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EC number: 254-663-8 | CAS number: 39872-57-6
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A with and without metabolic activation
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:
- 25 April - 21 Aug 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:
- adopted: 21 Jul 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
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain) - 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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment Ib (TA98): 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment 2: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Solvent/vehicle used: DMSO
- Justification for choice of solvent/ vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria. - Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (Experiment 1 and 1b); preincubation (Experiment 2)
DURATION
- Preincubation period: 1 h
- Exposure duration: at least 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 (3 for TA 98) independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- Mean values and standard deviations were calculated.
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see "remarks on result"
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item precipitated in the overlay agar in the test tubes from 2500 to 5000 μg/plate with S9 mix in experiment 1 and from 1000 to 5000 μg/plate with S9 mix in experiment 2 in all strains used. In experiment 1b no precipitation in the overlay agar in the test tubes was observed. No precipitation of the test item occurred in the overlay agar on the incubated agar plates in all experiments.
RANGE-FINDING/SCREENING STUDIES: The pre-experiment is reported as Experiment I (all strains tested). In strain TA98 in the pre-experiment no colonies were observed at 333 μg/plate and above and the decrease was steep and unexpected. Therefore, this part of the experiment was repeated (Exp 1b). Based on the outcome of experiment 1b the results of strain TA 98 without S9 mix in the pre-experiment 1 were judged to be invalid due to a technical error. Therefore this part of the experiment is not reported.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects, indicated by a reduced bacterial background lawn or decreased number of revertants (induction factor below 0.5), were observed in all strains used except srains TA 1535 and and WP2 uvrA in experiment I and II with and without S9 mix and in strain TA1537 in experiment I with and without metabolic activation. In Experiment 1 and 1b the strains TA1537, TA98 and TA100 showed reduced background growth. In Experiment 2 additionally strain TA1535 showed these quantitative signs of toxicity. - Remarks on result:
- other: Cytotoxicity:
- Remarks:
- Exp 1: at 333 µg/plate and above for TA 1537 and TA 100 with and without metabolic activation, at 1000 µg/plate and above for TA 98 with metabolic activation; Exp 1b: at 1000 µg/plate for TA 98 without metabolic activation; Exp 2: at 333 µg/plate and above for TA 1537, TA 98 and TA 100 with and without metabolic activation, at 1000 µg/plate and above for TA 1535 without metabolic activation
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five bacterial strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA) tested with and without metabolic activation.
Reference
Table 2. Results experiment 1
Metabolic Activation | Test Group | Dose Level (per plate) | Revertant Colony Counts (Mean ± SD) | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvrA | |||
Without Activation | DMSO | 12 ± 3 | 11 ± 4 | 1) |
184 ± 13 | 43 ± 5 | |
Untreated | 9 ± 3 | 9 ± 5 | 200 ± 16 | 39 ± 7 | |||
Test substance | 3 µg | 10 ± 5 | 14 ± 6 | 201 ± 30 | 37 ± 10 | ||
10 µg | 9 ± 3 | 9 ± 3 | 200 ± 8 | 38 ± 6 | |||
33 µg | 11 ± 3 | 10 ± 3 | 198 ± 8 | 37 ± 5 | |||
100 µg | 8 ± 2 | 8 ± 2 | 148 ± 11 | 40 ± 6 | |||
333 µg | 8 ± 3 | 14 ± 2R | 38 ± 3R | 44 ± 6 | |||
1000 µg | 11 ± 1 | 13 ± 2R | 29 ± 5M R | 36 ± 1 | |||
2500 µg | 10 ± 1 | 18 ± 6R | 22 ± 8M R | 48 ± 8 | |||
5000 µg | 9 ± 2 | 22 ± 6R | 11 ± 1R M | 38 ± 8 | |||
