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EC number: 237-859-8 | CAS number: 14024-61-4
- 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:
- 27 March-17 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, to GLP, with minor humidity deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Minor humidity deviations were expected to have no impact on the study outcome
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Minor humidity deviations were expected to have no impact on the study outcom
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Remarks:
- Minor humidity deviations were expected to have no impact on the study outcom
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Palladium di(4-oxopent-2-en-2-oate)
- IUPAC Name:
- Palladium di(4-oxopent-2-en-2-oate)
- Reference substance name:
- Palladium (II) di(4-oxopent-2-en-2-oate)
- EC Number:
- 237-859-8
- EC Name:
- Palladium (II) di(4-oxopent-2-en-2-oate)
- Cas Number:
- 14024-61-4
- Molecular formula:
- C10H14O4Pd
- IUPAC Name:
- Palladium (II) di(4-oxopent-2-en-2-oate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Palladium(II)di(4-oxopent-2-en-2-oate)
- Substance type: Technical product
- Physical state: Solid (yellow powder)
- Analytical purity:>99.5% (palladium content 34.96%)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components (in ppm): Pt (30); Ru (<2); Rh (<5); Ir (<2); Au (<2); Ag (<2); Al (<2); Ca (32); Co (<2); Cr (<1); Cu (<2); Fe (2); Mg (5); Mn (<1); Ni (<1); Pb (<3); Sb (<5); Si (<10); Sn (<5); Zn (<1)
- Purity test date: 14 December 2011
- Lot/batch No.:11011
- Expiration date of the lot/batch: 13 December 2012
- Stability under test conditions: no data
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)
- pH of test material: 6.01
Constituent 1
Constituent 2
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: ~12 weeks
- Body weight range at the beginning of the in-life phase: 3119 – 3200 g
- Body weight range at the end of the in-life phase: 3658 – 3752 g
- Housing: individually in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum): Purina and UNI diet (Lot number: 00701211, 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: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 24 – 61 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Following instillation into the conjunctival sac of one eye, the eyelids were held closed for several seconds. Washing with physiological saline was performed at 24, 48 and 72 hours.
- Observation period (in vivo):
- 3 weeks (The eyes were examined at 1, 24, 48, 72 hours, 1, 2 and 3 weeks after treatment).
- Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- Washing with physiological saline was performed at 24, 48 and 72 hours.
The eyes were examined at 1, 24, 48, 72 hours, 1, 2 and 3 weeks after treatment. The nature, severity and duration of all lesions observed were described.
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002).
TOOL USED TO ASSESS SCORE: none reported; presumably subjective observation by an experienced evaluator
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Remarks:
- Conjunctival chemosis
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 3.78
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: In one animal, chemosis persisted until study termination at 3 weeks
- Irritation parameter:
- other: Conjunctival discharge
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Discharge persisted in one animal until study termination at 3 weeks
- Irritation parameter:
- other: Conjunctival redness
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 2.56
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Redness persisted in two animals until study termination at 3 weeks
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity, degree of density
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Corneal opacity persisted in one animal until study termination at 3 weeks
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: The iris was not affected in any animal at any time point
- Irritant / corrosive response data:
- Initial Pain Reaction (IPR) (score 2) was observed in all animals.
One hour after the application: Conjunctival redness (score 2), discharge (score 3) and chemosis (score 2) were found in all animals. Two rabbits showed corneal opacity (score 1, area 4). The initial test in one rabbit showed no corneal effect at 1 hour.
At 24 hours after treatment: Conjunctival redness (score 2 or 3), discharge (score 3) and chemosis (score 3 or 4) were found in all animals. Additionally, corneal opacity (score 1 or 2, area 4) was seen in all animals.
At 48 hours after treatment: Conjunctival redness (score 2 or 3), discharge (score 3) and chemosis (score 4) were found in all animals. Additionally, corneal opacity (score 1 or 2, area 4) was seen in all animals. Surface damage on the conjunctivae and on the nictitating membrane was noted in all animals.
At 72 hours after treatment: Conjunctival redness (score 2 or 3), discharge (score 3) and chemosis (score 4) were found in all animals. Additionally, corneal opacity (score 1 or 2, area 4) was seen in all animals. Surface damage on the conjunctivae and on the nictitating membrane was noted in all animals.
At 1 week after treatment: Conjunctival redness (score 2 or 3), discharge (score 1, 2 or 3) and chemosis (score 1 or 2) were found in all animals. Additionally, corneal opacity (score 1 or 2, area 4) was seen in all animals. Surface damage on the conjunctivae and on the nictitating membrane was noted in one animal.
At 2 weeks after treatment: Conjunctival redness (score 1) and/or discharge (score 1) was found in two animals. Conjunctival chemosis (score 1) was observed in all animals. Corneal opacity (score 2, area 4) and surface damage on the conjunctivae and on the nictitating membrane was noted in one animal.
At 3 weeks after treatment: Conjunctival redness (score 1) was found in two animals. Conjunctival chemosis (score 1) and discharge (score 2) was observed in one animal. One rabbit showed corneal opacity (score 2, area 2).
During the study, the control eye of each animal was symptom-free.
The individual mean scores for each animal (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
chemosis : 3.67, 3.67, 4.00
discharge : 3.00, 3.00, 3.00
redness : 2.67, 2.00, 3.00
cornea opacity : 1.00, 1.00, 2.00
iris : 0.00, 0.00, 0.00
Surface damage on the conjunctivae and on the nictitating membrane was seen in all animals at 48 and 72 hours, and in one animal at 1 and 2 weeks. - Other effects:
- 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)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an OECD Test Guideline 405 study, to GLP, palladium di(4-oxopent-2-en-2-oate) was shown to cause significant conjunctival and corneal irritant effects in the eyes of New Zealand white rabbits within 1 hr of instillation, which were not fully reversible within the 3-week observation period.
- 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 powdered palladium di(4-oxopent-2-en-2-oate) was instilled into the conjunctival sac of one eye of 3 male New Zealand White rabbits. Following instillation the eyelids were held closed for several seconds. Washing with physiological saline was performed at 24, 48 and 72 hr. The eyes were examined at 1, 24, 48, 72 hr, 1, 2 and 3 weeks after treatment, and scored according to the Draize system.
Significant conjunctival redness, discharge, and chemosis were seen in all animals, and corneal opacity in 2 rabbits, within 1 hr of instillation. These were not fully reversible within the 3-week observation period. According to EU CLP criteria (EC 1272/2008), palladium di(4 -oxopent-2 -en-2 -oate) should be classified as Category 1 (irreversible effects on the eye).
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