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Diss Factsheets
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EC number: 916-226-6 | 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
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: well documented guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The mutagenic potential of m-tolylisocyanate was examined in the Salmonella/microsome test. Bacteria of 5 histidineauxotrophic Salmonella typhimurium LT2 mutant strains (TA 98, TA 100, TA 102, TA 1535, and TA 1537) were exposed to doses up to 5000 pg per plate. Both the plate incorporation method and the preincubation method was used.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzyldodecylbis(2-hydroxypropyl)ammonium chloride
- EC Number:
- 265-345-3
- EC Name:
- Benzyldodecylbis(2-hydroxypropyl)ammonium chloride
- Cas Number:
- 65059-91-8
- Molecular formula:
- C25H46NO2.Cl
- IUPAC Name:
- N-benzyl-N,N-bis(2-hydroxypropyl)dodecan-1-aminium chloride
- Details on test material:
- Catalysator WAZ 5596-B, content: 55-60 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: Firstly, they are deep rough since certain lipopolysaccharide side chains are missing in the bacterial cell wall. Secondly, their reduced ability to repair damage from UV light (e.g. thymidine dimers) allows the phenotypic detection of mutation events
- Metabolic activation:
- with and without
- Metabolic activation system:
- S 9-mix
- Test concentrations with justification for top dose:
- Plate incorporation method: up to and including 160 µg/plate;
Preincubation method: up to and including 128 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cumene hydroperoxide and 2-aminoanthracene
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:
- cytotoxicity
- Remarks:
- plate incorporation test: 10 µg/plate; preincubation test: 2 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the plate incorporation test doses of up to and including 10 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strainspecific bacteriotoxic effect, so that this range could only be used up to and including 80 µg per plate for assessment purposes.
In the preincubation test doses of up to and including 2 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used up to and including 64 µg per plate for assessment purposes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
Katalysator WAZ 5596-8 was initially investigated using the Salmonella/microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 µg per plate on five Salmonella typhimurium L T2 mutants. An independent repeat
was performed as preincubation for 20 minutes at 37°C with doses of up to and including 160 µg per plate. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537, TA 98 and TA 102. Other conditions remained unchanged. Due to the strong bacteriotoxic effects a second plate incorporation test with doses of up to and including 160 µg per plate and a further preincubation test was performed employing doses of up to and including 128 µg per plate.
In the plate incorporation test doses of up to and including 10 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strainspecific bacteriotoxic effect, so that this range could only be used up to and including 80 µg per plate for assessment purposes.
In the preincubation test doses of up to and including 2 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used up to and including 64 µg per plate for assessment purposes.
Evidence of mutagenic activity of Katalysator WAl 5596-8 was not seen. No biologically relevant increase in the mutant count, in comparison to the negative controls, was observed in any of the strains tested, without and with S9 mix, in the plate incorporation
as weil as in the preincubation modification, under the experimental conditions applied.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cu me ne hydroperoxide and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared
to the corresponding negative controls.
Therefore, Katalysator WAZ 5596-8 is considered to be non-mutagenic in the Salmonella/microsome test.
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