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

Genetic toxicity: in vitro

Administrative data

Endpoint:

genetic toxicity in vitro

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

Method

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 4.8828 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 4.8828 ... 5000 µg/plate

Details on test system and experimental conditions:

Concentration of the test substance resulting in precipitation: 0 µg/plate

Results and discussion

Test results

Test results 1

Species / strain:

other: as specified above

Metabolic activation:

with

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

( 5000 µg/plate)

Test results 2

Species / strain:

other: as specified above

Metabolic activation:

without

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

( 5000 µg/plate)

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation