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EC number: 947-953-7 | CAS number: -
- 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
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- Flash point
- Auto flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-02-14 to 2017-03-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Deviation of the study plan: three concentrations of the toxicity control were performed, instead of one concentration. This has no influence on the study results
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of Reaction product of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol with methyl diethanolamine and [3-(dodecyloxy)-2-hydroxypropyl]bis(2-hydroxyethyl)methylammonium chloride
- IUPAC Name:
- Reaction mass of Reaction product of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol with methyl diethanolamine and [3-(dodecyloxy)-2-hydroxypropyl]bis(2-hydroxyethyl)methylammonium chloride
- Test material form:
- other: solid, very viscous yellow paste
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: uvrB
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: uvrB
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: uvrB
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: uvrB
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1a (plate incorporation method):
up to concentrations of 5000 μg/plate in the absence and presence of S9; strains TA97a, TA98, TA100, TA102 and TA1535
Experiment 1b (plate incorporation method):
- 500 μg/plate + S9 in the bacteria strains TA98 and TA102
- 150 μg/plate + S9 in the bacteria strains TA97a and TA1535, and - S9 in the bacteria strains TA98 and TA1535
- 50 μg/plate + S9 in the bacteria strain TA100, and - S9 in the bacteria strains TA97a, TA100 and TA102
Experiment 2 (pre-incubation method):
- TA97a without metabolic activation: 15 μg/plate
- TA97a with metabolic activation: 50 μg/plate
- TA98 without metabolic activation: 50 μg/plate
- TA98 with metabolic activation: 150 μg/plate
- TA100 without metabolic activation: 15 μg/plate
- TA100 with metabolic activation: 15 μg/plate
- TA102 without metabolic activation: 15 μg/plate
- TA102 with metabolic activation: 150 μg/plate
- TA1535 without metabolic activation: 50 μg/plate
- TA1535 with metabolic activation: 50 μg/plate
Due to the toxicity in experiment 1a, a repetiton (experiment 1b) of this experiment was performed with lower concentrations.
- Justification: these concentrations were chosen according to the OECD guideline 471 and tested, because test items showing any toxicity below 5 mg/plate should be tested up to the lowest toxic concentration. - Vehicle / solvent:
- - Vehicle: demineralized water
- Justification: no precipitates on the agar plates at any of the listed concentrations
Controlsopen allclose all
- Untreated negative controls:
- other: demin. water
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene Diamine
- Remarks:
- Metabolic activation: none
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Metabolic activation: none
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-Anthracene
- Remarks:
- Metabolic activation: S9
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Metabolic activation: S9
- Negative solvent / vehicle controls:
- other: DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment 1a and 1b: plate incorporation method
- Experiment 2: pre-incubation method
DURATION
- Exposure duration: 48h at 37°C
NUMBER OF REPLICATIONS: 3
ACCEPTANCE CRITERIA:
The assay is considered acceptable if the following criteria are met:
- no precipitation of the test item was observed at any of the tested concentrations up to 5000 μg/plate
- the control of the titre was above the demanded value of 109 bacteria/mL
- the spontaneous reversion rates in the negative and solvent control are in the range of the historical data of the laboratory
- all numbers of revertant colonies of the positive controls were within the range of the historical data of the laboratory
and were increased in comparison with the negative controls - Rationale for test conditions:
- These are according to the OECD guideline 471
- Evaluation criteria:
- A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed.
A concentration-related increase over the range tested is also taken as a sign of mutagenic activity. - Statistics:
- The colonies were counted visually and the numbers were recorded. A validated spread-sheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, negative control, solvent control and positive control.
The mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction
(mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls.
Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants minus mean spontaneous revertants) was given.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- 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:
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The mean revertant values of the three replicates are presented in the following tables:
Mean Revertants Experiment 1a:
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin. Water |
Mean | 90 | 86 | 9 | 12 | 88 | 104 | 265 | 301 | 10 | 12 |
sd | 21 | 4.6 | 2.1 | 3.1 | 11.2 | 5.8 | 4.6 | 26.6 | 0.6 | 2.1 | |
DMSO | Mean | 84 | 88 | 10 | 11 | 87 | 79 | 263 | 296 | 15 | 15 |
sd | 12 | 10.4 | 1 | 3.6 | 9.2 | 4 | 46.6 | 66.1 | 2 | 3.1 | |
Positive Controls* | Mean | 376 | 245 | 421 | 59 | 483 | 589 | 1427 | 1472 | 173 | 121 |
sd | 114.3 | 31.1 | 48.1 | 5.5 | 122.9 | 48.9 | 91 | 117.8 | 34 | 28 | |
5000 μg/plate | Mean | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
sd | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
1500 μg/plate | Mean | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
sd | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
500 μg/plate | Mean | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
sd | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
150 μg/plate | Mean | 1 | 27 | 2 | 11 | 7 | 30 | 64 | 266 | 1 | 2 |
sd | 0.6 | 17.0 | 1.2 | 1.0 | 5.1 | 7.0 | 34.5 | 22.7 | 0.0 | 1.2 | |
50 μg/plate | Mean | 2 | 83 | 10 | 13 | 1 | 35 | 60 | 313 | 8 | 15 |
sd | 1.2 | 13.0 | 1.2 | 3.8 | 0.6 | 1.5 | 25.1 | 46.2 | 0.0 | 1.5 |
* Different positive controls were used
Mean Revertants Experiment 1b:
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin. Water |
Mean | 76 | 95 | 10 | 13 | 99 | 75 | 297 | 304.0 | 12 | 13.0 |
sd | 13.2 | 13.9 | 1.5 | 4.2 | 10.6 | 15.0 | 28.4 | 50.0 | 0.6 | 1.0 | |
DMSO | Mean | 84 | 84 | 10 | 10 | 79 | 73 | 277 | 301 | 11 | 12 |
sd | 18.8 | 18.8 | 1.7 | 0.6 | 14 | 12.2 | 36.3 | 30.3 | 2.6 | 2.3 | |
Positive Controls* | Mean | 340 | 436 | 235 | 77 | 439 | 643 | 1341 | 1205 | 324 | 101 |
sd | 52 | 131.6 | 33.2 | 13 | 87.3 | 196.3 | 146.7 | 344.3 | 64 | 12.2 | |
500 μg/plate | Mean | n.d. | n.d. | n.d. | 1 | n.d. | n.d. | n.d. | 0 | n.d. | n.d. |
sd | n.d. | n.d. | n.d. | 0.6 | n.d. | n.d. | n.d. | 0.0 | n.d. | n.d. | |
150 μg/plate | Mean | n.d. | 5 | 1 | 17 | n.d. | n.d. | n.d. | 331 | 1 | 2 |
sd | n.d. | 3.1 | 0.0 | 4.2 | n.d. | n.d. | n.d. | 20.1 | 0.0 | 1.2 | |
50 μg/plate | Mean | 1 | 72 | 10 | 15 | 0 | 0 | 0 | 265 | 9 | 12 |
sd | 0.6 | 16.8 | 0.6 | 6.1 | 0.0 | 0.0 | 0.0 | 37.2 | 1.5 | 3.8 | |
15 μg/plate | Mean | 61 | 72 | 10 | 16 | 96 | 73 | 324 | 365 | 12 | 11 |
sd | 1.2 | 11.4 | 0.6 | 4.7 | 19.1 | 18.2 | 58.9 | 67.2 | 2.6 | 0.6 | |
5 μg/plate | Mean | 79 | 64 | 8 | 10 | 67 | 77 | 252 | 291 | 9 | 12 |
sd | 12.5 | 6.9 | 1.5 | 4.4 | 11.5 | 15.3 | 48.0 | 44.1 | 3.2 | 0.6 | |
1.5 μg/plate | Mean | 71 | 77 | 11 | 11 | 74 | 86 | 289 | 285 | 11 | 8 |
sd | 10.5 | 14.8 | 1.2 | 0 | 12.5 | 18.8 | 28.4 | 36.3 | 1 | 1.2 | |
