Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 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