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EC number: 429-750-0 | CAS number: 180898-37-7
- 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:
- key study
- Study period:
- 1996-03-06 to 1996-03-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study reliable with restrictions, because it is performed acc. to an outdated guideline version (1983) and does not totally comply with the current guideline requirements (1997), since the use of a 5th strain TA102 or E.coli WP2 is missing which should be used for detection of cross-linking mutagens. However, it does comply with the guideline of 1983. Furthermore, data on precipitation were given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted May 26, 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 429-750-0
- EC Name:
- -
- Cas Number:
- 180898-37-7
- Molecular formula:
- C20H12N4O12S4.2Na
- IUPAC Name:
- disodium dihydrogen 2-[4-(5,7-disulfonato-1H-1,3-benzodiazol-2-yl)phenyl]-1H-1,3-benzodiazole-5,7-disulfonate
- Details on test material:
- - CAS name: 1H-Benzimidazole-4,6-disulfonic acid-2,2´-(1,4-diphenylene) bis, disodium salt
- Molecular formula: C20H12N4O12S4Na2
- Molecular weight: 674g/mol
- physical state: solid
Constituent 1
Method
- Target gene:
- not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - originally obtained from Dr. Bruce N. Arnes, University of California, Berkeley, California, U.S.A.
- Type and identity of media: For preparation of the master plates Vogel-Bonner minimal medium plates enriched with histidine (260µM) and biotin (3 µM). Ampicillin (25 µg per ml medium of the plate) is added to the plates used for strains with the R-factor. The tester strain cultures used in this study were grown in Oxoid nutrient broth No.2 (2.5%). The minimal agar plates contain 25 ml of 1.5 % agar in Vogel-Bonner medium E with 2 % glucose.
- Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- - originally obtained from Dr. Bruce N. Arnes, University of California, Berkeley, California, U.S.A.
- Type and identity of media: For preparation of the master plates Vogel-Bonner minimal medium plates enriched with histidine (260µM) and biotin (3µM). Ampicillin (25µg per ml medium of the plate) is added to the plates used for strains with the R-factor. The tester strain cultures used in this study were grown in Oxoid nutrient broth No.2 (2.5%).The minimal agar plates contain 25 ml of 1.5 % agar in Vogel-Bonner medium E with 2 % glucose.
- Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver homogenate (S9 mix)
- Test concentrations with justification for top dose:
- Experiment I: 0, 50, 150, 500, 1500, 5000 µg/plate (with and without S9-mix)
Experiment II: 0, 50, 150, 500, 1500, 5000 µg/plate (with and without S9-mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- concentration: 10% solution in distilled water
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water, 100 µL/plate
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9-mix
Migrated to IUCLID6: 0.5 µg/plate for TA1535 and TA100, dissolved in distilled water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water, 100 µL/plate
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9-mix
Migrated to IUCLID6: 2.5 µg/plate for TA1538 and TA98, dissolved in DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water, 100 µL/plate
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix
Migrated to IUCLID6: 50 µg/plate for TA1537, dissolved in distilled water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water, 100 µL/plate
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 1.0 µg/plate for TA1538, TA98, TA100 and 3.0 µg/plate for TA1535, 1537, dissolved in DMSO
- Remarks:
- with S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (standard plate incorporation assay)
- each culture tube contained 2 ml of top agar, 0.1 ml of bacteria, test solution and 0.5 ml of S9-mix or phosphate buffer in the assays without metabolic activation
DURATION
- Exposure duration: 48 h at 37 °C in the dark
NUMBER OF REPLICATIONS: 3
- The experiment was repeated in full after an interval of at least 3 days.
DETERMINATION OF CYTOTOXICITY
- Method: Evaluation of reduction in the number of spontaneous revertants or clearing of the bacterial background lawn.
OTHER EXAMINATIONS:
- The plates were examined for the existence of a normal background lawn and/or precipitates and microscopically for microcolony growth
- When there was any question about the nature of colonies scored as revertants and when positive mutagenic results are obtained, the genotype of revertant colonies are spot-checked by picking and streaking on histidine free plates. - Evaluation criteria:
- According to guideline. No information given in the study report.
- Statistics:
- A statistical analysis of the data is not required.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- In the concentration range investigated, HR 96/N00002Aq did not induce any increase in the spontaneous mutation frequency in any of the tester strains in the absence and presence of a metabolic activation system.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- At the concentrations tested HR 96/N00002Aq was not bacteriotoxic.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- In the concentration range investigated, HR 96/N00002Aq did not induce any increase in the spontaneous mutation frequency in any of the tester strains in the absence and presence of a metabolic activation system.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- At the concentrations tested HR 96/N00002Aq was not bacteriotoxic.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no data
RANGE-FINDING/SCREENING STUDIES: no data
COMPARISON WITH HISTORICAL CONTROL DATA: The number of spontaneous revertants observed using each of the five strains was very close
to those previously established in our laboratory and was within the range obtained by Ames et al. (1975) as well as reported by De Serres and Shelby (1979).
- Similarly, the results with the positive control substances confirmed the known reversion properties and specificity of the tester strains as well as the full activity of the metabolizing system.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- At the concentrations tested (50 - 5000 µg/plate) HR 96/N00002Aq was not bacteriotoxic.
STATISTICS:
The estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level, using a X2-test (Mohn and Ellenberger, 1977), did not reveal a significant effect at any of the test points. - 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
The results indicate that the test substance under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100 in the presence and absence of a metabolizing system.
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