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EC number: 235-715-9 | CAS number: 12607-70-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Ni hydroxycarbonate is currently classified as a dermal sensitizer (Skin Sens. 1; H317) according to the 1st ATP to the CLP Regulation. The Ni2+ ion is considered exclusively responsible for the immunological effects of nickel (Menné 1994). The results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate that Ni hydroxycarbonate releases less nickel (II) ion compared to water soluble nickel substances known to be skin sensitizers (including nickel sulphate and nickel chloride), but releases more nickel ions compared to nickel metal, which is also a known skin sensitizer. This suggests that nickel hydroxycarbonate is probably a skin sensitizer but with lesser potency than water soluble nickel compounds like nickel sulphate. Although the bioaccessibility method has not yet been validated in vivo, the classification for skin sensitization for nickel hydroxycarbonate is appropriate to be read-across (see above for justification) from nickel sulphate as worst case, since it is a skin sensitizer, based on the study in humans by Santucci et al. (1998). An explanation of the rationale and methodology is provided in Section 7.4.1 of IUCLID and as Appendix B3 in this CSR.
Both animal and human data for skin sensitization associated with nickel sulphate is summarized in the Nickel Sulphate IUCLID dossier Section 7.10.4. One of these studies, a meta-analysis of published patch test studies by Fischer et al. (2005) has been used as the basis for the derivation of a DNEL for dermal elicitation/sensitization with nickel sulphate as described in CSR Section 5.11. The aim of the study by Fischer et al. (2005) was to assess thresholds of response by making a statistical analysis of available dose-response studies with a single occluded exposure and comparing the results to thresholds from other modes of exposure. Eight occluded Ni dose-response studies were selected based on statistical considerations. The statistical analysis showed that 5% of a sensitized population reacts to 0.44 µg Ni/cm2 and 10% react to 1.04 µg Ni/cm2. In another study with a single open application, 7.8% of sensitized persons responded to a dose 6x higher than the dose to which 10% reacted in occluded exposure. The NOAEL of 0.00044 mg Ni/cm2 from the Fischer et al. (2005) study is carried forward as the basis for the derivation of DNEL for dermal elicitation/sensitization. The Ni ion release in synthetic sweat from Ni hydroxycarbonate relative to that released from Ni sulphate were used to derive a DNEL for Ni hydroxycarbonate that takes into account its lower Ni ion release in sweat. See Appendix B3.
The following information is taken into account for any hazard / risk assessment:
Ni hydroxycarbonate is currently classified as a dermal sensitizer (Skin Sens. 1; H317) according to the 1st ATP to the CLP Regulation. This is supported by results of recent bioaccessibility testing suggesting that Ni hydroxycarbonate releases less nickel (II) ion compared to water soluble nickel substances known to be skin sensitizers (including nickel sulphate), but releases more nickel ions compared to nickel metal, which is also a known skin sensitizer. Although the bioaccessibility method has not yet been validated in vivo, the classification for skin sensitization for nickel hydroxycarbonate is appropriate to be read-across from nickel sulphate, since it is a skin sensitizer. An explanation of the rationale and methodology is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the CSR.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No studies were identified characterizing respiratory sensitization following exposure to nickel hydroxycarbonate. A few case reports in the 1970s and 1980s suggest that nickel sulphate may be a respiratory sensitiser in humans. Considering the number of workers that have been exposed to soluble nickel compounds in the refining and metal finishing industry over the years, the number of reported cases is very small. No data regarding respiratory sensitisation in animals have been located. A recent comprehensive review of the available literature regarding the potential of soluble Ni compounds to induce respiratory sensitization is extensively reviewed in the background document attached in IUCLID Section 7.4.2 and provided as Appendix B5 to the CSR. In adition, the available bioaccessibility data (summarized in IUCLID Section 7.2.2 and CSR Appendix B2) indicate Ni hydroxycarbonate behaves in lung fluids like Ni subulfide, which is not considered a respiratory sensitizer.
The following information is taken into account for any hazard / risk assessment:
No studies were identified characterizing respiratory sensitization following exposure to nickel hydroxycarbonate. Based on a recent literature review (Appendix B5), the available data for soluble nickel compounds may not be sufficient for classification as a respiratory sensitizer. In addition, available bioaccessibility data (Appendix B2) indicate Ni hydroxycarbonate behaves in lung fluids like Ni subulfide, which is not considered a respiratory sensitizer. However, the existing harmonized classification in the 1st ATP to the CLP is carried forward in this registration file.
Justification for classification or non-classification
Ni hydroxycarbonate is currently classified as a dermal sensitizer (Skin Sens. 1; H317) according to the 1st ATP to the CLP Regulation. This is supported by results of recent bioaccessibility testing suggesting that Ni hydroxycarbonate releases less nickel (II) ion compared to water soluble nickel substances known to be skin sensitizers (including nickel sulphate) but releases more nickel ions compared to nickel metal. Although the bioaccessibility method has not yet been validated in vivo, the classification for skin sensitization for nickel hydroxycarbonate is appropriate to be read-across from nickel sulphate, since it is a skin sensitizer. An explanation of the rationale and methodology is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.
Ni hydroxycarbonate is currently classified as Resp. Sens. 1;H334 according to the 1st ATP to the CLP Regulation. Although there is some evidence to indicate that very water-soluble nickel compounds may be respiratory sensitisers in humans, the data seems insufficient to warrant classification of nickel hydroxycarbonate (and water insoluble nickel compounds) for this endpoint. The existing data are extensively reviewed in the attached background document in Section 7.4.2 of IUCLID and as Appendix B5 to the CSR. However, the existing harmonized classification in the 1st ATP to the CLP is carried forward in this registration file.
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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