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EC number: 700-972-2 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not available
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
- Principles of method if other than guideline:
- The genotoxic potential of the test substance was determined by the induction of gene mutations in L5178Y cells in a mouse lymphoma mutagenicity test both with and without metabolic activation as per the Myhr et al., (1985) protocol. Cells deficient in thymidine kinase (TK) due to the mutation of TK+/- to TK-/- are resistant to the cytotoxic effects of trifluorothymidine (TFT). Thymidine kinase proficient cells (TK+/-) are sensitive to TFT, which causes the inhibition of cellular metabolism and halts further cell division. Thus mutant cells are able to proliferate in the presence of TFT, whereas normal cells, which contain thymidine kinase, are not able to proliferate.
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- (9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide
- EC Number:
- 700-972-2
- Molecular formula:
- C22H43NO3
- IUPAC Name:
- (9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Supplemented Fischer’s medium (growth media) maintained at 37°C; normal cycling time was approximately 10 hours. For cloning the horse serum content was increased and noble agar was added.
- Properly maintained: Yes
- Periodically "cleansed" against high spontaneous background: Yes, by exposing to selective media containing thymidine, hypoxanthine, methotrexate, and glycine for 1 day; to medium containing thymidine, hypoxanthine, and glycine for 1 day; and to normal medium for 3 to 5 days - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from the livers of Aroclor 1254-induced male Fischer 344 rats
- Test concentrations with justification for top dose:
- Without metabolic activation: Trial 1: 0, 1.25, 2.5, 5 and 7.5 nL/ mL; Trial 2: 0, 2, 3, 4, 6, 8 and 12 nL/ mL; Trial 3: 0, 3, 4, 6, 8, 12, 15 and 20 nL/ mL
With metabolic activation: Trial 1: 0, 2.5, 5, 7.5, 10 and 15 nL/ mL; Trial 2: 0, 2.5, 5, 7.5, 10, 15 and 20 nL/ mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- -S9 : at 5 μg/mL concentration
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- +S9: at 2.5 μg/mL concentration
- Details on test system and experimental conditions:
- The experimental protocol is presented in detail by Myhr et al., 1985
METHOD OF APPLICATION: in medium
DURATION
Exposure duration: 4 h
- Expression time (cells in growth medium): 48 h
- Selection time (if incubation with a selection agent): 10 to 12 d (at 37°C in 5% CO2)
SELECTION AGENT (mutation assays): Yes, Trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: Triplicate (all treatment levels within an experiment, including concurrent positive and solvent controls, were replicated)
NUMBER OF CELLS EVALUATED: 6 × 10(6) cells in 10 mL medium
DETERMINATION OF CYTOTOXICITY
- Method: Cloning efficiency - Evaluation criteria:
- Minimum criteria for accepting an experiment as valid and a detailed description of the statistical analysis and data evaluation are as per Caspary et al., (1988). Data was evaluated statistically for trend and peak responses.
Positive response: When there are significant differences for two responses i.e., capable of inducing TFT resistance.
Equivocal response: When a single significant response is observed.
Negative response: When there is absence of both a trend and a peak response. - Statistics:
- All data was evaluated statistically for trend and peak responses as per Caspary et al., (1988).
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without metabolic activation: The highest doses of 7.5 nL/mL in trial 1 and ≥ 12 nL/mL in trial 3; With metabolic activation: 15 and 20 nL/mL in trial 1 and 2 respectively
- Additional information on results:
- No induction of TFT resistance was noted in L5178Y mouse lymphoma cells treated with ODEA in the presence or absence of S9 metabolic activation.
Any other information on results incl. tables
For detailed results table kindly refer to the attached background materials section of the IUCLID.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, no increase in the frequency of mutant colonies of L5178Y mouse lymphoma cells was noted after exposure to test substance, with or without metabolic activation.
- Executive summary:
A study was conducted to evaluate the in vitro genetic toxicity of the test substance, C18-unsatd. DEA, in a mouse lymphoma assay. The cells were exposed for 4 h to concentrations of 1.25, 2.5, 5 and 7.5 nL/ mL without metabolic activation and 2.5, 5, 7.5, 10 and 15 nL/ mL with metabolic activation in Trial 1. Cells were treated with test substance for 4 h at 52, 3, 4, 6, 8 and 12 nL/ mL without metabolic activation and 2.5, 5, 7.5, 10, 15 and 20 nL/ mL with metabolic activation in Trial 2. Cells were treated with test substance for 4 h at 3, 4, 6, 8, 12, 15 and 20 nL/ mL without metabolic activation in Trial 3. 6 X106 cells in triplicate cultures medium were exposed to the test substance (either in the presence or absence of metabolic activation), positive control and solvent control for 4 h. After a 48 h expression period, cells were plated for selection of TFT-resistant cells and cloning efficiency. The plates were scored after an incubation period of 10 to 12 d at 37±1°C in 5% CO2. Under the conditions of the study, no increase in the frequency of mutant colonies of L5178Y mouse lymphoma cells was noted after exposure to test substance, with or without S9 (NTP, 1999).
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