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EC number: 290-478-9 | CAS number: 90170-45-9
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-Alanine, N-coco acyl derivs., sodium salts
- EC Number:
- 290-478-9
- EC Name:
- L-Alanine, N-coco acyl derivs., sodium salts
- Cas Number:
- 90170-45-9
- Molecular formula:
- RHNNaO3
- IUPAC Name:
- L-Alanine, N-coco acyl derivs., sodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: (S)-Sodium 2-cocoylamino-propionate
BML-CODE: BML-8156
Lot No.: 050126BP
Purity: 30%
Concentration of impurities: 70% (water)
Appearance at room temperature: clear liquid
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- Without S9 mix: 2.4, 4.9, 10, 20, 39, 78, 156 and 313 μg/plate
With S9 mix: 10, 20, 39, 78, 156, 313, 625, 1250, 2500 and 5000 μg/plate - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene (with S9 mix); 2-(2-Furyl)-3-(5-mtro-2-furyl)acrylamide (without S9 mix)
- Details on test system and experimental conditions:
- The dose range for the main test was determined from the preliminary test using the following seven dose levels: 1.2, 4.9, 20, 78, 313, 1250 and 5000 μg/plate.
- Evaluation criteria:
- In the main tests carried out twice, if the number of revertant colonies on the test plates increased significantly in comparison with that on the control plates (based on twice as many as that of the negative control), and a dose-response and reproducibility were also observed, the test substance was to be judged positive. The results at each concentration were demonstrated with the mean and the standard deviation.
- Statistics:
- Standard statistical methods were used
Results and discussion
Test results
- Key result
- Species / strain:
- other: all strains tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test item was tested negative in a bacterial reverse mutation assay performed according to OECD GL 471 with GLP compliance when testet in Salmonella typhimurium TA 100, TA 1535, TA 98, TA1537 and Escherichia coli WP2 uvrA.
- Executive summary:
The mutagenic potential of Sodium N-Cocoyl-L-Alaninate was assessed with Salmonella typhimurium TA 100, TA 1535, TA 98, TA1537 and Escherichia coli WP2 uvrA. In this study, neither an increase in the number of revertant colonies more than twice in comparison with that of the negative control nor a dose-related response was observed in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation. Therefore, Sodium N-Cocoyl-L-Alaninate solution has no mutagenicity forward to bacteria under the described study conditions.
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