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EC number: 939-714-0 | CAS number: 1474044-77-3
- 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:
- 29 March 2012 to 10 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study conducted under GLP without significant deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid
- EC Number:
- 939-714-0
- Cas Number:
- 1474044-77-3
- Molecular formula:
- C18H30SO3 to C40H67SO3
- IUPAC Name:
- di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid
- Test material form:
- liquid: viscous
- Details on test material:
- CAS Number 25322-17-2
Description Brown highly viscous liquid (determined at NOTOX)
Batch 966018
Purity Provisional 84%
Constituent 1
Method
- Test concentrations with justification for top dose:
Test concentrations for the dose rangefinding: 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
For experiment 1:
TA1535, TA1537 and TA98:
Without S9-mix: 3, 10, 33, 100, 200 and 333 µg/plate
With S9-mix: 10, 33, 100, 333 and 1000 µg/plate
TA100 and WP2uvrA:
Without S9-mix: 3, 10, 33, 100 µg/plate
With S9-mix: 10, 33, 100, 333 and 1000 µg/plate
The following dose ranges were selected for the second mutation experiment:
Without S9-mix: 3, 10, 33, 100, 200 and 333 µg/plate
With S9-mix: 10, 33, 100, 333 and 1000 µg/plate- Vehicle / solvent:
- Dimethyl sulfoxide
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- See details of positive controls in next section
- Details on test system and experimental conditions:
Positive controls
Without metabolic activation (-S9-mix):
Strain Chemical
TA1535 : sodium azide (SA)
TA1537 : ICR-191
TA98 : 2-nitrofluorene (NF)
TA100 : methylmethanesulfonate (MMS)
WP2uvrA : 4-nitroquinoline N-oxide (4-NQO)
With metabolic activation (+S9-mix):
The positive control substance used for all tester strains was 2-aminoanthracene (2AA)- Evaluation criteria:
- Data evaluation and statistical procedures
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.
- Statistics:
- None required
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: TA98 TA1535 TA1537 TA100 and WP2uvrA
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 333 and 1000 ug/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA98 TA1535 TA1537 TA100 and WP2uvrA
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1000 ug/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Dose Range Finding
Di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid (DNNSA) was tested in the tester strains TA100 and WP2uvrA with concentrations of 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix. This dose range finding test is reported as a part of the first experiment of the mutation test.
Precipitate
Precipitation of DNNSA on the plates was observed at the start of the incubation period at the concentration of 5000 µg/plate and at 1000 µg/plate and above at the end of the incubation period.
Toxicity
To determine the toxicity of di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. The definitions are stated inAPPENDIX2.
Since DNNSA precipitated 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 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 test substance concentrations of 333 and 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.
Experiment 1
Based on the results of the dose range finding test, the following dose range was selected for the first mutation experiment in the absence and presence of 5% (v/v) S9-mix with theSalmonella typhimuriumstrains, TA1535, TA1537 and TA98:
Without S9-mix: 3, 10, 33, 100, 200 and 333 µg/plate
With S9-mix: 10, 33, 100, 333 and 1000 µg/plate
Results are presented in detail in attached document (Results Table Ames Test DNNSA).
Experiment 2
To obtain more information about the possible mutagenicity of di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid, a second mutation experiment was performed in the absence of
S9-mix and in the presence of 10% (v/v) S9-mix. The following dose ranges were selected for the second mutation experiment:
Without S9-mix: 3, 10, 33, 100, 200 and 333 µg/plate
With S9-mix: 10, 33, 100, 333 and 1000 µg/plate.
Detailed results are presented in the attached document.
Applicant's summary and conclusion
- Conclusions:
- Di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid (DNNSA) is non-mutagenic in the Ames bacterial reverse mutation assay.
- Executive summary:
Di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid (DNNSA) was evaluated for mutagenic activity in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay (with independent repeat). DNNSA 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 coli reverse 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.
Batch 966018 of di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid was a brown highly viscous liquid. A correction factor of 1.19 was used to correct for the provisional purity of 84%. The test substance was dissolved in dimethyl sulfoxide.
In the dose range finding test, di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. DNNSA precipitated on the plates at dose levels of 1000 μg/plate and upwards. Toxicity was observed at dose levels of 333 and 1000 μg/plate in the absence of S9-mix in both tester strains. Since DNNSA precipitated 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, DNNSA was tested in the first mutation assay at a concentration range of 3 to 333 µg/plate in the absence of S9-mix and at 10 to 1000 µg/plate in the presence of 5% (v/v) S9-mix in the tester strains TA1535, TA1537 and TA98. Di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid 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 and in tester strain TA98 in the presence of S9-mix.
In an independent repeat of the assay with additional parameters, DNNSA was tested at the same concentration range as the first assay in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. DNNSA precipitated on the plates at the top dose of 1000 μg/plate. Toxicity was only observed in the tester strains TA1535, TA1537, TA98, TA100 in the absence of S9-mix.
Di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid 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.
In this study, 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.
Based on the results of this study it is concluded that di C8-C10, branched, C9 rich, alkylnaphthalene sulfonic acid is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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