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:
yes

Test animals

Species:
other: rat, Wistar Hsd Cpb:Wu

Administration / exposure

Vehicle:
other: 2 % Cremophor EL

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The following clinical signs were observed:

- erythema in all animals (3h - 2d)

- increased water intake (4d - 6d)


There were no toxicological effects on body weight or body
weight gain.
Gross pathology:
Effects on organs:
Necropsies performed at the end of the study revealed no
particular findings.

Applicant's summary and conclusion

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