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EC number: 261-521-9 | CAS number: 58958-60-4
- 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
- Study period:
- 27 Apr - 18 Jun 2015
- 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)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Regulation and Inspection of Community of Madrid, Spain
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium strains)
trp operon (E. coli strain)
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 pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1 (plate incorporation method) and 2 (preincubation method): 0.06, 0.19, 0.56, 1.67 and 5.0 μL/plate, with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test substance was soluble in DMSO at a 1/3 dilution
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Remarks:
- -S9: 2-nitrofluorene (5 µg/plate) for TA98; sodium azide (2.5 or 3.5 µg/plate) for TA100 and TA1535; 9-aminoacridine (45 µg/plate) for TA1537; 4-nitroquinoline-N-oxide (0.4 µg/plate) for E coli; +S9: 2-aminoanthracene (1.5, 2.5 or 30 µg/plate) all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: in agar (plate incorporation); experiment 2: preincubation
DURATION
- Preincubation period: 20 min (experiment 2)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: three replications each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertant colonies, or a clearing or diminuition of the background lawn
OTHER EXAMINATIONS:
- Other: the test item sterility was tested by adding 5 μL/plate to a minimal agar plate and incubating at 37 ºC for 48 h.
OTHER: 2-aminoanthracene was used as the only positive control with metabolic activation. However, the ability of the S9-mix to activate B[a]P and 2-aminoanthracene was confirmed in an assay prior to the main study and 2-aminoanthracene is considered to be an appropriate positive control. - Evaluation criteria:
- The criteria used for determining a positive result take into account a dose-response effect in the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate, in at least one strain, with or without metabolic activation.
A result is considered positive when the number of revertants of the test item-treated plates is increased 2-fold (S. typhimurium TA98, TA100 and E .coli EP2(pKM101) or 3-fold (S. typhimurium TA1535, TA1537) when compared to the solvent-treated plates. - Statistics:
- The average plate count was presented with the mean and standard deviation for each set of triplicates per test item concentration.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic from 1.67 μL/plate without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was observed in the solubility test in 1/3 dilution in DMSO
RANGE-FINDING/SCREENING STUDIES: In the cytotoxicity assay, concentrations of 0.06 - 5 μL/plate were tested with S. typhimurium TA100. No cytotoxicity was observed at any concentration level. Therefore, 5.0 μL/plate was selected as the highest concentration in the main study.
COMPARISON WITH HISTORICAL CONTROL DATA: yes, results were within the historical control data range
