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EC number: 805-561-2 | CAS number: 350601-49-9
- 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
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 2013 to 1 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- METI Reverse Mutagenicity Test on Bacteria, Methods of Testing New Chemical Substances (Section 5.1-1 to 5.1-11): Japanese Act on Evaluation of Chemical Substances and Regulation of Their Manufacture, Act No. 117, Ministerial Ordinance No.1-3 (April 2004)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: Variable coloured powder
- Storage conditions of the test material: Ambient
Constituent 1
Method
- Target gene:
- Histidine requirement in the Salmonella typhimurium strains (Histidine operon).
Tryptophan requirement in the Escherichia coli strain (Tryptophan operon).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: S. typhimurium: all strains possess rfa and uvrB; TA98 and TA100 also possess the R-factor plasmid pKM101. E. coli strain possesses the uvrA mutation.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction prepared from induced rat liver
- Test concentrations with justification for top dose:
- Initial toxicity-mutation assay: 0, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Confirmatory mutation assay: 0, 100, 266, 707, 1880 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulphoxide (DMSO)
- Justification for choice of solvent/vehicle: DMSO is one of the organic vehicles compatible with this test system. The test material was found to form a solution in DMSO at 50 mg/mL and was stable and homogeneous in DMSO at 15.0372 and 50124 μg/mL after 4 and 24 hours when stored at room temperature.
Controls
- Untreated negative controls:
- no
- Remarks:
- Sterility control plates were observed for microbial colonies. Viable count plates were observed to determine the number of colony forming units per mL of each bacterial suspension.
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation
100 µL of the appropriate bacterial culture, 100 µL of the test material or control material solution and 500 µL of the S9 mix or PBS were transferred into sterile test tubes and were kept in an incubator shaker for approximately 20 ± 2 minutes at 37 ± 1 °C. After this period, 2 mL of soft agar containing histidine-biotin / tryptophan was added to each of the tubes and the constituents were overlaid onto VB agar plates. After the soft agar had set, the plates were incubated.
DURATION
- Exposure duration: 67 hours at 37 ± 1 °C under yellow light
NUMBER OF REPLICATIONS
- Initial toxicity-mutation assay: duplicate
- Confirmatory mutation assay: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: Examined for effects on the background lawn of bacterial growth - Evaluation criteria:
- The conditions necessary for determining a positive result are as follows:
There should be a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing doses of the test material either in the absence or presence of the metabolic activation system.
- Strains TA98, TA1535, and TA1537
Data sets will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 3.0 times the mean vehicle control value.
- Strain TA100 and WP2uvrA
Data sets will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2.0 times the mean vehicle control value.
A response that does not meet all three of the above criteria (magnitude, concentration-responsiveness, reproducibility) will not be evaluated as positive.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: Viable counts of all the tester strains were within the required range of 1 to 2 x10⁹ CFU/mL. The most concentrated test material dilution, the Sham (PBS) and S9 mixes were found to be sterile.
- Positive controls validity:
- valid
- Additional information on results:
- INITIAL TOXICITY-MUTATION ASSAY
The mean number of revertant colonies/plate in the vehicle control was within the range of the in-house spontaneous revertant counts for all the tester strains.
The test material did not precipitate on the basal agar plates up to 5000 µg/plate. No toxicity was observed up to 5000 µg/plate as the intensity of the bacterial background lawn was comparable to the vehicle control in the presence and absence of metabolic activation. The test material did not show any positive mutagenic response in any of the tester strains in any of the tested doses either in the presence or absence metabolic activation.
Positive control chemicals tested simultaneously produced more than a 3-fold increase in the mean numbers of revertant colonies for all the strains when compared to the respective vehicle control plates. No toxicity was observed in the positive controls as the intensity of the bacterial background lawn of all the tester strains was comparable to that of the respective vehicle control plates.
CONFIRMATORY MUTATION ASSAY
Summary results of the confirmatory mutation assay are presented in Table 1.
The mean number of revertant colonies/plate in the vehicle control was within the range of the in-house spontaneous revertant counts for all the tester strains.
