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EC number: 411-760-1 | CAS number: 116633-53-5 COMMERCIAL DRAGON II
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
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:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
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
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Aqueous 1% methylcellulose
- Details on exposure:
- A preliminary toxicity test had previously shown that 2000 mg/kg, which is the maximum recommended dose for this assay was tolerated.
- Duration of treatment / exposure:
- Sacrifice times: 24 and 40 hour
- Frequency of treatment:
- single acute oral administration
- Post exposure period:
- 48 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The positive control group was treated with mitomycin C at 12 mg/kg body weight
Examinations
- Tissues and cell types examined:
- Erythrocytes
- Details of tissue and slide preparation:
- no data
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- At the 48 hour sampling time mice treated with Commercial Dragon II did not show any significant increase in the frequency of micronucleated polychromatic erythrocytes. At the 24 hour sampling time a small but statistically significant increase in the incidence of micronuleated cells was obtained for the intermediate dose level of the test substance. However there was no evidence of a dose-response and all groups means as well as individual incidences of micronucleated cells for Commercial Dragon II at this sampling time fell well within the historical control range.
There was no substantial decrease in the ratio of polychromatic to normochromatic erythrocytes after treatment of the animals with Commercial Dragon II.
The positive control compound produced large, highly significant increases in the frequency of micronucleated polychromatic erythrocytes together with decrease in the ratio of polychromatic to normochromatic erythrocytes.
Any other information on results incl. tables
DOSES PRODUCING TOXICITY: Clinical signs consisting of pilo-erection were seen in both male and female animals, up to 3 hours after dosing.
OBSERVATIONS: At the 24 hour sampling time a small but statistically significant increase (P<0.001) in the incidence of micronucleated cells was obtained for the intermediate dose level of the substance. however there was no evidence of a dose response relationship and all group means and individual incidences of micronucleated cells at this time point fell within the historical control range. A re-examination of the slides from the 24 hour sampling time by a second slide reader failed to show any significant increase of micronucleated cells. The test substance did not cause any statistically significant increase in the number of micronucleated polychromatic erythocytes at the 48 hour sampling time.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Commercial Dragon II has not shown any evidence of causing chromosome damage in this in vivo test - Executive summary:
Results: Negative
Sacrifice times: After 24 and 40 hours
OBSERVATIONS: At the 24 hour sampling time a small but statistically
significant increase (P<0.001) in the incidence of
micronucleated cells was obtained for the intermediate dose
level of the test substance. However there was no evidence
of a dose-response relationship and all group means and individual
incidences of micronucleated cells at this time point fell
within the historical control range. A re-examination of
the slides from the 24 hour sampling time by a second slide
- reader failed to show any significant increase of
micronucleated cells.
The test substance did not cause any statistically
significant increase in the number of micronucleated
polychromatic erythocytes at the 48 hour sampling time.
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