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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:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported.
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The mutagenicity assay performed within the study was reported in very brief detail and the methodology is referenced to another publication. From the available information it is not possible to assess the quality of the conclusions drawn.

Data source

Reference
Reference Type:
publication
Title:
Structure Activity Relationship of Epoxides: Different Mutagenicity of the Two Diastereoisomeric 3-Bromo-1,2-Epoxycyclohexanes
Author:
Bellucci G, Lippi A, Marioni F, Citti L,Gervasi P & Turchi G
Year:
1984
Bibliographic source:
Chem.-Bio. Interactions, 51, 77-89

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The mutagenic potential of the test material was assessed by exposing V79 hamster cells to test material in culture bottles containing essential medium and scoring the induction of mutants resistant to 6-thioguanine and the surviving fraction were measured. 6-thioguanine resistance was determined at different expression times: 138 and 186 hours after treatment for 1 hour at 37 ºC. Two independent experiments were performed. The methodology according to Turchi et al (1983) was followed.
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 1,2-epoxycyclohexane
- Commercially obtained from Merck-Schuchardt
- Distilled before use.

Method

Target gene:
6-thioguanine (6-TG)
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
- Experimental procedure as described in Turchi et al 1983: Mutagenicity of 3 Structurally Related Epoxides, with Defined Stereochemical Configuration, in Saccharomyces cerevisiae and in V79 Chinese Hamster Cells, Mutat. Res., 117: 213.

DURATION
- Exposure duration: 1 h at 37 °C.
- Expression time (cells in growth medium):O138 and 186 hrs after

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
not specified
Genotoxicity:
positive
Remarks:
3.0 mutants/10⁶ cells/mM
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
The LD₅₀ was said to be approximately 6 mM.
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

Under the conditions of the test, the test material was shown to have a mutagenic effect on V79 Chinese Hamster cells. The rate of mutation was calculated to be 3.0 mutants/10⁶ cells/mM. The LD50 of the test material was also said to be approximately 6 mM.
Executive summary:

The mutagenic potential of the test material was determined in a mammalian somatic cell gene mutation assay according to the methodology set out in Turchi et al 1983. Under the conditions of the test, the test material was shown to have a mutagenic effect in V79 Chinese hamster cells at a rate of 3.0 mutants/10cells/mM. The LD₅₀of the test material was reported to be approximately 6 mM.