Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
other: Wistar - derived
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

Mortality

Male: >2000mg/kg bw; number of animals:5; number of deaths:0

female: >2000mg/kg bw; number of animals:5; number of deaths:0

Clinical signs

Signs of toxicity related to dose levels:

No significant signs observed.

Gross pathology

Effects on organs:

No macrospcopic abnormalities were detected at post mortem

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 >2000 mg/kg bw, therefore not classified.