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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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, -

Applicant's summary and conclusion