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EC number: 619-057-3 | CAS number: 94667-33-1
- 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
- Study period:
- April-May 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- EC Number:
- 619-057-3
- Cas Number:
- 94667-33-1
- Molecular formula:
- C29 H62 N O4 . C3 H5 O2
- IUPAC Name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- Reference substance name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- IUPAC Name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- Reference substance name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- IUPAC Name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- Reference substance name:
- Bardap 26
- IUPAC Name:
- Bardap 26
- Details on test material:
- The test substance, Hoe S3519 (N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium propionate in aqueous/alcohol solution), was described as a clear, yellow liquid and stable at room temperature. The test substance was stored in the dark at 22°C.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- Reversion to histidine dependence
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (Aroclor 1254 induced Sprague-Dawley rats)
- Test concentrations with justification for top dose:
- Cytotoxicity testing: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment 1: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment 2: 0, 0.032, 0.16, 0.8, 4, 20, 100 µg/plate - Vehicle / solvent:
- Double distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminothracene. With S9: TA1538, TA98, TA100, TA1537, WP2uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: With S9: TA1535, TA1537, TA1538, TA98, TA100, WP2uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: Without S9: TA1538, TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: Without S9: TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: Without S9: TA1535, TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: MNNG. Without S9: WP2uvrA
- Details on test system and experimental conditions:
- Cytotoxicity was evaluated in a preliminary study with and without S9, the parameters assessed were thinning of background lawn and reduction in colony numbers. Following this, two independent assays were performed both with and without S9.
Bacteria were grown overnight in nutrient broth at 37°C. The suitable amount of bacteria in the cell suspension was checked by nephelometry. For inoculation, stock cultures stored at -80°C were used.
Top agar was prepared for the Salmonella strains by mixing 100 ml agar with 10 ml of a 0.5 mM histidine-biotin solution. With E. coli histidine was replaced with tryptophan (2.5 ml, 0.5 mM). The following ingredients were added to 2 ml of molton top agar at 45°C: 0.1 ml of overnight broth culture of tester strain, 0.1 ml test compound solution, 0.5 ml S9 mix or buffer. After mixing, the liquid was poured intro a petri dish with minimal agar and incubated for 48-72 hours at 37°C in the dark. Colonies (his+ revertants) were then counted. - Evaluation criteria:
- Cytotoxicity: thinning of background lawn and reduction in colony numbers.
Genotoxicity: increase in revertant colony numbers - Statistics:
- Not required.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxic to most strains at either 4 or 20 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxic to most strains at either 4 or 20 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- 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
- Remarks:
- toxic to most strains at either 4 or 20 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- 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
- Remarks:
- toxic to most strains at either 4 or 20 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxic to most strains at either 4 or 20 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- In Experiment 1 the test substance was toxic to most strains at either 4 or 20 µg/plate and above, both with and without metabolic activation. Therefore 100 µg/plate was selected was the highest dose level in Experiment 2.
The test compound did not cause a significant increase in the number of revertant colonies with any of the tester strains, neither in the absence or presence of S9 mix. No dose-dependent effect was obtained.
Sterility of the S9 mix and test compound were confirmed in sterility check plates.
Any other information on results incl. tables
No further information.
Applicant's summary and conclusion
- Conclusions:
- No evidence of mutagenicity was observed in either the presence or absence of metabolic activation.
- Executive summary:
The mutagenic potential of Bardap 26 was evaluated in the bacterial reverse mutation assay (Ames Test). The test substance was applied to Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100, and Escherichia coli strain WP2uvrA, both in the presence and absence of metabolic activation (S9 mix). Test substance concentrations in the cytotoxicity test and first independent experiment were 0, 4, 20, 100, 500, 2500 and 10000 µg/plate. Cytotoxicity, evidenced by a thinning of the background lawn and a reduction in colony numbers, was observed in most strains with and without S9 at either 4 or 20 µg/plate and above. Therefore, test substance concentrations in the second independent experiment were reduced as follows: 0, 0.032, 0.16, 0.8, 4, 20 and 100 µg/plate. No significant increase in revertant colony numbers was observed, even at toxic dose levels, both with and without metabolic activation (S9 mix). It is concluded that the test substance is not mutagenic in the bacterial reverse mutation assay, and therefore does not require classification as a mutagen.
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