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EC number: 248-813-1 | CAS number: 28065-97-6
- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 - 29 Mar 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)
- EC Number:
- 248-813-1
- EC Name:
- Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)
- Cas Number:
- 28065-97-6
- Molecular formula:
- C34H69NO2 C36H67NO2 C36H69NO2 C36H71NO2 C36H73NO2
- IUPAC Name:
- oleic acid, compound with (Z)-octadec-9-enylamine (1:1)
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone.
- Test concentrations with justification for top dose:
- The range-finding study served as Experiment I.
Range-finding study/Experiment I:
3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation for all strains
Experiment I(a) (repeated):
0.3, 1, 3, 10, 33, 100, 333 and 1000 µg/plate with and without metabolic activation for TA100
Main study/Experiment II:
0.3, 1, 3, 10, 33, 100, 333 and 1000 µg/plate with and without metabolic activation for TA100
3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation for WP2uvrA
1, 3, 10, 33, 100, 333, 1000 and 2500 µg/plate with and without metabolic activation for TA98, TA1535 and TA1537 - Vehicle / solvent:
- - Solvent used: ethanol
- Justification for choice of solvent: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine: -S9: 10 and 50 µg/plate in TA98 and TA1537, respectively; 2-aminoanthracene: + S9: 2.5 or 10 µg/plate for all strains
- Remarks:
- Each batch of S9 was routinely tested for its capability to activate the known mutagens benzo[a]pyrene and 2-aminoanthracene in the Ames test.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants, clearing of the bacterial background lawn - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 2500 and ≥ 1000 µg/plate with and without metabolic activation, respectively; Experiment II: ≥ 2500 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 2500 µg/plate with and without metabolic activation and in Experiment II: ≥ 2500 µg/plate without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 1000 and ≥ 333 µg/plate with and without metabolic activation, respectively; Experiment II: ≥ 1000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I and Ia: ≥ 333 and ≥ 33 µg/plate with and without metabolic activation, respectively; Experiment II: ≥ 1000 and ≥ 10 µg/plate µg/plate with and without metabolic activation, respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 2500 µg/plate without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance precipitated in the overlay agar in the test tubes at 333 μg/plate and above. Precipitation of the test substance in the overlay agar on the incubated agar plates was observed in Experiment I at 1000 μg/plate and above, in Experiment Ia at 333 μg/plate and above, in Experiment II without S9 mix at 333 μg/plate and above and with S9 mix at 1000 μg/plate and above. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDIES: The range-finding study served as Experiment I. Since in Experiment I the acceptance criteria were not met in strain TA100 (without S9 mix) this part of the experiment was repeated and reported as Experiment I(a).
HISTORICAL CONTROL DATA
- Positive historical control data: The spontaneous reversion rates in the positive control are in the range of the historical control data.
- Negative (solvent/vehicle) historical control data: The spontaneous reversion rates in the negative and solvent control are in the range of the historical control data.
Any other information on results incl. tables
Table 2: Results of Experiment I
Revertant Colony Counts (Mean ±SD) | |||||||
Dose level (per plate) | TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvrA | ||
Without metabolic activation | Ethanol | 13 ± 4 | 10 ± 1 | 33 ± 8 | 184 ± 6 | 48 ± 6 | |
Untreated | 8 ± 3 | 13 ± 2 | 34 ± 6 | 200 ± 16 | 47 ± 5 | ||
Test substance | 3 µg | 15 ± 5 | 9 ± 3 | 31 ± 2 | 146 ± 15 | 47 ± 6 | |
10 µg | 11 ± 2 | 8 ± 2 | 38 ± 4 | 121 ± 17 | 51 ± 3 | ||
33 µg | 15 ± 6 | 14 ± 2 | 31 ± 1 | 54 ± 12 | 47 ± 8 | ||
100 µg | 13 ± 3 | 11 ± 4R | 16 ± 4R | 22 ± 2R | 51 ± 5 | ||
333 µg | 10 ± 2R | 11 ± 3R | 14 ± 5R | 6 ± 2R | 51 ± 3R | ||
