Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-609-1 | CAS number: 7651-02-7
- 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
- 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
- Study period:
- 2012-05-31 to 2012-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]stearamide
- EC Number:
- 231-609-1
- EC Name:
- N-[3-(dimethylamino)propyl]stearamide
- Cas Number:
- 7651-02-7
- Molecular formula:
- C23H48N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]octadecanamide
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material: Stearic acid 3-(dimethylaminopropyl)amide
- Physical state: solid
- Analytical purity: not indicated, treated as 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Fasting period before study: overnight prior to dosing and until approximately 1 hour after the second administration of the test substance
- Housing: 3/cage
- Diet (e.g. ad libitum): pelleted rodent diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Air changes (per hr): app. 15/h
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% w/w
- Amount of vehicle (if gavage): 10 mL/kg bw
DOSAGE PREPARATION (if unusual):
2000 mg/kg bw were achieved by administration of two times 1000 mg/kg bw, since a 20% w/w formulation was not homogenous based on trial formulations. - Doses:
- 2000 mg/kg bw, given as 2 dosages of 1000 mg/kg bw within 24 hours. The first on t=0 and the second on t=3 hours. Multiple dosages given within 24 hours are regarded as a single dose
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: mortality: twice daily; clinical signs: 0, 2, 4 h, daily thereafter
- Frequency of weighing:
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 2/6 animals died on day 2 and 3, respectively
- Clinical signs:
- other: Clinical signs shown by the animals found dead and surviving animals included lethargy, hunched posture, uncoordinated movements, piloerection, diarrhoea, chromodacryorrhoea, pallor, and/or ptosis. The surviving animals had recovered from the symptoms bet
- Gross pathology:
- One female found dead showed watery-turbid fluid in the stomach and watery-clear, yellowish fluid in the small intestines. The other female found dead showed a reduced size of the spleen. Pelvic dilation of the kidneys was noted in one surviving female. Other surviving females had no macroscopic abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of Stearic acid 3-(dimethylaminopropyl)amide in female rats was > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423, adopted 17 December 2001 and EU method B.1 tris, May 2008, 6 female, fasted, 8-9 weeks old Wistar strain ratswere given a single oral dose of Stearic acid 3-(dimethylaminopropyl)amide in Propylene glycol by gavage at a dose of 2000 mg/kg bw and observed for 14 days.
The test substance was administered as 2 dosages of 1000 mg/kg bw within 24 hours. The first on t=0 and the second on t=3 hours. Multiple dosages given within 24 hours are regarded as a single dose.
2/6 animals died on day 2 and 3, respectively. Clinical signs shown by the animals found dead and surviving animals included lethargy, hunched posture, uncoordinated movements, piloerection, diarrhoea, chromodacryorrhoea, pallor, and/or ptosis.
The surviving animals had recovered from the symptoms between days 7 and 10.
The two animals found dead showed either slight weight gain or weight loss. 3/4 surviving females showed body weight loss between days 1 and 8. These animals again gained body weight between days 8 and 15. One surviving female showed body weight gain that was considered to be similar to that expected of normal untreated animals of the same age and strain.
One female found dead showed watery-turbid fluid in the stomach and watery-clear, yellowish fluid in the small intestines. The other female found dead showed a reduced size of the spleen. Pelvic dilation of the kidneys was noted in one surviving female. Other surviving females had no macroscopic abnormalities.
Oral LD50 (rat, females) > 2000 mg/kg bw
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.