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EC number: 205-290-4 | CAS number: 137-40-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance was considered to be non-mutagenic with and without metabolic activation in bacteria.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 May 2017 - 18 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- 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:
- S9 mix induced by ß-Naphthoflavone/Phenobarbital in livers of rats
- Test concentrations with justification for top dose:
- 1st serie: 5.0, 15.8, 50.0, 158, 500, 1580, 5000 µg/plate
2nd serie: 50.0, 158, 500, 1580, 5000 µg/plate
top dose: maximum recommended concentration (according to OECD 471) - Vehicle / solvent:
- - Vehicle/solvent used: ultrapure water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: 2-aminoanthracene, daunomycin
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: 3 replicates for test item concentrations and positive controls, 6 replicates for solvent controls
DETERMINATION OF CYTOTOXICITY
- Method: counting numbers of revertants - Evaluation criteria:
- A test material was to be defined as negative or non-mutagenic in this assay if
- The assay was to be considered valid, and
- "no" or "weak increases" occurred in the test series performed ("weak increases" randomly occur due to experimental variation)
For valid data, the test material was considered to be positive or mutagenic if:
- a dose dependent (over at least two test material concentrations) increase in the number of revertants was induced, the maximal effect was a "clear increase", and the effects were reproduced at similar concentration levels in the same test system, or
- "clear increases" occurred at least at one test material concentration, higher concentrations showed strong precipitation or cytotoxicity, and the effects were reproduced at the same concentration level in the same test system. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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
- 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
- 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
- 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 and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test material precipitate was observed on the plates any concentration. - Conclusions:
- The test substance was considered to be non-mutagenic with and without metabolic activation in bacteria.
- Executive summary:
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from rats pretreated with (3-Naphthoflavone/Phenobarbital was used. In this study, two experimental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series, respectively.
Solvent and positive control treatments were included for all strains. The mean numbers of revertant colonies were all within acceptable ranges for solvent control treatments, or were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
Following treatment of all bacteria tester strains with the test item in the absence and presence of S9 mix, no relevant increases in revertant numbers were observed.
Reference
Table 1: Summary 1st series
Metabolic Activation |
Test Material |
Concentr. [µg/plate] |
Revertants per plate (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
H2O |
|
25 ± 7 |
116 ± 19 |
20 ± 5 |
10 ± 2 |
34 ± 4 |
|
Test item |
5.00 |
32 ± 4 |
105 ± 12 |
17 ± 4 |
8 ± 2 |
31 ± 4 |
|
|
15.8 |
25 ± 3 |
109 ± 12 |
14 ± 3 |
9 ± 2 |
23 ± 1 |
|
|
50.0 |
21 ± 6 |
108 ± 4 |
19 ± 3 |
9 ± 4 |
32 ± 7 |
|
|
158 |
19 ± 4 |
114 ± 9 |
16 ± 6 |
9 ± 2 |
30 ± 2 |
|
|
500 |
20 ± 3 |
111 ± 19 |
13 ± 3 |
9 ± 3 |
28 ± 5 |
|
|
1580 |
19 ± 3 |
113 ± 11 |
15 ± 1 |
8 ± 3 |
33 ± 3 |
|
|
5000 |
17 ± 4 |
94 ± 8 |
22 ± 6 |
7 ± 2 |
20 ± 10 |
|
|
|
|
|
|
|
|
|
DAUN |
1.00 |
779 ± 44 |
|
|
|
|
|
NaN3 |
2.00 |
|
1371 ± 46 |
688 ± 15 |
|
|
|
9-AA |
50.0 |
|
|
|
1485 ± 390 |
|
|
NQO |
2.00 |
|
|
|
|
1924 ± 242 |
|
|
|
|
|
|
|
|
With Activation |
H2O |
|
33 ± 6 |
123 ± 10 |
17 ± 4 |
9 ± 2 |
35 ± 8 |
|
Test item |
5.00 |
29 ± 5 |
135 ± 25 |
20 ± 6 |
11 ± 2 |
41 ± 8 |
|
|
15.8 |
21 ± 2 |
127 ± 20 |
19 ± 3 |
9 ± 3 |
33 ± 3 |
|
|
50.0 |
25 ± 5 |
144 ± 6 |
14 ± 2 |
11 ± 3 |
35 ± 3 |
|
|
158 |
28 ± 3 |
134 ± 8 |
13 ± 1 |
10 ± 4 |
32 ± 4 |
|
|
500 |
25 ± 3 |
122 ± 3 |
15 ± 2 |
13 ± 3 |
39 ± 4 |
|
|
1580 |
23 ± 5 |
140 ± 11 |
18 ± 2 |
14 ± 2 |
36 ± 3 |
|
|
5000 |
23 ± 1 |
114 ± 5 |
19 ± 5 |
9 ± 5 |
39 ± 4 |
|
|
|
|
|
|
|
|
|
2-AA |
2.00 |
614 ± 50 |
1661 ± 160 |
|
|
|
|
2-AA |
5.00 |
|
|
147 ± 2 |
519 ± 30 |
|
|
2-AA |
10.0 |
|
|
|
|
406 ± 11 |
NaN3: Sodium azide, 2-AA: 2-Aminoanthracene, 9-AA: 9-Aminoacridine, DAUN: Daunomycin, NQO: 4-NitroquinoIine-N-oxide
Table 2: Summary 2nd series
Metabolic Activation |
Test Material |
Concentr. [µg/plate] |
Revertants per plate (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
H2O |
|
40 ± 8 |
128 ± 7 |
20 ± 4 |
11 ± 3 |
24 ± 6 |
|
Test item |
50.0 |
39 ± 11 |
136 ± 7 |
20 ± 1 |
6 ± 3 |
28 ± 8 |
|
|
158 |
39 ± 5 |
118 ± 10 |
21 ± 6 |
10 ± 3 |
23 ± 2 |
|
|
500 |
28 ± 1 |
131 ± 8 |
21 ± 1 |
8 ± 3 |
26 ± 3 |
|
|
1580 |
33 ± 6 |
124 ± 14 |
21 ± 7 |
8 ± 3 |
25 ± 3 |
|
|
5000 |
28 ± 3 |
124 ± 27 |
17 ± 8 |
6 ± 5 |
21 ± 2 |
|
|
|
|
|
|
|
|
|
DAUN |
1.00 |
272 ± 7 |
|
|
|
|
|
NaN3 |
2.00 |
|
1395 ± 58 |
770 ± 35 |
|
|
|
9-AA |
50.0 |
|
|
|
999 ± 102 |
|
|
NQO |
2.00 |
|
|
|
|
1503 ± 33 |
|
|
|
|
|
|
|
|
With Activation |
H2O |
|
36 ± 6 |
124 ± 21 |
17 ± 6 |
12 ± 5 |
45 ± 3 |
|
Test item |
50.0 |
46 ± 4 |
152 ± 14 |
20 ± 3 |
12 ± 5 |
39 ± 3 |
|
|
158 |
36 ± 7 |
137 ± 2 |
20 ± 3 |
11 ± 3 |
39 ± 3 |
|
|
500 |
35 ± 7 |
144 ± 4 |
13 ± 1 |
13 ± 2 |
34 ± 4 |
|
|
1580 |
37 ± 8 |
149 ± 4 |
18 ± 6 |
11 ± 2 |
40 ± 4 |
|
|
5000 |
35 ± 9 |
134 ± 21 |
15 ± 5 |
12 ± 2 |
39 ± 2 |
|
|
|
|
|
|
|
|
|
2-AA |
2.00 |
352 ± 40 |
670 ± 88 |
|
|
|
|
2-AA |
5.00 |
|
|
101 ± 9 |
128 ± 4 |
|
|
2-AA |
10.0 |
|
|
|
|
196 ± 18 |
NaN3: Sodium azide, 2-AA: 2-Aminoanthracene, 9-AA: 9-Aminoacridine, DAUN: Daunomycin, NQO: 4-NitroquinoIine-N-oxide
Table 3: Historical Data - Negative Controls
Strain |
TA 98 |
TA 100 |
TA 1535 |
TA 1537* |
WP2 uvrA |
|||||
S9 Mix |
Without |
With |
Without |
With |
Without |
With |
Without |
With |
Without |
With |
Compound |
Solvent |
Solvent |
Solvent |
Solvent |
Solvent |
Solvent |
Solvent |
Solvent |
Solvent |
Solvent |
Total Plates |
402 |
410 |
397 |
413 |
270 |
282 |
276 |
287 |
385 |
398 |
Number of Values |
78 |
79 |
77 |
80 |
45 |
47 |
46 |
48 |
74 |
76 |
Minimum |
23 |
25 |
82 |
101 |
20 |
18 |
23 |
20 |
16 |
17 |
Maximum |
45 |
59 |
138 |
157 |
34 |
40 |
36 |
43 |
39 |
48 |
Mean |
34 |
40 |
110 |
126 |
27 |
26 |
28 |
30 |
30 |
36 |
Standard Deviation |
5.2 |
7.0 |
11.7 |
11.9 |
3.2 |
3.9 |
3.5 |
4.4 |
4.9 |
5.9 |
* The strain TA 1537 used in 2016 had a higher spontaneous revertant frequency compared to the strain used from 2017 onwards. As the historical data are generated on a yearly basis, this lower revertant frequency is not yet reflected in the historical control data presented here.
