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EC number: 286-924-7 | CAS number: 85392-65-0
- 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
Endpoint summary
Administrative data
Description of key information
In an OECD guideline GLP study, the acute oral LD50 value for tetraammonium decachloro-mu-oxodiruthenate was calculated to be 3110 mg/kg bw following gavage administration in female rats (Haferkorn, 2016).
No relevant acute dermal or inhalation toxicity data were identified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jan - 12 Feb 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- yes
- Remarks:
- Minor deviation: the dose level of 5000 mg/kg bw was administered as a volume of 20 ml/kg bw (concentration 250 mg/ml) as a concentration of 500 mg/ml 'was not applicable'
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CD / Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany.
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 170-205 g
- Fasting period before study: Approx. 16 hours.
- Housing: During the 14-day observation period the animals were kept individually in MAKROLON cages (type III plus). Granulated textured wood was used as bedding material for the cages, which were chaanged and cleaned twice a week. The rooms were lit and darked for 12 hour periods.
- Diet (e.g. ad libitum): Commercial ssniff® R/M-H V1534 produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum.
- Water (e.g. ad libitum): drinking water in bottles was offered ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 (maximum range)
- Humidity (%): 40 - 70 (maximum range)
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 55, 175 and 250 mg/mL.
- Amount of vehicle (if gavage): 1.7-1.8 mL for the dose levels 550 and 1750 mg/kg bw; 3.6-4.2 mL for the dose level 5000 mg/kg bw.
- Justification for choice of vehicle: Not specified.
- Lot/batch no. (if required): MKBQ9948V, Sigma-Aldrich
- Purity: Not specified.
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Rationale for the selection of the starting dose: Available information on two other ruthenium salts indicated an oral LD50 in rats between 595 and >2000 mg/kg bw. Thus the study was started with the Main Test at 550 mg/kg bw (from the sequence 1.75, 5.5, 17.5, 55, 175, 550, 1750 and 5000 mg/kg bw). - Doses:
- 550,
1750 or
5000 mg/kg bw - No. of animals per sex per dose:
- 1 (in the 550 mg/kg bw dose group); 3 (in the 1750 mg/kg bw dose group); 3 (in the 5000 mg/kg bw dose group).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. Body weights were recoded before administration and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
- Observations: these included the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsies: macroscopic examination of dissected animals. - Statistics:
- The LD50 value and the confidence interval were calculated using the software “AOT425statpgm (Version:1.0)”
[Acute Oral Toxicity (OECD Test Guideline 425) Statistical Programme (AOT 425 StatPgm). Version: 1.0, 2001.] - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 110 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 750 - <= 5 000
- Mortality:
- All 3 animals of the 5000 mg/kg bw dose group died within 4 days after administration (2 of them died within 2 days after administration). None of the animals of the 550 and 1750 mg/kg bw dose groups died prematurely.
- Clinical signs:
- Reduced motility, ataxia, reduced muscle tone, dyspnoea, piloerection and vocalization observed in 1 of 3 animals in the 5000 mg/kg bw dose group.
- Body weight:
- All surviving animals gained the expected body weight.
- Gross pathology:
- No pathological findings were noted at necropsy.
- Other findings:
- None.
- Interpretation of results:
- other: No classification required under CLP
- Conclusions:
- In a OECD guideline study, to GLP, the acute oral LD50 value for tetraammonium decachloro-mu-oxodiruthenate was calculated to be 3110 mg/kg bw following gavage administration in female rats.
- Executive summary:
The acute oral toxicity of tetraammonium decachloro-mu-oxodiruthenate was assessed in female rats, in a study carried out in accordance with OECD Test Guideline 425 and to GLP. Animals were treated by gavage with the test material (in corn oil) at doses of 550 (1 animal), 1750 (3 animals) or 5000 (3 animals) mg/kg body weight. Macroscopic examination was conducted on surviving animals.
There were no deaths, clinical signs, or effects on growth during the 14-day observation period for animals in the 550 and 1750 mg/kg bw dose groups. In the high dose group (5000 mg/kg bw) however, all 3 animals died within 4 days of administration of the test material and clinical signs of toxicity were apparent in one animal. There were no notable external or internal macroscopic findings upon necropsy in any of the treated animals.
The acute oral median lethal dose (LD50) of tetraammonium decachloro-mu-oxodiruthenate was calculated to be 3110 mg/kg bw using the Acute Oral Toxicity (OECD Test Guideline 425) Statistical Programme (AOT 425 Stat Pgm) software.
Based on the results of this study, the substance does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 110 mg/kg bw
- Quality of whole database:
- Overall, good-quality database which meets REACH Standard Information Requirements.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant acute toxicity human data were identified.
The acute oral toxicity of tetraammonium decachloro-mu-oxodiruthenate was assessed in female rats, in a study carried out in accordance with OECD Test Guideline 425 and to GLP. Animals were treated by gavage with the test material (in corn oil) at doses of 550 (1 animal), 1750 (3 animals) or 5000 (3 animals) mg/kg body weight. Macroscopic examination was conducted on surviving animals. There were no deaths, clinical signs, or effects on growth during the 14-day observation period for animals in the 550 and 1750 mg/kg bw dose groups. In the high dose group (5000 mg/kg bw) however, all 3 animals died within 4 days of administration of the test material and clinical signs of toxicity were apparent in one animal. There were no notable external or internal macroscopic findings upon necropsy in any of the treated animals. The acute oral median lethal dose (LD50) of tetraammonium decachloro-mu-oxodiruthenate was calculated to be 3110 mg/kg bw using the Acute Oral Toxicity (OECD Test Guideline 425) Statistical Programme (AOT 425 Stat Pgm) software (Haferkorn, 2016).
No acute inhalation toxicity data were identified. However, the compound is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure. Similarly, no acute dermal toxicity data were identified. However, this study does not need to be conducted as the substance does not meet the CLP criteria for classification for acute toxicity by the oral route.
Justification for classification or non-classification
Based on the results of the available and reliable acute oral rat study, tetraammonium decachloro-mu-oxodiruthenate does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
No evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.
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