Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Bacteriologcal test (Suspension of bacterial cells) with metabolic activation / without metabolic activation
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyl-4-chloro-4,5-dihydro-5-hydroxymethyl-1-[2'-(2-triphenylmethyl-1,2,3,4-2H-tetrazol-5-yl)-1,1'-biphenyl-4-methyl]-1H-imidazole
EC Number:
412-420-5
EC Name:
2-butyl-4-chloro-4,5-dihydro-5-hydroxymethyl-1-[2'-(2-triphenylmethyl-1,2,3,4-2H-tetrazol-5-yl)-1,1'-biphenyl-4-methyl]-1H-imidazole
Cas Number:
133909-99-6
Molecular formula:
C41H37ClN6O
IUPAC Name:
[2-butyl-4-chloro-1-({2'-[2-(triphenylmethyl)-2H-1,2,3,4-tetrazol-5-yl]-[1,1'-biphenyl]-4-yl}methyl)-1H-imidazol-5-yl]methanol

Method

Target gene:
Bacterial cells
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Supplemented liver fraction (S-9 mix) prepared from an animal previously treated with Aroclor 1254
Test concentrations with justification for top dose:
Concentration range in the main test (µg/plate)
with metabolic activation : 50 5000
without metabolic activation : 50 5000
Concentration of test substance observed to be toxic to bacteria (µg/plate) :
a) in a preliminary test with metabolic activation >5000
without metabolic activation > 5000
b) in the main test with metabolic activation >5000
without metabolic activation > 5000
Concentration of the test substance resulting in precipitation : 1500 µg/plate
Controls
Untreated negative controls:
yes
Remarks:
Dimethyl sulfoxide
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide

Results and discussion

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

Any other information on results incl. tables

With metabolic activation : negative

Without metabolic activation : negative

Applicant's summary and conclusion