Hydrazine

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: guideline study

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity test data of|existing chemical substances based on the toxicity|investigation system of the industrial safety and health law,

Author:

JETOC (Japan Chemical Industry Ecology-Toxicology and Information Center, Japan):

Year:

1996

Bibliographic source:

JETOC (Japan Chemical Industry Ecology-Toxicology and Information Center, Japan) p.31-34, 67, 306-308

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

OECD Guide-line 471, preincubation method, S9-mix from induced rat liver, solvent and positive controls (AF2, NaN3, 9AA).

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrazine

EC Number:

206-114-9

EC Name:

Hydrazine

Cas Number:

302-01-2

Molecular formula:

H4N2

IUPAC Name:

hydrazine

Details on test material:

IUCLID4 Test substance: other TS: hydrazine (anhydrous), purity: 97.5 %

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, E. coli WP2uvrA,

Metabolic activation:

with and without

Metabolic activation system:

male Sprague-Dawley rat liver induced by phenobarbital and 5,6-benzofravone

Test concentrations with justification for top dose:

0.0, 0.0763, 0.305, 1.22, 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate dissolved in water

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodiumazide, 2-nitrofluorene, 9-aminoacridine, 4-nitroquinoline-N-oxide, bleomycin, pyruvic aldehyde, 2-amino anthracene

Details on test system and experimental conditions:

OECD Guide-line 471, preincubation method.

Evaluation criteria:

The chemicals were considered to be mutagenic when a dose related increase in revertant colonycount is observed and the number of revertant colonies per plate with the test substance is more than twice of the negative controls and when a reproducibility of test result is observed.

Statistics:

no further data

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, E. coli WP2uvrA,

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

other: from 625 µg/plate onwards

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Hydrazine yielded a posive result.

Remarks on result:

other: other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, E. coli WP2uvrA,

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Hydrazine yielded a positive result.

Applicant's summary and conclusion

Executive summary:

Hydrazine was tested in the Ames test according to OECD TG 471 using Salmonella typhimurium TA100, TA1535, TA98, TA1537 and E coli WP2uvrA in the presence and in the absence of an additional metabolic activation system and yielded a positive result (JETOC 1996).