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EC number: 914-147-1 | CAS number: -
- 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:
- from 15 May 2009 to 30 October 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate
- IUPAC Name:
- Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate
- Substance type: UVCB
- Physical state: brown liquid
- Composition of test material, percentage of components: sodium hydroxyde: 1 - 8 % ; sodium sulfate: 7 - 20 % ; sodium amino-12-dodecanoate: 2 - 8 ; sodium dodecanoedioate: 0.5 - 5 % ; sodium chlorure: 0.05 - 0.3 % ; lactame 12: 0.2 - 1 % ; organic fraction : about 10 - 18 %
- Purity test date: 26 March 2009
- Lot/batch No.: T710/712
- Expiration date of the lot/batch: 20 March 2010
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 312.5 ; 625 ; 1250 ; 2500 and 5000 µg/plate, for all mutagenicity experiments, with and without S9 mix.
- Vehicle / solvent:
- - Vehicle used: water for injections
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: and 9-Aminoacridine; 2-Nitrofluorene; Mitomycin C; 2-Anthramine; Benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
The preliminary test, all experiments without S9 mix and the first and third experiments with S9 mix were performed according to the direct plate incorporation method. The second experiment with S9 mix was performed according to the preincubation method.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 or 72 hours
- Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
- Statistics:
- Not applicable.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium. - Executive summary:
A preliminary toxicity test was performed to define the dose-levels of Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate to be used for the mutagenicity study. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes,).
Five strains of bacteriaSalmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose‑level). After 48 to 72 hours of incubation at, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate was dissolved in water for injections.
The dose-levels of the positive controls were as follows:
without S9 mix
· 1 µg/plate of sodium azide (NaN3): TA 1535 and TA 100 strains,
· 50 µg/plate of 9-Aminoacridine (9AA): TA 1537 strain,
· 0.5 µg/plate of 2-Nitrofluorene (2NF): TA 98 strain,
· 0.5 µg/plate of Mitomycin C (MMC): TA 102 strain.
with S9 mix
· 2 µg/plate of 2-Anthramine (2AM): TA 1535, TA 1537 and TA 98 strains,
· 5 µg/plate of Benzo(a)pyrene (BAP): TA 100 strain,
· 10 µg/plate of 2-Anthramine (2AM): TA 102 strain.
Results
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered as valid.
Since the test item was freely soluble and non-toxic in the preliminary assay, the highest dose‑level was 5000 µg/plate, according to the criteria specified in the international guidelines.
The selected treatment-levels were: 312.5, 625, 1250, 2500 and 5000 µg/plate for all mutagenicity experiments, with and without S9 mix.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose-levels.
No noteworthy toxicity was noted towards all the strains used, either with or without S9 mix.
A noteworthy increase (up to 2.0-fold the vehicle control value) in the number of revertants was noted in the TA 100 strain, in the first experiment with S9 mix (direct plate incorporation method). This increase exceeded the threshold of 2‑fold the vehicle control value, however it was not observed in the second experiment, using the preincubation method. In the third experiment (performed under the same experimental conditions as for the first one), no noteworthy increase in the number of revertant was observed. Consequently, since it was not reproducible, the increase was not considered as biologically relevant.
The test item did not induce any noteworthy increase in the number of revertants, in any of the four other strains, either with or without S9 mix.
Conclusion
Under the experimental conditions of the study, the test item Reaction mass of sodium sulfate, sodium amino‑12-dodecanoate and sodium dodecanoedioate did not show any mutagenic activity in the bacterial reverse mutation test withSalmonella typhimurium.
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