3-(dimethylamino)propylurea

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

The studies were performed in accordance with EC Directives 84/449 (Official Journal of the European Communities 27, 1984, L 251, 103).

Principles of method if other than guideline:

Five healthy male and five healthy female Wistar rats were dosed dermally with
3-(Dimethy1amino)propylurea. The test article was kept in contact with the skin for 24 hours using an
occlusive wrap. Animals were observed for toxicity and pharmacological effects multiple times on the day
of dosing and at least once daily for an additional 14 days. All animals were observed twice a day for
mortality except on weekends and holidays (once). Body weights were recorded pretest, weekly and at
death or termination in the survivors. All animals were examined for gross pathology.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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-(dimethylamino)propyl]urea

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Males had 176 g +/- 20 % from average
Females had 180 g less than +/- 20 % from average

Administration / exposure

Type of coverage:

occlusive

Vehicle:

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

Duration of exposure:

24 h

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 050 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Treated animals exhibited a general decline in overall condition and necrosis of the treated skin. Three females had slight encrustations/scabs on the treated skin of the back.

Gross pathology:

Necropsy results of the surviving animals were normal in 711 0 animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of 3-(Dimethylamino)propylurea in rats is greater than 2050 mg/kg of body weight.

Executive summary:

The dermal LD50 of 3-(Dimethylamino)propylurea in rats is greater than 2050 mg/kg of body weight.

Five healthy male and five healthy female Wistar rats were dosed dermally with 3-(Dimethylamino)propylurea. The test article was kept in contact with the skin for 24 hours using an occlusive wrap. Animals were observed for toxicity and pharmacological effects multiple times on the day of dosing and at least once daily for an additional 14 days. All animals were observed twice a day for mortality except on weekends and holidays (once). Body weights were recorded pretest, weekly and at death or termination in the survivors. All animals were examined for gross pathology.

No animals died.

Treated animals exhibited a general decline in overall condition and necrosis of the treated skin.

Body weight changes were normal.

Necropsy results of the surviving animals were normal in 7/10 animals. Three females had slight encrustations/scabs on the treated skin of the back.