Registration Dossier

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:
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:
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 seen in four females,
partially closed eyelids in two females, reduced body
temperature in two animals, loose faeces and irregular
breathing were observed in one female. These signs were
first noted from one to three hours after dosing. Recovery
of animals, as judged by external appearance and behaviour,
was complete by Day 4 or 5.

No clinical signs were seen in any animal dosed at 300
mg/kg.

A bodyweight loss was noted for one animal dosed at 2000
mg/kg on day 15. A low bodyweight gain was noted for one
female on Day 15 dosed at 300 mg/kg and one female on Day 15
dosed at 2000 mg/kg.
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