N,N''-(isobutylidene)diurea

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: post observation period 7 days, no data on strain.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

post observation period 7 days, no data on strain.

GLP compliance:

no

Test type:

standard acute method

Limit test:

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:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 126-218 g

no further data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The doses were applied as 10%, 16% or 30% preparations of the test substance in water

Doses:

800, 1000, 1600, 3200, 6400, 10000 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 days
- Frequency of observations and weighing: Group-wise documentation of clinical signs was performed over the 7 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:

> 10 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: 800-1600 mg/kg bw: no symptoms 3200-10000 mg/kg bw: piloerection and tachypnoea

Gross pathology:

Four animals showed chronic bronchitis and bronchi ectases, all other animals without findings in the organs . Necropsy was
performed by a pathologist .

Any other information on results incl. tables

Results are given as dead animals/total number of animals at this dose

at 24 h, 48 h and 7 days after dosing:  

800 mg/kg bw: 0/10, 0/10, 0/10  

1000 mg/kg bw: 0/10, 0/10, 0/10  

1600 mg/kg bw: 0/10, 0/10, 0/10  

3200 mg/kg bw: 0/10, 0/10, 0/10  

6400 mg/kg bw: 0/10, 0/10, 0/10  

10000 mg/kg bw: 0/10, 0/10, 0/10