Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG. 6.14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- Molecular formula (if other than submission substance):C23H30N2O2
- Molecular weight (if other than submission substance):366.5
- Smiles notation (if other than submission substance):CCC(CC1=CC=CC=C1)(C(=O)C2=CC=C(C=C2)N3CCOCC3)N(C)C
- InChl (if other than submission substance):1S/C23H30N2O2/c1-4-23(24(2)3,18-19-8-6-5-7-9-19)22(26)20-10-12-21(13-11-20)25-14-16-27-17-15-25/h5-13H,4,14-18H2,1-3H3
- Physical state: Powder
- Analytical purity: >99%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 1537
Metabolic activation:
with and without
Metabolic activation system:
ArocJor-induzierte Rattenleber S9-Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20 ... 5000 ~plate
Concentration range in the main test (without metabolic activation): 20 ... 5000 ~plate
Vehicle / solvent:
Solvent Aceton
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 313 IJglplate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>5000 ug/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion