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EC number: 203-661-5 | CAS number: 109-28-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD guideline 423 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]oleamide
- EC Number:
- 203-661-5
- EC Name:
- N-[3-(dimethylamino)propyl]oleamide
- Cas Number:
- 109-28-4
- Molecular formula:
- C23H46N2O
- IUPAC Name:
- (9Z)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- Test material form:
- other: liquid
- Details on test material:
- Name of test material (as cited in study report): Oleic acid, N-(3-dimethylaminopropyl)-amide, cis/trans-isomer
Physical state: yellow liquid (at room temperature)
Batch number: R401/57
Composition: 89% Oleic acid, N-(3-dimethylaminopropyl)-amide, cis/trans-isomer
Impurities: ca. 10% oleic acid
Purity of test item was considered to be 100% for the study.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Supplier: Elevage JANVIER
Age at beginning of study: 8 weeks
Weights of treated animals: 192-207 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Administration volume: 2.27 ml/kg bw (test substance), 2.0 ml/kg bw (control item)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- Study was performed as a limit test. The six animals in the treated group (2000 mg/kg) were tested sequentially in groups of three.
EXAMINATION OF THE ANIMALS:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. Mortality was determined every day.
The animals were weighed on day D0 (just before administering the test item), and then on D2, D7, and D14. Weight changes were calculated and recorded.
On D14, the animals were anaestetised with sodium phenobarbital, and administration continued to fatal levels.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- One animal from the treated group was found dead 48 hours after administration of the test substance.
- Body weight:
- The body weights of the rats treated with the test substance decreased by 10.1% within 48 hours after administration of the test substance, but developed normally thereafter (similar body weights in treated and control animals).
- Gross pathology:
- Necropsy revealed no abnormal findings, except for the following abnormalities in the stomach of animals treated with the test substance: White granular thickening on the forestomach in 5 rats, red/black foci on the forestomach and red coloration on the corpus in 1 rat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The test item Trennmittel ZM 121 was administered orally as a single dose of 2000 mg/kg bw to 6 female Sprague Dawley rats, following OECD guideline 423 to assess its potential acute oral toxicity. Mortality was observed in one animal treated with the test substance 48 hours after administration of the test substance. Macroscopical examination of this animal revealed red coloration on the corpus and the presence of red/dark foci on the forestomach.
A general decrease of spontaneous activity was observed in all treated animals on day 2 and day 3 of the study and piloerection in 2 treated animals on day 2 of the study. Body weight changes of the treated rats decreased by 10.1% 48 hours after administration of the test item but recovered thereafter. Macroscopical examination of the surviving animals at the end of the study revealed a white granular thickening on the forestomach.
In conclusion, the LD50 was determined to be >2000 mg/kg bw via the oral route.
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