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EC number: 600-768-2 | CAS number: 106726-11-8
- 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:
- other information
- Rationale for reliability incl. deficiencies:
- other: Non GLP screening study comparable to guideline study but only two strains of Salmonella typhimurium (TA98 and TA100) were used and the 2-Aminoanthracene positive control was the sole indicator of the efficacy of the S9-mix.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only two strains of Salmonella typhimurium tested. 2-Aminoanthracene positive control was the sole indicator of the efficacy of the S9-mix.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)
- EC Number:
- 600-768-2
- Cas Number:
- 106726-11-8
- Molecular formula:
- C30H57NdO6
- IUPAC Name:
- neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Neodymium versatate
- Physical state: Blue powder
- Storage condition of test material: Ambient conditions
Constituent 1
Method
- Target gene:
- Not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 61.7, 185, 556, 1670 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: no data
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- sterility control: plates were prepared to check the sterility of the test substance solutions and the S9 mix
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 2 µg/ plate; without metabolic activation; strain TA 98
- Untreated negative controls:
- yes
- Remarks:
- sterility control: plates were prepared to check the sterility of the test substance solutions and the S9 mix
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 1 µg/ plate; without metabolic activation; strain TA 100
- Untreated negative controls:
- yes
- Remarks:
- sterility control: plates were prepared to check the sterility of the test substance solutions and the S9 mix
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 1 µg/plate; with metabolic activation; strains TA 98 and TA 100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72h at 37°C
NUMBER OF REPLICATIONS: tested in duplicate
EVALUATION: After the period of incubation, the plates were scored by counting the number of revertant colonies on each plate, either manually, or using a calibrated Artek Model 890 Automatic colony counter
DETERMINATION OF CYTOTOXICITY
- Method: no data - Evaluation criteria:
- The data sets for the tester strains TA 98 and TA 100 were judged positive if the increase in the mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value
- Statistics:
- For each replicate plating, the mean and standard error of the number of revertants per plate were calculated and reported
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight toxicity, indicated by thinning of the background lawn and reduction in revertant numbers, was observed at the highest dose-level, both in the absence and presence of S9 metabolism
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight toxicity, indicated by thinning of the background lawn and reduction in revertant numbers, was observed at the highest dose-level, both in the absence and presence of S9 metabolism
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No further details
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
Under the conditions of this study, there is no indication that the test substance has mutagenic potential - Executive summary:
The ability of Neodymium Versatate test substance to induce gene mutations in Salmonella typhymurium was measured by examining the reversion of histidine auxotrophs to prototrophy.
Methods
The test item was tested in a single experiment, with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with phenobarbitone and betanaphthoflavone (Mixed Induction).
The experiment was performed according to the plate incorporation method. Two strains of bacteria Salmonella typhimurium: TA 98 an TA 100 were used. Each strain was exposed to five dose-levels of the test item (two plates/dose-level). After 72 hours of incubation at 37°C, 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 Neodymium Versatate was dissolved in ethanol.
The dose-levels of the positive controls were as follows:
without S9 mix:
- 2 μg/plate of 2 -Nitrofluorene: TA 98 strain
- 1 μg/plate of Sodium azide: TA 100 strain
with S9 mix:
- 1 μg/plate of 2-Aminoanthracene: TA 98 and TA 100 strains
Results
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. Sterility of the S9 mix and test substance solutions was confirmed by the absence of colonies on additional agar plates separately spread with these solutions. The study was therefore considered valid.
The selected treatment-levels both with and without S9 mix were:
- 61.7, 185, 556, 1670 and 5000 µg/plate, for the two tested strains
A slight toxicity was noted in highest dose-level with both strainTA98 and TA100, both in the absence and presence of S9 metabolic activation . The test item did not induce any noteworthy increase in the number of revertants, at any concentration, with any tester strain,in the absence or presence of S9 metabolic activation.
Conclusion
Under the experimental conditions, the test item Neodymium Versatate did not show any mutagenic potential in the bacterial reverse mutation test with Salmonella
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