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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-361-2 | CAS number: 25952-53-8
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- EC Number:
- 247-361-2
- EC Name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- Cas Number:
- 25952-53-8
- Molecular formula:
- C8H17N3.ClH
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-N'-ethylcarbodiimide hydrochloride
- Test material form:
- solid
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, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 11 weeks old
- Weight at study initiation: 162 to 189 g for all animals
- Fasting period before study: No
- Housing: Full barrier in an air-conditioned room. Housed individually in IVC cages including saw fibre bedding.
- Diet (e.g. ad libitum): Free access to Altromin maintenance diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): Artificial lighting (12 hours light/dark cycles)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua ad injectionem
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL or 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/Kg
- Justification for choice of vehicle: Standard vehicle for test type and chosen based on its non-toxic characteristics.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No toxicity data available and accordingly limit dose chosen. - Doses:
- The starting dose was selected to be 2000 mg/kg bw. This was then followed by two further doses of 300 mg/kg bw.
- No. of animals per sex per dose:
- 3 females per step (3 at 2000 mg/kg bw and 6 at 300 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed on Day 1 (prior to dosing) and days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were noted on the day of dosing and then once daily during the observation period. - Statistics:
- Not applicable to study type
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals that received 2000 mg/kg bw were found dead within 3 hours post dose (3/3). During step two (300 mg/kg bw), one animal was found dead 1 day post dose (1/6).
- Clinical signs:
- other: 2000 mg/kg bw: Signs observed in two animals included recumbency, apathy, ataxia and half-eyelid closure. 300 mg/kg bw: The most relevant signs at this dose (observed in the majority of animals) were piloerection, reduced spontaneous activity, recumbency
- Gross pathology:
- 2000 mg/kg bw: No significant necropsy findings were noted.
300 mg/kg bw: In the animal found dead a bloated stomach, duodenum, jejunum, ileum with Peyer’s patches, mesenteric lymph node, caecum and colon were noted along with a red discolouration of the lung. Red spots in the lung were also observed in another surviving animal and no other significant findings were observed in the groups
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- A reliable, guideline study is available providing an LD50 cut-off value of 500 mg/kg bw to rats.
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.