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: 96/54/EG, B.1 tris (Akute-toxische-Klassen-Methode)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Wistar HsdCpb:WU

Administration / exposure

Vehicle:
other: 2 % Cremophor EL

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: 2000 mg/kg bw; No clinical signs apart from death; 300 mg/kg bw; Effects on body weight gain
Gross pathology:
Effects on organs:
2000 mg/kg bw;

stomach: fluid, gas-filled and partly reddening

kidneys: pale, discolorated


300 mg/kg bw;

No gross pathological findings

Applicant's summary and conclusion

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