ADDITIONAL INFORMATION ON CYTOTOXICITY: in the main study, clear cytotoxicity (50%) was observed at 1.67 and 5.0 μL/plate in the E. coli strain. This is not considered to have affected the results of the study.
Any other information on results incl. tables
Table 1: Experiment 1
EXPERIMENT 1 (direct incorporation test) |
|||||
S9-Mix |
Without
|
||||
Test item (µL/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2(pKM101) |
NC |
16 ± 1.5 |
82 ± 10.7 |
14 ± 3.0 |
7 ± 2.0 |
217 ± 28.9 |
0.06 |
16 ± 3.6 |
95 ± 19.5 |
16 ± 4.0 |
7 ± 3.2 |
209 ± 47.5 |
0.19 |
18 ± 2.0 |
102 ± 15.3 |
14 ± 2.9 |
7 ± 1.5 |
218 ± 29.2 |
0.56 |
18 ± 4.0 |
104 ± 15.6 |
13 ± 4.4 |
4 ± 3.0 |
237 ± 34.5 |
1.67 |
16 ± 3.8 |
95 ± 15.7 |
13 ± 1.0 |
6 ± 1.5 |
248 ± 8.7 |
5.0 |
18 ± 3.1 |
107 ± 21.9 |
17 ± 5.1 |
5 ± 1.5 |
179 ± 11.1 |
2-NF |
462 ± 57.2 |
- |
- |
- |
- |
SA |
- |
675 ± 34.7 |
762 ± 58.5 |
- |
- |
4NQO |
- |
- |
- |
- |
1999 ± 65.5 |
9-AA |
- |
- |
- |
172 ± 34.9 |
- |
S9-Mix |
With
|
||||
|
|
|
|
|
|
Test item (µL/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2(pKM101) |
NC |
19 ± 5.0 |
92 ± 4.0 |
16 ± 5.3 |
6 ± 2.5 |
215 ± 13.9 |
0.06 |
23 ± 8.0 |
101 ± 12.9 |
12 ± 5.8 |
5 ± 0.6 |
190 ± 41.3 |
0.19 |
19 ± 8.5 |
100 ± 15.0 |
16 ± 6.7 |
5 ± 4.2 |
212 ± 5.3 |
0.56 |
23 ± 3.2 |
104 ± 11.5 |
17 ± 6.1 |
6 ± 1.5 |
204 ± 24.3 |
1.67 |
20 ± 2.5 |
90 ± 20.1 |
15 ± 4.4 |
8 ± 1.2 |
213 ± 34.6 |
5.0 |
26 ± 3.6 |
91 ± 2.1 |
15 ± 6.1 |
7 ± 2.1 |
218 ± 24.4 |
2AA |
614 ± 101.5 |
1434 ± 161.2 |
380 ± 81.1 |
185 ± 15.4 |
1901 ± 138.8 |
NC = Vehicle Control, DMSO 2-NF: 2-nitrofluorene SA: sodium azide 4NQO: 4-nitroquinoline-N-oxide 9AA:9-aminoacridine 2AA: 2-aminoanthracene (for details see method description) |
|||||
Table 2: Experiment 2
EXPERIMENT 2 (preincubation test) |
|||||
S9-Mix |
Without
|
||||
Test item (µL/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2(pKM101) |
NC |
19 ± 4.7 |
74 ± 10.1 |
16 ± 3.5 |
5 ± 1.2 |
234 ± 22.2 |
0.06 |
17 ± 2.5 |
88 ± 5.6 |
17 ± 5.0 |
8 ± 2.1 |
218 ± 3.5 |
0.19 |
17 ± 2.3 |
74 ± 10.4 |
16 ± 2.1 |
5 ± 2.9 |
227 ± 33.7 |
0.56 |
20 ± 4.6 |
102 ± 4.0 |
12 ± 3.2 |
5 ± 2.1 |
93 ± 32.0 |
1.67 |
17 ± 1.2 |
87 ± 5.3 |
13 ± 4.4 |
8 ± 1.2 |
17 ± 10.0 |
5.0 |
17 ± 3.6 |
77 ± 11.4 |
15 ± 4.4 |
6 ± 2.5 |
0 ± 0.0 |
2-NF |
372 ± 45.0 |
- |
- |
- |
- |
SA |
- |
727 ± 12.0 |
837 ± 26.9 |
- |
- |
4NQO |
- |
- |
- |
- |
2186 ± 244.5 |
9-AA |
- |
- |
- |
168 ± 15.0 |
- |
S9-Mix |
With
|
||||
|
|
|
|
|
|
Test item (µL/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2(pKM101) |
NC |
23 ± 2.6 |
91 ± 17.0 |
13 ± 1.2 |
5 ± 2.5 |
224 ± 37.0 |
0.06 |
23 ± 0.6 |
90 ± 5.0 |
15 ± 1.5 |
5 ± 0.6 |
187 ± 33.1 |
0.19 |
24 ± 0.6 |
84 ± 8.6 |
13 ± 5.2 |
6 ± 1.2 |
211 ± 49.5 |
0.56 |
20 ± 3.1 |
83 ± 16.0 |
15 ± 3.5 |
7 ± 2.5 |
219 ± 20.0 |
1.67 |
25 ± 3.8 |
81 ± 4.0 |
16 ± 2.1 |
9 ± 0.6 |
223 ± 20.3 |
5.0 |
22 ± 7.2 |
85 ± 6.4 |
12 ± 1.2 |
6 ± 2.5 |
230 ± 41.4 |
2AA |
490 ± 41.2 |
1311 ± 67.5 |
327 ± 51.7 |
169 ± 25.7 |
1849 ± 58.1 |
NC = Vehicle Control, DMSO 2-NF: 2-nitrofluorene SA: sodium azide 4NQO: 4-nitroquinoline-N-oxide 9AA:9-aminoacridine 2AA: 2-aminoanthracene (for details see method description) |
|||||
Applicant's summary and conclusion
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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