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EC number: 812-907-6 | CAS number: 34989-82-7
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Density
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- Endpoint summary
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Carcinogenicity
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance was determined to be non-mutagenic in a bacterial reverse mutation study.
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:
- 2016-08-15 to 2016-08-24
- 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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Lot: 216-106
- Expiry date: 2018-06-16
- Storage conditions: Keep at room temperature - Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- → his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA1535, TA100) and frameshift (TA1537, TA98) mutations.
The Escherichia coli WP2 uvrA (trp) reversion system measures trp– → trp+ reversions. The Escherichia coli WP2 uvrA strain detects mutagens that cause other base-pair substitutions (AT to GC). - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of Phenobarbital and β-naphthoflavone induced rat liver
- Test concentrations with justification for top dose:
- 5000, 1600, 500, 160, 50 and 16 μg/plate
Selection of the concentrations was done on the basis of a solubility test and a concentration range finding test. - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: good solubility and guideline conform - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene (2AA), with metabolic activation in all strains; 4-nitro-1,2-phenylene-diamine (NPD), without metabolic activation in TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: colony and background lawn development - Evaluation criteria:
- A test item is considered mutagenic if:
- a dose-related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase is considered biologically relevant if:
- in strain TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control.
- in strain TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control.
Criteria for a Negative Response:
A test item is considered non-mutagenic in this bacterial reverse mutation assay if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Statistics:
- The colony numbers on the untreated, vehicle and positive controls and the test item treated plates were determined, the mean values, standard deviations and the mutation rates were calculated.
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- 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:
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the Initial Mutation Test no precipitation of the test item was observed on the plates in the examined bacterial strains at any examined concentration level (±S9 Mix); however in the Confirmatory Mutation Test (Pre-Incubation Test) heavy precipitate was noticed on the plates at the highest examined concentration of 5000 μg/plate in absence and presence of exogenous metabolic activation (±S9 Mix). The obtained precipitate disturbed the scoring of colonies and background lawn development; therefore the precipitated plates were evaluated additionally by microscope (at 40X magnification).
HISTORICAL CONTROL DATA
All observed colony number remained within the historical control values, except for TA100 without S9 at 5000 μg/plate in the Confirmatory Mutation Test. There a lower revertant colony number was observed, that remained without any biological significance. - Conclusions:
- Under the experimental conditions the test substance was considered non-mutagenic in the bacterial reverse mutation assay.
- Executive summary:
The mutagenicity of the substance was studied with four mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in Escherichia coli WP2 uvrA according to OECD 471. The study was performed as two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). Each assay was conducted with and without metabolic activation (±S9 Mix). The concentrations (5000, 1600, 500; 160; 50 and 16 μg/plate), including the controls, were tested in triplicate. In the performed experiments positive and negative (vehicle) controls were run concurrently. In the performed experiments all of the validity criteria, regarding the investigated strains, negative (vehicle) and positive controls, S9 activity and number of investigated analyzable concentration levels were fulfilled. No substantial increases were observed in revertant colony numbers of any of the five test strains following treatment with the test substance at any concentration level, either in the presence or absence of metabolic activation. Sporadic increases in revertant colony numbers compared to the vehicle control values within the actual historical control data ranges were observed in both independently performed main experiments. However, there was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments. In the performed experiments inhibitory effect of the test item (decreased number of revertant colony numbers and/or affected background lawn development) was not observed in any case. In the Confirmatory Mutation Test (Pre-Incubation Test) heavy, interfering precipitate was noticed on the plates in the examined bacterial strains at the highest examined concentration level of 5000 μg/plate in absence and also in the presence of exogenous metabolic activation (±S9 Mix). The reported data of this mutagenicity assay show, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, the test substance is considered non-mutagenic in this bacterial reverse mutation assay.