NaN3 | 10 µg | 1365 ± 40 | 2341 ± 189 | ||||
4-NOPD | 10 µg | ||||||
4-NOPD | 50 µg | 70 ± 16 | |||||
MMS | 2.0 µL | 972 ± 44 | |||||
With Activation | DMSO | 11 ± 2 | 13 ± 5 | 32 ± 5 | 166 ± 11 | 47 ± 6 | |
Untreated | 11 ± 4 | 16 ± 6 | 44 ± 7 | 181 ± 17 | 58 ± 2 | ||
Test substance | 3 µg | 12 ± 0 | 13 ± 1 | 35 ± 14 | 152 ± 23 | 50 ± 8 | |
10 µg | 9 ± 2 | 12 ± 5 | 37 ± 10 | 161 ± 16 | 54 ± 3 | ||
33 µg | 15 ± 1 | 13 ± 2 | 28 ± 3 | 163 ± 10 | 64 ± 5 | ||
100 µg | 10 ± 4 | 11 ± 2 | 33 ± 6 | 173 ± 17 | 61 ± 12 | ||
333 µg | 11 ± 2 | 11 ± 2R | 26 ± 3 | 52 ± 10R | 45 ± 3 | ||
1000 µg | 11 ± 2 | 19 ± 4R | 26 ± 5R | 31 ± 5R | 44 ± 6 | ||
2500 µg | 9 ± 3 | 19 ± 4R | 13 ± 2M R | 30 ± 6M R | 37 ± 3 | ||
5000 µg | 8 ± 1 | 22 ± 3R | 9 ± 4M R | 21 ± 6M R | 41 ± 5 | ||
2-AA | 2.5 µg | 491 ± 21 | 204 ± 47 | 4024 ± 726 | 4041 ± 138 | ||
2-AA | 10.0 µg | 342 ± 13 |
1) experiment not valid; no results reported
NaN3: sodium azide
2AA: 2-Aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
R: reduced background growth
M: manual count
Table 3: Results experiment 1b
Metabolic Activation | Test Group | Dose Level (per plate) | Revertant Colony Counts (Mean ±SD) |
TA 98 | |||
Without Activation | DMSO | 24 ± 1 | |
Untreated | 19 ± 3 | ||
Test substance | 3 µg | 27 ± 2 | |
10 µg | 20 ± 3 | ||
33 µg | 25 ± 7 | ||
100 µg | 20 ± 5 | ||
333 µg | 22 ± 6 | ||
1000 µg | 18 ± 4R | ||
2500 µg | 19 ± 2M R | ||
5000 µg | 21 ± 6M R | ||
4-NOPD | 10 µg | 487 ± 16 |
4-NOPD: 4-nitro-o-phenylene-diamine
R: reduced background growth
M: manual count
Table 4. Results experiment 2
Metabolic Activation | Test Group | Dose Level (per plate) | Revertant Colony Counts (Mean ±SD) | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvrA | |||
Without Activation | DMSO | 12 ± 2 | 10 ± 1 | 22 ± 7 | 139 ± 9 | 40 ± 7 | |
Untreated | 13 ± 3 | 8 ± 3 | 29 ± 7 | 161 ± 10 | 47 ± 5 | ||
Test substance | 3 µg | 25 ± 3 | 131 ± 13 | ||||
10 µg | 25 ± 3 | 133 ± 3 | |||||
33 µg | 12 ± 3 | 7 ± 3 | 22 ± 6 | 134 ± 18 | 40 ± 3 | ||
100 µg | 8 ± 2 | 9 ± 2 | 15 ± 1 | 63 ± 17 | 38 ± 10 | ||
333 µg | 10 ± 3 | 8 ± 1R | 21 ± 8R | 31 ± 9R | 37 ± 4 | ||
1000 µg | 9 ± 3R | 3 ± 2R M | 11 ± 1M R | 14 ± 3M R | 27 ± 5 | ||
2000 µg | 4 ± 1M R | ||||||
2500 µg | 10 ± 5R | 6 ± 2M R | 6 ± 1M R | 40 ± 3 | |||
3000 µg | 2 ± 1M R | ||||||
4000 µg | 0 ± 1M R | ||||||
5000 µg | 11 ± 5R | 0 ± 0M R | 4 ± 2M R | 0 ± 1M R | 38 ± 6 | ||
NaN3 | 10 µg | 1334 ± 26 | 2333 ± 91 | ||||
4-NOPD | 10 µg | 301 ± 18 | |||||
4-NOPD | 50 µg | 99 ± 27 | |||||
MMS | 2.0 µL | 603 ± 35 | |||||
With Activation | DMSO | 13 ± 2 | 10 ± 2 | 38 ± 4 | 160 ± 12 | 53 ± 5 | |
Untreated | 12 ± 3 | 10 ± 3 | 41 ± 5 | 174 ± 26 | 56 ± 3 | ||
Test substance | 3 µg | 32 ± 4 | 148 ± 3 | ||||
10 µg | 43 ± 3 | 161 ± 9 | |||||
33 µg | 12 ± 2 | 11 ± 4 | 33 ± 4 | 156 ± 6 | 48 ± 8 | ||
100 µg | 10 ± 2 | 10 ± 4 | 39 ± 2 | 106 ± 16 | 57 ± 7 | ||
333 µg | 11 ± 3 | 12 ± 5R | 33 ± 8R | 35 ± 5R | 57 ± 15 | ||
1000 µg | 9 ± 3 | 10 ± 1M R | 10 ± 2M R | 10 ± 2M R | 49 ± 6 | ||
2000 µg | 10 ± 3M R | ||||||
2500 µg | 8 ± 1 | 6 ± 2M R | 12 ± 1M R | 46 ± 5 | |||
3000 µg | 9 ± 2M R | ||||||
4000 µg | 7 ± 3M R | ||||||
5000 µg | 10 ± 6 | 5 ± 1M R | 2 ± 0M R | 2 ± 1M R | 45 ± 4 | ||
2-AA | 2.5 µg | 403 ± 86 | 141 ± 28 | 4973 ± 717 | 3765 ± 212 | ||
2-AA | 10.0 µg | 518 ± 29 | |||||
NaN3: sodium azide
2AA: 2-Aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
R: reduced background growth
M: manual count
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
A bacterial gene mutation assay with the test substance was performed in accordance with OECD Guideline 471 and in compliance with GLP (2017). In this study the substance was not mutagenic in any of the five bacterial strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvr A) tested with and without metabolic activation up to 5000 µg/plate.
Additional information
Justification for classification or non-classification
The available data on genetic toxicity meet criteria for data requirements of Annex VII but are not sufficient for classification or non-classification according to Regulation (EC) 1272/2008.
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