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EC number: 816-285-7 | CAS number: 1263133-33-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- other: MAFF Japan Notification No. 12-Nousan-8147 Guideline No. 2-1-19-1 (2000)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 1263133-33-0
- Test material form:
- solid
- Details on test material:
- Purity: 97.04%
Impurities: Not reported
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- In the toxicity-mutation test, 66.7, 100, 333, 667, 1000, 3000, 4000 and 5000 μg/plate and in the Confirmatory test: 667, 1000, 3000, 4000, and 5000 μg/plate
- Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 4-nitroquinoline N-oxide, acridine mutagen ICR-191, and 2-aminoanthracene
- Evaluation criteria:
- For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 2.0-times the mean vehicle control value.
A data set may be judged equivocal if there is a biologically relevant increased response that only partially meets criteria for a positive response. A response will be evaluated as negative if it is neither positive nor equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 4000 and 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 4000 and 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 4000 and 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1 - Mutagenicity test in Salmonella typhimurium TA98 without S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
21 |
5 |
Positive Control* |
306 |
46 |
667 |
18 |
1 |
1000 |
26 |
4 |
3000 |
22 |
2 |
4000 |
37 |
7 |
5000 |
23 |
5 |
* 1.0 μg/plate 2-Nitrofluorene
Table 2 - Mutagenicity test in Salmonella typhimurium TA100 without S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
94 |
15 |
Positive Control* |
1145 |
45 |
667 |
78 |
19 |
1000 |
90 |
12 |
3000 |
71 |
5 |
4000 |
90 |
6 |
5000 |
83 |
17 |
* 2.0 μg/plate Sodium azide
Table 3 - Mutagenicity test in Salmonella typhimurium TA1535 without S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
12 |
3 |
Positive Control* |
965 |
56 |
667 |
13 |
6 |
1000 |
13 |
1 |
3000 |
12 |
3 |
4000 |
12 |
1 |
5000 |
12 |
3 |
* 2.0 μg/plate sodium azide
Table 4 - Mutagenicity test in Salmonella typhimurium TA1537 without S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
9 |
3 |
Positive Control* |
1321 |
148 |
667 |
7 |
3 |
1000 |
10 |
4 |
3000 |
7 |
3 |
4000 |
7 |
3 |
5000 |
5 |
3 |
* 2.0 μg/plate ICR-191
Table 5 - Mutagenicity test in Escherichia coli WP2uvrA without S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
21 |
1 |
Positive Control* |
698 |
76 |
667 |
19 |
1 |
1000 |
17 |
5 |
3000 |
19 |
4 |
4000 |
18 |
5 |
5000 |
12 |
1 |
* 1.0 μg/plate 4-Nitroquinoline-N-oxide
Table 6 - Mutagenicity test in Salmonella typhimurium TA98 with S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
26 |
5 |
Positive Control* |
473 |
12 |
667 |
21 |
9 |
1000 |
34 |
8 |
3000 |
30 |
6 |
4000 |
24 |
2 |
5000 |
26 |
8 |
* 2.5 μg/plate Benzo(a)pyrene
Table 7 - Mutagenicity test in Salmonella typhimurium TA100 with S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
98 |
14 |
Positive Control* |
1445 |
101 |
667 |
88 |
5 |
1000 |
85 |
11 |
3000 |
95 |
3 |
4000 |
91 |
10 |
5000 |
86 |
8 |
* 2.5 μg/plate 2-Aminoanthracene
Table 8 - Mutagenicity test in Salmonella typhimurium TA1535 with S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
7 |
1 |
Positive Control* |
147 |
10 |
667 |
10 |
6 |
1000 |
12 |
5 |
3000 |
7 |
4 |
4000 |
10 |
4 |
5000 |
8 |
3 |
* 2.5 μg/plate 2-Aminoanthracene
Table 9 - Mutagenicity test in Salmonella typhimurium TA1537 with S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
8 |
1 |
Positive Control* |
76 |
5 |
667 |
5 |
1 |
1000 |
8 |
2 |
3000 |
6 |
2 |
4000 |
6 |
2 |
5000 |
8 |
6 |
* 2.5 μg/plate 2-Aminoanthracene
Table 10 - Mutagenicity test in Escherichia coli WP2uvrA with S9
Dose (µg/plate) |
Mean Revertants/plate |
SD |
Vehicle (DMSO) |
19 |
5 |
Positive Control* |
145 |
22 |
667 |
19 |
9 |
1000 |
20 |
4 |
3000 |
24 |
4 |
4000 |
16 |
4 |
5000 |
18 |
7 |
* 25 μg/plate 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test substance showed no evidence of mutagenicity in the Bacterial Reverse Mutation Test either in the absence or presence of Aroclor-induced rat liver S9. It was concluded that the test substance was negative in this in vitro test.
