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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 July to 26 August 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Preliminary tests for a guideline LLNA study performed to GLP. The main study was not performed on the basis of animal welfare, given that the test substance appeared to be a strong sensitiser in these preliminary tests. Humidity slightly exceeded the upper limit recommended by the guideline (77% vs 70%), as did test animal age (13 weeks, not 8-12 weeks, in one preliminary study).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Humidity slightly exceeded the upper limit recommended by the guideline (77% vs 70%), as did test animal age (13 weeks, not 8-12 weeks, in one preliminary study). These deviations are considered to have no impact on the results and integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Palladium (II) di(4-oxopent-2-en-2-oate)
- Substance type: No data
- Physical state: Yellow solid
- Analytical purity: "100%"
- Impurities (identity and concentrations) (ppm): platinum (40), rhodium (6), iridium, antimony and silicon (<10 each), manganese and tin (<5 each), ruthenium, gold, silver, aluminium, cobalt, copper, iron, magnesium, lead and zinc (<2 each), calcium, chromium and nickel (<1 each)
- Composition of test material, percentage of components: Palladium at 34.98%
- Purity test date: 29 May 2013
- Lot/batch No.: 21613
- Expiration date of the lot/batch: June 2014
- Stability under test conditions: No data
- Storage condition of test material: Room temperature, under inert gas, protected from heat and light
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 13 weeks in preliminary test 2 (no further data)
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): 31-77% during acclimation period (no further data)
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test 1: 10 or 25% (w/v)
Preliminary test 2: 2.5 or 5% (w/v)
Preliminary test 3: 0.5 or 1% (w/v) - No. of animals per dose:
- 2
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Tested in a range of solvents (N,N-dimethylformamide, methyl ethyl ketone, propylene glycol, dimethyl sulfoxide and Pluronic). Acetone/olive oil (AOO) was considered the best vehicle "taking into account the test item characteristics, its usage and requirements of the relevant OECD guideline". The highest achievable concentration was 25% (w/v).
- Irritation: Three preliminary tests were conducted (described throughout this IUCLID record; the "main" study was not conducted).
- Lymph node proliferation response: No data.
MAIN STUDY - Not conducted due to responses indicative of a strong sensitiser seen in the preliminary tests.
TREATMENT PREPARATION AND ADMINISTRATION: No data. - Positive control substance(s):
- other: Not required for preliminary study.
- Statistics:
- Not required for preliminary study.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Not calculated (main study not performed).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not calculated (main study not performed).
Any other information on results incl. tables
No evidence of erythema was seen in any animal. No mortality was observed. Marked body weight loss (of more than 5%) was seen in one animal treated with 25%, and both of the animals in the groups treated with 2.5, 5 and 10%. Clinical signs of toxicity included a hunched back in the groups treated with 10 or 25%. Alopecia was observed in the 0.5, 1, 2.5 and 5% dose groups. Scale was seen in the 1, 2.5 and 5% groups.
Increased ear thickness (>25%) was seen in all dose groups. Ear punch weights were outside the historical control range in the 2.5, 5, 10 and 25% dose groups.
The lymph nodes were larger than normal (subjectively) in all dose groups.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In preliminary studies conducted prior to a planned guideline local lymph node assay, performed to GLP, effects observed after treatment with palladium (II) di(4-oxopent-2-en-2-oate) were consistent with those of a strong skin sensitiser. The main study was not conducted, based on animal welfare considerations.
- Executive summary:
It was planned that the skin sensitising potential of palladium di(4-oxopent-2-en-2-oate) should be assessed in a mouse local lymph node assay (LLNA), performed in accordance with OECD Test Guideline 429, and to GLP. Preliminary irritation/toxicity studies were first conducted on groups of 2 female CBA/J Rj mice.
Initially, the test substance at 10 or 25% (in acetone: olive oil, 4:1) was applied dermally to mice. However, increased ear thickness was observed, without any visible erythema. Preliminary tests were subsequently performed on mice treated with 2.5 or 5%, and then on groups treated with 0.5 or 1%. Increased ear thickness was seen, without erythema, in all dose groups. Ear punch weight was above the historical control range in all but the lowest of the dose groups. The draining lymph nodes were also considered subjectively to be larger than normal in all dose groups.
As the dilution of irritant materials “will usually reduce the ear swelling to acceptable levels”, and no erythema was observed, the study investigator concluded that the observed results were indicative of sensitisation rather than irritation. For reasons of animal welfare, further animal use was therefore not considered justified, and the full LLNA was not performed.
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