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EC number: 800-353-8 | CAS number: 1379524-06-7
- 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
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and test guideline compliant study with no deviations affecting study integrity/validity
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan but it was not considered to have compromised the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- see above
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- (9E)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- EC Number:
- 800-353-8
- Cas Number:
- 1379524-06-7
- Molecular formula:
- C23H46N2O
- IUPAC Name:
- (9E)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- Details on test material:
- Test article name : Emulsamine AT-O
Chemical name : alkylamidoamine
Batch Number: 6514
Purity: > 95 %
Origin : Feuchy plant
Expiration date of the lot/batch: july 2003
Physical state: dark brown liquid
Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: 187+/-13g for the males and 177+/-10g for the females
- Fasting period before study: overnight period of approximately 18 hours before dosing but free access to water ; food was given back approximatety 4 hours after administration of the test item.
- Housing: polycarbonate cages with stainless steel lid (48cmx27cmx20cm)
- Diet : free access to A04C pelleted diet (UAR, Villemoisson, Epinay sur Orge, France)
- Water : drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 30 to 70
- Air changes (per hr): 12 cycles /hour of filtered, non recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 22 days
- Clinical signs and mortality : frequent observation during the hours following administration of the test item, then at least once a day until day 15 and 22.
- Body weight : just before administration of the test item on day 1 and then on days 8, 15 and 22.
- Macroscopic necropsy examination : yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Three out of five males and 1/5 female died during the study between day 2 and day 8
- Clinical signs:
- other: Hypoactivity or sedation, piloerection, dyspnea, hypersalivation and swollen abdomen were recorded in these animals prior to death as well as in the surviving animals from day 1. Recovery was complete in almost all surviving males on day 12 but piloerect
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under our experimental conditions, the oral LD50 of the test substance is higher than 2000 mg/kg in rats.
- Executive summary:
The acute oral toxicity of the test substance was evaluated in rats according to OECD (No. 401, 24thFebruary 1987) and EC (92/69/EEC, B.1, 31stJuly 1992) guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
The test substance was administered by oral route (gavage) to one group of ten fasted Sprague-Dawley rats (five males and fives females).
The test substance was administered undiluted at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 0.896 g/ml.
Clinical signs, mortality, and body weight gain were checked for a period of up to 21 days following the single administration of the test item.
All animals were subjected to necropsy.
Three out of five males and 1/5 female died during the study between day 2 and day 8. Hypoactivity or sedation, piloerection, dyspnea, hypersalivation and swollen abdomen were recorded in these animals prior to death as well as the surviving animals from day 1.
Recovery was complete in almost all surviving males on day 12 but piloerection, dyspnea and swollen abdomen persisted in one male up to day 20.
A reduced weight gain was seen in one of the surviving males between day 1 and day 8. The overall body weight gain of the other animals was similar to that of CIT historical control animals. No apparent abnormalities were observed at necropsy in any animals.
Under the experimental conditions, the oral LD50 of the test substance is higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test substance does not present a significant acute toxic risk of swallowed.
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