Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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).
- 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)
- 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 - 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.
- 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).
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No relevant human sensitisation data were identified.
Migrated from Short description of key information:
Preliminary GLP studies were conducted prior to a planned OECD Test Guideline 429 mouse LLNA. Effects observed in the preliminary study were consistent with those of a strong sensitiser. The main study was not conducted, based on animal welfare considerations (Váliczkó, 2014).
Justification for selection of skin sensitisation endpoint:
Good quality preliminary study, to GLP, and the only skin sensitising study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No respiratory tract sensitisation data are available. A new study was not conducted as no standard and validated test method is available and it is not a REACH Standard Information Requirement. Further, the compound is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure.
Migrated from Short description of key information:
No respiratory tract sensitisation data are available.
Justification for classification or non-classification
Palladium di(4-oxopent-2-en-2-oate) showed clinical signs in mice consistent with a strong sensitiser in preliminary studies conducted prior to a guideline LLNA. As such, it should be classified as a skin sensitiser (Category 1). The data do not allow distinction between Category 1A and 1B. On a precautionary basis, the substance should be classified as Cat 1A according to EU CLP criteria (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.