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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Comparative mutagenicity of aliphatic epoxides in Salmonella
Author:
Canter D.A. et al.
Year:
1986
Bibliographic source:
Mutation Research 172, 105-138

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
- Short description of test conditions:
Chemicals were tested in Salmonella strains TA98, TA100, TA1535, and TA1537 and/or TA97 without metabolic activation and with liver S9 preparations from Aroclor 1254-induced male, Sprague-Dawley rats and Syrian hamsters, in a liquid incubation protocol with the tubes covered to retard loss of the volatile chemicals. The test doses used were determined by the solubility or toxicity of the individual chemicals but did not exceed 10 mg/plate. Testing was performed at 5 doses, using triplicate plates. Tests were repeated at least once; a chemical was not designated positive or negative unless the results were reproducible. A positive response was defined as a reproducible, dose-related increase in his + revertants over the solvent control level; it was not necessary for the increase to equal 2-fold over background. A chemical was considered mutagenic if at least one strain/activation combination yielded a reproducible positive response.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- CAS No.: 7665-72-7
- Supplier: Howard Hall International

Method

Target gene:
Histidine locus
Species / strain
Species / strain / cell type:
other: TA97, TA98, TA100, TA1535 and TA1537
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 metabolic activation system
Test concentrations with justification for top dose:
- The test doses used were determined by the solubility or toxicity of the individual chemicals, but did not exceed 10 mg/plate.
Vehicle / solvent:
Not specified
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Not specified
Rationale for test conditions:
Not specified
Evaluation criteria:
- A positive response was defined as a reproducible, dose-related increase in his + revertants over the solvent control level; it was not necessary for the increase to equal 2-fold over background.
Statistics:
Fold increase was measured.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
other: TA97, TA98 and TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
other: TA1535 and TA100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
In this study, the mutagenicity of the test substance was tested in Salmonella strains TA98, TA100, TA1535, TA1537 and TA97 with and without S9 metabolic activation system. The test doses used were determined by the solubility or toxicity of the individual chemicals, but did not exceed 10 mg/plate. The test substance was found to be active in TA100 and TA1535 with and without activation and showed varying responses in other strains.
Executive summary:

In this study, the mutagenicity of the test substance was tested in Salmonella strains TA98, TA100, TA1535, TA1537 and TA97 with and without S9 metabolic activation system. The test doses used were determined by the solubility or toxicity of the individual chemicals, but did not exceed 10 mg/plate.The test substance was found to be active in TA100 and TA1535 with and without activation and showed varying responses in other strains.