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: The study is not GLP compliant but equivalent to guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200 to 250 g
- Fasting period before study: 16 hours
- Diet: Ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
3200, 4000, 5000, 6250 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For mortality at 1 and 6 hours and daily thereafter
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 700 mg/kg bw
Based on:
test mat.
95% CL:
> 4 700 - < 6 700
Mortality:
Dosis - Number of died animals from 10
4000 mg/kg bw ; 2/10
5000 mg/kg bw; 5/10
6250 mg/kg bw; 7/10


Clinical signs:
The rats experienced lethargy and slow respiration.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test substance was determined to be 5700 mg/kg bw.
Executive summary:

In the non-GLP compliant but guideline similar acute oral toxicity test with rats the following doses were tested 3200, 4000, 5000, 6250 mg/kg bw. 10 Wistar rats were used per dose.

The animals were observed for 14 days and necropsy of survivors was performed. The rats experienced lethargy and slow respiration. The LD50 of the test substance was determined to be 5700 mg/kg bw.