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EC number: 610-122-1 | CAS number: 433733-94-9
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:
- 23.5.2009 - 29.5.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [(2S,3R,5S)-3-acetoxy-5-(5-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-2-yl]methyl acetate
- EC Number:
- 610-122-1
- Cas Number:
- 433733-94-9
- Molecular formula:
- C14H18N2O7
- IUPAC Name:
- [(2S,3R,5S)-3-acetoxy-5-(5-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-2-yl]methyl acetate
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- other: TA97, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix
- Test concentrations with justification for top dose:
- 100, 333, 1000, 3330 and 5000 μg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9: sodium azide (TA1535), 2-nitrofluorene (TA98), methylmethanesulfonat (TA100), cumene hydroperoxide (TA102), ICR-191 (TA97); with S9: 1,8 dihydroxyanthraquinone (TA102), 2-aminoanthracene (all other strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: three replications in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of bacterial background lawn - Evaluation criteria:
- A test substance is considered positive in the test, if:
- The total number of revertants in tester strains TA100, TA97 and TA102 is greater than two times the concurrent control or the total number of revertants in tester strains TA1535 and TA98 is greater than three times the concurrent control.
- In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA97, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
The test substance did not induce a significant dose-related increase in the number of revertant colonies in each of the five tester strains (TA1535, TA97, TA98, TA100 and TA102) both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Applicant's summary and conclusion
- Conclusions:
- All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that LDT600 C3 is not mutagenic in the Salmonella typhimurium reverse mutation assay.
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