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EC number: 209-639-1 | CAS number: 589-18-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The mutagenicity of the test item was determined in a study according to OECD guideline 471. The results indicate that the test item under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100, and to the Escherichia coli strain WP2 uvrA in the presence and absence of a metabolizing system.
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:
- May - September 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:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
- 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:
- Phenobarbital/β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500, and 5000 μg/plate
No toxic effects were observed at 5000 μg/plate in the pre-experiment. - Vehicle / solvent:
- DSMO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (Without metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 1537, TA98 (Without metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- WP2 uvrA (Without metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA (With metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 60 min at 37 °C
- Exposure duration: 48 h at 37 °C
SELECTION AGENT: L-Histidin for S. typhimurium, Tryptophan for E. coli
NUMBER OF REPLICATIONS: 3
Titer of the incubated culture: 10^8 - 10^9 cells/mL.
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn - Evaluation criteria:
- Since a reduced background lawn is regarded to be a cytotoxic effect, plates with reduced background lawn (only at 5000 μg/plate) were not included into evaluation procedures.
The test item is to be interpreted mutagenic if there is a concentration effect relationship and the induction rate is >=2. - 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
- 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:
- valid
- 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate
- 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
- Remarks:
- at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRE-EXPERIMENT:
3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
No toxic effects occurred in the Pre-experiment
HISTORICAL CONTROL DATA
see table at "Any other information"
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: reduced background lawn
- TA 100: with and without metabolic activation at 5000 μg/plate cytotoxic effects
- WP2 uvrA:with metabolic activation at 5000 μg/plate cytotoxic effects - Conclusions:
- The mutagenicity of the test item was determined in a study according to OECD guideline 471. The results indicate that the test item under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100, and to the Escherichia coli strain WP2 uvrA in the presence and absence of a metabolizing system.
- Executive summary:
The mutagenicity of the test substance was studied with four mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and one strain of Escherichia coli (WP2 uvrA) according to OECD guideline 471 and EU method B13/14. The investigations were carried using the standard plate incorporation assay with and without liver homogenate (S9) from Phenobarbital/β-naphthoflavone induced rat liver. The test substance was dissolved in DMSO and tested in concentrations of 33 to 5000 µg per plate. Cytotoxicity was recorded as reduced background lawn with the strain TA 100 at 5000 μg/plate with and without metabolic activation and with the strain WP2 uvrA at 5000 μg/plate with metabolic activation. Sodium azide, 4-nitro-o-phenylene-diamine, methyl methane sulfonate and 2-aminoanthracene served as positive controls to confirm the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system. In the concentration range investigated, the test substance did not induce a significant increase in the mutation frequency of the tester strains in the presence and absence of a metabolic activation system. In conclusion, these results indicate that under the experimental conditions described, the test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 or to Escherichia coli strain WP2 uvrA in the presence and absence of a metabolizing system.
