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EC number: 425-270-0 | CAS number: 134620-00-1
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.23 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As no relevant data on effects of repeated inhalation exposure to tetraamminepalladium(II) hydrogen carbonate in humans or laboratory animals are available, route-to-route extrapolation to calculate an inhalation DNEL from a reproductive/developmental oral toxicity study on a member of the "tetraamminepalladium salts" category, tetraamminepalladium(II) dichloride, was considered a suitable alternative (particularly as first pass effects are not expected to be significant for an inorganic compound).
The oral NOAEL for tetraamminepalladium(II) dichloride was 4 mg/kg bw/day. This equates to NOAELs of 1.76 and 4.91 mg/kg bw/day for palladium and tetraamminepalladium(II) hydrogen carbonate, respectively (based on MWt ratios).
In the absence of data allowing quantitative comparison between absorption following oral and inhalation exposure, this derivation utilised the REACH default assumption that the absorption percentage for the oral route is half that of the inhalation route, and a default factor of 2 is proposed for absorption differences in the case of oral-to-inhalation extrapolation.
Expressed as tetraamminepalladium(II) hydrogen carbonate the corrected inhalatory NOAEC (worker, 8 h exposure/day) = oral NOAEL*(1/sRv[rat])*(ABS[oral-rat]/ABS[inh-human]) *(sRV[human]/wRV)
= 4.91 mg/kg bw/day*(1/0.38 m3/kg bw/day)*(1/2)*(6.7 m3 [8h]/10 m3 [8h]) = 4.33 mg/m3
It is noted that the standard respiratory rate conversion figure (0.38 m3/kg bw/day) already incorporates a factor of 4 for allometric scaling from rat to human. An assessment factor (AF) for allometric scaling is not considered to be justified in this scenario, given that the metabolism of inorganic metal cations is conventionally assumed not to occur to any relevant extent. Moreover, ECHA guidance notes that “allometric scaling is an empirical approach for interspecies extrapolation of various kinetic processes generally applicable to substances which are renally excreted, but not to substances which are highly extracted by the liver and excreted in the bile. It appears that species differences in biliary excretion and glucuronidation are independent of caloric demand (Walton et al. 2001)” (ECHA, 2012a). Oral toxicokinetic studies have demonstrated that systemically available palladium is excreted predominantly via the biliary/faecal route.
It is therefore appropriate to increase the corrected inhalatory NOAEC by a factor of 4.
Dose descriptor starting point (after route to route extrapolation) = Corrected inhalatory NOAEC (worker, 8 h exposure/day)*4 = 4.33*4 = 17.3 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF; NOAEL from a well-conducted reproductive/developmental toxicity study; the highest dose was set at 100 mg/kg bw/day on the basis of a 14 day dose range finding study (the aim was to induce toxic effects but no death or suffering at the highest dose and to achieve a NOAEL at the lowest dose)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default ECHA AF for subacute (28-day) to chronic extrapolation. Male animals were dosed for 28-days in total, while females received treatment for a longer period of time (incorporating the gestation period and proceeding up until postpartum day 4)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA AF for rat for toxicokinetic differences in metabolic rate (allometric scaling) is not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA AF for (healthy) worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA AF; the human health effects data are reliable and consistent, and confidence in the database is high. Read-across from the structurally similar compound, tetraamminepalladium(II) dichloride was used to fill the reproductive/developmental toxicity endpoint. No AF is considered necessary for the use of read-across since the source substance displays a high degree of similarity to the target compound. Notably, the counter ions (chloride or hydrogen carbonate) are not anticipated to differentially influence the toxicity of the palladium (II) species. Also the systemic NOAEL for the hydrogen carbonate (from a reliable 28-day gavage study) was slightly higher (15 mg/kg bw/day). Moreover, the DNEL was derived on the basis of palladium itself.
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 24.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As no relevant data on effects of repeated dermal exposure to tetraamminepalladium(II) hydrogen carbonate in humans or laboratory animals are available, route-to-route extrapolation to calculate a dermal DNEL from a reproductive/developmental oral toxicity study on a member of the "tetraamminepalladium salts" category, tetraamminepalladium(II) dichloride, was considered a suitable alternative (particularly as first pass effects are not expected to be significant for inorganic compounds).
