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EC number: 952-252-4 | 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 09 Jan - 26 Mar 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- - strain TA102 or E.coli WP2 was not tested
- Principles of method if other than guideline:
- Study was performed before actual guideline was adopted (21 Jul 1997).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse 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
- Molecular formula:
- CH3(CH2)7CH=CH(CH2)7CH2NH2
- 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): ODA-FG-11-27-84 (Oleylamine)
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 homogenate: from male Sprague-Dawley rats that had been injected with Aroclor 1254 at 500 mg/kg (Aroclor was diluted in corn oil 200 mg/mL); 5 days after injection, the livers were excised and prepared
- Test concentrations with justification for top dose:
- test 1:
with metabolic activation: 2, 10, 50, 100, 200 µg/plate
without metabolic activation: 0.2, 1, 5, 10, 20 µg/plate
test 2:
with metabolic activation: 2, 10, 25, 50, 100 µg/plate
without metabolic activation: 0.2, 1, 5, 10, 15 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with metabolic activation: 2-aminoanthracene; without metabolic activation: 2-nitrofluorene, sodium azide, 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Incubation period: 48 hours
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS: triplicate
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other: - Evaluation criteria:
- For a test article to be considered positive, it must cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- with metabolic activation: 200 µg/plate; without metabolic activation: 20 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The results of a preliminary toxicity study of the test article conducted in the presence and absence of S9 mix indicated that the appropriate maximum dose level to be tested in the mutagenicity assay would be 200 µg/plate (with metabolic activation) and 20 µg/plate (without metabolic activation). However, in the mutagenicity experiments, cytotoxicity was observed at lower concentrations (test 1). Therefore, the experiment was repeated in a less toxic dose range (test 2).
Applicant's summary and conclusion
- Conclusions:
- The test item proved to be negative in this Ames-test
- Executive summary:
Octadecenylamine was not mutagenic in bacterial tester strains Salmonella typhimurium TA 98, TA 100, Ta1535, TA1537 and TA1538 in doses up to 20 µg/plate without metabolic activation and up to 200 µg/plate with metabolic activation (Arochlor induced rat liver S-9 mix).
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