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Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate
EC number: 941-533-7 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al. 1973, 1975
- Principles of method if other than guideline:
- The test method followed the procedure described at Ames et al, 1973 and Ames et al, 1975.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- EC Number:
- 401-560-2
- EC Name:
- Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- Cas Number:
- 108624-00-6
- Molecular formula:
- C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5
- IUPAC Name:
- Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Blue FC 05717
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from rat liver
- Test concentrations with justification for top dose:
- First plate incorporation test, with and without S9 mix:
0 (negative control), 16, 80, 400, 2000 and 10,000 µg/plate
Positive control:
sodium azide: 10 µg/plate (only TA 1535)
nitrofurantoin: 0.2 µg/plate (only TA 100)
4-nitro-o-phenylendiamine: 10 µg/plate (only TA 1537)
4-nitro-o-phenylendiamine: 0.5 µg/plate (only TA 98)
2-aminoanthracene: 3 µg/plate
Second plate incorporation test, with and without S9 mix:
The doses of test substance were increased to 625 - 10,000 µg/plate as no toxicity was observed. - Vehicle / solvent:
- Deionized water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Only for TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Nitrofurantoine
- Remarks:
- Only for TA 100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- Only for TA 1537 and TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Evaluation criteria:
- Criteria for a positive response
A response is considered positive if there is a reproducible dose-dependent increase in the number of mutants in at least one strain, with numbers reaching approximately the double of those of the negative control.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was not found to be mutagenic in the bacterial reverse mutation assay.
- Executive summary:
An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to the method of Ames (1973, 1975), in compliance with GLP. Two independent assays were conducted, using the plate incorporation method, in the absence and presence of a metabolizing system derived from a rat liver homogenate (i.e. S9 mix). The substance was tested at five concentrations in the range of 16 - 10,000 µg/plate in the first assay and, as no toxicity occurred, at 625 - 10,000 µg/plate in the second assay. The tested strains were Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100. Doses up to and including 10,000 µg/plate did not induce any bacteriotoxic effects. The total bacteria counts remained unchanged. No inhibition of growth was observed. Evidence of mutagenic activity of the test substance was not found. Neither a dose-related doubling of mutant counts nor a biologically relevant increase in the same, in comparison with the negative controls, was seen. The positive controls had a marked mutagenic effect. Under the study conditions, the test substance was not found to be mutagenic in the bacterial reverse mutation assay (Herbold, 1986).
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