Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
800-1600 mg/kg bw: no symptoms
3200-10000 mg/kg bw: piloerection and tachypnoea
Body weight:
no further data
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

Applicant's summary and conclusion