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EC number: 807-008-0 | CAS number: 1173693-36-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 2 012
- Report date:
- 2012
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:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- 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:
- other: MAFF Japan Test Guidelines for Agricultural Chemicals 12-Nousan-8147: Guideline Number 2-1-19-1 (2000)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid
- Details on test material:
- - Purity: 99.9%
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from male Sprague-Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- toxicity-mutation test: 33.3, 66.7, 100, 333, 667, 1000, 3333, and 5000 μg per plate
mutagenicity test: 333, 667, 1000, 3333, and 5000 μg per plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Based on the solubility of the test substance and compatibility with the target cells
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- triethylenemelamine
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene, Acridine mutagen ICR-191
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: agar plate incorporation
DURATION
- All samples were vortexed and overlaid onto the surface of minimum glucose agar plates. After the overlay solidified, the plates were inverted and incubated for approximately 50-54 hours at 37 ± 2ºC. Plates that were not evaluated immediately following the incubation period were stored at approximately 4ºC. All toxicity-mutation test dose preparations of negative (vehicle) controls, test substance, and positive controls were plated in duplicate. All mutagenicity test dose preparations of negative (vehicle) controls, test substance, and positive controls were plated in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: The appearance of the bacterial background lawn was assessed microscopically for test substance toxicity and precipitation. Toxicity was scored relative to the concurrent tester strain specific negative control, and evaluated as a decrease in the mean number of revertant bacterial colonies per plate. In addition, the thinning or disappearance of the bacterial background lawn was considered as signs of toxicity. A minimum of 3 non-toxic scorable dose levels are required to validate the study. A dose level is considered toxic if it causes:
• A > 50% reduction in the mean number of revertants per plate relative to the mean negative control value and exhibits a dose-dependent drop in the revertant count, or
• A reduction in the background lawn. - Evaluation criteria:
- Strains TA1535 and TA1537: Data will be judged positive if the increase in mean revertants at the highest numerical dose response is ≥ 3.0-fold the mean concurrent negative control value (vehicle control). This increase in the mean number of revertants per plate must be accompanied by a dose response associated with increasing concentrations of the test substance unless observed at the top dose level only.
Strains TA98, TA100 and WP2uvrA: Data sets will be judged positive if the increase in mean revertants at the highest numerical dose response is ≥ 2.0-fold the mean concurrent negative control value (vehicle control). This increase in the mean number of revertants per plate must be accompanied by a dose response associated with increasing concentrations of the test substance unless observed at the top dose level only. - Statistics:
- For each tester strain, the mean of the number of revertants and the standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Toxicity was observed as a >50% reduction in revertant colonies with tester strain TA1537 starting at 3333 μg per plate in the absence of S9 activation. Toxicity was observed as a reduction in background lawn with tester strain TA100 starting at 3333 μg per plate in the presence of S9 activation and at 5000 μg per plate in the absence of S9 activation. No other appreciable toxicity was observed. No test substance precipitation was observed.
No positive mutagenic responses were observed at any dose level in any tester strain in the absence or presence of S9 metabolic activation.
