5,5'-Bi-2H-tetrazole, ammonium salt (1:2)

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

2000/32/EG, B.13, B.14 (Ames-Test)

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:

-

EC Number:

485-290-0

EC Name:

-

Cas Number:

3021-02-1

Molecular formula:

C2H8N10

IUPAC Name:

5-(1H-1,2,3,4-tetrazol-5-yl)-1H-1,2,3,4-tetrazole diamine

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

other: histidine dependent

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 4 ... 403 µg/plate
Concentration range in the main test (without metabolic activation): 4 ... 403 µg/plate

Vehicle / solvent:

Solvent: deionised water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

historical data

Positive controls:

yes

Positive control substance:

other: 4-Nitro-1,2-phenylene diamine, Sodium azide, Benzo(a)pyrene, 2-Aminoanthracene (2-AA

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:

cytotoxicity

Remarks:

(> 403 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: main test

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test item BHT-2NH3 5,5'-Bis-1H-tetrazole diammonium salt is considered as "not mutagenic under the conditions of the test".