α-acetyl-γ-butyrolactone

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28.02 - 07.08.2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

study performed according to GLP and OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

α-acetyl-γ-butyrolactone

EC Number:

208-235-2

EC Name:

α-acetyl-γ-butyrolactone

Cas Number:

517-23-7

Molecular formula:

C6H8O3

IUPAC Name:

3-acetyloxolan-2-one

Details on test material:

-

Method

Target gene:

TA97a: hisD6610, TA 98: hisD3052; TA 100 and TA 1535 hisG46, TA102: hisG428

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA97a, TA98, TA100, TA102, TA 1535

Details on mammalian cell type (if applicable):

- Type and identity of media: Salmonella typhimurium LT2
- Properly maintained: yes

Additional strain / cell type characteristics:

other: rfa, delta-uvrB, pKM101

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

main experiment: 5, 2.5, 1.25, 0.625, 0.1 mg/l

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

+ Sodiumazide ; 4-Nitro-1,2-phenylendiam

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation assay; and a preincubation modification assay

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA97a, TA98, TA100, TA102, TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

-

Cytotoxicity / choice of top concentrations:

not determined

Remarks:

-

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Substance is not mutagenic

Executive summary:

A-Lactone was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a preincubation modification assay in absence and in presence of an exogenous metabolic activation system (S9) were performed. Five Salmonella typhimurium tester strains (TA1535, TA97, TA98, TA100, and TA102) were employed. The activity of the S9 -mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment. The substance was dissolved in water. Concentration ranges between 0.1 to 5 mg/plate were chosen for the main experiments.

No significant increase in the number of revertant colonies was apparent in all five tester strains (TA1535, TA97, TA98, TA100, and TA102) using both methods, after treatment with A-Lactone.

Based on these data A-Lactone can be considered as not mutagenic in the Ames test under the described experimental conditions.