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EC number: 680-602-3 | CAS number: 98133-47-2
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:
- From September 12, 2012 to October 16, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Remarks:
- All testing was conducted in accordance with non-GLP Protoocal M12-4404
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(acetyloxy)-1-{[3-(acetyloxy)propyl]carbamoyl}-2,2-dimethylpropyl acetate
- Cas Number:
- 98133-47-2
- Molecular formula:
- C15H25NO7
- IUPAC Name:
- 3-(acetyloxy)-1-{[3-(acetyloxy)propyl]carbamoyl}-2,2-dimethylpropyl acetate
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Lot No: 61449
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Concentration tested at 5; 1; 0.5; 0.1 and 0.05 mg/plate
- Vehicle / solvent:
- Sterile Deionized Water
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile Deionized Water
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191 Acridine
- Remarks:
- TA97a
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile Deionized Water
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin
- Remarks:
- TA98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile Deionized Water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 & TA1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile Deionized Water
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- TA102
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile Deionized Water
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (w/S9)
- Remarks:
- All Strains
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- The results show that the test strains were sensitive to the positive controil mutagens and had a spontaneous reversion rate well within the accepted values of each strain, indicating that under the test conditions, the strains were sensitive to the detection of potentially genotoxic agents. The test samples were not cytotoxic at the concentrations tested. The metabolic activation using the S9 activation mixture shows an active microsomal preparation.
Using the same conditions, there was no detectable genotoxic activity associated with the non-cytotoxic concentrations (5; 1; 0.5; 0.1; 0.05 mg) of test samples M12-4404.01 (D-Panthenyltriacetate Lot#: 61449)
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