Registration Dossier
Registration Dossier
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EC number: 411-760-1 | CAS number: 116633-53-5 COMMERCIAL DRAGON II
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate
- EC Number:
- 411-760-1
- EC Name:
- Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate
- Cas Number:
- 116633-53-5
- Molecular formula:
- C18 H42 Mn2 N6 O3 . 2 F6 P
- IUPAC Name:
- dimanganese(4+) bis(1,4,7-trimethyl-1,4,7-triazonane) bis(hexafluoro-λ⁵-phosphanuide) hydrate trioxidandiide
- Details on test material:
- no data
Constituent 1
Method
- Target gene:
- no data
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- no data
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S-9 mix
- Test concentrations with justification for top dose:
- at least 100, 250 and 2500 ug/ml
- Vehicle / solvent:
- no data
Controls
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Commercial Dragon II was tested in vitro to determine whether it would cause chromosomal abberations or polyploidy in a mammalian cell line derived from Chinese hamster ovary tissue. The cells were incubated with the test substance both with and without supplementary metabolic activation (rat S-9 mix). Three treatment periods were used in absence of the S-9 mix and one treatment was used in the presence of S-9 mix. For each treatment period cultures were treated with a range of dose levels, the solvent control and positive control compounds
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- In the presence o f S-9 mix, statistically significant increases in the number of aberrant cells were seen at 100 and 200 ug/ml. Both these increases lie outside the historical control range. In the absence of S-9 mix, for the 6 hour treatment, a stitistically significant increase in the proportion of metaphase figures with chromosomal aberrations was observed at 2500 ug/ml. This increase lies well outside the historical control range.
No statistically significant increases in the proportion of polyloid cells were seen at any concentration in the presence or absence ofr S-9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Commercial Dragon II has shown evidence of clastogenic activity in the presence of S-9 mix, and in its absence when the cells were treated for 6 hours. Commercial Dragon II has shown no evidence of polypoidy-inducing activities - Executive summary:
Commercial Dragon II has shown evidence of clastogenic activity in the presence of S-9 mix, and in its absence when the cells were treated for 6 hours. Commercial Dragon II has shown no evidence of polypoidy-inducing activities
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