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Diss Factsheets
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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Deviations:
- not specified
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Limit test:
- no
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:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- see details study design
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 13 weeks, 7 days/week
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1 mg/kg of body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
15 mg/kg of body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
40 mg/kg of body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
200 mg/kg of body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg of body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- varies.
doses 1, 15, 40 and 200 mg/kg body weight have 10 animals of each sex per dose
doses 0 and 1000 mg/kg body weight have 20 animals of each sex per dose - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Five groups of 20 male and 20 female rats were dosed by oral gavage with Commercial Dragon II (0.01, 0.1, 1, 5 and 500 mg/kg/d) for 13 weeks. A control group of 20 male and 20 female rats were dosed with the vehicle (water). In addition two further groups of 10 male and 10 female rats from both the control and the high dose groups were continued for a recovery period of 8 weeks after the 13 weeks treatment period. Also satellite groups of 10 male and 10 female rats from the control and high dose groups were killed at the end of the 13 weeks treatment period and a range of tissues was taken for analysis of manganese.
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- Faecal analysis, urinalysis, heamatology and clinical chemistry examinations were performed. Histological changes were examined as well as manganese levels in a range of tissues.
- Sacrifice and pathology:
- see details on study design
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- changes in rats from top dose groups
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- changes in rats from top dose groups
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- changes in rats from top dose groups
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- dose level: Dose/concentration showing no effect
- Effect level:
- > 5 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Following an eight week recovery period most of these changes regressed or reverted to normal levels. All the males and five out of 10 of the females treated with 500 mg/kg/day showed an increase in the number of thyroid follicles.
Applicant's summary and conclusion
- Conclusions:
- The no observed adversed effect level (NOAEL) was greater than 5 mg/kg/d of Commercial Dragon II
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