Summary of the toxicity-mutation test without rat liver S9 |
||||||||||
Dose (µg/plate) |
Number of Revertants Per Plate |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
Vehicle |
18 |
2 |
95 |
2 |
14 |
10 |
10 |
5 |
28 |
9 |
Positive control |
169 |
9 |
1311 |
43 |
1164 |
31 |
1628 |
171 |
448 |
23 |
33.3 |
16 |
4 |
109 |
13 |
14 |
3 |
8 |
3 |
33 |
6 |
66.7 |
21 |
5 |
91 |
8 |
11 |
6 |
9 |
5 |
36 |
1 |
100 |
25 |
2 |
103 |
8 |
12 |
1 |
7 |
1 |
30 |
3 |
333 |
22 |
1 |
102 |
3 |
15 |
4 |
8 |
3 |
23 |
1 |
667 |
28 |
1 |
97 |
4 |
12 |
0 |
8 |
4 |
28 |
1 |
1000 |
21 |
8 |
87 |
9 |
14 |
7 |
8 |
3 |
27 |
0 |
3333 |
13 |
4 |
81 |
2 |
11 |
0 |
4 |
0 |
27 |
4 |
5000 |
15 |
6 |
59 |
1 |
12 |
1 |
3 |
1 |
22 |
4 |
Experiment No: T-1 Plate Aliquot: 100 µL |
Summary of the toxicity-mutation test with rat liver S9 |
||||||||||
Dose (µg/plate) |
Number of Revertants Per Plate |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
Vehicle |
27 |
11 |
111 |
5 |
12 |
1 |
6 |
1 |
35 |
6 |
Positive control |
489 |
28 |
2323 |
53 |
186 |
11 |
107 |
6 |
214 |
20 |
33.3 |
30 |
6 |
111 |
3 |
15 |
2 |
7 |
4 |
37 |
6 |
66.7 |
30 |
0 |
132 |
11 |
10 |
1 |
8 |
6 |
34 |
0 |
100 |
28 |
7 |
118 |
6 |
14 |
2 |
8 |
2 |
36 |
4 |
333 |
29 |
1 |
122 |
23 |
12 |
10 |
8 |
4 |
32 |
2 |
667 |
28 |
1 |
103 |
19 |
9 |
0 |
9 |
2 |
35 |
3 |
1000 |
31 |
2 |
127 |
4 |
8 |
3 |
10 |
1 |
34 |
1 |
3333 |
30 |
4 |
134 |
33 |
10 |
1 |
10 |
1 |
28 |
13 |
5000 |
25 |
12 |
113 |
13 |
9 |
5 |
5 |
1 |
32 |
4 |
Experiment No: T-1 Plate Aliquot: 100 µL |
Summary of the mutagenicity test without rat liver S9 |
||||||||||
Dose (µg/plate) |
Number of Revertants Per Plate |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
Vehicle |
16 |
4 |
82 |
9 |
12 |
2 |
9 |
3 |
30 |
5 |
Positive control |
189 |
47 |
1065 |
112 |
948 |
19 |
1149 |
34 |
529 |
66 |
333 |
15 |
4 |
81 |
20 |
8 |
4 |
8 |
3 |
23 |
8 |
667 |
18 |
4 |
71 |
12 |
12 |
1 |
5 |
2 |
25 |
4 |
1000 |
16 |
6 |
83 |
20 |
9 |
2 |
7 |
2 |
18 |
5 |
3333 |
13 |
3 |
67 |
5 |
7 |
3 |
2 |
1 |
31 |
7 |
5000 |
14 |
3 |
53 |
8 |
9 |
3 |
3 |
2 |
23 |
1 |
Experiment No: E-1 Plate Aliquot: 100 µL |
Summary of the mutagenicity test with rat liver S9 |
||||||||||
Dose (µg/plate) |
Number of Revertants Per Plate |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
Vehicle |
26 |
4 |
118 |
14 |
10 |
2 |
8 |
4 |
33 |
2 |
Positive control |
409 |
24 |
2013 |
189 |
160 |
11 |
108 |
25 |
188 |
5 |
333 |
20 |
7 |
120 |
7 |
11 |
4 |
9 |
4 |
36 |
8 |
667 |
25 |
3 |
121 |
9 |
12 |
5 |
7 |
4 |
34 |
4 |
1000 |
20 |
5 |
134 |
20 |
11 |
6 |
11 |
4 |
35 |
5 |
3333 |
20 |
5 |
114 |
9 |
10 |
7 |
7 |
3 |
32 |
5 |
5000 |
14 |
4 |
107 |
18 |
7 |
2 |
3 |
3 |
31 |
2 |
Experiment No: E-1 Plate Aliquot: 100 µL |
Applicant's summary and conclusion
- Conclusions:
- 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). 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.
The dose levels selected for the mutagenicity test were 333, 667, 1000, 3333, and 5000 μg per plate.
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. Toxicity was observed as a reduction in background lawn starting at 3333 μg per plate with tester strain TA100 in the presence of S9 activation and strain TA1537 both in the presence and absence of S9 activation. A >50% reduction in revertant colonies was also observed for tester strain TA1537 starting at 3333 μg per plate in the absence of S9 activation and at 5000 μg per plate in the presence of S9 activation.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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