1H-Tetrazole, 5-(4-chlorobutyl)-1-cyclohexyl-

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study followed the procedures indicated by the following internationally accepted guidelines and recommendations: - Ninth Addendum to OECD Guidelines for Testing Chemicals, Section 4, No. 471, "Bacterial Reverse Mutation Test" - Commission Regulation (EC) No 440/2008 B13/14 - EPA Health Effects Test Guidelines, OPPTS 870.5100 "Bacterial Reverse Mutation Test" EPA 712-C-98-247 -ICH Guidance S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests For Pharmaceuticals -ICH Guidance S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole

EC Number:

616-036-0

Cas Number:

73963-42-5

Molecular formula:

C11H19ClN4

IUPAC Name:

5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole

Test material form:

solid: crystalline

Details on test material:

White powder.

Method

Target gene:

Histidine, tryptophan

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA 98, 100, 1535 and 1537 and Escherichia coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

Arochlor induced / rat liver S9

Test concentrations with justification for top dose:

5000, 1581, 500, 158, 50, and 15.8 microgram/plate (initial and confirmation mutation tests)

Vehicle / solvent:

Based on the solubility test and the Range finding test the test item was dissolved in Dimethyl sulfoxide in a concentration of 100 mg/mL (stock solution).

Controls

Untreated negative controls:

yes

Remarks:

DMSO for Test Item, NPD, 9AA and 2AA Distilled water for SAZ and MMS

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: NPD, SAZ, 9AA,MMS,2AA

Details on test system and experimental conditions:

Plate incorporation technique.

Evaluation criteria:

Well established, according to Guideline.

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Preliminary experiment: effect of mutagenitity or toxicity was not observed.
Main Study: effect of mutagenitity or toxicity was not observed.
Validation study: S9 concentration increase in S9 mix has not resulted as mutagenic effect.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In the above experimental conditions the substance has no mutagenic activity on the applied bacterium tester strains.