N,N''-(isobutylidene)diurea

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: post dose observation period only 7 days for some dose groups, no data on strain

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Principles of method if other than guideline:

The substance preparations were injected into the peritoneal cavity of mice. The mice were observed for 7 days an the LD50 was calculated.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N''-(isobutylidene)diurea

EC Number:

228-055-8

EC Name:

N,N''-(isobutylidene)diurea

Cas Number:

6104-30-9

Molecular formula:

C6H14N4O2

IUPAC Name:

N,N''-(2-methylpropane-1,1-diyl)diurea

Details on test material:

purity ca. 90-96% (0-3% urea, 2% potassium sulfate)

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 20-34 g

no further data

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Details on exposure:

The doses were administered at concentrations of 4 %, 8 %,10 %, 16% or 30% preparations of the test substance in
aqua dest. as a single dose.

Doses:

320, 400, 500, 640, 800, 1000, 1600, 3200, 6400 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7-14 days
- Frequency of observations and weighing: Group-wise documentation of clinical signs was performed over the 7- to 14- day study period.
Body weight was determined before the start of the study only, as it was needed for determination of dose.
- Necropsy of survivors performed: yes
- Other examinations performed: The clinical signs and findings were reported in summary form .

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 500 mg/kg bw

Mortality:

yes, deaths occured at all dose levels, see remarks

Clinical signs:

320-400 mg/kg bw: irregular respiration, piloerection, reduced general state, smeared eyelids, tremor
500-800 mg/kg bw: as mentioned above but more pronounced
1600-6400 mg/kg bw : convulsions, tremor, dyspnoe, piloerection, abdominal position, ptosis, apathy

Body weight:

no further data

Gross pathology:

Animals that died showed pale kidneys and dark red kidney pulp.In animals that where sacrificed, one mouse showed pale
kidneys; all other animals without findings in the organs. Necropsy was performed by a pathologist .

Other findings:

no further data

Any other information on results incl. tables

- Number and time of death(s) per dose group: Results are given as dead   animals/total number of animals at this dose at 24 h, 48 h, 7 days and 14 days after dosing:  

320 mg/kg bw: 0/10, 0/10, 2/10, 2/10  

400 mg/kg bw: 0/10, 1/10, 3/10, 3/10  

500 mg/kg bw: 0/10, 1/10, 3/10, 3/10  

640 mg/kg bw: 0/10, 7/10, 9/10, 9/10  

800 mg/kg bw: 0/10, 7/10, 10/10, -  

1000 mg/kg bw: 1/10, 9/10, 9/10, 9/10  

1600 mg/kg bw: 3/10, 10/10, 10/10, -  

3200 mg/kg bw: 5/10, 10/10, 10/10, -  

6400 mg/kg bw: 3/10, 10/10, 10/10, -