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EC number: 212-161-6 | CAS number: 766-09-6
- 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
- Study period:
- April 17, 2012 to September 03, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- (adopted July 21, 1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- dated May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 1-ethylpiperidine
- EC Number:
- 212-161-6
- EC Name:
- 1-ethylpiperidine
- Cas Number:
- 766-09-6
- Molecular formula:
- C7H15N
- IUPAC Name:
- 1-ethylpiperidine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): N-Ethylpiperidine
- Physical state: Liquid, colorless to yellow
- Analytical purity: 97.1 g/100 g determined by 1H-NMR-analysis
- Lot/batch No.: 000STD77L0
- Test substance No.: S1325711
- Stability in solvent: Not indicated
- Storage condition of test material: Room temperature
- On the day of the experiment (immediately before treatment), the test item was dissolved in deionised water. The final concentration of deionised water in the culture medium was 10 % (v/v).
- The osmolarity and pH-value were determined in the solvent control and in the highest concentration of the pre-experiment without metabolic activation: solvent control: Osmolarity mOsm: 378 / pH-value: 7.39; N-Ethylpiperidine (1140 µg/mL): Osmolarity mOsm 333 / pH-value: 7.95
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (minimal essential medium) containing Hank’s salts, neomycin (5 μg/mL) and amphotericin B (1 %). For the selection of mutant cells the complete medium was supplemented with 11 μg/mL 6-thioguanine.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: no data
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of 8 - 12 weeks old male Wistar rats [Hsd Cpb: WU], treated with 80 mg/kg b.w. phenobarbital i.p. and β-naphthoflavone orally each on three consecutive days.
- Test concentrations with justification for top dose:
- Range finding pre-experiment: 8.9 to 1140 μg/mL (≈10 mM), in the presence (4 hours treatment) and absence (4 hours and 24 hours treatment) of metabolic activation.
Main experiment: 35.6; 71.3; 142.5; 285; 570; 1140 μg/mL
1st Experiment: with and without S9 mix (4-hour exposure period):
2nd Experiment: without S9 mix (24-hour exposure period); with S9 mix (4-hour exposure period)
The cultures at the lowest concentration in the presence and absence of metabolic activation (experiment I and II) were not continued since a minimum of only four analysable concentrations is required by the guidelines. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 0.150 mg/mL (1.2 mM). Dilutions of the stock solution were prepared on the day of the experiment and used immediately.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- 1.1 µg/mL (4.3 µM)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
DURATION
- Exposure duration:
1st experiment: 4 h exposure with and without S9 mix.
2nd experiment: 4 h exposure with S9 mix and 24 h without S9 mix.
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 8 days
- Fixation time (start of exposure up to fixation or harvest of cells): 15 days
SELECTION AGENT (mutation assays): 6-thioguanine (10 μg/mL)
NUMBER OF REPLICATIONS: duplicates
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; - Evaluation criteria:
- A test item was classified as positive if it induced either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points.
A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points was considered non-mutagenic in this system.
A positive response was described as follows:
- A test item was classified as mutagenic if it reproducibly induced a mutation frequency that was three times above the spontaneous mutation frequency at least at one of the concentrations in the experiment.
- The test item was classified as mutagenic if there was a reproducible concentration-related increase of the mutation frequency. Such evaluation was considered also in the case that a threefold increase of the mutant frequency was not observed.
- However, in a case by case evaluation this decision depend on the level of the corresponding solvent control data. If there was by chance a low spontaneous mutation rate within the laboratory's historical control data range, a concentration-related increase of the mutations within this range was discussed. The variability of the mutation rates of solvent controls within all experiments of the study was also taken into consideration. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend was judged as significant whenever the p-value (probability value) was below 0.05. However, both, biological and statistical significance was considered together.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: There was no relevant shift of pH and osmolarity of the medium even at the maximum concentration of the test item.
- Precipitation: The test medium was checked for precipitation or phase separation at the end of each treatment period (4 or 24 hours) prior to removal to the test item. No precipitation occurred up to the highest concentration with and without metabolic activation following 4 and 24 hours treatment.
RANGE-FINDING/SCREENING STUDIES:
- Based on the results of the pre-experiment, the individual concentrations of the main experiments were selected. The individual concentrations were spaced by a factor of 2
COMPARISON WITH HISTORICAL CONTROL DATA:
- In both experiments of the study (with and without S9 mix) the range of the solvent controls was from 8.5 up to 54.6 mutants per 10E6 cells; the range of the groups treated with the test item was from 4.5 up to 56.8 mutants per 10E6 cells. In experiment I with metabolic activation the number of mutants in the solvent control in culture I exceeded the upper limit of the historical control data. The data were regarded as acceptable however since the data of the mutant frequency in culture II and the mean value of both cultures were within the historical range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- A cytotoxic effect indicated by a relative cloning efficiency I below 50% in both parallel cultures was solely observed in the second experiment without metabolic activation at the maximum concentration of 1140 μg/mL equal to approximately 10 mM. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
- No relevant and reproducible increase in mutant colony numbers/10E6 cells was observed in the main experiments up to the maximum concentration. The threshold of three times the mutation frequency of the corresponding solvent control was exceeded in the first culture of the second experiment without metabolic activation at 1140.0 μg/mL. This isolated increase was judged as biologically irrelevant however, as it was not reproduced in the parallel culture under identical experimental conditions at almost an identical level of cytotoxicity. Cytotoxicity was severe at this experimental point with a relative cloning efficiency I of 16.1% indicating an irreproducible cytotoxic artefact.
- A linear regression analysis (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. A p-value below 0.05 was solely detected in culture I of the second experiment without metabolic activation. This trend however, was judged as biologically irrelevant as it was not reproduced in culture II and based on a cytotoxic artefact as described above.
- In the first culture of experiment I the cloning efficiency II (viability) of the solvent control with metabolic activation fell just short of the acceptance criteria (40% versus 50%). The data were regarded as acceptable however, as the cloning efficiency II of the parallel culture was fully acceptable (60%).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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