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EC number: 401-950-2 | CAS number: 31506-43-1 3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
- 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
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- Nanomaterial pour density
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- 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:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- The studies were performed in accordance with EC Directives 84/449 (Official Journal of the European Communities 27, 1984, L 251, 96).
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(dimethylamino)propylurea
- EC Number:
- 401-950-2
- EC Name:
- 3-(dimethylamino)propylurea
- Cas Number:
- 31506-43-1
- Molecular formula:
- C6H15N3O
- IUPAC Name:
- [3-(dimethylamino)propyl]urea
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- We conducted the acute toxicity experiment with young adult SPF-bred Wistar rats (Bor strain: WISW (SPF Cpb), breeder: Winkelmann, Borchen).
This rat is the species of choice for studying acute oral toxicity in mammals.
The male and female rats were approximately 9 and 14 weeks old respectively at the start of the experiment.
The male animals had an average baseline weight of 162 g, the female animals 173 g.
The distribution of the animal weights was less than 20% from the mean.
The females were nullipara and not pregnant.
The health status of the animals was checked prior to the start of the experiment. Only symptom-free, healthy animals were used for the experiment.
Five rats were used per dose and sex.
The rats were kept in groups of 5 in conventional fashion in Makrolon cages of Type III on dust-free wood granulate (manufacturer: Forsbach GmbH, Solingen) at an ambient temperature of 22 +/– 2 degrees Celsius and a 12-hour light/dark cycle (artificial lighting from 6:00 a.m. to 6:00 p.m. MET) and a relative humidity of approximately 50 +/– 10%.
As food, the animals received "Altromin 1324 – Maintenance Diet for Rats and Mice" in pellet form (manufacturer: Altromin GmbH, Lage) along with tap water ad libitum (water bottles).
Feed, water and litter are checked for harmful substances and impurities at regular intervals. The documents are filed at Bayer AG, Central Office for Questions Regarding Experimental Animals, Wuppertal.
The animals were acclimated for 5 days prior to the start of the experiment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- The feed was removed from approximately 16 hours before to 4 hours after the application, the rest of the time it was freely available.
The substance was formulated in Lutrol (manufacturer: Merck-Schuchard, Art. No.: 807485) at room temperature and administered once intragastrically to 5 male and 5 female animals by using a rigid metal stomach probe at a constant application volume of 10 ml/kg of body weight.
The test substance was formulated immediately prior to the start of the experiment in the polyethylene glycol 400 (Lutrol) application medium, whereby each concentration was prepared separately. Because of the brief period of time between preparation and application, no analytical studies were performed with regard to stability in the application medium. A homogeneous mixture was obtained through mixing in a magnetic stirrer. - Doses:
- The following dosages were used: 3178, 5125 mg/kg of body weight.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The studies were performed in accordance with EC Directives 84/449 (Official Journal of the European Communities 27, 1984, L 251, 96).
All the animals were allotted to the treatment groups by means of a random list based on random numbers. A label was affixed to each cage, listing the substance name, type of animal, dosage, study number, type of application, sex, and the number of animals.
Identification within a cage was carried out by marking the fur with picric acid.
The feed was removed from approximately 16 hours before to 4 hours after the application, the rest of the time it was freely available.
The substance was formulated in Lutrol (manufacturer: Merck-Schuchard, Art. No.: 807485) at room temperature and administered once intragastrically to 5 male and 5 female animals by using a rigid metal stomach probe at a constant application volume of 10 ml/kg of body weight.
The test substance was formulated immediately prior to the start of the experiment in the polyethylene glycol 400 (Lutrol) application medium, whereby each concentration was prepared separately. Because of the brief period of time between preparation and application, no analytical studies were performed with regard to stability in the application medium. A homogeneous mixture was obtained through mixing in a magnetic stirrer.
On the day of the application, the animals were inspected multiple times, twice daily during the 14-day observation period (once on weekends and holidays); as this was done, the type, start, duration and intensity of the clinical symptoms were logged, and dead animals were removed as necessary. The time of death of dead animals was logged.
Immediately before the application, one week after and at the end of the 14-day observation period, the surviving animals were weighed individually. The calculation of each animal's application volume was performed using the body weight recorded immediately before the application.
All of the animals that died during the experiment and all animals that were killed at the end of the experiment by means of deep diethylether narcosis were evaluated pathologically and anatomically. Dissection protocols were prepared for all animals that died or were killed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 125 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The LD50 was approximately 5125 mg/kg of body weight.
- Clinical signs:
- other: The following symptoms were observed following one-time administration of the 5125 mg/kg dosages: Decline in general condition, sedation, ruffled fur. Intensity, timing of the occurrence of the symptoms and the incidence of death cases in the individuall
- Gross pathology:
- In the pathological-anatomical evaluation of the animals that died from the 5125 mg/kg dosage, the gastric mucous membrane was coated and severely reddened, the intestines were slightly reddened.
The animals from the 3178 and 5125 mg/kg dosages that were terminated and examined at the end of the experiment were macroscopically normal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for male and female rats was approximately 5125 mg/kg (5.0 ml/kg) of body weight.
The test substance can thus be considered as relatively non-toxic following oral exposition, and accordingly is not to be classified in accordance with the EC Directive. - Executive summary:
Using N-(3-(dimethylamino)-propyl)urea = HST 2844, acute toxicological studies were performed involving oral administration to male and female Wistar rats.
The LD50for male and female rats was approximately 5125 mg/kg (5.0 ml/kg) of body weight.
Beginning at 5125 mg/kg, the following were observed as symptoms of poisoning:
Decline in general condition, sedation, ruffled fur, retarded growth in one female animal.
A dose of 3178 mg/kg was tolerated by female and male rats with no symptoms.
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