Reference
Initial Mutation Test (Plate Incorporation)
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
|
Results without S9 |
|||||
Untreated |
8.7 ± 5.13 |
6.7 ± 2.08 |
18 ± 1 |
104 ± 9.17 |
20 ± 0 |
DMSO |
11.3 ± 4.04 |
5.3 ± 0.58 |
19 ± 1.73 |
85.7 ± 6.03 |
17 ± 3 |
Ultrapure Water Control |
7.3 ± 1.15 |
102.7 ± 2.31 |
17.7 ± 3.79 |
||
5000 |
12.3 ± 1.53 |
4 ± 2.65 |
10 ± 0 |
78.7 ± 8.33 |
14.7 ± 2.31 |
1600 |
15.3 ± 3.21 |
6.7 ± 4.04 |
13.3 ± 3.51 |
88.7 ± 7.02 |
16.7 ± 3.06 |
500 |
15.7 ± 3.21 |
4.7 ± 3.79 |
17 ± 3.61 |
100 ± 17.32 |
19.3 ± 3.79 |
160 |
11.3 ± 4.16 |
4.7 ± 2.52 |
20.3 ± 4.73 |
97.3 ± 11.37 |
22 ± 3.61 |
50 |
13.3 ± 4.16 |
6 ± 5.29 |
13.7 ± 7.51 |
89.3 ± 12.22 |
23 ± 2 |
16 |
13 ± 1.73 |
3 ± 2.65 |
17.3 ± 4.62 |
101.3 ± 12.7 |
24 ± 8.54 |
NPD (4) |
342.7 ± 26.1 |
||||
SAZ (2) |
672 ± 66.81 |
1245.3 ± 185.44 |
|||
9AA (50) |
750 ± 84.59 |
||||
MMS (2 µL) |
818.7 ± 118.68 |
||||
Results with S9 |
|||||
Untreated |
12.3 ± 4.93 |
6.3 ± 1.63 |
21.7 ± 6.11 |
132 ± 11.14 |
29.3 ± 4.16 |
DMSO |
14 ± 2.65 |
7.3 ± 3.06 |
21.7 ± 7.02 |
128 ± 18.33 |
28 ± 2 |
5000 |
11.3 ± 4.51 |
8.3 ± 5.03 |
20.3 ± 4.04 |
119.3 ± 11.72 |
21.7 ± 4.73 |
1600 |
12 ± 1 |
9.7 ± 3.21 |
24.7 ± 3.79 |
109.3 ± 11.02 |
21 ± 4.58 |
500 |
13.3 ± 5.86 |
8 ± 3.46 |
23 ± 2 |
117.3 ± 6.11 |
27.7 ± 9.07 |
160 |
14.7 ± 1.53 |
9 ± 5 |
22.3 ± 2.52 |
113.7 ± 14.84 |
29.7 ± 8.96 |
50 |
14.3 ± 2.89 |
10 ± 3.61 |
25 ± 2 |
120.7 ± 6.43 |
32 ± 6.56 |
16 |
10.3 ± 3.06 |
8.7 ± 3.51 |
24.3 ± 4.73 |
122.7 ± 9.87 |
33 ± 3 |
2AA (2) |
199.3 ± 37.65 |
110 ± 17.06 |
1512 ± 246.45 |
2200 ± 381.58 |
|
2AA (50) |
234 ± 15.62 |
NPD: 4-nitro-1,2-phenylene-diamine; SAZ: Sodium acide; 9AA: 9-aminoacridine; MMS: methylmethanesulfonate; 2AA: 2-aminoanthracene
Confirmatory Mutation Test (Pre-Incubation)
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
|
Results without S9 |
|||||
Untreated |
9.3 ± 2.52 |
8 ± 2.65 |
17.7 ± 9.07 |
90.3 ± 13.2 |
19.3 ± 2.52 |
DMSO |
11 ± 3 |
8 ± 4 |
16.7 ± 0.58 |
78 ± 9.64 |
24.3 ± 6.43 |
Ultrapure Water Control |
11.7 ± 3.79 |
93.3 ± 6.66 |
28.3 ± 1.15 |
||
5000 |
15 ± 6.56 |
8.3 ± 4.73 |
11.7 ± 6.11 |
58 ± 7 |
17 ± 2.65 |
1600 |
11.3 ± 1.53 |
7.7 ± 4.73 |
16 ± 4.58 |
76.3 ± 8.74 |
21.3 ± 2.31 |
500 |
9.3 ± 1.53 |
9.7 ± 2.31 |
10 ± 0 |
73.7 ± 2.52 |
25.7 ± 8.08 |
160 |
14.3 ± 0.58 |
8.7 ± 4.04 |
12.3 ± 1.53 |
85.3 ± 11.59 |
25.3 ± 3.06 |
50 |
11.3 ± 3.79 |
8.3 ± 4.93 |
14 ± 2.65 |
74.3 ± 5.69 |
22.3 ± 115 |
16 |
10.7 ± 3.21 |
6.7 ± 4.62 |
15.7 ± 3.21 |
77 ± 2.65 |
16.7 ± 4.51 |
NPD (4) |
254 ± 40.6 |
||||
SAZ (2) |
965.3 ± 53.27 |
1210.7 ± 122.46 |
|||
9AA (50) |
356 ± 107.63 |
||||
MMS (2 µL) |
962.7 ± 158.86 |
||||
Results with S9 |
|||||
Untreated |
11.7 ± 0.58 |
7.7 ± 4.93 |
28.7 ± 3.51 |
129.7 ± 8.96 |
32.3 ± 4.51 |
DMSO |
13.3 ± 3.21 |
6.3 ± 3.06 |
27.7 ± 2.89 |
108.7 ± 17.62 |
27.7 ± 4.04 |
5000 |
9.7 ± 4.51 |
7.3 ± 4.93 |
17.7 ± 1.53 |
