Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
EC Number:
812-024-6
Cas Number:
1638534-24-3
Molecular formula:
C20H23ClN2
IUPAC Name:
(3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride

Method

Species / strain
Species / strain / cell type:
other: TA 1535, TA 100, TA 1537, TA 98, TA 102
Metabolic activation:
with and without
Metabolic activation system:
Aroclor rat liver S9-Mix
Test concentrations with justification for top dose:
Preliminary test with metabolic activation >= 320 µg/plate
Preliminary test without metabolic activation >= 160 µg/plate
Main test with metabolic activation: >= 320 µg/plate
Main test without metabolic activation: >= 320 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
cumene hydroperoxide
other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
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