The oral NOAEL for tetraamminepalladium(II) dichloride was 4 mg/kg bw/day. This equates to NOAELs of 1.76 and 4.91 mg/kg bw/day for palladium and tetraamminepalladium(II) hydrogen carbonate, respectively (based on MWt ratios).
Estimation of dermal absorption is based on relevant available information (mainly water solubility, molecular weight and log Pow) and expert judgement. Tetraamminepalladium(II) hydrogen carbonate, with a low partition coefficient (<-2.73) and high water solubility (56.2 g/L) (Lumsden et al., 1997), may be unable to cross the lipid-rich environment of the stratum corneum, especially given the lack of skin irritation potential observed in rabbits (Allen, 1995b). In spite of this, in the light of the relatively low molecular weight, ECHA guidance indicates a default value of 100% dermal absorption (ECHA, 2014). However, specific guidance on the health risk assessment of metals indicates that molecular weight and log Pow considerations do not apply to these substances (“as inorganic compounds require dissolution involving dissociation to metal cations prior to being able to penetrate skin by diffusive mechanisms”) and tentatively proposes dermal absorption figures: 1.0 and 0.1% following exposure to liquid/wet media and dry (dust) respectively (ICMM, 2007). Given the low penetration expected from metals, the low log Pow and high water solubility (and, thus, low expected lipophilicity), and the lack of skin irritation potential (which could, in theory, disrupt skin barrier function and facilitate dermal penetration), it is suitably health precautionary to take forward the lower of the two ECHA default values for dermal absorption, of 10%, for the safety assessment of tetraamminepalladium(II) hydrogen carbonate.
In the absence of absorption data for the starting route, a pragmatic assumption has to be made (i.e. a limited absorption for the oral route). In line with REACH guidance, it is considered that the absorption percentage for the oral route is 50% (instead of 100%).
Accordingly, use of an oral benchmark to assess a dermal exposure necessitates an increase in the starting point by a corrective factor of 5 to account for the difference in absorption between these two routes.
Dose descriptor starting point (after route to route extrapolation) = NOAEL*(ABS[oral-rat]/ABS[der-human]) = 4.91 mg/kg bw/day*(50%/10%) = 24.6 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF; NOAEL from a well-conducted reproductive/developmental toxicity study; the highest dose was set at 100 mg/kg bw/day on the basis of a 14-day dose range finding study (the aim was to induce toxic effects but no death or suffering at the highest dose and to achieve a NOAEL at the lowest dose)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default ECHA AF for subacute (28-day) to chronic extrapolation. Male animals were dosed for 28-days in total, while females received treatment for a longer period of time (incorporating the gestation period and proceeding up until postpartum day 4)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The default ECHA AF of 4 for rat for toxicokinetic differences in metabolic rate (allometric scaling) is considered unnecessary as the compound is inorganic and is consequently not metabolised to any relevant extent. Moreover, ECHA guidance notes that “allometric scaling is an empirical approach for interspecies extrapolation of various kinetic processes generally applicable to substances which are renally excreted”, while systemically available palladium is excreted predominantly via the biliary/faecal route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA AF for (healthy) worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA AF; the human health effects data are reliable and consistent, and confidence in the database is high. Read-across from the structurally similar compound, tetraamminepalladium(II) dichloride was used to fill the reproductive/developmental toxicity endpoint. No AF is considered necessary for the use of read-across since the source substance displays a high degree of similarity to the target compound. Notably, the counter ions (chloride or hydrogen carbonate) are not anticipated to differentially influence the toxicity of the palladium (II) species. Also the systemic NOAEL for the hydrogen carbonate (from a reliable 28-day gavage study) was slightly higher (15 mg/kg bw/day). Moreover, the DNEL was derived on the basis of palladium itself.
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
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 tetraamminepalladium(II) hydrogen carbonate, no uses have been identified in which consumers are exposed to tetraamminepalladium(II) hydrogen carbonate. In all uses with potential consumer exposure due to service life or articles, tetraamminepalladium(II) hydrogen carbonate is chemically transformed into another substance before reaching the consumers, and the subsequent lifecycle steps after this transformation of tetraamminepalladium(II) hydrogen carbonate 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 tetraamminepalladium(II) hydrogen carbonate 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.
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