Registration Dossier

Diss Factsheets

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
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: Rat (Sprague-dawley)

Administration / exposure

Vehicle:
other: 1% w/v aqueous methylcellulose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Clinical signs of reaction to treatment observed in animals dosed at 2000 mg/kg comprised hunched posture, abnormal gait (unsteady), piloerection, urine staining (perigenital area). In addition, underactivity
Gross pathology:
Effects on organs:
No abnormalities were noted in any animal at the macroscopic
examination at study termination on Day 15.

Applicant's summary and conclusion

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