25, 50, 100, 200, 400, 800 µg/plate
10, 20, 30, 40, 50, 60, 70 µg/plate TA 100 with 10 %, 30 %, 50 % S9 - Vehicle / solvent:
- methanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- historical for methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 w/o S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- historical for methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: nitrofurantion
- Remarks:
- TA 100 w/o S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- historical for methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-1,2-phenylene diamine
- Remarks:
- TA 1537, TA 98 w/o S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- historical for methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation: 0.1 mL TS+0.1 mL bacteria+0.5 mL S9+2 mL soft agar: 30 sec at 45 °C
- Incubation period: 48 hours at 37°C
NUMBER OF REPLICATIONS: 4 plates/strain/concentration
DETERMINATION OF CYTOTOXICITY
- Method: - background growth
- marked and dose-dependent reduction in mutant count compared to negative controls
- titer determination
Acceptance criteria:
a) The negative controls had to be within the expected range, as defined by published data (i.e. Maron and Ames, 1983) and the laboratory's own historical data
b) The positive controls had to show sufficient effects, as defined by the laboratory's experience
c) Titer determinations had to demonstrate sufficient bacterial density in the suspension.
An assay which did not comply with at least one of the above criteria was not used for assessment. Furthermore, the data generated in this assay needed to be confirmed by two additional independent experiments. Even if the criteria for points (a), (b) and (c) were not met, an assay was accepted if it showed mutagenic activity of the test compound. - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result.
For TA 1535, TA 100 and TA 98 this increase should be about twice the amount of negative controls, whereas for TA 1537, at least a threefold increase should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgement. - Statistics:
- NA
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- TA 100: 1.6-fold increase at cytotoxic concentrations
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There was no indication of a bacteriotoxic effect of C.I. Basic Yellow 28 at 8 µg per plate. The total bacteria counts consistently produced results comparable to the negative controls, or differed only insignificantly. Nor was any inhibition of growth noted. Higher doses had a strong, strain-specific bacteriotoxic effect. Therefore they could only be used to a limited extent up to 1000 µg per plate for assessment purposes.
In the first trial, none of the four strains concerned showed a dose related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix.
The negative findings for Salmonella typhimurium TA 1535, TA 1537 and TA 98 were confirmed by further repeat tests. In the TA 100 strain, a dose-related minimal increase in mutant counts to 1.6-fold of negative controls was found in the second test. The findings of the second trial for Salmonella typhimurium TA 100 were confirmed by further repeat tests using 30 % and 50 % S9 mix. No relevant increase was found using 10 % S9 mix.
The lowest dose at which this finding was reproducible was approximately 30 µg per plate for Salmonella typhimurium TA 100. Minimally increased mutation rates - below the theshold for positive effects - were obtained only with S9 mix containing 30 % and 50 % S9 fraction in S9 mix. - 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
Basic Yellow 28 methyl sulfate showed a minimal increase (1.6-fold) in revertant mutations in TA 100 at cytotoxic concentrations with an increased amount of the metabolic activation system. - Executive summary:
C.I. Basic Yellow 28 methyl sulfate was investigated using the Salmonella/microsome test for point mutagenic effects in doses up to 5000 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.
8 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a limited extent up to 1000 µg per plate for assessment purposes.
On Salmonella typhimurium TA 100, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. A minimal increase in reverse mutations (1.6 -fold) was found only with S9 mix depending on S9 mix composition. The lowest reproducible effective dose was 30 µg per plate for Salmonella typhimurium TA 100.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2‑aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
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