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EC number: 259-653-7 | CAS number: 55466-76-7
- 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 a guideline study, to GLP, no irritation potential was observed when ruthenium acetate was applied (under occlusion for 4 hr) to the clipped, intact skin of three rabbits (Allen 1995b).
In a GLP eye irritation study, according to OECD guidelines, ruthenium acetate (0.1 g) produced severe eye irritation following instillation into the eye of a single rabbit (Allen, 1995c).
No relevant respiratory tract data were identified.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-Nov-1995 to 12-Nov-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.38-2.48 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Stanrab SQC rabbit diet, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: >=5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18
- Humidity (%): 56-65
- Air changes (per hr): ~15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 09-Nov-1995 To: 12-Nov-1995- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable, crystalline solid moistened with water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): not applicable, solid test material moistened with water
- Lot/batch no. (if required): not applicable
- Purity: not stated, distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: not stated
- Type of wrap if used: cotton gauze patch (2.5 cm x 2.5 cm) secured with Blenderm (2.5 cm x 4.0 cm) (note: this is an occlusive tape), trunk wrapped in an elasticated Tubigrip corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gentle swabbing with cotton wool soaked in distilled water, followed by 74% Industrial Methylated Spirits
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize (erythema and eschar 0-4, oedema 0-4; primary irritation index calculated as total of scores for both endpoints, for both timepoints, for all 3 rabbits (12 values) divided by 6; classification according to Draize scheme)- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24- and 72-hour timepoints combined
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No skin reactions (erythema or oedema) were seen at any timepoint (1, 24, 48 and 72 hours after removal of patches) in any of the 3 test animals; scores of 0.0 were recorded on each occasion giving a primary irritation index of 0.0
- Other effects:
- Faint green/black staining at all treatments sites
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, no irritation potential was observed when ruthenium acetate was applied (under occlusion for 4 hr) to the clipped, intact skin of three rabbits.
- Executive summary:
In an OECD Test Guideline 404 study, conducted according to GLP, ruthenium acetate (0.5 g, moistened with 0.5 mL water) was applied (occluded) to the clipped intact skin of 3 New Zealand White rabbits. After 4 hours, the dressings were removed and the treated skin sites were washed and subsequently observed for erythema and oedema 1, 24, 48 and 72 hours.
No skin reactions were recorded at any time point in any animal during the 72-hr observation period. The primary dermal irritation index was therefore 0, and ruthenium acetate was classified as a non-irritant to rabbit skin under the conditions of the test.
No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22-Nov-1995 to 23-Nov-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.72 kg
- Housing: singly in a suspended metal cage
- Diet (e.g. ad libitum): Stanrab SQC rabbit diet, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: >= 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18
- Humidity (%): 68-69
- Air changes (per hr): ~15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 22-Nov-1995 To: 23-Nov-1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- Test substance not washed from eyes, but presumably physiological mechanisms acted to remove it; eyes examined at 1 and 24 hours
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize
- cornea (degree of opacity 0-4, area of opacity 1-4, total = 5 x product of scores (max 80))
- iris (0-2, total = 5 x score (max 10))
- conjunctivae (redness 0-3, chemosis 0-4, discharge 0-3, total = 2 x sum of 3 scores (max 20))
- maximum total score 110
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope - Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 17
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 5
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 12
- Max. score:
- 20
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 63
- Max. score:
- 110
- Reversibility:
- other: animal humanely killed at 24 hours
- Remarks on result:
- other: severe irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 40
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 5
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 18
- Max. score:
- 20
- Irritant / corrosive response data:
- At 1 hour: cornea 0 (degree of opacity 0 with dulling of the normal lustre of the corneal surface and black-coloured staining, area of opacity 4), iris 5 (1 with black-coloured staining), conjunctivae 12 (redness 2 with black-coloured staining, chemosis 2, discharge 2 with residual test material around eye), total 17;
At 24 hours: cornea 40 (degree of opacity 2 with black-coloured staining, area of opacity 4), iris 5 (1 with black-coloured staining), conjunctivae 18 (redness 2 with black-coloured staining, chemosis 4, discharge 3 with residual test material around eye) - Other effects:
- Signs of pain and discomfort at 24 hours (therefore animal killed for humane reasons)
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline eye irritation study, according to GLP, ruthenium acetate (0.1 g) produced severe eye irritation following instillation into the eye of a single rabbit.
- Executive summary:
In an in vivo rabbit eye irritation study, conducted in accordance with OECD Test Guideline 405 and to GLP, ruthenium acetate (0.1 g) was instilled into one eye of a single New Zealand white rabbit. Observations of the cornea, iris and conjunctiva were made at 1 and 24 hr after application and the Draize scale was used to assess the degree of irritation.
The total eye irritation score was 17 (out of 110) at 1 hr and 63 (out of 110) at 24 hr. Due to signs of pain and discomfort the animal was killed immediately after the 24-hr time point and no further animals were tested. The 24-hr score indicated that the test substance was a severe eye irritant.
As the results were based on only one rabbit, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant irritation/corrosion human data were identified.
In an OECD Test Guideline 404 study, conducted according to GLP, ruthenium acetate (0.5 g, moistened with 0.5 mL water) was applied (occluded) to the clipped intact skin of 3 New Zealand White rabbits. After 4 hours, the dressings were removed and the treated skin sites were washed and subsequently observed for erythema and oedema 1, 24, 48 and 72 hours. No skin reactions were recorded at any time point in any animal during the 72 -hr observation period. The primary dermal irritation index was therefore 0, and ruthenium acetate was classified as a non-irritant to rabbit skin under the conditions of the test (Allen, 1995b).
In an in vivo rabbit eye irritation study, conducted in accordance with OECD Test Guideline 405 and to GLP, ruthenium acetate (0.1 g) was instilled into one eye of a single New Zealand white rabbit. Observations of the cornea, iris and conjunctiva were made at 1 and 24 hr after application and the Draize scale was used to assess the degree of irritation. The total eye irritation score was 17 (out of 110) at 1 hr and 63 (out of 110) at 24 hr. Due to signs of pain and discomfort the animal was killed immediately after the 24-hr time point and no further animals were tested. The 24-hr score indicated that the test substance was a severe eye irritant (Allen, 1995c).
No
respiratory tract data were identified. A new study was not conducted as
it is not a REACH Standard Information Requirement.
Justification for classification or non-classification
Based on the results of the available reliable skin and eye irritation studies (in rabbits), hexakis[mu-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate / ruthenium acetate need not be classified for skin irritation, but should be classified for eye damage (category 1), according to EU CLP criteria (EC 1272/2008).
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