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EC number: 941-484-1 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- 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 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride
- EC Number:
- 941-484-1
- Molecular formula:
- not possible
- IUPAC Name:
- Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride
- Test material form:
- liquid: viscous
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- TA 98: his D 3052; rfa-; uvrB-; R-factor: frame shift mutations
TA 100: his G 46; rfa-; uvrB-; R-factor: base-pair substitutions
TA 1535: his G 46; rfa-; uvrB-: base-pair substitutions
TA 1537: his C 3076; rfa-; uvrB-: frame shift mutations
TA 102: his G 428 (pAQ1); rfa-; R-factor: base-pair substitutions
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat)
- Test concentrations with justification for top dose:
- Experiment I:
3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
(for TA 98 with and without metabolic activation and TA 100 with metabolic activation)
0.316, 1.00, 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
(for TA 100 without metabolic activation and all other tester strains with and without metabolic activation)
Experiment II:
0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100, 316, 1000 and 2500 μg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- dest. water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Remarks:
- Negative/solvent controls (A. dest.) and solvent controls (DMSO) were treated in the same way as all dose groups.
- Positive controls:
- yes
- Remarks:
- 10 μg/plate
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 10 μg/plate for TA 98, 40 μg/plate for TA 1537
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 98, TA 1537 Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 1 μL/plate
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102 Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 2.5 μg/plate; 10 μg/plate for TA 102
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 98, TA 100, TA 1535, TA 1537 and TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st main experiment: in agar (plate incorporation); 2nd main experiment: preincubation
DURATION
- 1st main experiment: 48 hours incubation (37°C)
- 2nd main experiment: 60 min preincubation (37°C), 48 hours incubation (37°C)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: determination of background lawn, reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control - Evaluation criteria:
- A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100, TA 102)
- the control plates with and without S9 mix are within the historical control data range
- corresponding background growth on negative control, solvent control and test plates is observed
- the positive controls show a distinct enhancement of revertant rates over the control plate
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
Toxic effects of the test item were noted in all tester strains evaluated in experiment I and II.
In experiment I toxic effects of the test item were observed in tester strains TA 100, TA 1535, TA 1537 and TA 102 at concentrations of 316 μg/plate and higher (without metabolic activation). In tester strain TA 98 toxic effects of the test item were observed at concentrations of 1000 μg/plate and higher (without metabolic activation) and in tester strains TA 100 and TA 1535 (with metabolic activation). Also, in tester strains TA 98, TA 1537 and TA 102 toxic effects of the test item were noted at concentrations of 2500 μg/plate and higher (with metabolic activation).
In experiment II toxic effects of the test item were noted in all tester strains at concentrations of 100 μg/plate and higher (without metabolic activation).
In tester strain TA 100 toxic effects of the test item were observed at concentrations of 316 μg/plate and higher (with metabolic activation) and in tester strains TA 98, TA 1535, TA 1537 and TA 102 toxic effects of the test item were noted at concentrations of 1000 μg/plate and higher (with metabolic activation). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
Under the conditions of this test the susbstance did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the substance is considered to be non-mutagenic in this bacterial reverse mutation assay.
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