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EC number: 275-604-2 | CAS number: 71550-24-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 January 2002 to 27 April 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- July 21, 1997
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- GLP compliance:
- yes
- Type of assay:
- other: HPRT forward mutation in mammalian cells
Test material
- Reference substance name:
- [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride
- EC Number:
- 275-604-2
- EC Name:
- [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride
- Cas Number:
- 71550-24-8
- Molecular formula:
- C24H30N3O2.Cl
- IUPAC Name:
- [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- appearance: yellow powder
sample: laboratory sample purified
Constituent 1
- Specific details on test material used for the study:
- purified laboratory sample
Method
- Target gene:
- 6-thioguanine
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: University of Ulm, Germany
- Cell cycle length, doubling time or proliferation index: 10-14 hours
- Methods for maintenance in cell culture: stock kept under liquid nitrogen
- Modal number of chromosomes: 22
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: maintained in plastic vessels at 37 °C and 5%CO2, recloned by subculturing twice weekly (checked regularly for karyotype and mycoplasma presence)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability:yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 derived from Aroclor 1254 induced rat liver homogenate (concentration in test medium 5%)
- Test concentrations with justification for top dose:
- exp 1 without metabolic activation: 10, 20, 40, 60, 80 and 100 µg/mL
exp 2 without metabolic activation: 15, 30, 60, 90, 120 and 240 µg/mL
exp 1 with metabolic activation: 60, 80, 100, 120, 160, 200 and 240 µg/mL
exp 2 with metabolic activation: 60, 80, 100, 120, 160, 200 and 240 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionized water
- Justification for choice of solvent/vehicle: substance soluble up to 250 mg/mL in pre-test (precipitate in culture medium at 240 µg/mL and above)
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- other: dimethylbenzanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Exponentially growing cells were plated in culture medium in 250 mL flasks for 16-24 hours to allow attachment. Thereafter the cells were exposed for 5 hours. Monolayers were washed with PBS, trypsinized and replated in 20 mL culture medium (1.5E06 cells/250 mL) in flasks and in 3 petri dishes (5 mL medium with 200 cells/dish).
Petri dishes were incubated for 6 days and used to assess cytotoxicity (survival to treatment).
The cells in the flasks were incubated to permit growth and expression of mutations. After 6 days the cells were re-seeded in 8 petri dishes per culture at 3E05 cells/dish in presence of 6-thioguaninine. Three additional petri dishes with 200 cels/dish were used to calculate cloning efficiency.
After 6-8 days of incubation colonies were fixed, stained with Chiemsa and counted.
NUMBER OF REPLICATIONS: 8/concentration
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency and relative total growth - Evaluation criteria:
- 1) assessment in at least 5 replicates per concentration with relative survival, relative population growth and absolute cloning efficiency > 10%
2) positive result with dose related increase in mutant frequency (at least 2-3 times of vehicle controls) and this finding can be reproduced in a separate experiment
3) no unphysiological culture conditions (effects on pH and osmolality)
4) scientific judgement - Statistics:
- ANOVA and Dunnet test
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- maximum concentrations based on cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: NA
- Precipitation: at and above 240 µg/mL
RANGE-FINDING/SCREENING STUDIES:without metabolic activation: 100% cell death at 100 µg/mL; with metabolic activation 100% cell death at 240 µg/mL
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: included in the report
- Negative (solvent/vehicle) historical control data: included in the report
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- cloning efficiency, rel growth: no effects up to 240 µg/mL:
- survival to treatment: in all experiments with and without metabolic activation cell death (100%) at 240 µg/mL
Applicant's summary and conclusion
- Conclusions:
- The substance did not induce mutations in mammalian cells
- Executive summary:
In a HPRT assay according to OECD 476 the substance did not induce mutations in V79 cells both in presence and absence of metabolic activation. The substance was tested up to cytotoxic concentrations.
It can be concluded that the substance is negative in this test and does not induce mutations in mammalian cells.
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