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EC number: 263-218-7 | CAS number: 61792-31-2
- 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:
- 12 May - 17 Jun 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- adopted in 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
- Version / remarks:
- adopted in 2000
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
- EC Number:
- 263-218-7
- EC Name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
- Cas Number:
- 61792-31-2
- Molecular formula:
- C17H36N2O2
- IUPAC Name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9 - 10 weeks
- Weight at study initiation: 168 – 192 g
- Fasting period before study: 20 h
- Housing: Up to 5/sex in polycarbonate cages (Makrolon MIV type, 18 cm height) containing sterilised wooden fibers as bedding material and enriched with paper.
- Diet: pelleted rodent diet SM R/M-Z (SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known: SPF quality
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24 (21 °C daily mean temperature)
- Humidity (%): 41 - 69
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Rationale for the selection of the starting dose: The dose level was selected based on the results of a pilot study in which a single female rat was dosed at 2000 mg/kg bw. The female was found dead on Day 2, showing ante mortem clinical signs and macroscopic abnormalities at gross necropsy (for details please refer to “Results and discussion, Preliminary study”). A second pilot animal was dosed at 300 mg/kg bw and no mortality was observed. Therefore the main study was conducted at 300 mg/kg bw.
- Doses:
- Pilot study: 2000 mg/kg bw (step 1) and 300 mg/kg bw (step 2)
Main study: 300 mg/kg bw - No. of animals per sex per dose:
- Pilot study: 1 female per step (2 steps)
Main study: 4 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
- Frequency of weighing: Animals were weighed individually on Day 1 (pre-dose), 8 and 15. A fasted weight was recorded on the day of dosing. Terminal body weights were collected for animals found dead or moribund animals euthanised after Day 1.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed.
Results and discussion
- Preliminary study:
- In a pilot study a single female rat was dosed at 2000 mg/kg bw at the first step. The rat was found dead on Day 2 and prior to death showed clinical signs including lethargy, hunched posture, piloerection, decreased locomotor activity, and shallow respiration. Advanced autolysis was found in this animal at macroscopic post mortem examination. In a second step one female rat was dosed at 300 mg/kg bw. No clinical signs of toxicity were observed and no mortality occurred. Therefore the main study was conducted at 300 mg/kg bw.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Pilot study:
300 mg/kg bw: 0/1 females died
2000 mg/kg bw: 1/1 females (at 2 days post dose)
Main study: No mortality occured during the study period. - Clinical signs:
- other: Pilot study: 300 mg/kg bw: No clinical signs of toxicity were observed up to the end of the 14-day observation period. 2000 mg/kg bw: 1/1 females showed lethargy, hunched posture, piloerection, decreased locomotor activity, and shallow respiration. The e
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute Oral 4, H302 according to Regulation (EC) No. 1272/2008
- Conclusions:
- In this acute oral toxicity study in rats a test item dose of 2000 mg/kg bw induced hunched posture in all rats, which was was fully reversible within 48 hours post-administration. The LD50 value was determined to be between 300 - 2000 mg/kg bw.
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