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EC number: 457-280-6 | 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
- 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 Ames study returned a negative result. Therefore the test substance is not classified for genetic toxicity.
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:
- From Jan. 20, 2004 to Feb. 2, 2004
- 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:
- 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:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Corporate Toxicology
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark with desiccant - Target gene:
- TA 1537: his C 3076 (Frameshift mutation)
TA98: his D 3052 (Frameshift mutation)
TA 1535: his G 46 (Base-pair substitution)
TA 100: his G 46 (Frameshift and base-pair substitution)
WP2uvrA: trpE (Base-pair substitution) - Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Aroclor 1254-induced rat liver S9
- method of preparation of S9 mix: The S9 was prepared from male Sprague-Dawley rats induced with a single intraperitoneal injection of Aroclor 1254, 500 mg/kg, five days prior to sacrifice.
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL of S9 or Sham mix
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Each bulk preparation of S9 was assayed for its ability to metabolize 2-aminoanthracene and 7,12-dimethylbenz(a)anthracene to forms mutagenic to Salmonella typhimurium TAl00.To confirm the sterility of the S9 and Sham mixes, a 0.5 mL aliquot of each was plated on selective agar. - Test concentrations with justification for top dose:
- Initial toxicity-mutation assay: The dose levels tested were 2.5, 7.5, 25, 75, 200, 600, 1800 and 5000 μg per plat.
Confirmatory mutagenicity assay: The dose levels tested were 75, 200, 600, 1800 and 5000 μg per plate. The top dose was selected based on the findings of the initial toxicity-mutation assay. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: A solubility test was conducted to select the vehicle. The test was conducted using dimethyl sulfoxide (DMSO). The test article was tested to determine the vehicle, selected in order of preference, that permitted preparation of the highest soluble or workable stock concentration, up to 500 mg/mL. Dimethyl sulfoxide (DMSO) was selected as the solvent of choice based on solubility of the test article and compatibility with the target cells. - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other:
- Remarks:
- With S9
All salmonella strains and WP2uvrA: 2-aminoanthracene:
Without S9:
TA98: 2-nitrofluorene
TAI00, TA1535: Sodium azide
TA1537: 9-aminoacridine
WP2uvrA: Methyl methanesulfonate - Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Duplicate in the initial toxicity-mutation assay, triplicate in the confirmatory Mutagenicity Assay.
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): approximately 10^9 cells/mL
- Test substance added in: agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 to 72 hours at 37±2°C.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope. - Evaluation criteria:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2.0-times the mean vehicle control value. - Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Solubility Test
Dimethyl sulfoxide (DMSO) was selected as the solvent of choice based on solubility of the test article and compatibility with the target cells. The test article forms a soluble and clear solution in dimethyl sulfoxide (DMSO) at 500 mg/mL, the highest concentration tested.
Sterility Results
No contaminant colonies were observed on the sterility plates for the vehicle control, the test article dilutions and the S9 and Sham mixes.
Initial toxicity-mutation assay
The maximum dose tested was 5000 μg per plate; this dose was achieved using a concentration of 100 mg/mL and a 50 μL plating aliquot. The dose levels tested were 2.5, 7.5, 25, 75, 200, 600, 1800 and 5000 μg per plate. Neither precipitate nor appreciable toxicity was observed. Based on the findings of the initial toxicity-mutation assay, the maximum dose pIated in the confirmatory mutagenicity assay was 5000 μg per plate. Νo positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation (Table 1).
Confirmatory Mutagenicity Assay
The dose levels tested were 75, 200, 600, 1800 and 5000 μg per plate. Neither precipitate nor appreciable toxicity was observed. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation (Table 2). - Conclusions:
- All criteria for a valid study were met. The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate did not cause a positive response in the presence and absence of metabolic activation and thus it is negative in the Bacterial Reverse Mutation Assay.
- Executive summary:
The mutagenic potential of N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate was assessed in the Bacterial Reverse Mutation Assay using Salmonella typhimuriu1n tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvrA in the presence and absence of Aroclor-induced rat liver S9.
The assay was performed in two phases, using the plate incorporation method. The first phase, the initial toxicity-mutation assay, was used to establish the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, the confirmatory mutagenicity assay, was used to evaluate and confirm the mutagenic potential of the test article. Dimethyl sulfoxide (DMSO) was selected as the solvent of choice based on solubility of the test article and compatibility with the target cells.
In the initial toxicity-mutation assay, the dose levels tested were 2.5, 7.5, 25, 75, 200, 600, 1800 and 5000 μg per plate. No positive mutagenic response was observed in the presence or absence of metabolic activation. Neither precipitate nor appreciable toxicity was observed. In the confirmatory mutagenicity assay, the dose levels tested were 75, 200, 600, 1800 and 5000 μg per plate. Νo positive mutagenic response was observed in the presence or absence of metabolic activation. Neither precipitate nor appreciable toxicity was observed.
Under the conditions of this study, N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate was concluded to be negative in the Bacterial Reverse Mutation Assay.
