Hydrazinium nitrate

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: Study performed to guidelines and to GLP.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2004

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrazine nitrate

IUPAC Name:

Hydrazine nitrate

Constituent 2

Reference substance name:

Hydrazinium nitrate

EC Number:

236-690-7

EC Name:

Hydrazinium nitrate

Cas Number:

13464-97-6

Molecular formula:

H4N2.HNO3

IUPAC Name:

hydrazinium nitrate

Details on test material:

- Name of test material (as cited in study report): Hydrazine nitrate

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Arochlor induced rat liver S9 homogenate

Test concentrations with justification for top dose:

0.03-3.0 mg/plate (0.32-30 mM).

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-anthramine dissolved in DMSO, diluted with DDH2O

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS:3

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index

Evaluation criteria:

Appearance of background lawn of bacterial growth.

Statistics:

Mean and standard deviation

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed in any of the chemical dilutions.

RANGE-FINDING/SCREENING STUDIES: 5 log concentrations (0.0005-5.0 mg/plate) were tested in TA 98, TA 100 and TA 102 with modified standard plate incorporation, the pre-incubation method. No precipitation was observed in any of the chemical dilutions.

ADDITIONAL INFORMATION ON CYTOTOXICITY: At 3 mg/plate, toxicity was observed in TA98, TA100, and TA 1537 with and without S9 and for TA 102 and TA 1535 without S9. 1 mg/plate was toxic to all strains without S9 activation.

Remarks on result:

other: strain/cell type: TA 1535 and TA 102

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive with metabolic activation

Hydrazine nitrate was positive for mutagenicity when tested with metabolic activation.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA102, TA1535 and TA 1537 of S. typhimurium were exposed to hydrazine nitrate, at concentrations of 0.03 -3 mg/plate in the presence and absence of mammalian metabolic activation. 

The positive controls induced the appropriate responses in the corresponding strains.   There was evidence of induced mutant colonies over background for the test substance.

 

This study is classified as acceptable.  This study satisfies the requirement for Test Guideline EPA OTS 798.5265 for in vitro mutagenicity (bacterial reverse gene mutation) data.