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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-265-8 | CAS number: 10102-05-3
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
- See discussion section (Hazard via inhalation route: systemic effects following long-term exposure)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
- See discussion section (Hazard via dermal route: systemic effects following long-term exposure)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Hazard via inhalation route: systemic effects following long-term exposure
Justification and comments
No relevant repeated dose toxicity data were identified for palladium dinitrate. However, good support for the conclusion that a repeated dose toxicity study can be waived comes from two sources. Firstly, a consideration of the known toxicity and physico-chemical properties of this compound. Palladium dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another palladium (II) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of palladium(II) dihydroxide up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, palladium dinitrate would not be expected to cause any significant systemic toxicity.
Hazard via inhalation route: systemic effects following acute exposure
Justification and comments
DNELs for acute toxicity should be calculated if an acute toxicity hazard, leading to classification and labelling (i.e. under EU CLP regulations) has been identified and there is a potential for high peak exposures (this is only usually relevant for inhalation exposures).
There are no data in relation to acute inhalation exposure to palladium dinitrate. In a guideline (OECD TG 423) acute oral toxicity study in rats with palladium dinitrate, the LD50 value was determined to lie between 200 and 2000 mg/kg bw (van Huygevoort, 2003a). The compound is classified in Category 4 according to CLP criteria. An oral N(L)OAEL (for sub-lethal effects) could be modified into an inhalation N(L)OAEC using route-to-route extrapolation. However, ECHA (2012a) guidance on DNEL calculation notes that this “procedure introduces significant uncertainties especially in relation to what inhalation time-frame this extrapolated N(L)OAEC would represent, and the procedure is therefore discouraged”. “A qualitative risk characterisation for this endpoint could be performed for substances of very high or high acute toxicity classified in Category 1, 2 and 3 according to CLP…. when the data are not sufficiently robust to allow the derivation of a DNEL” (ECHA, 2012b). However, palladium dinitrate is classified in Category 4, so a qualitative assessment is not required.
Further, as the substance is marketed or used in a non solid or granular form, inhalation is not considered to be a significant route of exposure.
Hazard via inhalation route: local effects following long-term exposure
Justification and comments
There are no data in relation to respiratory tract irritation or sensitisation in humans or laboratory animals. Consequently, no worker-DNELs for respiratory tract irritation/corrosion or sensitisation have been calculated.
Palladium dinitrate is not classified as a skin sensitiser.
Palladium nitrate is considered corrosive to the skin (Lehmeier, 2013a,b, 2014) and therefore serious damage to eyes is implicit. Despite the lack of respiratory tract irritation data, it would appear prudent to assume that palladium nitrate would also irritate the respiratory tract if inhaled at sufficient levels/durations. According to ECHA (2012b) guidance “substances classified for skin corrosion Category 1B/1C in CLP” or “Serious eye damage Category 1 in CLP “… “which relate to corrosive or severe irritant effects to the eye or irritant effects to the eyes, respiratory tract and skin simultaneously, are allocated to the moderate hazard band on the basis that exposure to such corrosives, eye damaging or irritant substances should be well-controlled”. Therefore, consider recommended Risk Management Measures/Operational Conditions (RMMs/OCs) in Table E.3-1 of ECHA (2012b).
Hazard via inhalation route: local effects following acute exposure
Justification and comments
There are no data in relation to respiratory tract irritation or sensitisation in humans or laboratory animals. Consequently, no worker-DNEL for acute local effects in the respiratory tract has been calculated.
Palladium dinitrate is not classified as a skin sensitiser.
Palladium nitrate is considered corrosive to the skin (Lehmeier, 2013a,b, 2014) and therefore serious damage to eyes is implicit. Despite the lack of respiratory tract irritation data, it would appear prudent to assume that palladium nitrate would also irritate the respiratory tract if inhaled at sufficient concentrations/durations. According to ECHA (2012b) guidance “substances classified for skin corrosion Category 1B/1C in CLP” or “Serious eye damage Category 1 in CLP “… “which relate to corrosive or severe irritant effects to the eye or irritant effects to the eyes, respiratory tract and skin simultaneously, are allocated to the moderate hazard band on the basis that exposure to such corrosives, eye damaging or irritant substances should be well-controlled”. Therefore, consider recommended RMMs/OCs in Table E.3-1 of ECHA (2012b).
Hazard via dermal route: systemic effects following long-term exposure
Justification and comments
No relevant repeated dose toxicity data were identified for palladium dinitrate. However, good support for the conclusion that a repeated dose toxicity study can be waived comes from two sources. Firstly, a consideration of the known toxicity and physico-chemical properties of this compound. Palladium dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another palladium (II) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of palladium(II) dihydroxide up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, palladium dinitrate would not be expected to cause any significant systemic toxicity.
Hazard via dermal route: systemic effects following acute exposure
Justification and comments
DNELs for acute toxicity should be calculated if an acute toxicity hazard, leading to classification and labelling (i.e. under EU CLP regulations) has been identified and there is a potential for high peak exposures (this is only usually relevant for inhalation exposures).
No acute dermal toxicity study was conducted. In a guideline (OECD TG 423) acute oral toxicity study in rats with palladium dinitrate, the LD50 value was determined to lie between 200 and 2000 mg/kg bw (van Huygevoort, 2003a). The compound is classified in Category 4 according to CLP criteria. However, as high peak exposures are not anticipated, a DNEL for acute toxicity is considered unnecessary (particularly via the dermal route). Long-term DNELs for systemic effects are expected to be sufficient to ensure that adverse effects do not occur.
“A qualitative risk characterisation for this endpoint could be performed for substances of very high or high acute toxicity classified in Category 1, 2 and 3 according to CLP…. when the data are not sufficiently robust to allow the derivation of a DNEL” (ECHA, 2012b). However, palladium dinitrate is classified in Category 4, so a qualitative assessment is not required.
Hazard via dermal route: local effects following long-term exposure
Justification and comments
In guideline (OECD TG 435) in vitro membrane barrier tests, palladium dinitrate (as palladium dinitrate hydrate (solid), palladium dinitrate solution type H and palladium dinitrate solution) was classified as corrosive sub-category 1B under GHS, on the basis of mean breakthrough times of about 14, 3 -6 and 4 minutes, respectively (Lehmeier, 2013a,b, 2014). Further, no dose-response data was available from which to derive a DNEL, therefore a qualitative assessment was considered appropriate. At worst this would be considered in the moderate hazard band according to ECHA (2012b) guidance.
In another guideline (OECD TG 406) study, palladium dinitrate hydrate failed to induce skin sensitisation in the guinea pig maximisation test (GPMT) (van Huygevoort, 2003b). The compound is not classified for skin sensitisation under CLP.
According to ECHA (2012b) guidance “substances classified for skin corrosion Category 1B/1C in CLP”… “which relate to corrosive or severe irritant effects to the eye or irritant effects to the eyes, respiratory tract and skin simultaneously, are allocated to the moderate hazard band on the basis that exposure to such corrosives, eye damaging or irritant substances should be well-controlled”.
Therefore, consider recommended RMMs/OCs in Table E.3-1 of ECHA (2012b).
Hazard via dermal route: local effects following acute exposure
Justification and comments
In guideline (OECD TG 435) in vitro membrane barrier tests, palladium dinitrate (as palladium dinitrate hydrate (solid), palladium dinitrate solution type H and palladium dinitrate solution) was classified as corrosive sub-category 1B under GHS, on the basis of mean breakthrough times of about 14, 3-6 and 4 minutes, respectively (Lehmeier, 2013a,b, 2014). Further, no dose-response data was available from which to derive a DNEL, therefore a qualitative assessment was considered appropriate. At worst this would be considered in the moderate hazard band according to ECHA (2012b) guidance.
In another guideline (OECD TG 406) study, palladium dinitrate hydrate failed to induce skin sensitisation in the GPMT (van Huygevoort, 2003b). The compound is not classified for skin sensitisation under CLP.
According to ECHA (2012b) guidance “substances classified for skin corrosion Category 1B/1C in CLP…which relate to corrosive or severe irritant effects to the eye or irritant effects to the eyes, respiratory tract and skin simultaneously, are allocated to the moderate hazard band on the basis that exposure to such corrosives, eye damaging or irritant substances should be well-controlled”.
Therefore, consider recommended RMMs/OCs in Table E.3-1 of ECHA (2012b).
Hazard for the eyes
Justification and comments
According to ECHA guidance on the application of CLP criteria (ECHA, 2015), “if a substance or mixture is classified as Skin corrosive Category 1 then serious damage to eyes is implicit and there is no need to proceed with classification for eye effects”. Palladium dinitrate is classified for skin effects as corrosive sub-category 1B. Consequently, the compound is classified for eye effects in Category 1 under EU CLP.
No dose-response data was available from which to derive a DNEL, therefore a qualitative assessment was considered appropriate. Substances classified for serious eye damage (Category 1 in CLP) should be allocated to the “moderate hazard band on the basis that exposure to such corrosives, eye damaging or irritant substances should be well-controlled”. Therefore, consider recommended RMMs/OCs in Table E.3-1 of ECHA (2012b).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
DNELs have been derived only for workers, not for consumers/general population. During assessment of the identified uses for palladium dinitrate, no uses have been identified in which consumers are exposed to palladium dinitrate. In all uses with potential consumer exposure due to service life of articles, palladium dinitrate is chemically transformed into another substance before reaching the consumers, and the subsequent lifecycle steps after this transformation of palladium dinitrate are appropriately included in the assessment of this newly formed substance. Regarding the general population, and following the criteria outlined in ECHA guidance R16 (2016), an assessment of indirect exposure of humans via the environment for palladium dinitrate has not been performed as the registered substance is manufactured/imported/marketed <100 tpa and is not classified as STOT-RE 1 or as CMR.
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.