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EC number: 220-027-3 | CAS number: 2610-10-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed under GLP, well reported with many details on the results acceptable for the assessment of the endpoint. Include also the Prival and Mitchell procedure for mutagenicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
- EC Number:
- 220-027-3
- EC Name:
- Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
- Cas Number:
- 2610-10-8
- Molecular formula:
- C45H32N10O21S6.6Na
- IUPAC Name:
- hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulpho
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 102, TA 1535, TA 1537
- Details on mammalian cell type (if applicable):
- TA 1535 and TA 100 bear the base-pair substitution, his G 46, and TA 100 additionally contains the plasmid pKM 101. This R factor, asso contained in TA 98 and TA 102, codes for an ampicillin resistance and should raise the sensitivity of the strains. TA 102 carries the ochre mutation his G 428 ora the multicopy plasmid pAQ1, which codes in addition for tetracycline resistance. TA 1537 and TA 98 bear frameshift markers. TA 1537 exhibits the +1 mutant, his C 3076, while TA 98 bears the +2 type, his D 3052.Furthermore, the strains have other properties, which should increase their sensitivity. They are all Jeep rough, i.e. partiy deficient in lipopolysaccharide side chains in their celi walis, enabling larger molecules to penetrate the bacterial celi wall and pro-duce mutations. With the exception of TA 102, ali strains have reduced capability to repair DNA-damage which increases the likelihood that such damage results in mutations.
- Additional strain / cell type characteristics:
- other: see details above
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 16, 50, 160, 500, 1600 and 5000.0 µg/plate
- Vehicle / solvent:
- Levaceli Rot E10B was dissolved in deionized water and formed red solutions. Ganga red and mitomycin C were dissolved in deionized water. The other positive controls were dissolved in DMSO.The solvent used was chosen out of the following solvents, in the order given: water, DMSO, methanol, ethanol, acetone, ethylene glycol dimethylether (EGDE), and DMF according to information given by the internai sponsor. The order of these solvents is based on their bacteriotoxic effects in preincubation experiments.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-1,2-phenylendiamine (4-NPDA)
- Remarks:
- TA98 and TA1537 without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: nitrofurantoin
- Remarks:
- TA100 without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- TA102 without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- all strains with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)NUMBER OF REPLICATIONS: The assay was performed in two independent experiments. The first under Ames test conditions and the second under the Prival and Mitchell procedure both with and without liver microsomal activation.
- Evaluation criteria:
- The following criteria determined the acceptance of an assay:a) The negative controls had to be within the expected range, as defined by pub-lished data (e.g. Maron and Ames, 1983) andl or the laboratories' own historical data (see Chapter 8).b) The positive controls had to show sufficient effects, as defined by the laboratories' experience (see Chapter 8).c) Titer determinations had to demonstrate sufficient bacterial density in the suspension.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: :negative
Under the experimental conditions reported, the test article did not induce point mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test article is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
The study followed OECD guideline 471 and the principles of GLP. In the presence and absence of rat liver S-9 microsomal activation system and at doses of up to 5000 μg/plate, S. typhimurium strains TA 98, TA 100, TA102, TA 1535 and TA 1537 did not show an increased number of revertant colonies. Therefore, no evidence of a mutagenic potential was associated with the test substance.
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