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EC number: 273-282-8 | CAS number: 68955-56-6
- 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
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- Water solubility
- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 05 May - 26 Sep 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to acceptable standards including GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- - limited documentation
- GLP compliance:
- yes
- Type of assay:
- bacterial forward mutation assay
Test material
- Reference substance name:
- (Z)-octadec-9-enylamine
- EC Number:
- 204-015-5
- EC Name:
- (Z)-octadec-9-enylamine
- Cas Number:
- 112-90-3
- IUPAC Name:
- octadec-9-en-1-amine
- Reference substance name:
- (Z)-octadec-9-en-1-amine
- IUPAC Name:
- (Z)-octadec-9-en-1-amine
- Reference substance name:
- Oleyl Alkylamines
- IUPAC Name:
- Oleyl Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Oleylamine
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- thymidine kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9-mix
- Test concentrations with justification for top dose:
- initial tests:
without metabolic activation: 0.13-10 nL/mL
with metabolic activiation: 1.3-100 nL/mL
confirmatory test.
without metabolic activation: 0.2-2 nL/mL
with metabolic activation: 1.5-15 nL/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aceton
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulphonate in DMSO (nonactivated), 7,12-dimethylbenzanthracene in DMSO (activated)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 2 days
SELECTION AGENT (mutation assays): trifluorthymidine (final concentration: 4 µg/mL)
NUMBER OF REPLICATIONS: two initial assays (using single cultures per dose) were performed to achieve the desired range of toxicity and one confirmatory assay (using duplicate cultures per dose) was carried out
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was determined by comparing the cell population growth at each dose level with that of the solvent controls. - Evaluation criteria:
- Positive - if there is a positive dose response and one or more of the 3 highest doses in the 10% or greater Total Growth range exhibit a mutant frequency wich is two-fold greater tahn the background level. All data including that from cultures with less than 10% Total Growth will be used to establish the dose response relationship. The first assay and the confirmatory assay must both demonstrate a positive response to call a test article a positive mutagen.
The spontaneous mutant frequency of the solvent control must be between 0.2 and 1.0 per 10000 surviving animals.
The plating efficiency of the solvent controls must be greater than 50%.
Mutant frequency of the positive control at least twice that of the solvent control.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 100% toxicity at 100 nL/mL (with metabolic activation); 100% toxicity at 10 nL/mL (without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Confirmatory assay:
None of the nonactivated cultures that was cloned exhibited a mutant frequency which was two times the mean mutant frequency of the solvent controls. The total growths of these cultures ranged from 6% to 109%. A dose dependent response was not noted in the treated cultures. None of the S9 activated cultures that was cloned showed a mutant frequency which was twice the mean mutant frequency of the solvent controls. The total growth of these cultures ranged from 2% to 115%. A dose dependent response was not noted in the treated cultures. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the study results the test article oleylamine was negative in both the presence and absence of exogenous metabolic activation in this Mouse Lymphoma Mutagenesis Assay. - Executive summary:
The test article Oleylamine was tested in the L5178Y TK+/- Mouse Lymphoma Mutagenesis Assay in the presence and absence of Aroclor induced rat liver S-9. Two initial and one confirmatory assays were conducted.
The nonactivated cultures selected for cloning in the first initial assay were treated with doses of 0.32 to 0.13 nl/ml and exhibited total growths from 75% to 99%. The S-9 activated cultures selected for cloning in the first initial assay were treated with doses of 10 to 1.3 nl/ml which produced from 6% to 106% total growths. None of the nonactivated or S-9 activated cultures that was cloned exhibited a mutant frequency which was at least twice the mean mutant frequency of the solvent controls. A dose dependent response was not noted in the treated cultures.
The nonactivated cultures selected for cloning in the second initial assay were treated with doses of 1.8 to 0.13 nl/ml and exhibited total growths from 3% to 110%. The S-9 activated cultures selected for cloning in the second initial assay were treated with doses of 13 to 1.3 nl/ml which produced from 13% to 107% total growths. None of the nonactivated or S-9 activated cultures that was cloned exhibited a mutant frequency which was at least twice the mean mutant frequency of the solvent controls. A dose dependent response was not noted in the treated cultures.
The nonactivated cultures selected for cloning in the confirmatory assay (duplicate cultures) were treated with doses of 1.0 to 0.2 nl/ml and exhibited total growths from 6% to 109%. The S-9 activated cultures selected for cloning in the confirmatory assay were treated with doses of 11 to 1.5 nl/ml which produced from 2% to 115% total growths. None of the nonactivated or S-9 activated cultures that was cloned exhibited a mutant frequency which was at least twice the mean mutant frequency of the solvent controls. A dose dependent response was not noted in the treated cultures.
The results indicate that, under the conditions of these mutagenicity tests, the test article Oleylamine was negative in both the presence and absence of exogenous metabolic activation in the Mouse Lymphoma Mutagenicity Assay.
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