Butyl 2,3-epoxypropyl ether

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key 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:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

To evaluate the in vitro genotoxicity of the test material an Ames test was performed on the Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 with and without a metabolic activation system (S-9).

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Butyl 2,3-epoxypropyl ether

EC Number:

219-376-4

EC Name:

Butyl 2,3-epoxypropyl ether

Cas Number:

2426-08-6

Molecular formula:

C7H14O2

IUPAC Name:

2-(butoxymethyl)oxirane

Test material form:

liquid

Specific details on test material used for the study:

Test material is indicated as R0065 in the study report.

Method

Target gene:

his revertants

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Remarks:

and TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver Homogenate (S-9)

Test concentrations with justification for top dose:

8.2, 24.7, 74.0, 222.2, 666.7, and 2000 µg/plate.
Based on preliminary toxicity testing.

Vehicle / solvent:

Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

other: Methylnitronitrosoguanidine (MNNG) for strain TA1535 and TA100 without metabolic activation and, 2-aminoanthracene for all strains with metabolic activation.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);

NUMBER OF REPLICATIONS: 3
To each of 2 mL of complete top agar, 0.1 mL of an overnight broth culture of each tester strain, 0.1 ml of the test material or diluent and 0.5 mL of the S-9 mix for the activated test will be added. The contents of the tube will be mixed thoroughly and poured onto VBE minimal agar plates. Plates will be gently rotated and tilted to assure uniform distribution of the top agar, allowed to harden on an even surface for 1 hour, inverted and put in a dark 37±0.5 °C incubator. After two days, the colonies in both test plates and controls were counted.

Evaluation criteria:

The following criteria were established in the testing laboratory:
- Demonstration of toxicity of the chemical for the S. typhimurium strains
- The solvents control are within normal range, and
- Confirmation of sensitivity and responsiveness of the tester strains to mutagenic action.
If above mentioned criteria are met, a chemical that exhibits a positive, dose-related response over 3 concentrations with the baseline increase equal to twice the solvent control is considered to be mutagenic.
A chemical will be considered negative if the maximum non-inhibitory level exhibits less than a twofold increase in the number of induced revertants when compared to the solvent control. A non-linear dose response over three concentrations of the test substance will indicate mutagenic potential, but a dose-related response provided more persuasive evidence of mutagenesis.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Remarks:

and TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium, other: TA 1537, TA 1538, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The sensitivity of TA1535 to the action of the test material was demonstrated over 6 concentrations and activation improved this response at the 666.7 and 2000 µg/plate levels. In contrast, increased revertant numbers of TA100 were recorded only at the 3 highest concentrations of the test material and no substantial enhancement was obtained with the addition of a metabolic activation system (S-9).