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EC number: 939-688-0 | 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:
- January 21, 2013 - March 04, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)
- EC Number:
- 939-688-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)
- Test material form:
- other: solid
- Details on test material:
- - Name of test material: Fatty acids, C16-18, reaction products with tetraethylenepentamine, acetates (salts)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Fatty acids, C16-18, reaction products with tetraethylenepentamine, acetates (salts)
Method
- Target gene:
- Thymidine Kinase Locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment I:
without S9 mix: 6.9; 13.8; 27.5; 55.0; 110.0 (p); 165.0 (p) µg/mL
with S9 mix: 6.9; 13.8; 27.5; 55.0; 110.0 (p); 165.0 (p) µg/mL
Experiment II:
without S9 mix: 0.9; 1.7; 3.4; 6.9; 13.8; 27.5; 55.0; 110.0 µg/mL
with S9 mix: 6.9; 13.8; 27.5; 55.0; 82.5; 110.0 µg/mL
(p) = precipitation visible to the unaided eye - Vehicle / solvent:
- deionised water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding: 1E07 (3E06 during 24 h exposure) cells/flask
- Test substance added in medium
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration: 4 h / 24 h
FOR GENE MUTATION:
- Expression time: 48 h
- Selection time: 10 - 15 days
- Method used: microwell plates
- selective agent: trifluorothymidine, 5 μg/mL
- Number of cells seeded and method to enumerate numbers of viable and mutants cells: 4E03 cells in selective medium
- Criteria for small (slow growing) and large (fast growing) colonies: Criteria to determine colony size were the absolute size of the colony (more than 1/3 of a well for large colonies) and the optical density of the colonies (the optical density of the small colonies is generally higher than the optical density of the large ones).
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- viability (cloning efficiency), relative total growth (RTG) - Evaluation criteria:
- A test item is classified as mutagenic if the induced mutation frequency reproducibly exceeds a threshold of 126 colonies per 1E06 cells above the corresponding solvent control.
A relevant increase of the mutation frequency should be dose-dependent.
A mutagenic response is considered to be reproducible if it occurs in both parallel cultures.
A test item is considered equivocal in this assay if the threshold is reproducibly exceeded but the increase of the mutation frequency is not dose dependent.
However, in the evaluation of the test results the historical variability of the mutation rates in the solvent controls of this study are taken into consideration.
Results of test groups are generally rejected if the relative total growth is less than 10 % of the vehicle control unless the exception criteria specified by the IWGT recommendations are fulfilled.
Whenever a test item is considered mutagenic according to the above mentioned criteria, the ratio of small versus large colonies is used to differentiate point mutations from clastogenic effects. If the increase of the mutation frequency is accompanied by a reproducible and dose dependent shift in the ratio of small versus large colonies clastogenic effects are indicated.
A test item is classified as non-mutagenic if the induced mutation frequency does not reproducibly exceed a threshold of 126 colonies per 1E06 cells above the corresponding solvent control.
A test item not meeting the conditions for a classification as mutagenic or non-mutagenic will be considered equivocal in this assay and may be considered for further investigation. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT11 (SYSTAT Software, Inc., 501, Canal Boulevard, Suite C, Richmond, CA 94804, USA) statistics software. The number of mutant colonies obtained for the groups treated with the test item was compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological relevance and statistical significance were considered together.
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
Any other information on results incl. tables
Summary Table
relative | mutant | relative | mutant | |||||
conc. µg | S9 | total | colonies/ | total | colonies/ | |||
per mL | mix | growth | 106cells | threshold | growth | 106cells | threshold | |
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
Experiment I / 4 h treatment | culture I | culture II | ||||||
Solv. control with water | - | 100.0 | 40 | 166 | 100.0 | 53 | 179 | |
Pos. control with MMS | 19.5 | - | 28.5 | 240 | 166 | 27.9 | 305 | 179 |
Test item | 6.9 | - | 112.8 | 24 | 166 | 69.0 | 24 | 179 |
Test item | 13.8 | - | 65.1 | 26 | 166 | 38.1 | 94 | 179 |
Test item | 27.5 | - | 36.5 | 21 | 166 | 22.6 | 43 | 179 |
Test item | 55.0 | - | 4.2 | 28 | 166 | 1.9 | 55 | 179 |
Test item | 110.0 (P) | - | culture was not continued# | culture was not continued# | ||||
Test item | 165.0 (P) | - | culture was not continued# | culture was not continued# | ||||
Experiment I / 4 h treatment | culture I | culture II | ||||||
Solv. control with water | + | 100.0 | 69 | 195 | 100.0 | 95 | 221 | |
