Registration Dossier
Registration Dossier
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EC number: 700-402-2 | CAS number: 860035-10-5
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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl}oxy)ethyl 2-methylpropanoate
- EC Number:
- 700-402-2
- Cas Number:
- 860035-10-5
- Molecular formula:
- C11H15NO7
- IUPAC Name:
- 1-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl}oxy)ethyl 2-methylpropanoate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- 15, 50, 150, 500, 1500, 5000mcg/plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- GSk1873183A was considered to be non-mutagenic under the conditions of the test.
- Executive summary:
Salmonella typhimurium strains TA1535, 1537, TA98 and TA100 and Escherichia coli strain WP2urvApKM101 were treated with solutions of GSK187318A using the Ames plate incorporation method at six dose levels in triplicate, both with and without metabolic activation (10% rat liver S9 in standard cofactors). A dose range of 15 to 5000mcg/plate was employed. the vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within normal range.All positive control chemicals used induced marked increases in the frrequency of revertant colonies, both with and without metabolic activation. GSK1873183A caused a visible reduction in the growth of the bacterial lawns initially at 1500 and 5000mcg/plate. However, no increases in the frquency of revertant colonies was recorded for any of the bacterial strains, with any dose either with or without metabolic activation
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