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EC number: 700-043-1 | 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:
- April 6-27, 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results. Conducted to method equivalent to OECD and to Japanese GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- To set the dose levels in this study, a dose-setting study was conducted to examine the number of reverse mutant colonies, antimicrobial activity and precipitation. In the dose-setting study, six dose levels were set up with 5000 μg/plate as the highest level and common ratio of 4.
The test article neither showed antimicrobial activity to any of the microbial strains regardless of the presence or absence of a metabolic activator at all dose levels nor increased the number of reverse mutant colonies twice or more than that in the negative vehicle. The test article precipitated at concentrations of 1250 μg/plate or higher regardless of the presence or absence of a metabolic activator but this had no effect on the counting of reverse mutant colonies.
Based on the above results, it was decided to use 5 dose levels with 5000 μg/plate as the highest dose level and common ratio of 2 for all microbial strains regardless of the presence or absence of a metabolic activator. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2R)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2R)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate; (2S)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2S)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate
- EC Number:
- 700-043-1
- Molecular formula:
- C24H56O8Si5
- IUPAC Name:
- (2R)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2R)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate; (2S)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2S)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): L1
-Lot numbeer: 060620
- Appearance: liquid
Constituent 1
Method
- Target gene:
- Genes involved in histidine synthesis
Genes involved in tryptophan synthesis
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 specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5, 20, 78, 313, 625, 1250, 2500 and 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: The vehicle for the test article was decided based on the result of the dissolution test, which was conducted in distilled water, DMSO, and acetone. The concentration of the dissolution test was set at 50 mg/mL in distilled water and DMSO and 100 mg/mL in acetone. The test article was added to each of the vehicles to give 50 or 100 mg/mL and solubility and reactions with the vehicle such as heat and fume generation were observed macroscopically. As a result, the test article dissolved in acetone. It also gave a uniformly dispersed suspension in DMSO by ultrasonication. Dispersion by ultrasonication was also attempted in distilled water but a uniform dispersion was not observed. The reactivity of the test article with vehicles such as heat and fume generation was examined. No reaction was observed with any of the vehicles. Based on the above results, acetone, which gave a solution of the test article without reacting and in which the test article was stable as a solution, was selected as the vehicle. The acetone used in the preparation was dehydrated by molecular sieving.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- benzo(a)pyrene
- other: 2-(-2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
Revertant colonies and checking background lawn. - Evaluation criteria:
- Dose-dependent increase in the reverse mutant colonies of any of the microbial strains regardless of the presence or absence of metabolic activation and a twice or more increase in comparison to the negative (vechicle) control.
- Statistics:
- Standard deviation.
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:
- valid
- Positive controls validity:
- valid
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Six dose levels in total were prepared with the highest dose level of 5000 μg/plate, which was diluted by a common ratio of 4.
COMPARISON WITH HISTORICAL CONTROL DATA:
The reverse mutant colony counts in the negative (vehicle) control and the positive controls were within the normal ranges based on the respective background data. 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 9—aminoacridine, 2-aminoanthracene and benzo[α]pyrene, used as positive controls, increased the reverse mutant colonies twice or more in comparison to the negative (vehicle) control. These results demonstrate appropriate conduct of the study. Neither environmental factor that might have affected the study reliability adversely nor deviation from the protocol was observed.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test article did not show a dose-dependent increase in the reverse mutant colonies of any of the microbial strains regardless of the presence or absence of metabolic activation and a twice or more increase in comparison to the negative (vehicle) control. The result was reproduced in the dose-setting study and the main study. In the sterility test performed in Nutrient broth No. 2 used in the pre-culture, in the test article solution at the highest concentration used in the study, S9 Mix and 0.1 M phosphate buffer, no microbial contamination was confirmed.
The test article did not show antimicrobial activity to any of the microbial strains regardless of the presence or absence of a metabolic activator. It was precipitated at doses of 625 μg/plate or higher in the absence of a metabolic activator and 1250 μg/plate or higher in the presence of a metabolic activator. - Remarks on result:
- other: not mutagenic under the conditions of this study.
Any other information on results incl. tables
Please refer to the attached background material for the results of the dose-setting study (Table 1) and the result of the main study (Table 2).
Applicant's summary and conclusion
- Conclusions:
- The test article did not show a dose-dependent increase in the reverse mutant colonies of any of the microbial strains regardless of the presence or absence of metabolic activation and a twice or more increase in comparison to the negative (vehicle) control. The result was reproduced in the dose-setting study and the main study. It was concluded that the test article was not mutagenic under the conditions of this study.
- Executive summary:
In a reverse gene mutation assay in bacteria strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium and strain WP2 uvr A of E. coli were exposed to the test substance in acetone, at concentrations of 5, 20, 78, 313, 625, 1250, 2500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation pre-incubation.
The test substance was tested up to cytotoxic the limit concentration (5000 µg/plate). The test article precipitated at doses of 625 µg/plate or higher in the absence of a metabolic activator and 1250 µg/plate or higher in the presence of a metabolic activator.
No growth inhibition was detected.
The number of reverse mutant colonies was within the range of the historical data both in the negative and positive controls. Absence of contamination in the study system was also confirmed validating proper conduct of the study.
Based on the results, it was concluded that the test article was not mutagenic under the conditions of the study.
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