1000 µg | 5 ± 3P R | 11 ± 1R P | 5 ± 7P R | 2 ± 1R P | 41 ± 9P R | ||
2500 µg | 4 ± 1P R | 1 ± 1P R | 1 ± 1P R | 0 ± 0R P | 60 ± 3P R | ||
5000 µg | 4 ± 1P R | 1 ± 2P R | 1 ± 1P R | 0 ± 0R P | 63 ± 8P R | ||
NaN3 | 10 µg | 1309 ± 29 | - | - | 2114 ± 104 | - | |
4-NOPD | 10 µg | - | - | 395 ± 25 | - | - | |
4-NOPD | 50 µg | - | 86 ± 6 | - | - | - | |
MMS | 2.0 µL | - | - | - | - | 1034 ± 66 | |
With metabolic activation | Ethanol | 18 ± 3 | 13 ± 3 | 47 ± 14 | 187 ± 18 | 62 ± 7 | |
Untreated | 16 ± 7 | 12 ± 3 | 39 ± 5 | 189 ± 10 | 56 ± 3 | ||
Test substance | 3 µg | 13 ± 2 | 11 ± 1 | 40 ± 5 | 183 ± 23 | 61 ± 4 | |
10 µg | 20 ± 7 | 12 ± 4 | 36 ± 4 | 175 ± 15 | 57 ± 3 | ||
33 µg | 22 ± 2 | 14 ± 5 | 40 ± 7 | 170 ± 19 | 48 ± 3 | ||
100 µg | 12 ± 3 | 13 ± 2 | 40 ± 6 | 152 ± 7 | 50 ± 3 | ||
333 µg | 19 ± 7 | 16 ± 3R | 43 ± 6 | 45 ± 9R | 62 ± 4 | ||
1000 µg | 13 ± 2P R | 11 ± 3P R | 10 ± 5P R | 5 ± 2R P | 56 ± 9P R | ||
2500 µg | 5 ± 2P R M | 3 ± 1P R M | 3 ± 0P R M | 1 ± 1R P M | 24 ± 6P R M | ||
5000 µg | 2 ± 1P R M | 2 ± 1P R M | 3 ± 1P R M | 0 ± 0R P M | 16 ± 4P R M | ||
2-AA | 2.5 µg | 439 ± 19 | 144 ± 16 | 3843 ± 832 |
4759 ± 526 | - | |
2-AA | 10.0 µg | - | - | - | - | 387 ± 24 |
NaN3: sodium azide
2-AA: 2-aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
R: Reduced background growth
P: Precipitate
M: Manual count
Table 3: Results of Experiment I(a) (repeated experiment for TA100)
Revertant Colony Counts (Mean ±SD) |
|||
Dose Level(per plate) | TA 100 | ||
Without metaolic activation | Ethanol | 192 ± 21 | |
Untreated | 188 ± 13 | ||
Test substance | 0.3 µg | 176 ± 13 | |
1 µg | 178 ± 13 | ||
3 µg | 173 ± 19 | ||
10 µg | 156 ± 18 | ||
33 µg | 58 ± 6 | ||
100 µg | 15 ± 2R M | ||
333 µg | 0 ± 1P R | ||
1000 µg | 0 ± 0P R | ||
NaN3 | 10 µg | 2409 ± 101 |
NaN3: sodium azide
R: Reduced background growth
P: Precipitate
M: Manual count
Table 4: Results of Experiment II
Dose Level(per plate) | Revertant Colony Counts (Mean ±SD) |
||||||
TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvrA | |||
Without metabolic activation | Ethanol | 12 ± 5 | 10 ± 1 | 33 ± 7 | 193 ± 15 | 42 ± 6 | |
Untreated | 11 ± 4 | 14 ± 3 | 25 ± 10 | 204 ± 29 | 44 ± 4 | ||
Test substance | 0.3 µg | - | - | - | 182 ± 38 | - | |
1 µg | 11 ± 5 | 11 ± 4 | 37 ± 10 | 203 ± 21 | - | ||
3 µg | 10 ± 3 | 9 ± 4 | 32 ± 6 | 112 ± 9 | 48 ± 7 | ||
10 µg | 11 ± 1 | 10 ± 4 | 30 ± 3 | 76 ± 5 | 39 ± 7 | ||
33 µg | 11 ± 4 | 12 ± 1 | 26 ± 4 | 48 ± 15 | 44 ± 4 | ||
100 µg | 10 ± 4 | 8 ± 2 | 18 ± 3 | 30 ± 3 | 46 ± 14 | ||
333 µg | 8 ± 2M P | 6 ± 1P | 15 ± 4P M | 9 ± 2P M | 39 ± 6P | ||
1000 µg | 6 ± 1M P | 5 ± 1P M | 7 ± 2P M | 0 ± 1P M | 60 ± 18P | ||
2500 µg | 3 ± 1P M | 4 ± 1P M | 5 ± 2P M | - | 31 ± 3P M | ||
5000 µg | - | - | - | - | 29 ± 3P M | ||
NaN3 | 10 µg | 1404 ± 50 | - | - | 2228 ± 68 | - | |
4-NOPD | 10 µg | - | - | 269 ± 16 | - | - | |
4-NOPD | 50 µg | - | 98 ± 5 | - | - | - | |
MMS | 2.0 µL | - | - | - | - | 675 ± 31 | |
With metabolic activation | Ethanol | 17 ± 4 | 11 ± 5 | 41 ± 7 | 183 ± 6 | 57 ± 4 | |
Untreated | 10 ± 1 | 18 ± 3 | 47 ± 14 | 215 ± 19 | 60 ± 3 | ||
Test substance | 0.3 µg | - | - | - | 163 ± 5 | - | |
1 µg | 17 ± 2 | 9 ± 4 | 53 ± 9 | 181 ± 7 | - | ||
3 µg | 15 ± 3 | 13 ± 4 | 51 ± 3 | 197 ± 7 | 54 ± 7 | ||
10 µg | 13 ± 4 | 17 ± 6 | 47 ± 11 | 185 ± 14 | 50 ± 7 | ||
33 µg | 14 ± 2 | 19 ± 2 | 43 ± 4 | 190 ± 10 | 58 ± 5 | ||
100 µg | 13 ± 3 | 17 ± 3 | 52 ± 13 | 170 ± 20 | 65 ± 3 | ||
333 µg | 16 ± 5 | 18 ± 3 | 57 ± 5 | 138 ± 6 | 63 ± 6 | ||
1000 µg | 8 ± 3P M | 16 ± 4P M | 11 ± 3P M | 22 ± 4P M | 64 ± 18P | ||
2500 µg | 6 ± 2P M | 16 ± 3P M | 8 ± 2P M | - | 74 ± 17P | ||
5000 µg | - | - | - | - | 50 ± 5P M | ||
2-AA | 2.5 µg | 356 ± 31 | 168 ± 5 | 3792 ± 372 |
4303 ± 250 |
- | |
2-AA | 10.0 µg | - | - | - | - | 329 ± 26 |
NaN3: sodium azide
2-AA: 2-aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
R: Reduced background growth
P: Precipitate
M: Manual count
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the Ames test, the test substance did not reveal mutagenic properties in TA100, TA98, TA1535, TA1537 and WP2uvrA with and without metabolic activation.
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