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EC number: 235-219-2 | CAS number: 12135-22-7
- 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
No relevant acute oral, dermal or inhalation toxicity data were identified with palladium dihydroxide.
Via a weight-of-evidence argumentation, the registrants consider it justified to avoid in vivo testing for acute toxicity(oral) for this substance (as exemplified in ECHA Guidance R.7a Figure 7.4-4) and consider the substance of low acute hazard via the oral route with an assumed LD50>2000 mg/kg(bw). Based on this experimental evidence, palladium dihydroxide is considered to have an LD50>2000 mg/kg(bw).
The substance is also considered to fall withing the scope of the read-across category 'Palladium, palladium monoxide and Palladium dihydroxide'. In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: weight of evidence justification
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Weight-of-Evidence argumentation
- GLP compliance:
- no
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Via a weight-of-evidence argumentation, the registrants consider it justified to avoid in vivo testing for acute toxicity(oral) for this substance (as exemplified in ECHA Guidance R.7a Figure 7.4-4) and consider the substance of low acute hazard via the oral route with an assumed LD50>2000 mg/kg(bw).
- Executive summary:
Via a weight-of-evidence argumentation, the registrants consider it justified to avoid in vivo testing for acute toxicity(oral) for this substance (as exemplified in ECHA Guidance R.7a Figure 7.4-4) and consider the substance of low acute hazard via the oral route with an assumed LD50>2000 mg/kg(bw).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted prior to standard OECD/EU test guidelines and GLP. While there is somewhat limited reporting of methods and results, the study appears scientifically acceptable.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In the lethal dose experiments, male Sprague-Dawley rats received the tested palladium salt by gavage and were observed through a 14-day period. The LD50 values were calculated by the method of Litchfield and Wilcoxon. The exact dosing strategy is unclear and no details on pathological assessment are given.
- GLP compliance:
- no
- Remarks:
- (prior to GLP)
- Test type:
- other: No data
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 100-110 g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): Presumably ad libitum
- Water (e.g. ad libitum): Presumably ad libitum
- Acclimation period: 1-1.5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No data - Statistics:
- The LD50 values were calculated by the method of Litchfield and Wilcoxon.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 900 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL was not determined
- Mortality:
- Palladium salts often kill 4-10 days after administration. An LD50 of >40 mmol/kg bw, using a molecular weight of approximately 122.42 g/mol, equates to >4896.8 mg/kg bw.
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study, an LD50 of greater than 4.9 g/kg bw was reported in male rats gavaged with palladium monoxide, and observed for up to 14 days.
- Executive summary:
In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw.
Based on the results of this study, palladium monoxide should not be classified for acute oral toxicity according to EU CLP criteria (EU 1272/2008).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted prior to standard OECD/EU test guidelines and GLP. While there is somewhat limited reporting of methods and results, the study appears scientifically acceptable.
- Justification for type of information:
- Substance considered to fall within the scope of the read-across category 'Palladium, Palladium monoxide and Palladium dihydroxide'
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In the lethal dose experiments, male Sprague-Dawley rats received the tested palladium salt by gavage and were observed through a 14-day period. The LD50 values were calculated by the method of Litchfield and Wilcoxon. The exact dosing strategy is unclear and no details on pathological assessment are given.
- GLP compliance:
- no
- Remarks:
- (prior to GLP)
- Test type:
- other: No data
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 100-110 g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): Presumably ad libitum
- Water (e.g. ad libitum): Presumably ad libitum
- Acclimation period: 1-1.5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No data - Statistics:
- The LD50 values were calculated by the method of Litchfield and Wilcoxon.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 900 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL was not determined
- Mortality:
- Palladium salts often kill 4-10 days after administration. An LD50 of >40 mmol/kg bw, using a molecular weight of approximately 122.42 g/mol, equates to >4896.8 mg/kg bw.
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study, an LD50 of greater than 4.9 g/kg bw was reported in male rats gavaged with palladium monoxide, and observed for up to 14 days.
- Executive summary:
In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw.
Based on the results of this study, palladium monoxide should not be classified for acute oral toxicity according to EU CLP criteria (EU 1272/2008).
The substance is considered to fall within the scope of the read-across category 'Palladium, Palladium monoxide and Palladium dihydroxide'
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- database is considered reliable and consistent to fill the REACH information requirements
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant human or laboratory animal acute toxicity data were identified with palladium dihydroxide as test item.
Via a weight-of-evidence argumentation, the registrants consider it justified to avoid in vivo testing for acute toxicity(oral) for this substance (as exemplified in ECHA Guidance R.7a Figure 7.4-4) and consider the substance of low acute hazard via the oral route with an assumed LD50>2000 mg/kg(bw).
The substance is considered to fall withing the scope of the read-across category 'Palladium, palladium monoxide and Palladium dihydroxide'. In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw.
Based on this experimental evidence, palladium dihydroxide is considered to have an LD50>2000 mg/kg(bw).
The substance 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 (Selck and Parr 2012 a,b - cf section 4.5).
Since a substance is required to be bioavailable in order to induce systemic toxicity following acute exposure, palladium dihydroxide is not considered to pose an acute toxicity hazard. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered a last resort. Consequently, no testing for acute toxicity of palladium dihydroxide is considered justified.
Justification for classification or non-classification
No acute toxicity data are available for palladium dihydroxide. However, such effects are not expected, based on a lack of bioavailability following exposure via the oral, dermal and inhalation routes, and read-across from palladium monoxide and palladium dihydroxide. As such, there is no evidence to classify palladium dihydroxide for acute toxicity 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.
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