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EC number: 242-522-3 | CAS number: 18718-11-1
- 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
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Endpoint summary
Administrative data
Description of key information
Value used for CSA (read-across from Nickel sulphate or Nickel ion):
NOAEL (oral, systemic, animal): 100 mg NiSO4.6H2O/kg bw(22 mg Ni/kg bw/day) (FDRL, 1983)
LOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999)
NOAEC (inhalation, systemic, animal): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009b)
LOAEC (inhalation, local, animal data): 0.7 mg Ni/m3(DNEL calculation is based on 16-day repeated dose study-Benson et al, 1988; no acute data was available)
An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel sulphate inhalation. The shortest-term study available examining those effects in animals is a 16-day repeated exposure study. An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure. SeeAppendix C3for more information.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
No reliable studies were available to characterize the acute oral toxicity of nickel bis(dihydrogen phosphate), so data on acute inhalation toxicity of Ni bis(dihydrogen phosphate) are read-across from Ni sulphate study. A comprehensive read-across assessment was recently completed based on bioaccessibility data in synthetic gastric fluid of various nickel compounds combined in vivo verification data for three source nickel substances. The read-across paradigm presented in a summary document in IUCLID Section 7.2.1 and Appendix B1 of the CSR enables grouping of target Ni substances for classification purposes according to bioaccessibility in gastric fluid as demonstrated. This assessment supports that Ni bis(dihydrogen phosphate) should be read-across from Ni sulphate for acute oral toxicity, based on similar bioaccessibility data after 2 hours in gastric fluid: % nickel content release by nickel sulphate and nickel bis(dihydrogen phosphate) was 95.6% and 93.4%, respectively. Ni sulphate hexahydrate has been shown to have an acute oral LD50 of 361.9 mg NiSO4/kg/bw (EPSL, 2009a) and a NOAEL of 100 mg NiSO4.6H2O/kg (or 22 mg Ni/kg) (FDRL, 1983). Therefore, application of this read-across paradigm suggests that Ni bis(dihydrogen phosphate)should be classified as Acute Tox 4; H302.
No reliable studies were available to characterize the acute inhalation toxicity of nickel bis(dihydrogen phosphate), so data on acute inhalation toxicity of Ni bis(dihydrogen phosphate) are read-across from Ni sulphate. A comprehensive read-across assessment was recently completed based on bioaccessibility data in synthetic lung fluids of various nickel compounds combined in vivo verification data for three source nickel substances. The read-across paradigm presented in a summary document in IUCLID Section 7.2.2 and Appendix B2 of the CSR enables grouping of target Ni substances for classification purposes according to bioaccessibility in interstitial fluid as demonstrated. This assessment supports that Ni bis(dihydrogen phosphate) should be read-across from Ni sulphate for acute inhalation toxicity based on use of Ni sulphate as a worst case scenario and the most conservative estimate of potential respiratory toxicity. Ni sulphate hexahydrate has been shown to have an acute inhalation LC50 of 2.48 mg NiSO4/L and a NOAEC of 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009b). Therefore, application of this read-across paradigm suggests that Ni bis(dihydrogen phosphate)should be classified as Acute Tox 4; H332.
There are no available data on which to evaluate acute dermal toxicity. However, acute toxicity is expected to be low in view of the poor absorption by this route. As oral and inhalation routes of exposure are more relevant and data for these have been provided, testing for acute dermal toxicity is therefore waived based on this information.
The following information is taken into account for any hazard / risk assessment:
ORAL: Data are read-across from Ni sulphate. In a GLP, guideline-based study, the acute oral LD50 of Ni sulphate was determined in female rats using the up and down procedure. Statistical evaluation of mortality data resulting from exposures ranging from 159 to 2000 mg/kg indicated an oral LD50 of 361.9 mg/kg body weight. These newly generated data demonstrate via read-across that Ni bis(dihydrogen phosphate) should be classified as Acute Tox. 4; H302.
INHALATION: Data are read-across from Ni sulphate. The outcome of a recently completed read-across assessment based on bioaccessibility and in vivo animal data for various nickel comounds indicates that Ni bis(dihydrogen phosphate) should be read-across from Ni sulphate for acute inhalation toxicity. Ni sulphate hexahydrate has been shown to have an acute inhalation LC50 of 2.48 mg NiSO4/L and a NOAEC of 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3). Therefore, application of this read-across paradigm suggests that Ni bis(dihydrogen phosphate) should be classified as Acute Tox 4; H332.
DERMAL: No risk characterisation will be conducted for acute dermal toxicity. Acute systemic effects are not relevant due to the very low dermal absorption of nickel. Acute local effects are covered by the long term DNEL based on prevention of dermal sensitization.
Justification for classification or non-classification
Ni bis(dihydrogen phosphate) has not previously been classified for acute oral or inhalation toxicity in the EU. However, comprehensive read-across assessments were recently completed based on bioaccessibility data in synthetic gastric and lung fluids of various nickel compounds combined in vivo verification data for three source nickel substances. The read-across paradigms presented in summary documents in Appendix B1 and Appendix B2 of the CSR enables grouping of target Ni substances for classification purposes according to bioaccessibility in gastric, interstitial and/or lysosomal fluid as demonstrated. The outcome of this assessment indicates that Ni bis(dihydrogen phosphate) should be read-across from Ni sulphate for acute oral and inhalation toxicity. Therefore, application of this read-across paradigm suggests that Ni bis(dihydrogen phosphate) should be classified as Acute Tox 4; H302 and H332.
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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