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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Liver cell-mediated mutagenesis of V79 cells by hydrazine and related compounds.
Author:
Kuszynski C,
Year:
1981
Bibliographic source:
Environmental mutagenesis, 3:323–324; cited in WHO 2000, Phenylhydrazine. CICAD 19, Wissenschaftliche Verlagsgesellschaft mbH
Reference Type:
secondary source
Title:
Concise International Assessment Document 19: Phenylhydrazine
Author:
WHO
Year:
2000
Bibliographic source:
Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, ISBN 92 4 153019 7; ISSN 1020-6167
Reference Type:
secondary source
Title:
Unnamed
Year:
1994

Materials and methods

Principles of method if other than guideline:
The liver cell-mediated-V79 mutagenesis system (Langenbach et al. PNAS 75:2864-2867, 1978) with ouabain resistance as a marker was used. Cocultivation of the liver cells and V79 cells in the presence of carcinogens was shown to induce ouabain-resistant mutants of V79 cells. In the absence of liver cells, the carcinogens did not induce ouabain resistance.
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): phenylhydrazine (PH)

Method

Target gene:
Na+K+-ATPase
Species / strain
Species / strain:
Chinese hamster lung fibroblasts (V79)
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
primar cultures of rat liver cells
Test concentrations with justification for top dose:
no data
Controls
Negative controls:
yes
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
N-dimethylnitrosamine
Details on test system and conditions:
METHOD OF APPLICATION: in medium;

DURATION
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 12 - 14 days
- Fixation time (start of exposure up to fixation or harvest of cells): 16 - 18 days

SELECTION AGENT (mutation assays): Ouabain

Results and discussion

Test resultsopen allclose all
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Phenylhydrazine was mutagenic only with primary liver cell activation.

Applicant's summary and conclusion