1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

Genetic toxicity: in vitro

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

Test material information

Constituent 1

Reference substance name:

4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1H-imidazole-5-carboxylic acid

EC Number:

646-413-5

Cas Number:

144689-24-7

Molecular formula:

C24H26N6O3

IUPAC Name:

4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1H-imidazole-5-carboxylic acid

Test material form:

solid - liquid: suspension

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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 / solvent:

- Vehicle(s)/solvent(s) used: DMSO at 50 mg/ml (5%)

Controls

Negative solvent / vehicle 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 / choice of top concentrations:

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.