1,3-bis[3-(dimethylamino)propyl]urea

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

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).

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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-dimethylaminopropyl urea

Test material form:

liquid

Remarks:

extremely pale straw coloured viscous liquid

Specific details on test material used for the study:

Name: N-(3-(dimethylamino)-propy1)urea = HST 2844
Batch no.: Batch 12
Aggregate state: Liquid
External properties: Brownish clear liquid
Storage: At room temperature

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 mammal s.
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.

Administration / exposure

Vehicle:

other: Lutrol (manufacturer: Merck-Schuchard, Art. No.: 807485)

Details on oral exposure:

The substance was formulated in Lutrol (manufacturer: Merck-Schuchard, Art. No.: 807485) at room temperature and administered once intragastrically to 5 maleand 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.

Doses:

10 ml/kg of body weight

No. of animals per sex per dose:

5 male and 5 female animals

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 126 mg/kg bw

Based on:

test mat.

Mortality:

The LD50 was approximately 5125 mg/kg of body weight.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of 3-(dimethylamino)propylurea in rats was approximately 5125 mg/kg (5.0 ml/kg) of body weight.