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EC number: 262-110-7 | CAS number: 60223-95-2
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Start : 16 March 2012 Completion : 04 July 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study without deficiencies. Close analog to DNNSA.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)
- IUPAC Name:
- Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: Beige-brown crystalline powder with lumps
Batch: 278-123
Purity: UVCB (treated as 100% pure)
Constituent 1
Method
- Target gene:
- Chromosomal aberrations. No target gene.
Species / strain
- Species / strain / cell type:
- other: Peripheral human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- (phenobarbital and ß-naphthoflavone induced rat liver S9-mix
- Test concentrations with justification for top dose:
- In the dose range finding study, at the 3 h exposure time, blood cultures were treated with 3, 10, 33, 100 and 333 μg Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)/ml culture medium with and without S9-mix. At the 24 h and 48 h continuous exposure time blood cultures were treated with 3, 10, 33, 100, 333 and 1000 μg Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)/ml culture medium without S9-mix. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested beyond the limit of solubility to obtain adequate toxicity data.
Based on the results of the dose range finding test the following dose levels were selected for the cytogenetic assay:
Without and with S9-mix: 33, 100 and 150 μg/ml culture medium
(3 h exposure time, 24 h fixation time).
Batch 278-123 of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was initially determined to have a purity of 90% . Based on this all concentrations reported were corrected for the purity with a correction factor of 1.11. After setting doses and running the assay the test substance was designated as UVCB with purity of 100%. Therefore, the test doses reported here are 10% lower than the doses when considered as UVCB. - Vehicle / solvent:
- dimethyl sulfoxide
- Details on test system and experimental conditions:
Cultured peripheral human lymphocytes were used as test system. Peripheral human lymphocytes are recommended in international guidelines (e.g. OECD, EC).
Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was dissolved in dimethyl sulfoxide of spectroscopic quality (SeccoSolv, Merck, Darmstadt, Germany). The stock solution was treated with ultrasonic waves until Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) had completely dissolved. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) concentrations were used within 1.5 hour after preparation. The final concentration of the solvent in the culture medium was 1.0% (v/v).
Environmental conditions
All incubations were carried out in a controlled environment in the dark, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 67 - 90%), containing 5.0 ± 0.5% CO2 in air, at a temperature of 37.0 ± 1.0°C (actual range 34.8 - 37.1°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day. Temporary deviations from the temperature (in the range of 35.3 - 36.0°C), humidity (with a maximum of 13%) and CO2 percentage (with a maximum of 1%) occurred that were caused by opening and closing of the incubator door, but the time of these deviations did not exceed 1 hour. Based on laboratory historical data these deviations are considered not to affect the study integrity.- Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) It induced a dose-related statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of cells with chromosome aberrations.
b) A statistically significant and biologically relevant increase in the frequencies of the number of cells with chromosome aberrations was observed in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic) in the chromosome aberration test if none of the tested concentrations induced a statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of cells with chromosome aberrations. - Statistics:
- Chi-square statistics
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: human peripheral lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cell lysis at 333 and 1000 ug/ml
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the first cytogenetic assay, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to 150 μg/ml for a 3 h exposure time with a 24 h fixation time in the absence and presence of 1.8% (v/v) S9-fraction. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated in the culture medium at this dose level.
In the second cytogenetic assay, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to 130 μg/ml for a 24 h continuous exposure time with a 24 h fixation time and up to 100 μg/ml for a 48 h continuous exposure time with a 48 h fixation time in the absence of S9-mix. Appropriate toxicity was reached at these dose levels. In the presence of S9-mix Barium bis
( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to 250 μg/ml for a 3 h exposure time with a 48 h fixation time. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated in the culture medium at this dose level.
The number of cells with chromosome aberrations found in the solvent control cultures was within the laboratory historical control data range. Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments.
No effects of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report.
Finally, it is concluded that this test is valid and that Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) is not clastogenic in human lymphocytes under the experimental conditions described in this report.
Applicant's summary and conclusion
- Conclusions:
- Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) is not clastogenic in human lymphocytes.
- Executive summary:
Evaluation of the ability of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) to induce chromosome aberrations in cultured peripheral human lymphocytes (with repeat experiment). This study evaluates the effect of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) on the number of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (phenobarbital and ß-naphthoflavone induced rat liver S9-mix). The possible clastogenicity of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested in two independent experiments.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 278-123 of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was a beige-brown crystalline powder with lumps with an estimated purity of 90% . All concentrations reported were corrected for the purity. A correction factor of 1.11 was used (after setting doses and running the assay the test substance was designated as UVCB with purity of 100%. Therefore, the test doses reported here are 10% lower than the doses when considered as UVCB. This change does not affect the integrity of the study or the validity of the results). Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was dissolved in dimethyl sulfoxide.
In the first cytogenetic assay, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to 150 μg/ml for a 3 h exposure time with a 24 h fixation time in the absence and presence of 1.8% (v/v) S9-fraction. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated in the culture medium at this dose level.
In the second cytogenetic assay, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to 130 μg/ml for a 24 h continuous exposure time with a 24 h fixation time and up to 100 μg/ml for a 48 h continuous exposure time with a 48 h fixation time in the absence of S9-mix. Appropriate toxicity was reached at these dose levels. In the presence of S9-mix, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to 250 μg/ml for a 3 h exposure time with a 48 h fixation time. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated in the culture medium at this dose level.
The number of cells with chromosome aberrations found in the solvent control cultures was within the laboratory historical control data range. Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments.
No effects of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report.
Finally, it is concluded that this test is valid and that Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) is not clastogenic in human lymphocytes under the experimental conditions described in this report.
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