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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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: NTP study considered to be well conducted and meet generally accepted scientific principles, acceptable for assessment. 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:
- secondary source
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- A study was conducted to evaluate the potential of the test material to induce micronuclei in B6C3F1 mice. After completion of a 13-wk dermal treatment period, the study animals were sacrificed and the peripheral blood samples were collected and blood smears were processed as per the standard NTP protocol. Thereafter, the slides from different test groups and control were evaluated for the induction of micronucleus.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Oleic acid diethanolamine condensate
- IUPAC Name:
- Oleic acid diethanolamine condensate
- 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
- Details on test material:
- - Name of test material (as cited in study report): Oleic acid diethanolamine condensate (CAS 93-83-4)
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- No data
- Details on exposure:
- No data
- Duration of treatment / exposure:
- 13 wk
- Frequency of treatment:
- Assumed to be daily
- Post exposure period:
- Not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 100, 200, 400 and 800 mg/kg bw/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 animals per sex per dose were evaluated for micronuclei induction
- Control animals:
- yes
- Positive control(s):
- Not applicable
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- Tissue: Peripheral blood
Cell: Normochromatic erythrocytes - Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of the test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 wk. - Executive summary:
A study was conducted to assess the clastogenic potential of the test substance.The test substance was applied dermally for 13 wk at 0, 50, 100, 200, 400 and 800 mg/kg bw. Peripheral blood samples were obtained from male and female mice, and smears were immediately prepared and fixed in absolute methanol.
Under the conditions of the study, the test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 wk.
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