Reference
Table 1. Average Revertants Per Plate ± SD. Experiment No: B1 | |||||
| |||||
Liver Microsomes: None | |||||
Dose (μg/plate) | TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA |
Vehicle | 18 ± 0 | 120 ± 2 | 16 ± 4 | 6 ± 0 | 17 ± 4 |
2.5 | 18 ± 4 | 109 ± 4 | 17 ± 3 | 7 ± 1 | 18 ± 1 |
7.5 | 15 ± 1 | 129 ± 10 | 16 ± 2 | 3 ± 0 | 17 ± 1 |
25 | 16 ± 1 | 126 ± 16 | 20 ± 3 | 4 ± 1 | 13 ± 1 |
75 | 15 ± 3 | 121 ± 8 | 22 ± 4 | 7 ± 6 | 17 ± 1 |
200 | 16 ± 7 | 110 ± 7 | 22 ± 1 | 6 ± 1 | 12 ± 6 |
600 | 21 ± 2 | 142 ± 10 | 17 ± 1 | 5 ± 3 | 16 ± 4 |
1800 | 16 ± 1 | 119 ± 14 | 19 ± 0 | 9 ± 1 | 16 ± 6 |
5000 | 15 ± 2 | 124 ± 19 | 18 ± 1 | 7 ± 5 | 17 ± 1 |
Positive control | 190 ± 15 | 566 + 43 | 331 + 39 | 659 + 28 | 122 + 27 |
| |||||
Liver Microsomes: Rat liver S9 | |||||
Dose (μg/plate) | TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA |
Vehicle | 26 ± 5 | 145 ± 6 | 16 ± 4 | 8 ± 1 | 16 ± 1 |
2.5 | 26 ± 6 | 147 ± 6 | 14 ± 2 | 10 ± 2 | 19 ± 1 |
7.5 | 32 ± 11 | 166 ± 22 | 15 ± 3 | 8 ± 2 | 15 ± 6 |
25 | 29 ± 0 | 168 ± 18 | 14 ± 1 | 8 ± 0 | 21 ± 1 |
75 | 37 ± 4 | 161 ± 17 | 17 ± 1 | 8 ± 1 | 25 ± 5 |
200 | 33 ± 1 | 179 ± 24 | 11 ± 0 | 9 ± 1 | 19 ± 3 |
600 | 35 ± 2 | 150 ± 16 | 15 ± 1 | 10 ± 1 | 26 ± 4 |
1800 | 30 ± 1 | 185 ± 4 | 13 ± 4 | 8 ± 1 | 19 ± 1 |
5000 | 33 ± 1 | 180 ± 6 | 16 ± 4 | 12 ± 1 | 20 ± 4 |
Positive control | 740 ± 33 | 852 ± 42 | 120 ± 1 | 82 ± 19 | 525 ± 143 |
Table 2. Average Revertants Per Plate ± SD. Experiment No: B2 | |||||
| |||||
Liver Microsomes: None | |||||
Dose (μg/plate) | TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA |
Vehicle | 16 ± 2 | 115 ± 19 | 21 ± 3 | 6 ± 2 | 15 ± 5 |
75 | 16 ± 1 | 112 ± 15 | 23 ± 1 | 7 ± 1 | 15 ± 1 |
200 | 17 ± 1 | 128 ± 11 | 23 ± 10 | 8 ± 2 | 15 ± 3 |
600 | 16 ± 6 | 123 ± 15 | 18 ± 6 | 8 ± 3 | 12 ± 1 |
1800 | 15 ± 3 | 125 ± 4 | 21 ± 3 | 8 ± 2 | 13 ± 2 |
5000 | 15 ± 2 | 131 ± 6 | 18 ± 5 | 7 ± 1 | 18 ± 2 |
Positive control | 356 ± 27 | 537 ± 33 | 314 ± 33 | 455 ± 28 | 87 ± 8 |
| |||||
Liver Microsomes: Rat liver S9 | |||||
Dose (μg/plate) | TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA |
Vehicle | 27 ± 1 | 129 ± 7 | 14 ± 2 | 9 ± 1 | 15 ± 6 |
75 | 24 ± 3 | 131 ± 18 | 14 ± 3 | 10 ± 1 | 17 ± 1 |
200 | 25 ± 3 | 154 ± 36 | 15 ± 2 | 9 ± 2 | 19 ± 1 |
600 | 23 ± 5 | 150 ± 14 | 15 ± 4 | 6 ± 4 | 16 ± 2 |
1800 | 29 ± 6 | 140 ± 10 | 13 ± 2 | 9 ± 1 | 13 ± 1 |
5000 | 33 ± 2 | 143 ± 10 | 14 ± 4 | 10 ± 2 | 16 ± 2 |
Positive control | 908 ± 37 | 967 + 98 | 126 + 16 | 94 + 18 | 690 + 125 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The Ames study returned a negative result. Therefore the test substance is not classified for genetic toxicity.
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