Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (B1)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Wistar

Administration / exposure

Vehicle:
other: Arachis oil BP

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: One male was found dead on Day 3. No clinical signs of toxicity were noted in this animal on Days 1 and 2 or in any other animal during the study period. All surviving animals showed expected gains in body
Gross pathology:
Effects on organs:
Abnormalities noted at necropsy of the male that died during
the study were haemorrhagic lungs, pale liver, dark kidneys
and sloughing of the non-glandular epithelium of the
stomach.


No abnormalities were noted at necropsy of animals killed at
the end of the study period.

Applicant's summary and conclusion

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