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: 92/69/EWG, B.1tris (Akute-toxische-Klassen-Methode)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Vehicle:
corn oil

Results and discussion

Effect levels
Sex:
male/female
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
2000 mg/kg bw, signs between 5 h and 4 d after
administration:

piloerection, decreased motility, reactivity decreased,
uncoordinated gait, abdominal position, temporary tremor,
labored breathing, narrowed palpebral fissure and

increased lacrimation.


300 mg/kg bw:

There were no toxicological effects on body weight or body
weight gain.

No clinical signs were observed.
Gross pathology:
Effects on organs:
In animals treated with 2000 mg/kg bw. that died during the
observation period the following changes were detected:
liver, discolorations, pale


The necropsies performed at the end of the study revealed n
particular findings in animals treated with 300 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU