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EC number: 441-520-1 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 February 1997 to 28 March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Standards for Toxicity Investigations
- Version / remarks:
- Japan's Ministry of Labor, No.77, September 1, 1988
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Notification on Partial Revision of Testing Methods Relating to the New Chemical Substances
- Version / remarks:
- Notification No. 700 of the Planning and Coordination Bureau, EA, No. 1039 of the Pharmaceutical Affairs Bureau, MHW & No. 1014 ( 1986) of the Basic Industries Bureau, MITI, December 5, 1986
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 441-520-1
- EC Name:
- -
- Cas Number:
- 170577-61-4
- Molecular formula:
- C28H38O4S
- IUPAC Name:
- 2-{[2-tert-butyl-4-({5-tert-butyl-2-methyl-4-[(oxiran-2-yl)methoxy]phenyl}sulfanyl)-5-methylphenoxy]methyl}oxirane
- Test material form:
- solid: crystalline
- Details on test material:
- - Appearance: White to light yellow crystalline
- Storage Conditions: Stored in a cold and dark place.
Constituent 1
Method
- Target gene:
- - Histidine requirement in the Salmonella typhimurium strains (Histidine operon).
- Tryptophan requirement in the Escherichia coli strain (Tryptophan operon).
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):
- CELLS USED
- Source of cells: Dr. B.N. Ames, University of California, U.S.A., on June 20, 1990
- Storage of cells: After 0.045 mL of spectrophotometric grade of dimethyl sulfoxide (DMSO) was added to 0.5 mL of the bacterial culture, it was stored at -80 °C until use.
-The amino acid requirements were confirmed using histidine. The presence or absence of R-factor were confirmed by ampicillin resistance, and mutations in membrane and DNA repair were examined by sensitivity to crystal violet and UV sensitivity, respectively.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Japan Bioassay Research Centre on January 7, 1997.
- Storage of cells: After 0.045 mL of spectrophotometric grade of dimethyl sulfoxide (DMSO) was added to 0.5 mL of the bacterial culture, it was stored at -80 °C until use.
-The amino acid requirements were confirmed using tryptophan. The presence or absence of R-factor were confirmed by ampicillin resistance, and mutations in membrane and DNA repair were examined by sensitivity to crystal violet and UV sensitivity, respectively.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- - 5000, 2500, 1250, 625 and 313 μg/plate.
- The results of the dose-range-finding test showed that both growth inhibition and increases in the revertant colonies were not observed at 1000, 500, 100, 50, 10 and 5 μg/plate and so 5000 µg/plate was used as the highest dose in the main test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dehydrolysed DMSO
- The test material was dissolved in dehydrolysed DMSO (Lot No. DN072), to make 5 w/v % concentration and diluted with the same solvent to make lower concentrations. DMSO was dehydrated with Molecular Sieves 3A 1/8.
- The test material was prepared just before use and used within 0.5 hour. The test material solutions were kept at room temperature until use.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylarnide (AF-2), 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino ]acridine.2HCl (ICR-191) and 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation
- After 0.1 mL of the test material solution, 0.5 mL of 0.1 M sodium phosphate buffer (pH 7.4) or S9 mix, and 0.1 mL of the bacterial culture were added to a tube, the mixtures were incubated for 20 min at 37 ± 0.5 °C. Two mL of the soft agar was then added to each tube and poured onto a minimal glucose agar plate. After incubation for 48 hours at 37 ± 0.5 °C, the number of revertant colonies was counted.
- As the sterility test, 0.1 mL of each bacterial strain, test material solution, and S9 mix or 0.1 M sodium phosphate buffer (pH 7.4) were smeared on a minimal glucose agar plate, which was incubated at 37 ± 0.5 °C for 48 hours to check the bacterial contamination. Dehydrolysed DMSO was used as a negative control, and appropriate positive controls were used for each bacterial strain.
NUMBER OF REPLICATIONS: Three plates were used for the negative control and two plates for the test material and positive controls.
OBSERVATION AND COLONY COUNTING
- Microscopic Observation: The state of revertant colonies (size and number of colonies), deposition of the test material and the growth inhibition were examined with a stereo microscope.
- Colony Counting: The number of colonies was counted with a manual counter or a colony analyser. Correction for counting errors was made for measurements with the colony analyser. Each plate was measured three times, and the average of these three measurements was adopted as the number of revertant colonies on the plate. The average for each dose was calculated from the values of the plates used. Decimals of the average figures were rounded off. - Evaluation criteria:
- JUDGEMENT CRITERIA OF TEST RESULTS
- The test material was judged to be positive when the number of revertant colonies increased twice or more that of the negative control in a dose-dependent manner, and the reproducibility of the test results was also obtained.
- It was judged to be negative in other cases. - Statistics:
- Any statistical procedures were not applied.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - The test results demonstrated that the number of the revertant colonies in all the test strains was less than twice that of the negative control with and without S9 mix.
- The deposition of the test material was observed at more than 1000 μg/plate with and without S9 mix, however, the deposition did not interfere with counting the revertant colonies.
- The positive controls induced significant increases in the revertant colonies, and the number of revertant colonies in the positive controls and the negative control was found to be within a range of the background data in the testing laboratory.
- There were no fluctuations that affected the test results, since it was confirmed that there was no contamination in the test system by the sterility test.
Any other information on results incl. tables
Table 1: Summary of Results of the Main Test
± S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
Solvent 313 625 1250* 2500* 5000* |
124 127 124 113 112 120 |
10 12 10 12 14 11 |
29 28 32 32 32 39 |
23 20 26 22 28 23 |
10 8 8 10 9 6 |
+ |
Solvent 313 625 1250* 2500* 5000* |
126 108 112 124 108 117 |
9 11 10 11 9 11 |
29 29 30 33 36 30 |
32 32 35 31 29 31 |
20 17 16 13 14 15 |
Positive Controls |
||||||
- |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1 |
|
Mean no. colonies/plate |
544 |
338 |
152 |
469 |
2223 |
|
+ |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean no. colonies/plate |
883 |
170 |
651 |
361 |
162 |
* deposition of test material
AF-2 = 2-(2-Furyl )-3-(5 -nitro-2-furyl)acrylamide
2AA = 2-aminoanthracene
ICR-191 = 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine · 2HCI
NaN3 = Sodium azide
Applicant's summary and conclusion
- Conclusions:
- The test material was not mutagenic under the conditions of the study.
- Executive summary:
The mutagenicity of the test material was examined in Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 as well as Escherichia coli strain WP2 uvrA using the pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). The testing was performed under GLP conditions.
The test results demonstrated that the number of the revertant colonies in all the test strains was less than twice that of the negative control with and without S9 mix. The deposition of the test material was observed at more than 1000 μg/plate with and without S9 mix, however, the deposition did not interfere with counting the revertant colonies.
The positive controls induced significant increases in the revertant colonies, and the number of revertant colonies in the positive controls and the negative control was found to be within a range of the background data in the testing laboratory.
There were no fluctuations affected the test results, since it was confirmed that there was no contamination in the test system by the sterility test.
Under the conditions of this study, the test material displayed no reverse mutagenic potential.
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