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EC number: 214-478-5 | CAS number: 1132-61-2
- 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
In a study according to OECD TG 471 under GLP conditions, the substance was not mutagenic in five strains (TA97, TA98, TA100, TA102, TA1535) with and without metabolic activation (reference 7.6.1 -1).
Moreover, based on the results of an analogue approach (read-across), the substance is considered to be not genotoxic in an in vitro micronucleus assay (OECD 487, reference 7.6.1 -2) and in an in vitro mammalian gene mutation assay (OECD 476, reference 7.6.1 -3).
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:
- 2003-09-30 to 2003-10-30
- 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:
- July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 :
obtained by RCC, Roßdorf
- method of preparation of S9 mix:
producted from the livers of male Wistar rats which were treated with 80 mg Phenobarbital/kg bw intraperitoneally; on the following day, with 80 mg beta-Naphthoflavon/kg bw orally
- concentration or volume of S9 mix and S9 in the final culture medium : 1 mL, 4 %
- quality controls of S9: no data - Test concentrations with justification for top dose:
- First experiment: 0.05.; 0.15; 0.5; 1.5; 5.0 mg/plate, where 5 mg/plate is the recommended maximum test concentration for soluble non-cytotoxic substances
Second experiment: 1.25; 2.5; 5.0 mg/plate, where 5 mg/plate is the recommended maximum test concentration for soluble non-cytotoxic substances - Vehicle / solvent:
- - solvent used: water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Remarks:
- without metabolic activation, TA97, TA98, TA102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation, TA100, TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation, TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation, TA97, TA 100, TA102 and TA1535
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 4
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation); preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 20 min
- Exposure duration: 48 h (both experiments)
DETERMINATION OF CYTOTOXICITY
- Method: titre ratio - Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor > 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
- Statistics:
- none
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- 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:
- valid
- True negative controls validity:
- not applicable
- 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:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test item is soluble in deionised water. A stock solution containing 50 g/L was prepared.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : The treatments for the confirmation of the genotype, the sterility control and the determination of the titre didn't show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.
Ames test:
- Signs of toxicity :
No signs of toxicity towards the tested strains could be observed. The determined values for the toxicity control were in the range of the titre. The background lawn was visible and the number of revertant colonies was not reduced.
- Individual plate counts :
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
- Mean number of revertant colonies per plate and standard deviation :
see tables
HISTORICAL CONTROL DATA
- no data reported - Conclusions:
- The substance was not mutagenic in five strains (TA97, TA98, TA100, TA102, TA1535) with and without metabolic activation.
- Executive summary:
The mutagenic potential of the substance was investigated in a bacterial reverse mutation assay according to OECD TG 471 under GLP. The substance was soluble and non-cytotoxic up to 5 mg/plate, i.e. the recommended maximum concentration. The substance was tested in five strains (TA97, TA98, TA100, TA102, TA1535) with and without metabolic activation (S9). In a first experiment, five concentrations (0.05; 0.15; 0.5; 1.5; 5.0 mg/plate) were tested for 48 hours in the plate incorporation method. In the second experiment the concentrations 1.25, 2.5 and 5.0 mg/plate were tested (48 h) in the pre-incubation method. The number of colonies were evaluated by eye. While the positive controls were clearly mutagenic, the substance did not increase the number of colonies. Therefore, the substance is considered to be not mutagenic.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to section 13 for Read-Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to section 13 for Read-Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Referenceopen allclose all
