Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2000-01-25 into 2000-02-08
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC, B.1 Acute toxicity (oral). OECD Guideline No. 401
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test batch no.: 7/99

Test animals

Species:
other: rat - Wistar
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wistar
- Housing: cage T4, 5 rats per cage per sex
- Diet (e.g. ad libitum): standart food ST-1/ Bergman, mlýn Koccanda
- Water (e.g. ad libitum): ad libidum
- Acclimation period: 1 week
-12 hours light / 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: The sample was applied in delivered form "as is" tempered at 20-C.
Details on oral exposure:
Tested substance was administrated by gavage directly into stomak once.
Doses:
2000 mg/kg
No. of animals per sex per dose:
Male dose: 2000 mg/kg nr. of animals: 5
Female 2000 mg/kg 5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
95% CL:
ca. 95
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Males: The clinical symptoms of intoxication were observed in four animals- from the 4th to the 7th day, in one animal until eighth day after administration. The animals had motional distresses, the distresses in reaction to impulses,the easy effluences from the eyes and nostrils were detected, the intake of food was delimited and the exaggeration was also detected. On the 9th day after application the visible symptoms of health disorder were finished. No animal was died. Female: Negative impact of tested substance was not so strong in the female group. Moderate health disorders were observed in four animals from the 4th to the 6th day and in one animal until 7th day after the application. The animals showed the decreased reactions to the impulses, their breathing was slow and they did not accept the food. No visible clinical symptoms of intoxication were observed on the 8th day after application. No animal died.
Body weight:
Body weight was observed at the begining and at the end of test . Weight increase or decrease was calculated from difference.
Gross pathology:
Effects on organs: During the test no toxic expose was observed. After 14-days of testing period the surviving animals (from the male group) were killed and disemboweled. The morbid- anatomical diagnosis was negative four animals without any change, one animal was partially peaked with liver hyperemis. For the female group the morbid-anatomical diagnosis was negative only for one animal the liver repletion was registered.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU