Registration Dossier
Registration Dossier
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EC number: 208-235-2 | CAS number: 517-23-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- 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 with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- repeat restricted to two S. typhimurium strains
- Principles of method if other than guideline:
- -
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- 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:
- -
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/naphthoflavone induced male Wistar rat liver S9 mix
- Test concentrations with justification for top dose:
- Experiment I: 5000 µg/plate (+/-S9 mix, all strains)
Experiment II: 5000, 2500, 1250, 625, 100 µg/plate (+/-S9 mix, TA97a); 5000, 2500 µg/plate (+/-S9 mix, TA98) - Vehicle / solvent:
- water (test substance)
DMSO (positive control)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-nitro-1,2-phenylenediamine
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA 1535
- Remarks:
- Experiment I
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- -
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- -
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA97a, TA98
- Remarks:
- Experiment I
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA97a, TA98
- Remarks:
- Experiment II
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- negative
- Executive summary:
The test substance was evaluated for mutagenic activity in the Ames test. A standard plate incorporation in absence and in presence of an exogenous metabolic activation system (S9) were performed. Five Salmonella typhimurium tester strains (TA1535, TA97a, 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 experiments. No cytotoxicity and precipitation were observed up to and including 5 mg/plate.
No significant increase in the number of revertant colonies was apparent in all five tester strains (TA1535, TA97a, TA98, TA100, and TA102) after treatment with the test substance.
Based on these data test substance can be considered as not mutagenic in the Ames test under the described experimental conditions.
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