Table with results for 1st Experiment (plate incorporation)
strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
water |
mean |
83 |
66 |
19 |
23 |
144 |
145 |
144 |
131 |
14 |
17 |
sd |
43.3 |
52.2 |
11.8 |
3.5 |
17 |
11 |
28.1 |
29.1 |
7.2 |
5.0 |
|
DMSO |
mean |
78 |
112 |
18 |
21 |
126 |
130 |
123 |
134 |
12 |
11 |
sd |
66.9 |
24.5 |
2.2 |
4.5 |
4 |
26 |
6.8 |
12.4 |
2.8 |
3.9 |
|
pos.contr. |
mean |
924 |
560 |
1038 |
70 |
633 |
754 |
656 |
717 |
590 |
439 |
sd |
103 |
126 |
221 |
25 |
163 |
256 |
32 |
184 |
76,1 |
49 |
|
f(I) |
11.9 |
5.0 |
57.7 |
3.4 |
4.4 |
5.8 |
5.3 |
5.4 |
42.9 |
40.8 |
|
5 mg/pl. |
mean |
79 |
116 |
13 |
16 |
136 |
148 |
129 |
141 |
12 |
12 |
sd |
86 |
78 |
5 |
7 |
28 |
18 |
11 |
13 |
2 |
4 |
|
f(I) |
0.95 |
1.75 |
0.69 |
0.70 |
0.94 |
1.02 |
0.90 |
1.07 |
0.89 |
0.7 |
|
1.5 mg/pl. |
mean |
61 |
62 |
16 |
13 |
121 |
104 |
101 |
81 |
10 |
13 |
sd |
50 |
48 |
3 |
4 |
14 |
20 |
11 |
10 |
6 |
2 |
|
f(I) |
0.73 |
0.94 |
0.83 |
0.58 |
0.84 |
0.72 |
0,70 |
0,62 |
0,73 |
0,77 |
|
0.5 mg/pl. |
mean |
91 |
52 |
14 |
13 |
129 |
83 |
102 |
65 |
14 |
18 |
sd |
11 |
53 |
3 |
3 |
23 |
25 |
10 |
5 |
1 |
1 |
|
f(I) |
1.10 |
0.78 |
0.73 |
0.59 |
0.90 |
0.57 |
0.71 |
0.49 |
1.00 |
1.03 |
|
0.15 mg/pl. |
mean |
73 |
59 |
18 |
16 |
71 |
74 |
107 |
57 |
11 |
12 |
sd |
37 |
39 |
4 |
3 |
14 |
11 |
20 |
10 |
4 |
1 |
|
f(I) |
0.88 |
0.90 |
0.95 |
0.69 |
0.49 |
0.51 |
0,74 |
0,43 |
0,76 |
0.67 |
|
0.05 mg/pl. |
mean |
90 |
87 |
15 |
16 |
127 |
101 |
117 |
72 |
14 |
16 |
sd |
17 |
24 |
2 |
5 |
41 |
21 |
11 |
17 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|||
f(I) |
1.08 |
1.32 |
0.75
|
0.72
|
0.88
|
0.70 |
0.82
|
0.54
|
1.02
|
0.90
|
Table with results for 2nd Experiment (pre-incubation)
strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
water |
mean |
149 |
117 |
10 |
11 |
131 |
120 |
128 |
119 |
10 |
10 |
sd |
55.1 |
67.9 |
2.1 |
2.6 |
22 |
18 |
16.8 |
7.5 |
2.6 |
2.2 |
|
DMSO |
mean |
93 |
118 |
9 |
11 |
93 |
96 |
119 |
116 |
8 |
11 |
sd |
67.8 |
18.6 |
2.5 |
4.1 |
28 |
6 |
36.8 |
11.9 |
1.7 |
2.6 |
|
pos.contr. |
mean |
571 |
721 |
604 |
61 |
948 |
575 |
847 |
678 |
1024 |
223 |
sd |
275 |
198 |
121 |
6 |
153 |
236 |
62 |
173 |
157 |
11 |
|
f(I) |
6.17 |
6.14 |
65.3 |
5.40 |
7.24 |
5.98 |
7.12 |
5.84 |
98.9 |
19.8 |
|
5 mg/pl. |
mean |
93 |
110 |
6 |
8 |
122 |
129 |
131 |
121 |
12 |
9 |
sd |
44 |
25 |
4 |
1 |
24 |
20 |
20 |
7 |
6 |
2 |
|
f(I) |
0.62 |
0.94 |
0.64 |
0.74 |
0.93 |
1.08 |
1.02 |
1,02 |
1.2 |
0.85 |
|
2.5 mg/pl. |
mean |
112 |
103 |
7 |
10 |
98 |
120 |
135 |
111 |
11 |
9 |
sd |
30 |
64 |
3 |
6 |
13 |
9 |
35 |
9 |
2 |
2 |
|
f(I) |
0.75 |
0.88 |
0.74 |
0.95 |
0.75 |
1.00 |
1.05 |
0.93 |
1.02 |
0.85 |
|
1.25 mg/pl. |
mean |
108 |
71 |
7 |
8 |
97 |
95 |
102 |
94 |
8 |
10 |
sd |
49 |
70 |
3 |
3 |
9 |
7 |
16 |
7 |
1 |
2 |
|
f(I) |
0.72 |
0.60 |
0.69 |
0.76 |
0.74 |
0.79 |
0.80 |
0.79 |
0.78 |
0.95 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames test
The mutagenic potential of the substance was investigated in a bacterial reverse mutation assay according to OECD TG 471 under GLP. The substance was soluble and non-cytotoxic up to 5 mg/plate, i.e. the recommended maximum concentration. The substance was tested in five strains (TA97, TA98, TA100, TA102, TA1535) with and without metabolic activation (S9). In a first experiment, five concentrations (0.05; 0.15; 0.5; 1.5; 5.0 mg/plate) were tested for 48 hours in the plate incorporation method. In the second experiment the concentrations 1.25, 2.5 and 5.0 mg/plate were tested (48 h) in the pre-incubation method. The number of colonies were evaluated by eye. While the positive controls were clearly mutagenic, the substance did not increase the number of colonies. Therefore, the substance is considered to be not mutagenic.
