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EC number: 241-230-3 | CAS number: 17185-29-4
- 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:
- key study
- Study period:
- Not stated but QA inspections on 07-Jan-1991 and 15-Jan-1991 during the experimental phase
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Carbonylhydrotris(triphenylphosphine)rhodium
- EC Number:
- 241-230-3
- EC Name:
- Carbonylhydrotris(triphenylphosphine)rhodium
- Cas Number:
- 17185-29-4
- Molecular formula:
- C55H46OP3Rh
- IUPAC Name:
- carbonylhydrotris(triphenylphosphine)rhodium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report): Carbonylhydridotris(triphenylphosphane)-rhodium(I)
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: >99%
- Impurities (identity and concentrations): not stated
- Composition of test material, percentage of components: not stated
- Isomers composition: not stated
- Purity test date: not stated
- Lot/batch No.: FM 36/4/90
- Expiration date of the lot/batch: not stated
- Stability under test conditions: stable
- Storage condition of test material: in a closed container at room temperature
- Other:
- Purity test method: gravimetric Rh analysis
- Solubility: insoluble in water and n-hexane, soluble in chloroform (1 g/60 ml), soluble in acetone (1 g/ 100 ml)
- pH: ~7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG
- Age at study initiation: male 8 months, females 8 and 10 months
- Weight at study initiation: male 2.74 kg, females 2.90 and 3.17 kg
- Housing: stainless steel cages with grating floor, type ASTA, 48.5 cm (l) x 40 cm (b) x 36.5 cm (h); 1/cage
- Diet (e.g. ad libitum): ~120 g/animal per day; standard diet, Ssniff K, special diet for rabbits
- Water (e.g. ad libitum): municipal water supply, using an automatic drinking water system with drinking nipples, ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 40-55
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Not stated but QA inspections on 07-Jan-1991 and 15-Jan-1991 during the experimental phase
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each animal was not treated and acted as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.038 or 0.032 g (approximate volume 0.1 ml)
- Concentration (if solution): not applicable
VEHICLE: none - Duration of treatment / exposure:
- Treated eyes not rinsed but physiological processes would be expected to result in the removal of the test substance
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable
SCORING SYSTEM: Observations made at 1, 24, 48 and 72 after application of test material; signs of irritation assessed qualitatively and quantitatively using Draize scale - cornea (opacity 0-4, area involved 1-4), iris (0-2) and conjunctiva (redness 0-3, chemosis 0-4, discharge 0-3); irritation index calculated as the sum of these scores (0-110); graded according to Gilman et al., 1983
TOOL USED TO ASSESS SCORE: Cliptrix pencil light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Overall irritation index: 2;
Cornea - opacity and area involved: 0 for all 3 animals at all 4 time points;
Iris: 0 for all 3 animals at all 4 time points;
Conjunctiva - redness - 1, 24, 48 and 72 hours: 1, 2, 1 and 0 (#1), 1, 1, 0, 0 (#2), 0, 1, 1 0 (#3);
Conjunctiva - chemosis: 0 for all 3 animals at all 4 time points;
Conjunctiva - discharge: 2 for all 3 animals at 1 hour, 0 for all 3 animals at all other time points;
No effects in untreated eye of each animal - Other effects:
- No systemic toxicity; no effect on general condition of animals
Any other information on results incl. tables
Table 1: Individual irritation scores
Ocular lesions | Time after exposure/hr | Draize grade | ||
Animal 1 | Animal 2 | Animal 3 | ||
Corneal opacity | 1 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | |
Corneal area | 1 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | |
Iris | 1 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | |
Conjunctival redness | 1 | 1 | 1 | 0 |
24 | 2 | 1 | 1 | |
48 | 1 | 0 | 1 | |
72 | 0 | 0 | 0 | |
Conjunctival chemosis | 1 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | |
Conjunctival discharge | 1 | 2 | 2 | 2 |
24 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 |
EU criteria: classification in category 2 applies when a positive response is seen in >=2/3 treated animals at >=1 for cornea and/or >=1 for iris and/or >=2 conjunctival redness and/or >=1 for conjunctival oedema, calculated as a mean score at 24, 48 and 72 hours
This calculation produces mean values of 0 for cornea for all 3 animals, 0 for iris for all 3 animals, 1, 0.3 and 0.7 for conjunctival redness for the 3 animals respectively, 0 for conjunctival discharge; therefore category 2 does not apply and the test material is classified as non-irritant by EU criteria
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, carbonylhydridotris(triphenylphosphane)-rhodium(I) was not irritating to rabbit eyes following instillation of 0.038 or 0.032 g (volume 0.1 mL) of the test material to the conjunctival sac of 3 animals.
- Executive summary:
The eye irritation potential ofcarbonylhydridotris(triphenylphosphane)-rhodium(I) was evaluated in White Russian rabbits in a study conducted in accordance with OECD Test Guideline 405 and to GLP. A quantity of 0.038 or 0.032 g (volume 0.1 mL) of the test material was placed in the conjunctival sac of 3 animals. The other eye of each animal was not treated and acted as a control. The treated eyes were evaluated at 1, 24, 48 and 72 hr after application and scored for irritation of the cornea, iris and conjunctiva according to the Draize system.
No effects were seen on the cornea or iris of any animal at any time point. Slight or moderate redness was seen in the conjunctivae of all animals, but this had reversed after 72 hr. Moderate conjunctival discharge was seen in all animals at 1 hr, but this had reversed after 24 hr. No corrosive or systemic effects were noted.
Based on the results of this study, no classification for eye irritation is required according to EU CLP criteria (EC 1272/2008).
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