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:
Between march 10, 1994 and august 18, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from Handbook or collection of data.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No guideline available
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension

Method

Target gene:
Histidine
Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 prepared from rat livers
Test concentrations with justification for top dose:
Each test substance was tested at the maximal concentration of 5000 µg/plate along with four lower concentrations.
Vehicle:
- Vehicle(s)/solvent(s) used: DMSO at 50 mg/ml (5%)
Controls
Solvent controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, 2-aminoanthracene, ICR-191
Evaluation criteria:
Responses were considered positive when the mean number of revertant colonies in a treated group was more than twice that of the solvent group and the increase in the number of revertant colonies also showed a dose-dependency. However, for TA1535 and TA1537, the criterion used for a positive response was a 3-fold or greater increase over solvent control colony count.
Statistics:
Statistical analyses were not carried out.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

No dose-dependent increase in the number of revertant colonies was observed with Olmesartan with any tester strain with or without metabolic activation.