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EC number: 248-957-5 | CAS number: 28313-51-1
- 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:
- Start of experimental phase: 23 January 2018; End of experimental phase: 05 March 2018;
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate
- EC Number:
- 248-957-5
- EC Name:
- [2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate
- Cas Number:
- 28313-51-1
- Molecular formula:
- C22H29N6S.CH3O4S
- IUPAC Name:
- {2-[ethyl({3-methyl-4-[(E)-2-(3-phenyl-1,2,4-thiadiazol-5-yl)diazen-1-yl]phenyl})amino]ethyl}trimethylazanium methyl sulfate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Red 23 MeSO4
Constituent 1
Method
- Target gene:
- The test item Basic Red 23 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:
- liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone and a liver S9 fraction from uninduced hamsters (reductive metabolic activation system with Prival modification method)
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 5000,1580, 500, 158 and 50.0 µg/plate.
Main Assay I:
Tester strain S9 Dose level (µg/plate)
TA1535 ± 250, 125, 62.5, 31.3 and 15.6
TA1537 − 250, 125, 62.5, 31.3 and 15.6
TA1537 + 1000, 500, 250, 125, 62.5 and 31.3
TA98, WP2 uvrA ± 2000, 1000, 500, 250 and 125
TA100 − 62.5, 31.3, 15.6, 7.81, 3.91 and 1.95
TA100 + 125, 62.5, 31.3, 15.6, 7.81, 3.91 and 1.95
Main Assay II:
Tester strain S9 Dose level (µg/plate)
TA1535 ± 188, 93.8, 46.9, 23.4 and 11.7
TA1537 − 188, 93.8, 46.9, 23.4 and 11.7
TA1537 + 375, 188, 93.8, 46.9 and 23.4
TA98, WP2 uvrA ± 1500, 750, 375, 188 and 93.8
TA100 - 23.4, 11.7, 5.86, 2.93 and 1.46
+ 62.5, 31.3, 15.6, 7.81, 3.91 and 1.95
Main Assay III
Tester strain S9 Dose level (µg/plate)
TA1535, TA1537 − 11.3, 5.63, 2.81, 1.41 and 0.703
TA98, WP2 uvrA − 90.0, 45.0, 22.5, 11.3, 5.63 and 2.81
TA98 + 90.0, 45.0, 22.5, 11.3, 5.63 and 2.81 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile water for injection
- Justification for choice of solvent/vehicle: compatible with the survival of the bacteria and the S9 metabolic activity
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- congo red
- methylmethanesulfonate
- other: Trypan blue
- Remarks:
- Marked increases in revertant numbers were obtained in these tests following treatment with the positive control items, indicating that the assay system was functioning correctly.
- Details on test system and experimental conditions:
- The preliminary toxicity test and the first Main assay were performed using the plate-incorporation method and the standard metabolic activation system (Rat-Mixed Induction).
The second and third Main assays were performed using the pre-incubation method and the reductive metabolic activation system (Prival modification) - 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
- Key result
- Species / strain:
- other: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- 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.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the test item Basic Red 23 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 Basic Red 23 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, using a liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone (standard metabolic activation) in the preliminary toxicity test and in Main Assay I, and a liver S9 fraction from uninduced hamsters (reductive metabolic activation system with Prival modification method), in Main Assay II and Main Assay III.
The test item was used as a solution in sterile water for injection.
Toxicity test
The test item Basic Red 23 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 precipitation of the test item was observed at the end of the incubation period at any concentration. Dose related toxicity was observed with all tester strains at higher dose levels, both in the absence and presence of S9 metabolism. A less pronounced toxic effect was seen with TA98 and WP2 uvrA tester strains.
Main Assays
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:
Tester strain S9 Dose level (µg/plate)
TA1535 ± 250, 125, 62.5, 31.3 and 15.6
TA1537 − 250, 125, 62.5, 31.3 and 15.6
TA1537 + 1000, 500, 250, 125, 62.5 and 31.3
TA98, WP2 uvrA ± 2000, 1000, 500, 250 and 125
TA100 − 62.5, 31.3, 15.6, 7.81, 3.91 and 1.95
TA100 + 125, 62.5, 31.3, 15.6, 7.81, 3.91 and 1.95
Toxicity was observed with all tester strains at higher dose levels both in the absence and presence of S9 metabolism.
As no relevant increase in revertant numbers was observed at any concentration tested, Main Assay II was performed. Based on the chemical structure of the test item (azo-dye), the experiment was performed using the pre-incubation method in the presence of a reductive metabolic system (hamster S9 supplemented with flavin mononucleotide cofactor). The dose-range was slightly modified to take into account the toxicity results of Main Assay I. The test item was assayed at the following dose levels:
Tester strain S9 Dose level (µg/plate)
TA1535 ± 188, 93.8, 46.9, 23.4 and 11.7
TA1537 − 188, 93.8, 46.9, 23.4 and 11.7
TA1537 + 375, 188, 93.8, 46.9 and 23.4
TA98, WP2 uvrA ± 1500, 750, 375, 188 and 93.8
TA100 - 23.4, 11.7, 5.86, 2.93 and 1.46
+ 62.5, 31.3, 15.6, 7.81, 3.91 and 1.95
No increase in the revertant colonies was noted with any tester strain, at any concentration tested, in the absence or presence of S9 metabolism. However, dose related toxicity, mainly indicated by thinning of the background lawn, was observed at higher dose levels with all tester strains, in the absence and presence of S9 metabolic activation. Since mutagenic effects have to be evaluated at non-toxic concentrations, an additional experiment was performed in the absence of S9 metabolism with all tester strains with the exception of TA100 and in the presence of S9 metabolism with TA98 tester strain.
In Main Assay III, the test item was assayed at the following dose levels:
Tester strain S9 Dose level (µg/plate)
TA1535, TA1537 − 11.3, 5.63, 2.81, 1.41 and 0.703
TA98, WP2 uvrA − 90.0, 45.0, 22.5, 11.3, 5.63 and 2.81
TA98 + 90.0, 45.0, 22.5, 11.3, 5.63 and 2.81
A sufficient number of analysable dose levels were obtained and no increase in revertant colonies was noted at any concentration tested, with any tester strain/activation condition combinations.
No precipitation of the test item, evident to the unaided eye, was observed at the end of the incubation period, at any concentration, in any experiment.
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.
Conclusion
It is concluded that the test item Basic Red 23 does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
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