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: 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode); OECD 423 (2001)
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 in tab water.

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:
A dose of 2000 mg/kg body weight was tolerated by female
rats without mortalities, or effects on weight gain.
Gross pathology:
Effects on organs:
A dose of 2000 mg/kg body weight was tolerated by female
rats without gross pathological findings.

Applicant's summary and conclusion

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