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Diss Factsheets
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EC number: 269-125-8 | CAS number: 68187-80-4
- 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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment and compliant with GLP. Conducted with the structural analogue oleic acid diethanolamine condensate.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- 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:
- Suspensions of bacterial cells are exposed to the test substance by the plate incorporation method in the presence and in the absence of an exogenous metabolic activation system. In this method, the suspensions are mixed with an overlay agar and plated immediately onto the minimal medium and incubated for two days at 37˚C, The results are interpreted by counting the revertant colonies and comparing to the number of spontaneous revertant colonies on solvent-control plates.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)oleamide
- EC Number:
- 202-281-7
- EC Name:
- N,N-bis(2-hydroxyethyl)oleamide
- Cas Number:
- 93-83-4
- Molecular formula:
- C22H43NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)octadec-9-enamide
- Reference substance name:
- Oleic acid diethanolamine condensate
- IUPAC Name:
- Oleic acid diethanolamine condensate
- Details on test material:
- Name of test material (as cited in study report): Oleic acid diethanolamine condensate (ODEA) obtained from Radian Corporation (Austin, TX).
Constituent 1
Constituent 2
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA97, TA98, TA100 and TA1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver)
- Test concentrations with justification for top dose:
- Without metabolic activation: 0, 0.1, 0.3, 1, 3.3 and 10 µg/plate
With metabolic activation: 0, 3.3, 10, 33, 100 and 200 µg/plate - Vehicle / solvent:
- Ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Ethanol)
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- (for strains TA100 and TA1535)
- Positive control substance:
- sodium azide
- Remarks:
- absence of metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Ethanol)
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- (for strain TA 98)
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- absence of metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Ethanol)
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- (for strain TA 97)
- Positive control substance:
- 9-aminoacridine
- Remarks:
- absence of metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Ethanol)
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (all strains)
- Remarks:
- metabolic activation
- Details on test system and experimental conditions:
- - Test medium: Top agar supplemented with L-histidine and d-biotin
- Method of application: In agar (plate incorporation)
- Duration of incubation: 2 d at 37 °C
- Number of replicates: Three - Evaluation criteria:
- - Positive response: Reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination.
- Equivocal response: An increase in revertants that are not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of m utagenicity.
- Negative response: When no increase in revertant colonies is observed following chemical treatment.
- There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive. - Statistics:
- Not reported
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: S. typhimurium TA97, TA98, TA100 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at ≥3.3 µg/plate without metabolic activation; at 200 µg/plate with metabolic activation) .
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None
- 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):
other: Negative with and without metabolic activation
Under the test conditions, the test substance, was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation. - Executive summary:
A NTP study was conducted to determine the mutagenic potential of the test substance.
Salmonella typhimurium strains TA97, TA98, TA100 and TA1535 were treated with the test substance using the Ames plate incorporation method at up to five dose levels for each bacterial strain, in triplicate, both with and without the addition of S9 mix (i.e., Aroclor induced rat and hamster liver homogenate metabolising system). The dose range was 0.1 to 10 µg/plate (-S9 -mix) and 3.3 to 200 µg/plate (+S9 -mix).
Cytotoxicity was observed at ≥3.3 µg/plate without metabolic activation and at 200 µg/plate with metabolic activation. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test substance, either with or without metabolic activation.The vehicle (ethanol) control or the negative control plates produced counts of revertant colonies within the normal range. All the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies, both with and without the S9 -mix.
Under the test conditions, the test substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation.
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