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EC number: - | 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:
- 10 january 2007 - 15 February 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Phytosteryldecyltetradecyl N-myristoyl-N-methylaminopropionate
- Substance type: Organic UVCB
- Physical state: Pale yellow waxy solid
- Analytical purity: 100%
- Lot No.: 609074
- Stability under test conditions: stable
- Storage condition of test material: Room temperature, in the dark away from heat and moisture.
Constituent 1
Method
- Target gene:
- Histidine encoding gene for Salmonella.
Tryptophan encoding gene for E.Coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/betanaphthoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
Preliminary Toxicity Test: 1.2,4.9,20,78,313,1250, and 5000 µg/plate.
Main test:
0.15, 0.31, 0.61, 1.2, 2.4, 4.9, 313, 625, 1250, 2500 and 5000 µg/plate (without S9 mix)
313, 625, 1250, 2500 and 5000 µg/plate (with S9 mix)- Vehicle / solvent:
- Solvent(s) used: Acetone
- Justification for choice of solvent:
Based on the information from the sponsor that the test substance was insoluble in water, the solubility test was performed with DMSO, acetone. And the test substance was insoluble at 50 mg/mL in DMSO, and was dissolved at 100 mg/mL in acetone, and neither exothermic reaction nor generation of gas was observed. Therefore acetone was used as solvent for preparation and the test was performed. In consideration of growth inhibition of acetone to test strains, twice the usual concentration was made and 0.05 mL of the test solution was used. And the tests were conducted in the preincubation method.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine-2HCl
- Remarks:
- without S9 mix
- Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hrs
NUMBER OF REPLICATIONS: 1 for Preliminary test and 3 for main test.
DETERMINATION OF CYTOTOXICITY : Growth inhibiton.
OTHER EXAMINATIONS:
Counting Procedure: The number of revertant colonies was counted visually due to the precipitate of the test substance. But the
revertant colonies of positive controls were counted with a colony counter.- Evaluation criteria:
- 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 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.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- at 4.9 µg/plate only for TA98, TA1537 without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: the precipitate on the plates was observed at 1250 µg/plate and more both with and without metabolic activation.
- During the study period, there was no environmental factor that was thought to have affected the reliability of the study, and there was no deviation from the protocol.
RANGE-FINDING/SCREENING STUDIES:
Preliminary Toxicity Test:
The growth inhibition by the test substance was observed at 4.9 µg/plate and more in S.typhimurium TA98, TA1537 without metabolic activation. And precipitate of the test substance on the plates was observed at 1250 µg/plate and more both with and without metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA:
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory).
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Not recorded- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results and Discussion:
In the main tests carried out twice, an increase in the number of revertant colonies (more than twice as many as that of the negative control) was not observed at any doses in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation. The revertant colonies of the positive controls showed an increase of more than twice that of the negative controls and they were within limit of controls (mean ± 3SD)in background data, indicating that this study was performed correctly (Appendix). From these results, mutagenicity of the test substance was judged negative. The growth inhibition of the test strains by the test substance was observed at the doses marked with " * " in the Tables, and the precipitate on the plates was observed at 1250 µg/plate and more both with and without metabolic activation. In the sterility test on the test solution and the S9 mix, no growth of bacteria was obsenved.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
From the results described above, it is concluded that Phytosteryl.decyltetradecyl N-myristoyl-N-methylaminopropionate is not mutagenic in the bacterial reverse mutation assay carried out under the experimental conditions, with and without S9. - Executive summary:
Mutagenicity potential of Phytosteryl.decyltetradecyl N-myristoyl-N-methylaminopropionate was assessed with Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA in the presence and absence of S9 in an AMES Test.. 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.
The substance is considered to be non-mutagenic with and without S9.
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