Registration Dossier
Registration Dossier
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EC number: 929-513-6 | CAS number: 1400584-86-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 16 - November 09, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1997
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- EC Number:
- 929-513-6
- Cas Number:
- 1400584-86-2
- Molecular formula:
- C9H13N2O3 · Na
- IUPAC Name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- Test material form:
- solid: bulk
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix of Aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- Pre-test: 0, 10, 50, 100, 200, 400, 800, 1600 and 2400 for 4 and 18 hours treatment
Main study: 0, 600, 1200 and 2400 µg/ml for 4 hours treatment
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C, cyclophosamide
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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
Applicant's summary and conclusion
- Conclusions:
- Based on this test, the test item is considered not to be clastogenic for mammalian cells in vitro.
- Executive summary:
The clastogenic potential of the test item was evaluated in a chromosome aberration test in vitro. Initially Chinese hamster V79 cells were exposed in the absence and in the presence of S9 mix for 4 hours to concentrations of 600, 1200 and 2400 ug/ml.
Without S9 mix cytotoxic effects were not observed after 4 hours treatment and after 18 hours treatment. With S9 mix cytotoxic effects were observed at 2400 ug/ml. Precipitation in the medium did not occur. However, the test item was tested up to and over the requested limit concentration of 10mM (equal to 2202 ug/ml).
None of the cultures treated with the test item in the absence and in the presence of S9 mix showed biologically relevant or statistically significant increased numbers of aberrant metaphases.
The positive controls mitomycin C and cyclophosphamide induced clastogenic effects and demonstrated the sensitivity of the test system and the activity of the used S9 mix.
Based on this test, the test item is considered not to be clastogenic for mammalian cells in vitro.
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