Pos. control with CPA | 3.0 | + | 31.3 | 331 | 195 | 65.9 | 207 | 221 |
Pos. control with CPA | 4.5 | + | 33.3 | 475 | 195 | 59.6 | 279 | 221 |
Test item | 6.9 | + | 90.4 | 81 | 195 | 84.8 | 58 | 221 |
Test item | 13.8 | + | 72.7 | 83 | 195 | 114.7 | 66 | 221 |
Test item | 27.5 | + | 69.0 | 90 | 195 | 123.4 | 42 | 221 |
Test item | 55.0 | + | 99.6 | 34 | 195 | 106.8 | 56 | 221 |
Test item | 110.0 (P) | + | 20.9 | 44 | 195 | 11.3 | 43 | 221 |
Test item | 165.0 (P) | + | culture was not continued# | culture was not continued# | ||||
Experiment II / 24 h treatment | culture I | culture II | ||||||
Solv. control with water | - | 100.0 | 72 | 198 | 100.0 | 91 | 217 | |
Pos. control with MMS | 13.0 | - | 9.1 | 491 | 198 | 12.9 | 571 | 217 |
Test item | 0.9 | - | culture was not continued## | culture was not continued## | ||||
Test item | 1.7 | - | culture was not continued## | culture was not continued## | ||||
Test item | 3.4 | - | 71.1 | 39 | 198 | 92.8 | 32 | 217 |
Test item | 6.9 | - | 62.6 | 54 | 198 | 49.8 | 130 | 217 |
Test item | 13.8 | - | 40.7 | 68 | 198 | 53.8 | 60 | 217 |
Test item | 27.5 | - | 21.2 | 43 | 198 | 20.0 | 58 | 217 |
Test item | 55.0 | - | 0.0 | 72 | 198 | 0.0 | 39 | 217 |
Test item | 110.0 (P) | - | culture was not continued# | culture was not continued# | ||||
Experiment II / 4 h treatment | culture I | culture II | ||||||
Solv. control with water | + | 100.0 | 45 | 171 | 100.0 | 53 | 179 | |
Pos. control with CPA | 3.0 | + | 52.7 | 163 | 171 | 61.2 | 154 | 179 |
Pos. control with CPA | 4.5 | + | 45.9 | 239 | 171 | 31.6 | 315 | 179 |
Test item | 6.9 | + | culture was not continued## | culture was not continued## | ||||
Test item | 13.8 | + | 155.1 | 44 | 171 | 157.4 | 48 | 179 |
Test item | 27.5 | + | 98.2 | 50 | 171 | 134.2 | 24 | 179 |
Test item | 55.0 | + | 70.4 | 68 | 171 | 99.5 | 33 | 179 |
Test item | 82.5 (P) | + | 43.0 | 44 | 171 | 42.7 | 37 | 179 |
Test item | 110.0 (P) | + | 19.5 | 50 | 171 | 18.2 | 31 | 179 |
Threshold = number of mutant colonies per 1E06 cells of each solvent control plus 126
(p) precipitation visible to the unaided eye
# culture was not continued due to exceedingly severe cytotoxic effects
## culture was not continued as a minimum of four concentrations is required by the guidelines
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test substance C16-18FA-TEPA-compound was concluded to be not mutagenic with and without metabolic activation in the L5178Y/TK Mouse Lymphoma Mutagenesis Assay when tested up to cytotoxic concentrations. - Executive summary:
In a mammalian cell gene mutation assay thymidine kinase locus according to OECD guideline 476, L5178Y mouse lymphoma cells cultured in vitro were exposed to C16-18FA-TEPA-compound at the following concentrations in the presence and absence of mammalian metabolic activation (S9- mix):
Experiment I:
without S9 mix: 6.9; 13.8; 27.5; and 55.0 µg/mL
with S9 mix: 6.9; 13.8; 27.5; 55.0; and 110.0 µg/mLExperiment II:
without S9 mix: 3.4; 6.9; 13.8; 27.5; and 55.0 µg/mL
with S9 mix: 13.8; 27.5; 55.0; 82.5; and 110.0 µg/mLThe assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 h. The second experiment was performed in the absence of metabolic activation with a treatment period of 24 hours and in the presence of metabolic activation with a treatment time of 4 hours.The experimental part of the second experiment without metabolic activation was terminated prior to the generation of any data on mutagenicity as strong cytotoxic effects completely inhibited cell growth down to low concentrations. This experimental part was repeated in a lower concentration range. The data are reported as experiment II without metabolic activation.
The test medium was checked for precipitation visible to the naked eye at the end of the 4 hours treatment just before the test item was removed. Precipitation was observed at 110.0 and 165.0 µg/mL in experiment I with and without metabolic activation. In experiment II precipitation occurred at 110.0 µg/mL without metabolic activation and at 82.5 and 110.0 µg/mL with metabolic activation.
Relevant toxic effects indicated by a relative total growth of less than 50% of survival in both parallel cultures were observed in experiment I at 27.5 µg/mL and above without metabolic activation and at 110.0 µg/mL with metabolic activation following 4 hours of treatment. In experiment II cytotoxic effects as described above occurred at 27.5 µg/mL and above without metabolic activation (24 hours treatment) and at 82.5 µg/mL and above with metabolic activation (4 hours treatment). The recommended cytotoxic range of approximately 10-20% RTG was covered with and without metabolic activation.
No substantial and reproducible dose dependent increase of the mutation frequency was observed with and without metabolic activation up to cytotoxic concentrations. The positive control substances induced the appropriate responses.
There was no evidence of induced mutant colonies over background. Under the conditions of the study, the test substance was negative for mutagenic potential.
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