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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.
Body weight:
Growth was influenced in one male rat from the 5125 mg/kg dosage

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.