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

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

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

Limit test:

no

Test animals

Species:

other: Rats

Administration / exposure

Route of administration:

oral: unspecified

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/dayMale: 5 animals at 15 mg/kg bw/dayMale: 5 animals at 50 mg/kg bw/dayMale: 5 animals at 150 mg/kg bw/dayFemale: 5 animals at 0 mg/kg bw/dayFemale: 5 animals at 15 mg/kg bw/dayFemale: 5 animals at 50 mg/kg bw/dayFemale: 5 animals at 150 mg/kg bw/day

Results and discussion

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

150 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

15 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Classified as: Not classified