Table 4: Historical Data - Positive Controls
Strain |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||||
S9 Mix |
Without |
With |
Without |
With |
Without |
With |
Without |
With |
Without |
With |
Compound |
DAUN |
2-AA |
NaN3 |
2-AA |
NaN3 |
2-AA |
9-AA |
2-AA |
NQO |
2-AA |
Total Plates |
201 |
205 |
199 |
207 |
135 |
141 |
138 |
144 |
193 |
199 |
Number of Values |
79 |
79 |
77 |
80 |
45 |
47 |
46 |
48 |
74 |
76 |
Minimum |
117 |
105 |
412 |
512 |
583 |
92 |
122 |
125 |
395 |
112 |
Maximum |
887 |
1632 |
2075 |
3337 |
1847 |
390 |
2882 |
1103 |
2286 |
1313 |
Mean |
352 |
529 |
1337 |
1262 |
900 |
200 |
1175 |
418 |
1613 |
347 |
Standard Deviation |
146.3 |
296.1 |
316.8 |
435.4 |
193.4 |
64.2 |
564.2 |
201.3 |
438.7 |
192.4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Bacterial Reverse Mutation Test
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from rats pretreated with (3-Naphthoflavone/Phenobarbital was used. In this study, two experimental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series, respectively.
Solvent and positive control treatments were included for all strains. The mean numbers of revertant colonies were all within acceptable ranges for solvent control treatments, or were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
Following treatment of all bacteria tester strains with the test item in the absence and presence of S9 mix, no relevant increases in revertant numbers were observed.
Chromosomal aberration test in mammalian cells
A chromosomal aberration test was carried out with the test item using a Chinese hamster fibroblast cell line (CHL). The test item was dissolved in physiological saline. The cells were exposed to the test item at three different doses (maximum dose: 2 mg/mL, selected by a preliminary test) for 24 and 48 hours without a metabolic activation system. Colcemid (final concentration 0.2 g/mL) was added to the culture 2 hours before cell harvesting. The cells were then trypsinised and suspended in a hypotonic KCl Solution (0.075 M) for 13 min at room temperature. After centrifugation the cells were fixed with acetic acid-methanol (1:3, v/v) and spread on clean glass slides. After air-drying, the slides were stained with Giemsa Solution (1.5%, at pH 6.8) for 12-15 min. A hundred well-spread metaphases were observed under the microscope (x600 with a nocover objective lens). The incidence of cells with structural chromosomal aberrations as well as of polyploid cells was recorded on each culture plate.
Untreated cells and solvent-treated cells served as negative controls, in which the incidence of aberrations was usually less than 3.0%.
Exposure to the test item (maximum dose: 2 mg/mL) resulted in an incidence of polyploid cells of 2.0 % after 48 hour exposure and in an incidence of aberrations of 3.0 % after 24 hour exposure. Therefore, the test item was considered to be non-clastogenic.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The results indicate that the substance is non-mutagenic. Based on available data on genetic toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No 2017/776.
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