- Executive summary:
The test substance was evaluated for mutagenicity in the Bacterial Reverse Mutation Test using the plate incorporation method. Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 and Escherichia coli strain WP2uvrA were tested in the absence and presence of an exogenous metabolic activation system (Aroclor-induced rat liver S9) (OECD Section 4 (Part 471), Guideline for the Testing of Chemicals (1997); U.S. EPA OPPTS Guideline 870.5100 (1998); EC Directive 440/2008/EC Method B.13/14; and MAFF Japan 12-Nousan-8147 Guideline Number 2-1-19-1 (2000)).
The test was performed in 2 phases. The first phase was the toxicity-mutation test, which established the dose range for the mutagenicity test and provided a preliminary mutagenicity evaluation. The second phase was the mutagenicity test, which evaluated and confirmed the mutagenic potential of the test substance.
Dimethyl sulfoxide (DMSO) was chosen as the dosing vehicle based on the solubility of the test substance and compatibility with the target cells. The test substance was soluble in DMSO at 50 mg/mL, the highest stock concentration that was prepared for use on this study.
In the toxicity-mutation test, the maximum dose evaluated was 5000 μg/plate for tester strains TA98, TA100, TA1535, TA1537, and WP2uvrA in the absence and presence of S9 metabolic activation. This dose was achieved using a concentration of 50 mg/mL and a 100 μL plating aliquot. The dose levels used in this test were 66.7, 100, 333, 667, 1000, 3000, 4000 and 5000 μg/plate. The plate incorporation method was employed. No positive mutagenic responses were observed at any dose level in any tester strain in the absence or presence of S9 metabolic activation. No appreciable toxicity was observed at any dose level with any tester strain in either the absence or presence of S9. Test substance precipitation was observed starting at 4000 μg/plate with tester strains TA98, TA1535, and TA1537 in the presence of S9 activation; and at 5000 μg/plate with tester strains TA100 and WP2uvrA in the presence of S9 activation and tester strains TA1535 and TA1537 in the absence of S9 activation.
Based on the toxicity-mutation test, the maximum dose evaluated in the mutagenicity test was 5000 μg/plate for tester strains TA98, TA100, TA1535, TA1537, and WP2uvrA in the absence and presence of S9 metabolic activation. This dose was achieved using a concentration of 50 mg/mL and a 100 μL plating aliquot. The dose levels used in this test were 667, 1000, 3000, 4000, and 5000 μg/plate for all tester strains. The plate incorporation method was employed. No positive mutagenic responses were observed at any dose level or with any tester strain in either the absence or presence of S9 metabolic activation (see Tables 1 -10 in the "Any other information on results incl. tables" section for details). No appreciable toxicity was observed at any dose level with any tester strain in either the absence or presence of S9. Test substance precipitation was observed starting at 4000 μg/plate for all tester strains in both test condition with the exception of TA1535 without S9 activation where precipitation was observed only at 5000 μg/plate and for WP2uvrA without S9 activation where no test substance precipitation was observed.
All criteria for a valid study were met. Under the conditions of this study, the test substance showed no evidence of mutagenicity in the Bacterial Reverse Mutation Test either in the absence or presence of Aroclor-induced rat liver S9. It was concluded that the test substance was negative in this in vitro test.
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