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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 23 March 2012 - 03 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The relative humidity was occasionally out of the target range during the study and the acclimatisation period, and the draft report was issued later than indicated in the study plan.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetraammonium decachloro-μ- oxodiruthenate
- IUPAC Name:
- Tetraammonium decachloro-μ- oxodiruthenate
- Reference substance name:
- Tetraammonium decachloro-μ-oxodiruthenate(4-)
- EC Number:
- 286-924-7
- EC Name:
- Tetraammonium decachloro-μ-oxodiruthenate(4-)
- Cas Number:
- 85392-65-0
- Molecular formula:
- Cl10ORu2.4H4N
- IUPAC Name:
- tetraammonium decachloro-μ-oxodiruthenate(4-)
- Reference substance name:
- Tetraammonium decachloro-μ-oxodiruthenate (IV)
- IUPAC Name:
- Tetraammonium decachloro-μ-oxodiruthenate (IV)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Tetraammonium decachloro-μ-oxodiruthenate
- Substance type: Technical product
- Physical state: solid (brown powder)
- Analytical purity: >95%
- Composition of test material, percentage of components: 28.73% ruthenium
-Impurities: Ammonium chloride (0.7%), water (4.0%) and 'metallic impurities' (0.3%).
- Purity test date: 20 July 2015
- Lot/batch No.: 10111
- Expiration date of the lot/batch: 31 July 2012
- Storage condition of test material: Room temperature
- pH: 2.54
The purity analysis was performed in 2015 (after the experimental period, and after the expiration date of the test article). The analytical purity of the substance seems to have in that time decreased from 99% to 95%. This has had no influence on the results of this study, and the compound is still valid with regards to its chemical specifications.
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár road 135, Hungary
- Age at study initiation: approximately 11 weeks
- Weight at study initiation: 2727 g
- Housing: AAALAC approved metal wire rabbit cages of an open wire structure, placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet (e.g. ad libitum): Purina and UNI diet (Lot number: 0030 03 12 and 0060 04 12) for rabbits, produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water (e.g. ad libitum): municipal tap water, as for human consumption, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 24 – 67 % (relative humidity)
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item. Rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72 hours, 1, 2 and 3 weeks after treatment.
- Number of animals or in vitro replicates:
- 1 male
- Details on study design:
- Rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks.
Individual reactions of the animal were recorded at each observation time. The nature, severity and duration of all lesions observed were described.
Any clinical signs of toxicity or signs of ill- health during the study were recorded.
At the end of the observation period, the animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia.
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD guideline no. 405 shown (see below in "Any other information on materials and methods including tables").
TOOL USED TO ASSESS SCORE: apparently visual assessment, presumably by an experienced technician.
Results were presented and interpreted according to Regulation (EC) No 1272/2008, as follows:
Irreversible effects on the eye/serious damage to eyes (Category 1): Substances that have the potential to seriously damage the eyes are classified in Category 1 (irreversible effects on the eye). These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight.
Category for irreversible eye effects: If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days;
and/or
— at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 3 and/or iritis > 1.5 when calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
Reversible effects on the eye/irritating to eyes (Category 2): Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).
Category for reversible eye effects: If, when applied to the eye of an animal, a substance produces (at least in 2 of 3 tested animals) a positive response of:
- corneal opacity ≥ 1 and/or
- iritis ≥ 1, and/or
- conjunctival redness ≥ 2 and/or
- conjunctival oedema (chemosis) ≥ 2
... when calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Initial pain reaction
- Time point:
- other: 0 hr
- Score:
- 2
- Remarks on result:
- other: Based on this response, 2 additional animals were not treated
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 weeks
- Irritation parameter:
- other: Conjunctival discharge
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Maximum-scoring discharge continued until the end of the observation period of 3 weeks
- Irritation parameter:
- other: Conjunctival redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: The conjunctivae were discoloured black by the test item; redness of 3.00 was assumed for the reading 24 hours after exposure
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 weeks
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effects on the iris were reported
- Irritant / corrosive response data:
- One hour after the application: Conjunctival discharge (score 3), chemosis (score 2) and corneal opacity (score 2, area 4) were observed. The conjunctivae and the cornea were discoloured black by the test item, therefore observation of the redness of the iris and the conjunctivae was not possible.
At 24 hours after treatment: Conjunctival discharge (score 3), chemosis (score 2) and corneal opacity (score 1, area 4) were observed. The conjunctivae and the cornea remained discoloured black by the test item therefore observation of the redness of the iris and the conjunctivae was not possible.
At 48 and 72 hours after treatment: Conjunctival redness (score 3), discharge
(score 3), chemosis (score 2) and corneal opacity (score 1, area 4) were observed. The conjunctivae and the cornea remained discoloured black by the test item.
At 1 week after treatment: Conjunctival redness (score 2), discharge (score 3), chemosis (score 2) and corneal opacity (score 1, area 4) were observed. Test item residue was observed on the conjunctivae and on the nictitating membrane.
At 2 weeks after treatment: Conjunctival redness (score 2), discharge (score 3) and chemosis (score 2) were observed and corneal opacity (score 1, area 1) was seen in the animal. Test item residue was observed on the conjunctivae and on the nictitating membrane.
At 3 weeks after treatment: Conjunctival redness (score 2), discharge (score 3) and chemosis (score 1) were observed and corneal opacity (score 1, area 1) was seen in the animal. Test item residue was observed on the conjunctivae and on the nictitating membrane. - Other effects:
- The conjunctivae and the cornea were discoloured black by the test item; this colouration remained for 72 hours and, at the end of the 3-week observation period, test item residue remained on the conjunctivae and on the nictating membrane.
Any other information on results incl. tables
No mortality was observed during the study.
The body weight and body weight change were considered to be normal with no indication of treatment related effect.
There were no clinical signs observed that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline study, to GLP, tetraammonium decachloro-μ-oxodiruthenate caused immediate significant conjunctival and corneal irritant effects when applied to the eye of a single male rabbit, which were not fully reversible within 3 weeks.
- Executive summary:
In an in vivo eye irritation study carried out in accordance with OECD Test Guideline 405, and to GLP, 0.1 g of tetraammonium decachloro-μ-oxodiruthenate was instilled into the conjunctival sac of the left eye of a single male New Zealand White rabbit. Following instillation the eyelids were held closed for several seconds; rinsing with physiological saline was performed at 24 and 48 hours, and after 1 and 2 weeks. The other eye remained untreated and was used for control purposes. The eyes were examined at 1, 24, 48, 72 hours, as well as 1, 2 and 3 weeks after treatment, and scored according to the Draize system.
Immediate significant conjunctival and corneal irritant effects were observed within one hour that persisted at 72 hours and were not fully reversible within the 3-week observation period.
Based on the results of this study, the substance should be classified for serious eye damage (category 1) according to EU CLP criteria (EC 1272/2008).
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