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EC number: 854-560-3 | CAS number: 1891094-25-9
- 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
- Study period:
- Date of experimental starting : May 26, 2016 experimental completed June 3, 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 (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- EC Number:
- 854-560-3
- Cas Number:
- 1891094-25-9
- Molecular formula:
- C53H38N4Na6O22S5
- IUPAC Name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- Histidine for Salmonella.
Tryptophan for E.Coli
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced rat liver,phenobarbital (PB) injection of 5,6-benzoflavone, S9 mix
- Test concentrations with justification for top dose:
- The tests were conducted in the presence (+S9mix) and absence (−S9mix) of metabolic
activation. Prior to the main study, a dose-finding test for each strain using the test
item at concentrations of 62, 185, 556, 1667, and 5000 µg/plate was conducted. The results showed that the test
item did not increase the number of revertant colonies more than 2-fold compared to the negative
control, in the presence or absence of metabolic activation, at all concentrations tested and for all
the strains used.
In addition, water was used , as a negative control . 5 doses of 5,000 µg/plate (highest dose) with a common ratio of 2.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA100 ,0.01 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- without S9mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA 1535 ,0.5 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9mix
- Untreated negative controls:
- yes
- Remarks:
- spontaneous mutation WPuvRA ,0.01µg/plate
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA98, 0.1 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1537, 80 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA100, 5µg/plate
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1535 2µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of WPuvRA, 10µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA98, 5µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1537,2µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- Concentration of test substances and number of tests:
・Dose-finding test : 5 doses of 5,000 µg/plate (highest dose) with a common ratio of 3.
・Main study : 5 doses of 5,000 µg/plate (highest dose) with a common ratio of 2. Bacterial strains tested TA100, TA1535, WP2uvrA, TA98, and TA1537 (5 strains). Metabolic system: Induced rat S9 (concentration of S9 in S9mix: 10% v/v)
Test method: Pre-incubation method.
Pre-incubation : 37°C for 20 min.
Incubation : 37°C for 48 h.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium 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
- Remarks:
- upto 5000 μg/plate (highest dose)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- upto 5000 μg/plate (highest dose)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- upto 5000 μg/plate (highest dose)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- upto 5000 μg/plate (highest dose)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- upto 5000 μg/plate (highest dose)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test item was deemed non-mutagenic for the five bacterial strains listed above.
- Executive summary:
Introduction
The study, a reverse mutation test of the test item in bacteria (mutagenicity test in microorganisms),
was carried out to determine whether the test item has the mutagenicity, and if it does, how potent the mutagenicity is, following the guideline of “OECD GUIDELINE FOR TESTING CHEMICALS 471” (July 21, 1997)
Results and conclusion
The mutagenicity of the test item was tested in four strains of Salmonella typhimurium (TA100, TA1535, TA98, and TA1537) and Escherichia coli (WP2uvrA). The results showed that the test item did not increase the number of revertant colonies more than 2-fold compared to the negative control, in the presence or absence of metabolic activation, at all concentrations tested and for all strains used.
The test item was deemed non-mutagenic for the five bacterial strains listed above.
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