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:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102.
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 31.6 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 µg/plate
Details on test system and experimental conditions:
Metabolic activation system: Phenobarbital/beta-naphthoflavone induced male wistar rats.
A stock of the supernatant containing the microsomes was frozen in ampoules of 2 and 4.5 ml and stored at < - 75°C.
The protein concentration in the S9 preparation was 35 mg/ml. The S9 mix preparation was performed according to Ames et al.
100 mN sodium-ortho phosphat-buffer, pH 7,4 were ice-cold added to the following reagents to give final concentrations in the S9 mix of:
8mM MgCl2, 33mM KCl, 5 mM glucose-6-phosphate and 5 mM NADP.

This solution was mixed with the liver 9000 x g supernatant flid in the following proportion:
co-factor solution 9.5 parts
liver preparation 0.5 parts
During the experiment the S9 mix was stored on ice.

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:
no 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