Ammonium dinitroazanide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 2003 - January 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2003

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Directive 200/32/EC, L1362000, Annex 4D, dated May 19, 2000

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:

453-090-2

EC Name:

-

Cas Number:

140456-78-6

Molecular formula:

NH4 N(NO2)2

IUPAC Name:

Ammonium dinitroazanide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- batch No.of test material: 2003 7026
- Expiration date of the lot/batch: December 31, 2013
- Purity test date: >99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, light protected
- On the day of the experiment, the test item ADN was dissolved in deionised water.

Method

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:

Type and composition of metabolic activation system:
Phenobarbital/ Beta-Naphthoflavone induced rat liver S9

Vehicle / solvent:

Solvent: deionised water.
The solvent was chosen because of its solubility properties.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-Nitro-o-phenylenediamine

Remarks:

The stability of the positive control substances in solution is unknown but a mutagenic response in the expected range will be sufficient evidence of biological stability.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Additional information on results:

No toxic effects, evident as a reduction in the number of revertants, occured in the test groups with and without S9 mix. Substantial and dose-dependent increases in revertant colony numbers were observed following treatment with ADN in strains TA 1535 and TA 100 in the èresence and absence of metabolic activation.

Applicant's summary and conclusion

Conclusions:

During the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by base pair changes in the genome of the strains used.
Therefore, ADN is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.