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: Annex V B1 bis
GLP compliance:
yes
Test type:
fixed dose procedure

Test animals

Species:
other: Rat - Wistar (Alpk: APfSD)

Administration / exposure

Vehicle:
corn oil
No. of animals per sex per dose:
Preliminary sighting study: 0 (male)
Preliminary sighting study: 1 (female)
Main study: 5 (male)
Main study: 5 (female)
Details on study design:
Main study:
2000mg/kg

Results and discussion

Preliminary study:
Species/strain: Rat - Wistar (Alpk: APfSD)
mg/kg bw: Evident toxicity: ; Mortality:
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Dose descriptor:
other: 2000 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 5
Clinical signs:
other: Signs of toxicity: None
Gross pathology:
Effects on organs:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information