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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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).