(tert-butoxymethyl)oxirane

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

(tert-butoxymethyl)oxirane

EC Number:

231-640-0

EC Name:

(tert-butoxymethyl)oxirane

Cas Number:

7665-72-7

Molecular formula:

C7H14O2

IUPAC Name:

2-[(tert-butoxy)methyl]oxirane

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:

S. typhimurium, 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 results

Test results 1

Key result

Species / strain:

S. typhimurium, 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

Test results 2

Key result

Species / strain:

S. typhimurium, 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.