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EC number: 246-309-6 | CAS number: 24549-06-2
- 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 and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-ethyl-2-toluidine
- EC Number:
- 246-309-6
- EC Name:
- 6-ethyl-2-toluidine
- Cas Number:
- 24549-06-2
- Molecular formula:
- C9H13N1
- IUPAC Name:
- 2-ethyl-6-methylaniline
- Details on test material:
- 2-methyl-6-ethylanilin purity: 99.9 %
Constituent 1
Method
- Target gene:
- ames assay
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: tester strains TA 1535, TA 100, TA 1537, TA 98, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix, S9 from male Sprague Dawley rats (liver enzyme induction by single intraperitonial injection of Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 50, 158, 500, 1581, 5000 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cumene hydroperoxide, +S9: 2-aminoanthracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: tester strains TA 1535, TA 100, TA 1537, TA 98, 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: tester strains TA 1535, TA 100, TA 1537, TA 98, TA 102
Any other information on results incl. tables
Doses up to and including 500 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only partly be used up to and including 5000 µg per plate for assessment purposes.
Evidence of mutagenic activity of 2 Methyl-6-ethylanilin was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cumene hydroperoxide and 2-aminoanthracene had a marked muta-genic effect, as was seen by a biologically relevant increase in mutant colonies com-pared to the corresponding negative controls.
Therefore, 2 Methyl-6-ethylanilin was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The mutagenic potential in bacteria of the test substance 2-ethyl-6-methylaniline (MEA) was evaluated in a GLP and OECD guideline study (TG 471). Here, the tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 102 were used. Treatments by the plate incorporation method and the pre-incubation method were done for doses up to 5000 µg/ plate. The tester strains were evaluated with and without metabolic activation. No toxic effects of MEA were noted up to 500 µg/plate; whereas higher doses had a strong, strain-specific toxic effect. In this study no biologically relevant and dose dependent increases in revertants was observed in any of the tester strains evaluated with and without metabolic activation. Therefore, 2 Methyl-6-ethylanilin was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test (Lanxess Deutschland GmbH 2009).
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