1,3-dimethylurea

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically valid study, comparable to guideline, but not according to current standards or GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2003

Report date:

2003

Reference 3

Reference Type:

publication

Title:

1,3-Dimethylurea (CAS: 96-31-1), SIDS Initial assessment report for SIAM 17

Author:

OECD SIDS

Year:

2009

Bibliographic source:

Unep publications

Report date:

2003

Materials and methods

Principles of method if other than guideline:

BASF test: In principle, the methods described in OECD Guideline 401 were used.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethylurea

EC Number:

202-498-7

EC Name:

1,3-dimethylurea

Cas Number:

96-31-1

Molecular formula:

C3H8N2O

IUPAC Name:

1,3-dimethylurea

Details on test material:

- Name of test material (as cited in study report): 1,3-Dimethylurea, N,N'-Dimethylurea
- Physical state: cristalline
- Analytical purity: technical grade

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder
- Age at study initiation: Young adult
- Weight at study initiation: Average weight at beginning of the test: 96 - 174 g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The doses were applied as 1 % or 10% preparations of the test substance in aqua dest.

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION (if unusual):
- The concentrations of these preparations were usually adjusted to achieve comparable volumes (e.g. 10 ml) per kg body weight.

Doses:

20; 79; 316; 1260 mg/kg (1 animal per dose); 3160; 5010; 6310; 7940; 10000 mg/kg (5 animals per dose)

No. of animals per sex per dose:

5 rats per dose group, except for the four lowest dose levels (1 rat/dose).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Body weight was determined before the beginning of the study for dose calculation.
Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: no, only of the died animal.

Statistics:

On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 000 mg/kg bw

Based on:

test mat.

Mortality:

Results are given as dead animals/total number of animals at this dose at 24 h, 48 h and 7 days after dosing:
20 mg/kg bw: 0/1, 0/1, 0/1
79 mg/kg bw: 0/1, 0/1, 0/1
316 mg/kg bw: 0/1, 0/1, 0/1
1260 mg/kg bw: 0/1, 0/1, 0/1
3160 mg/kg bw: 0/5, 0/5, 0/5
5010 mg/kg bw: 0/5, 0/5, 4/5
6310 mg/kg bw: 0/5, 4/5, 5/5
7940 mg/kg bw: 1/5, 5/5, 5/5
10000 mg/kg bw: 5/5, 5/5, 5/5

Clinical signs:

other: unspecific; apathy and narcotic like state at doses near to or exceeding the LD50. None of the animals had blood in the urine. SYMPTOMS PER DOSE GROUP: 20-3160 mg/kg bw: no symptoms 5010 mg/kg bw: piloerection, vocalisation during urination 6310-7940 m

Gross pathology:

In 2 animals stomach filled with liquid and dilated, all other animals without findings in the inner organs . Necropsy was performed by a pathologist.

Other findings:

No other fndings