Reference
Substance |
Concentration (µg/plate) |
S9 |
Mean revertants per plate |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
|||
Control |
0 |
- |
7.0 |
10.3 |
29.7 |
200.7 |
48.3 |
Solvent control |
0 |
- |
8.7 |
10.7 |
26.7 |
145.3 |
50.0 |
Test item |
33 |
- |
9.7 |
9.0 |
26.3 |
148.0 |
46.0 |
Test item |
100 |
- |
7.3 |
11.0 |
25.0 |
155.0 |
34.7 |
Test item |
333 |
- |
7.0 |
8.3 |
25.3 |
154.3 |
34.7 |
Test item |
1000 |
- |
11.0 |
8.0 |
25.0 |
100.7 |
36.0 |
Test item |
2500 |
- |
9.0 |
8.0 |
25.0 |
105.0 |
34.0 |
Test item |
5000 |
- |
8.3 |
10.3 |
17.7 |
55.3 |
17.7 |
NaN3 |
10 |
- |
111.3 |
|
|
1805.3 |
|
4-NOPD |
50 |
- |
|
103.3 |
|
|
|
4-NOPD |
10 |
- |
|
|
301.0 |
|
|
MMS |
2 |
- |
|
|
|
|
637.3 |
|
|
|
|
|
|
|
|
Control |
0 |
+ |
10.3 |
12.0 |
45.7 |
203.7 |
58.7 |
Solvent control |
0 |
+ |
12.3 |
15.7 |
41.3 |
138.0 |
52.3 |
Test item |
33 |
+ |
9.7 |
14.7 |
38.3 |
153.0 |
54.7 |
Test item |
100 |
+ |
12.3 |
11.7 |
38.3 |
134.0 |
53.7 |
Test item |
333 |
+ |
10.7 |
12.0 |
40.0 |
148.3 |
51.0 |
Test item |
1000 |
+ |
10.0 |
13.3 |
50.7 |
109.0 |
50.3 |
Test item |
2500 |
+ |
8.0 |
14.3 |
37.3 |
89.0 |
49.3 |
Test item |
5000 |
+ |
9.3 |
11.0 |
24.3 |
27.3 |
26.0 |
2-AA |
2.5 |
+ |
316.7 |
121.0 |
4196.7 |
2183.7 |
|
2-AA |
10 |
+ |
|
|
|
|
544.7 |
NaN3: sodium azide
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2-aminoanthracene
Historical control data
Strain |
|
Without S9 mix |
With S9 mix |
||||||
Mean |
SD |
Min |
Max |
Mean |
SD |
Min |
Max |
||
TA 1535 |
Solvent control |
12 |
2.5 |
6 |
25 |
12 |
2.5 |
7 |
26 |
Untreated control |
12 |
3.1 |
6 |
28 |
12 |
2.9 |
7 |
26 |
|
Positive control |
1130 |
143.1 |
334 |
1816 |
388 |
58.2 |
176 |
668 |
|
TA1537 |
Solvent control |
10 |
2.2 |
6 |
19 |
13 |
3.5 |
7 |
30 |
Untreated control |
11 |
2.7 |
5 |
21 |
14 |
4.0 |
7 |
31 |
|
Positive control |
82 |
12.7 |
43 |
157 |
191 |
60.8 |
83 |
434 |
|
TA 98 |
Solvent control |
25 |
4.4 |
13 |
43 |
34 |
6.2 |
15 |
58 |
Untreated control |
27 |
4.9 |
12 |
43 |
37 |
6.5 |
11 |
57 |
|
Positive control |
378 |
73.7 |
211 |
627 |
3949 |
771.8 |
360 |
6586 |
|
TA 100 |
Solvent control |
156 |
26.0 |
78 |
209 |
148 |
32.3 |
73 |
208 |
Untreated control |
176 |
23.6 |
79 |
217 |
172 |
25.4 |
85 |
218 |
|
Positive control |
1966 |
293.2 |
498 |
2767 |
3798 |
830.4 |
536 |
6076 |
|
WP2 uvr A |
Solvent control |
41 |
5.6 |
27 |
63 |
50 |
6.8 |
28 |
72 |
Untreated control |
42 |
5.8 |
30 |
63 |
52 |
6.8 |
36 |
88 |
|
Positive control |
798 |
362.7 |
319 |
4732 |
378 |
112.6 |
167 |
1265 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The mutagenicity of the test substance was studied with four mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and one strain of Escherichia coli (WP2 uvrA) according to OECD guideline 471 and EU method B13/14. The investigations were carried using the standard plate incorporation assay with and without liver homogenate (S9) from Phenobarbital/β-naphthoflavone induced rat liver. The test substance was dissolved in DMSO and tested in concentrations of 33 to 5000 µg per plate. Cytotoxicity was recorded as reduced background lawn with the strain TA 100 at 5000 μg/plate with and without metabolic activation and with the strain WP2 uvrA at 5000 μg/plate with metabolic activation. Sodium azide, 4-nitro-o-phenylene-diamine, methyl methane sulfonate and 2-aminoanthracene served as positive controls to confirm the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system. In the concentration range investigated, the test substance did not induce a significant increase in the mutation frequency of the tester strains in the presence and absence of a metabolic activation system. In conclusion, these results indicate that under the experimental conditions described, the test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 or to Escherichia coli strain WP2 uvrA in the presence and absence of a metabolizing system.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on genetic toxicity, the test item is not classified and labelled as mutagen according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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