(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile hemisulfate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Adequacy of study:

disregarded due to major methodological deficiencies

Data waiving:

other justification

Justification for data waiving:

other:

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test type:

standard acute method

Limit test:

no

Test animals

Species:

other: male and female

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 50 mg/kg bw

Mortality:

Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 50 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 250 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 1; Number of deaths: 1
Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 50 mg/kg bw; Number of animals: 5; Number of deaths: 0

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU