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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 August to 23 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- 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: solution
- 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): platinum at 40 ppm; iridium, antimony and silicon at <10 ppm; rhodium at 6 ppm; manganese and tin at <5 ppm; ruthenium, gold, silver, aluminium, cobalt, copper, iron, magnesium, lead and zinc at <2 ppm; calcium, chromium and nickel at <1 ppm
- Composition of test material, percentage of components: 34.98% palladium
- Isomers composition: no data
- 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: controlled room temperature (15-25°C, below 70% relative humidity), under inert gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan:(WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories S.r.l., S.Pietro al Natisone (UD), Zona Industriale Azzida, 57, 33040, Italy
- Age at study initiation: ~9-12 weeks
- Weight at study initiation: 166-203 g
- Fasting period before study: overnight
- Housing: individual caging (polypropylene/polycarbonate)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-24.7
- Humidity (%): 31-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Reception from: 21 August to 18 September 2013. Necrospy from: 10 September to 23 October 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: various
- Amount of vehicle (if gavage): various
- Justification for choice of vehicle: commonly used solvent
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw (1.7-2.0 ml/animal)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: LD50 expected to be between 300 and 2000 mg/kg bw - Doses:
- 550 or 2000 mg/kg bw
- No. of animals per sex per dose:
- 550 mg/kg bw: 2 females
2000 mg/kg bw: 5 females - Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: checked for clinical signs at 30 minutes, then 1, 2, 3, 4 and 6 hours after dosing. Then checked once daily for 14 days. Body weight measured on days -1, 0 (start of experiment), 7 and 14. Body weight of dead animals recorded at necropsy.
- Necropsy of survivors performed: yes (gross pathology of the cranial, thoracic and abdominal cavities) - Statistics:
- Not relevant
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- mortality
- Remarks on result:
- other: CL not determined.
- Mortality:
- Mortality was observed on days 1 and 12 in 2/5 animals receiving a single dose of palladium di(4-oxopent-2-en-2-oate) at 2000 mg/kg bw. No mortality was observed in the 2 animals treated with 550 mg/kg bw. See Table 1 in "any other information on results incl. tables" for details.
- Clinical signs:
- other: At 550 mg/kg bw, decreased activity and decreased general body tone was observed in one animal on days 2-5. The other animal remained symptom-free throughout the observation period. At 2000 mg/kg bw, the test item caused decreased activity, hunched back
- Gross pathology:
- Animals found dead:
Dark/red foci, found at the glandular mucosa of the stomach in 2/2 rats which were found dead, were considered to be potentially related to the administration of the test item. Other changes such as collapsed/non-collapsed lungs, dilatation of the stomach with gas, or clear liquid at the perinasal fur were regarded as agonal or post mortem.
Surviving animals (necropsy at day 14):
There were no macroscopic abnormalities in animals dosed at 550 mg/kg bw or in surviving rats dosed at 2000 mg/kg bw and terminated on Day 14. - Other findings:
- No data
Any other information on results incl. tables
Table 1. Mortality of animals treated via gavage with palladium di(4-oxopent-2-en-2-oate)
Animal Number |
Dosage (mg/kg bw) |
Dose volume (ml/animal) |
Viability/Mortality |
|
Short term |
Long term |
|||
2903 |
550 |
1.7 |
Survived |
Survived |
2904 |
2000 |
1.9 |
Survived |
Survived |
2905 |
2000 |
1.9 |
Died |
- |
2906 |
550 |
2.0 |
Survived |
Survived |
3477 |
2000 |
1.7 |
Survived |
Died |
3478 |
2000 |
1.9 |
Survived |
Survived |
3479 |
2000 |
2.0 |
Survived |
Survived |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity test (up and down procedure) on female rats, conducted to GLP and according to OECD Test Guideline 425, the LD50 for palladium di(4-oxopent-2-en-2-oate) was estimated to be 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of palladium (II) di(4-oxopent-2-en-2-oate) was assessed using the up and down procedure. The study was performed to GLP and according to OECD Test Guideline 425.
Female RccHan:(WIST) rats were treated with a single oral (gavage) dose of the test material (in distilled water) at 550 mg/kg bw (2 animals) or 2000 mg/kg bw (5 animals), before a 14-day observation period. Animals were checked for clinical signs of toxicity, and effects on body weight. Rats were subject to gross necropsy upon death or terminal killing.
Two of the five animals treated with 2000 mg/kg bw died, while neither of the two animals treated with 550 mg/kg bw died. Under the conditions of this study, the acute oral LD50 was estimated to be about 2000 mg/kg bw in female rats. The test compound would therefore be cautiously classified as Category 4 for acute toxicity via the oral route under the EU CLP regulation.
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