79.3 ± 8.74 |
24 ± 5 |
1600 |
11 ± 3.61 |
7.3 ± 3.51 |
16.7 ± 2.52 |
88 ± 11.27 |
26.7 ± 4.93 |
500 |
11.7 ± 4.04 |
6 ± 3.46 |
18 ± 1.73 |
90.7 ± 12.66 |
27.3 ± 4.16 |
160 |
12.3 ± 3.21 |
8.3 ± 1.53 |
23.7 ± 1.53 |
90 ± 7 |
38.3 ± 4.62 |
50 |
9.7 ± 2.89 |
9 ± 3.61 |
22.3 ± 6.81 |
101.7 ± 7.51 |
37.3 ± 7.51 |
16 |
11.3 ± 3.51 |
6.3 ± 3.21 |
17 ± 7 |
98.7 ± 4.73 |
38 ± 4.36 |
2AA (2) |
138 ± 7.81 |
164.7 ± 9.02 |
1117.3 ± 120.09 |
1114.7 ± 360.65 |
|
2AA (50) |
170.3 ± 15.57 |
NPD: 4-nitro-1,2-phenylene-diamine; SAZ: Sodium acide; 9AA: 9-aminoacridine; MMS: methylmethanesulfonate; 2AA: 2-aminoanthracene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity in vitro
The mutagenicity of the substance was studied with four mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in Escherichia coli WP2 uvrA according to OECD 471. The study was performed as two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). Each assay was conducted with and without metabolic activation (±S9 Mix). The concentrations (5000, 1600, 500; 160; 50 and 16 μg/plate), including the controls, were tested in triplicate. In the performed experiments positive and negative (vehicle) controls were run concurrently. In the performed experiments all of the validity criteria, regarding the investigated strains, negative (vehicle) and positive controls, S9 activity and number of investigated analyzable concentration levels were fulfilled. No substantial increases were observed in revertant colony numbers of any of the five test strains following treatment with the test substance at any concentration level, either in the presence or absence of metabolic activation. Sporadic increases in revertant colony numbers compared to the vehicle control values within the actual historical control data ranges were observed in both independently performed main experiments. However, there was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments. In the performed experiments inhibitory effect of the test item (decreased number of revertant colony numbers and/or affected background lawn development) was not observed in any case. In the Confirmatory Mutation Test (Pre-Incubation Test) heavy, interfering precipitate was noticed on the plates in the examined bacterial strains at the highest examined concentration level of 5000 μg/plate in absence and also in the presence of exogenous metabolic activation (±S9 Mix). The reported data of this mutagenicity assay show, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, the test substance is considered non-mutagenic in this bacterial reverse mutation assay.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The data did not indicate genetic mutation properties of the test substance. 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 ninth time in Regulation (EU) No 2016/1179.
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