The test material did not precipitate on the basal agar plates up to 5000 µg/plate. No toxicity was observed up to 5000 µg/plate as the intensity of the bacterial background lawn was comparable to the vehicle control in the presence and absence of metabolic activation. The test material did not show any positive mutagenic response in any of the tester strains in any of the tested doses either in the presence or absence metabolic activation.
Positive control chemicals tested simultaneously produced more than a 3-fold increase in the mean numbers of revertant colonies for all the strains when compared to the respective vehicle control plates. No toxicity was observed in the positive controls as the intensity of the bacterial background lawn of all the tester strains was comparable to that of the respective vehicle control plates.
S9 HOMOGENATE
The S9 homogenate was found to be sterile, the S9 homogenate was found to be active and the protein content was 28.75 mg/mL. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary Results of the Confirmatory Mutation Assay
+/- S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- - - - - - |
Solvent 100 266 707 1880 5000 |
112 108 105 104 105 105 |
14 13 14 12 13 12 |
160 149 148 141 138 135 |
28 25 27 26 24 27 |
13 12 12 11 10 11 |
+ + + + + + |
Solvent 100 266 707 1880 5000 |
120 115 111 109 111 105 |
15 15 15 14 14 15 |
155 149 144 146 141 132 |
30 29 24 25 26 27 |
14 13 13 11 12 10 |
Positive Controls |
||||||
- |
Name |
SA |
SA |
4NQO |
2NF |
9AA |
Concentration (µg/plate) |
1 |
1 |
4 |
2 |
50 |
|
Mean no. colonies/plate |
573 |
143 |
587 |
244 |
112 |
|
+ |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentration (µg/plate) |
4 |
4 |
30 |
4 |
4 |
|
Mean no. colonies/plate |
850 |
157 |
605 |
590 |
124 |
SA = sodium azide
2NF = 2-nitrofluorene
9AA = 9-aminoacridine
4NQO = 4-Nitroquinoline-1-oxide
2AA = 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the conditions of this study, the test material was considered to be non-mutagenic. - Executive summary:
The test material was assessed for mutagenic potential in the bacterial reverse mutation assay in accordance with the standardised guidelines OECD 471, EU Method B.13/14, USA EPA OPPTS 870.5100 and the Japanese METI Reverse Mutagenicity Test on Bacteria under GLP conditions.
The study was conducted using TA98, TA100, TA1535 and TA1537 strains of Salmonella typhimurium and the WP2uvrA (pKM101) strain of Escherichia coli in two phases. In the first phase, an initial toxicity-mutation test was performed. The second phase was an independent confirmatory mutation test. The bacterial tester strains were exposed to the test material in dimethyl sulphoxide in the presence and absence of a metabolic activation system (S9 fraction prepared from Aroclor 1254 induced rat liver) using a pre-incubation procedure.
In the initial toxicity-mutation assay, cultures were exposed to the test material in duplicate at 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate, along with the vehicle and appropriate positive controls.
Neither precipitation nor toxicity of the test material was observed on the basal agar plates up to 5000 µg/plate, either in the presence or absence of metabolic activation when compared to the vehicle control. There was no positive mutagenic response observed in any of the strains in any of the tested doses either in the presence or in the absence of metabolic activation.
Based on these initial findings, in the confirmatory mutation assay, cultures were exposed to the test material in triplicate at 100, 266, 707, 1880, and 5000 µg/plate, along with the vehicle and appropriate positive controls.
Neither precipitation nor toxicity of the test material was observed on the basal agar plates up to 5000 µg/plate, either in the presence or absence of metabolic activation when compared to the vehicle control. There was no positive mutagenic response observed in any of the strains in any of the tested doses either in the presence or in the absence of metabolic activation.
In this study, there was a more than 3-fold increase in the mean numbers of revertant colonies in the positive controls, demonstrating the sensitivity of the assay. All criteria for a valid study were met.
Under the conditions of this study, it was determined that the test material was non-mutagenic in both the presence and absence of metabolic activation.
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