An in vitro micronucleus test according to OECD TG 487 and an in vitro mammalian cell gene mutation test using the HPRT genes according to OECD TG 476 form the structurally similar substance CAS 1266615 -59 -1 are available. No experimental data with the test substance is available. Therefore, the studies conducted with the read-across source substance are used to investigate the genotoxicity of the target substance.
Micronucleus test
A study according OECD TG 487 was performed with the source substance CAS 1266615-59-1 to assess the genotoxic potential of the test item to induce formation of micronuclei in human lymphocytes cultured in vitro in the absence and the presence of an exogenous metabolic activation system (liver S9 mix from male rats, treated with Aroclor 1254).
The test item was dissolved in minimal culture medium to prepare a stock solution with a concentration of 100 mM corresponding to 10 mM as highest concentration in the test. In addition, a geometric series of dilutions was prepared from the stock solution.
Two independent and valid experiments were performed. Human peripheral blood lymphocytes, on whole blood culture, were stimulated to divide by addition of phytohaemagglutinin and exposed to solvent control, test item or positive control, respectively. After the culture harvest time, the cells were harvested and slides were prepared. Cytotoxicity and level of micronuclei were determined.
In each experiment, all cell cultures were set up in duplicates. In order to assess the toxicity of the test item to cultivated human lymphocytes, the cytokinesis-block proliferation index (CBPI) was calculated for all cultures treated with solvent control, positive control and test item. On the basis of these data, the concentrations to be scored for micronuclei were selected. No cytotoxic effect was detected in any of the tested concentrations in both experiments.
Therefore, the three highest test item concentrations were evaluated for micronuclei.
Neither a statistically significant nor a biologically relevant increase in the number of binucleated cells containing micronuclei at the evaluated concentrations was observed. All positive control compounds caused large, statistically significant increases in the proportion of binucleate cells with micronuclei, demonstrating the sensitivity of the test system. In conclusion, under the experimental conditions reported, the substance does not induce the formation of micronuclei in human lymphocytes in vitro.
HPRT test
A study according OECD TG 476 was performed with the source substance CAS 1266615-59 -1 to investigate the potential of the substance to induce mutations at the hypoxanthineguanine phosphoribosyl transferase (HPRT) locus in Chinese Hamster cells (V79). The assay comprised a pre-test and two independent experiments (experiment I and II). The pre-test was done to detect a potential cytotoxic effect of the test item. Based on the results of this test the concentrations for the main experiments were determined. The first main experiment (experiment I) was performed with and without metabolic activation (liver S9 mix from male rats, treated with Aroclor 1254) and a treatment period of 4 h. The second experiment (experiment II) was performed with a treatment period of 24 hours without metabolic activation. The highest nominal concentration (10 mM) applied was chosen based on the good solubility of the test item in organic solvents and aqueous media and on the absence of cytotoxicity. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed enough sensitivity of the testing procedure and the activity of the metabolic activation system. No substantial and reproducible dose-dependent increase in mutant colony numbers was observed in both experiments up to the maximal concentration (10 mM) of the test item. In conclusion, it can be stated that under the experimental conditions of this study the test item did not induce gene mutations at the HPRT locus in V79 cells in the absence and presence of metabolic activation.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Thus, the test item is considered not to be classified for genotoxicity under Regulation (EC) No 1272/2008, amended for the fifteenth time in Regulation (EU) 2020/1182.
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