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EC number: 939-718-2 | CAS number: 1474044-80-8
- 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
- Study period:
- March 29, 2012 to April 10, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: New OECD guideline GLP study without deficiencies that affect study validity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)
- EC Number:
- 939-718-2
- Cas Number:
- 1474044-80-8
- Molecular formula:
- C28H44O3S.1/2Ba
- IUPAC Name:
- barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)
- 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
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:
- Rat liver S9
- Test concentrations with justification for top dose:
- In preliminary trials, 8 doses were used: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in triplicate.
In definitive experiments 1 and 2, doses were 3 to 1000 ug/plate.
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:
- Ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see details section
- Details on test system and experimental conditions:
- Positive Controls
Strain Chemical
TA1535 sodium azide (SA)
TA1537 ICR-191
TA98 2-nitrofluorene (NF)
TA100 methylmethanesulfonate (MMS)
WP2uvrA 4-nitroquinoline N-oxide (4-NQO)
Cell culture
Preparation of bacterial cultures
Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth (Oxoid LTD, Hampshire, England) and incubated in a shaking incubator (37°C, 150 spm), until the cultures reached an optical density of 1.0 ± 0.1 at 700 nm (109 cells/ml). Freshly grown cultures of each strain were used for a test.
Agar plates
Agar plates (ø 9 cm) contained 25 ml glucose agar medium. Glucose agar medium contained per liter: 18 g purified agar (Oxoid LTD) in Vogel-Bonner Medium E, 20 g glucose (Fresenius Kabi, Bad Homburg, Germany). The agar plates for the test with the Salmonella typhimurium strains also contained 12.5 µg/plate biotin (Merck) and 15 µg/plate histidine (Merck) and the agar plates for the test with the Escherichia coli strain contained 15 µg/plate tryptophan (Acros Organics).
Top agar
Milli-Q water containing 0.6% (w/v) bacteriological agar (Oxoid LTD) and 0.5% (w/v) sodium chloride (Merck) was heated to dissolve the agar. Samples of 3 ml top agar were transferred into 10 ml glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121 ± 3°C.
Environmental conditions
All incubations were carried out in a controlled environment at a temperature of 37.0 ± 1.0°C (actual range 36.0 – 39.0°C) in the dark. - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent vehicle control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent vehicle control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 333 ug/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitate at 1000 ug/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 333 ug/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitate at 1000 ug/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- at 333 ug/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitate at 1000 ug/plate (exp 1 only)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 666 ug/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitate at 1000 ug/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 333 ug/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitate at 1000 ug/plate (exp 2 only)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Precipitate
Precipitation of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) on the plates was observed at the start of the incubation period at concentrations of 3330 and 5000 µg/plate. The test substance precipitated on the plates at dose levels of 1000 μg/plate and upwards in tester strain TA100 and at 3330 and 5000 µg/plate in tester strain WP2uvrA at the end of the incubation period.
Toxicity
To determine the toxicity of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate), the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
Since Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated moderately to heavily on the plates at test substance concentrations of 3330 and 5000 μg/plate, neither the bacterial background lawn nor the number of revertants of these dose levels could be determined.
In tester strain TA100 in the absence of S9-mix, a moderate reduction of the revertant colonies was observed at the test substance concentration of 333 μg/plate and an extreme reduction of the bacterial background lawn and an increase in the size of the micro-colonies compared to the solvent control plate was observed at the test substance concentration of 1000 μg/plate.
In tester strain WP2uvrA in the absence of S9-mix, a slight reduction of the bacterial background lawn was observed at the test substance concentration of 333 μg/plate and a moderate to extreme reduction of the bacterial background lawn and an increase in the size of the micro-colonies compared to the solvent control plate was observed at the test substance concentration of 1000 μg/plate.
In the presence of S9-mix, no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
Any other information on results incl. tables
See attached document for results tables for the definitive and repeat (confirmatory) assays.
Applicant's summary and conclusion
- Conclusions:
- Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was non-mutagenic in the Ames assay.
- Executive summary:
The mutagenic activity of Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was evaluated in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay (with independent repeat).
The test material was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia colireverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone).
The study procedures described in this report were based on the most recent OECD and EC guidelines. A correction factor of 1.11 was used to correct for the estimated purity of 90%. The test substance was dissolved in ethanol.
In the dose range finding test, Barium bis ( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance precipitated on the plates at dose levels of 1000 μg/plate and upwards in tester strain TA100 and at 3330 and 5000 µg/plate in tester strain WP2uvrA. Toxicity was observed at dose levels of 333 and 1000 μg/plate in the absence of S9-mix in both tester strains. Since Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated moderately to heavily on the plates at test substance concentrations of 3330 and 5000 μg/plate, neither the bacterial background lawn nor the number of revertants of these dose levels could be determined. Results of this dose range finding test were reported as part of the first experiment of the mutation assay.
Based on the results of the dose range finding test, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested in the first mutation assay up to the dose level of 1000 µg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated on the plates at the top dose of 1000 μg/plate. Toxicity was observed in all three tester strains in the absence of S9-mix.
In an independent repeat of the assay with additional parameters, Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) was tested up to the dose level of 1000 µg/plate in the tester strains TA98, TA100 and WP2uvrA, up to 666 µg/plate in tester strain TA1535 and up to 333 µg/plate in tester strain TA1537 in the absence of S9-mix. The test substance was tested up to the dose level of 1000 µg/plate in all tester strains in the presence of 10% (v/v) S9-mix. Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) precipitated on the plates at the top dose of 1000 μg/plate. Except in tester strain TA1537 where no precipitate was observed at the top dose of 1000 μg/plate. Toxicity was observed in all tester strains in the absence of S9-mix.
Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
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