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EC number: 277-242-0 | CAS number: 73037-34-0
- 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 mammalian cells
- 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: GLP study according OECD 476
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Disodium oxybis[methylbenzenesulphonate]
- EC Number:
- 277-242-0
- EC Name:
- Disodium oxybis[methylbenzenesulphonate]
- Cas Number:
- 73037-34-0
- Molecular formula:
- C14H12Na2O7S2
- IUPAC Name:
- disodium oxybis(methylbenzenesulfonate)
- Test material form:
- solid
- Details on test material:
- Active content reported: 90-95 %
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- other: These cells are characterized by their high proliferation rate (12-14 h doubling time) and their high plating efficiency of untreated cells.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix was prepared from livers of male Wistar rats that were induced by oral applications of phenobarbital and ß-naphthoflavone on 3 consecutive days.
- Test concentrations with justification for top dose:
- EXPERIMENT I
without S9-mix (4 hour treatment):
0.06, 0.13, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0 and 10 mM
with S9-mix (4 hour treatment)
0.06, 0.13, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0 and 10 mM
EXPERIMENT II
without S9-mix (20 hour treatment)
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 and 10 mM
with S9-mix (4 hour treatment)
3.25, 4.0, 4.75, 5.5, 6.25, 7.0, 7.75, 8.5, 9.25 and 10 mM
- Vehicle / solvent:
- treatment medium:
MEM and no FBS for the 4 hour treatment
MEM with 10 % FBS for the 20 hour treatment
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: EMS (= ethylmethane sulfonate) With metabolic activation: DMBA (= 7,12-dimethylbenz(a)anthracene)
- Details on test system and experimental conditions:
- The assay was performed in 2 independent experimentsm using 2 parallel cultures each.
The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours.
The second experiment was performed with a treatment time of 4 hours with and 20 hours without metabolid activation. - Evaluation criteria:
- A test is considered to be negative if there is no biological relevant increase in the number of mutants.
A test is considered positive with a reproducible three times higher mutation frequency than the solvent control or a concentration relateted increase in mutation frequency. - Statistics:
- no
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- At 64 µg/ml and above in the first and the second experiment in the presence of S9-mix. At 0.5 µg/ml and above in the second experiment without S9-mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Chinese hamster lung fibroblasts (V79)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments.
Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion it can be stated that under the reported experimental conditions ditolylether disulfonic acid disodium salt, isomer mixture did not induce gene mutations at the HPRT locus in V79 cells.
Therefore, ditolylether disulfonic acid disodium salt, isomer mixture is considered to be non-mutagenic in this HPRT assay. - Executive summary:
The study was performed to investigate the potential of ditolylether disulfonic acid disodium salt, isomer mixture to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476.
The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 20 hours without metabolic activation. No precipitation of the test item was noted in the experiments. No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.
In conclusion, under the reported experimental conditions ditolylether disulfonic acid disodium salt, isomer mixture is considered to be non-mutagenic in the HPRT-locus using V79 cells of the Chinese Hamster.
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