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EC number: 947-965-2 | 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 mammalian cells
- 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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- (2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
- IUPAC Name:
- (2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham’s F10 medium without thymidine and hypoxanthine, supplemented with 10% (v/v) horse serum, L-glutamine (2 mM)
and penicillin/streptomycin (50 U/ml and 50 µg/ml respectively).
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Dose range finding test: 10 to 5000 µg/ml
experiment 1 without S9 mix: 0.1, 0.5, 1, 5, 10, 15, 20 and 25 µg/ml
experiment 1 with 8 % S9 mix: 10, 50, 100, 200, 400 and 500 µg/ml
experiment 2 without S9 mix: 5, 10, 15, 20, 22.5, 25, 27.5 and 30 µg/ml
experiment 2 with 12 % S9 mix: 100, 200, 300, 350, 400, 450, 500 and 600 µg/ml
experiment 3 without S9 mix; 3 hours treatment: 10, 20, 25 and 27.5 µg/ml
experiment 3 without S9 mix; 24 hours treatment: 45, 60, 75 and 90 µg/ml - Vehicle / solvent:
- exposure medium (F10-medium)
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- exposure medium
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION: Exposure duration: 3 hours and 24 hours
SELECTION AGENT (mutation assays): trifluorothymidine
DETERMINATION OF CYTOTOXICITY: relative total growth - Evaluation criteria:
- A test substance was considered positive (mutagenic) in the mutation assay if:
1. It induced at least a 8-fold increase in the mutant frequency compared to the solvent control in a dose-dependent manner; and
2. The results were reproducible in an independently repeated test.
A test substance was considered negative (not mutagenic) in the mutation assay if:
1. None of the tested concentrations showed a mutant frequency of at least three-fold compared to the solvent control.
2. The results were confirmed in an independently repeated test. - Statistics:
- The experimental results were not subjected to statistical analysis.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: test substance concentration range of 10 to 5000 ug/ml in the absence of SS-mix with a 3 and 24 hour treatment period and in the presence of S9-mix with a 3 hour treatment period.
In the absence of S9 metabolic activation, REWOTERIC QAM 50 induced a 5.3-fold increase in the mutant frequency in the first experiment. No significant increase in the mutant frequency at the TK-locus was observed in the second experiment. Verification of this result was performed in the additional third experiment with a 3 hour treatment period and a prolonged treatment time of 24 hours, in which REWOTERIC QAM 50 showed no significant increase in the mutant frequency at the TK-locus.
Since the mutagenic effect observed in the first experiment was not confirmed by the additional assay nor in the short or prolonged treatment, this increase was considered to be not biologically relevant and REWOTERIC QAM 50 is considered to be not mutagenic in the absence of S9-mix.
In the presence of S9-mix, REWOTERIC QAM 50 induced no significant increase in the mutant frequency in both independent experiments. - Remarks on result:
- other: strain/cell type: L5178Y mouse lymphoma cells
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
REWOTERIC QAM 50 is not mutagenic in the TK mutation test system under the experimental conditions described. - Executive summary:
In a mammalian cell gene mutation assay according to OECD guideline 467, L5178Y mouse lymphoma cells cultured in vitro were exposed to Rewoteric Qam 50 in the following concentrations in the presence and absence of mammalian metabolic activation (S9 mix):
First experiment
Without S9-mix, 3 h treatment: 0.1, 0.5, 1, 5, 10, 15, 20 and 25 μg/mL
With 8% S9-mix, 3 h treatment: 10, 50, 100, 200, 400 and 500 μg/mL
Second experiment
Without S9-mix, 3 h treatment: 5, 10, 15, 20, 22.5, 25, 27.5 and 30 μg/mL
With 12% S9-mix, 3 h treatment: 100, 200, 300, 350, 400, 450, 500 and 600 μg/mL
Third experiment
Without S9 -mix, 3 h treatment: 10, 20, 25 and 27.5 µg/mL
Without S9 -mix, 24 h treatment: 45, 60, 75 and 90 µg/mL
Test substance was tested up to cyctotoxic concentrations.The positive controls induced the appropriate response.There was no evidence of induced mutant colonies over background.
In the absence of S9 metabolic activation, the substance induced a 5.3-fold increase in the mutant frequency in the first experiment. Since this mutagenic effect was not confirmed by the additional assay nor in the short or prolonged treatment, this increase was considered to be not biologically relevant and the substance is considered to be not mutagenic in the absence of SS-mix.
In the presence of S9 -mix, the substance induced no significant increase in the mutant frequency in both independent experiments.
In conclusion, the substance is not mutagenic in the TK mutation test system under the experimental conditions described.
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