0.5 μg/plate | Mean | 72 | 72 | 8 | n.d. | 75 | 71 | 265 | n.d. | 12 | 9 |
sd | 9.8 | 8 | 0.6 | n.d. | 22.2 | 12.2 | 12.9 | n.d. | 3.2 | 0.6 | |
0.15 μg/plate | Mean | 68 | n.d. | n.d. | n.d. | 75 | 77 | 272 | n.d. | n.d. | n.d. |
sd | 10.7 | n.d. | n.d. | n.d. | 4.6 | 6.4 | 36.7 | n.d. | n.d. | n.d. | |
0.05 μg/plate | Mean | 88 | n.d. | n.d. | n.d. | 71 | 76 | 331 | n.d. | n.d. | n.d. |
sd | 18.1 | n.d. | n.d. | n.d. | 16.7 | 15.6 | 42.8 | n.d. | n.d. | n.d. |
n.d. = not determined, due to the toxicity effect in experiment 1a
* Different positive controls were used
Mean Revertants Experiment 2:
Strain | TA98 | TA102 | |||
Induction | -S9 | +S9 | -S9 | +S9 | |
Demin. Water |
Mean | 16 | 20 | 295 | 331 |
sd | 4.9 | 7.8 | 32.5 | 79.4 | |
DMSO | Mean | 16 | 10 | 297 | 293 |
sd | 4.9 | 1.2 | 38 | 49.1 | |
Positive Controls* | Mean | 393 | 74 | 661 | 703 |
sd | 70.2 | 10.5 | 100.6 | 54.3 | |
150 μg/plate | Mean | n.d. | 11 | n.d. | 348 |
sd | n.d. | 1.2 | n.d. | 18.3 | |
75 μg/plate | Mean | n.d. | 14 | n.d. | 345 |
sd | n.d. | 9.2 | n.d. | 37.8 | |
37.5 μg/plate | Mean | n.d. | 19 | n.d. | 284 |
sd | n.d. | 1.0 | n.d. | 0.9 | |
18.8 μg/plate | Mean | n.d. | 18 | n.d. | 352 |
sd | n.d. | 0.9 | n.d. | 1.1 | |
9.4 μg/plate | Mean | n.d. | 17 | n.d. | 324 |
sd | n.d. | 4.6 | n.d. | 38.2 | |
4.7 μg/plate | Mean | n.d. | 20 | n.d. | 255 |
sd | n.d. | 2.6 | n.d. | 74.4 | |
2.3 μg/plate | Mean | n.d. | 18 | n.d. | 195 |
sd | n.d. | 1.5 | n.d. | 53.3 |
n.d. = not determined
* Different positive controls were used
Applicant's summary and conclusion
- Conclusions:
- The test item is not mutagenic.
- Executive summary:
The study procedures described in this report were based on the OECD 471 and EU guidelines B13/14. The study has been performed in compliance to GLP. The test item was tested in the Salmonella typhimurium reverse mutation assay with five bacteria strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535). The test was performed in three experiments in the presence and absence of metabolic activation. Due to the toxicity in experiment 1a, a repetition experiment (experiment 1b) was performed with lower concentrations. In experiment 1a and 1b the plate incorporation method was used and in experiment 2 the pre- incubation method.
All of the means of all replicates of the spontaneous revertants (in negative (demin. water) and solvent controls (DMSO)) were within the range of the historical data of the test facility. All numbers of revertant colonies of the positive controls were within the range of the historical data of the laboratory and were increased in comparison with the negative and solvent controls, which demonstrated the mutagenic potential of the diagnostic mutagens.
Based on the results of this study it is concluded, that the test item is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 with or without metabolic activation under the experimental conditions in this study.
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