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Toxicological information

Acute Toxicity: oral

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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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw of the test substance by stomach intubation. The animals were observed for 14 d.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Varamide A-7

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 150-250 g
- Fasting period before study: 24 h
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow (ad libitum)
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Six adult SD rats per dose group were given the test substance by stomach intubation.
Doses:
0, 5,000, 10,000 and 20,000 mg/kg.
No. of animals per sex per dose:
Males: 6/dose/group
Control animals:
not specified
Details on study design:
Male SD rats were fasted for 24 h and then administered single doses of the test substance by stomach intubation followed by 14 d of observation period.
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Mortality:
Number of dead/number dosed:
- No mortality occured at lowest dose of 5,000 mg/kg, i.e., 0/6
- 50% mortality was observed In the mid dose group of 10,000 mg/kg, i.e., 3/6
- Almost all animals died in the highest dose group of 20,000 mg/kg, i.e., 5/6.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of the test substance in SD rats was found to be 10000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 was therefore 10000 mg/kg bw (Casey, 1976).