Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 235-008-5 | CAS number: 12054-48-7
- 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

GHS
General Information
- Implementation:
- EU
- Type of classification:
- harmonised classification
- Remarks:
- Nickel dihydroxide is classified for acute oral toxicity as Acute Tox. 4; H302 under the 1st ATP to the CLP. A recently completed in vivo acute oral toxicity study concluded Ni dihydroxide has an LD50=5,000 mg/kg suggesting it should not be classified for this endpoint. However, an older study already exists in which the results correspond to the current harmonized classification, thus the harmonized classification continues to be reflected in this file.
- Recently generated data suggest that Ni dihydroxide should not be classified for 3 endpoints for which a harmonized classification currently exists according to the 1st ATP to the CLP. While no actual changes to any of these classifications are being proposed within this registration file, the background information is included below and within each endpoint's respective summary.
- Dermal Irritation. A recently completed in vivo dermal irritation study concluded Ni dihydroxide was not an irritant suggesting it should not be classified for this endpoint.
- Dermal Sensitization. Ni dihydroxide is currently classified as a dermal sensitizer (Skin Sens. 1; H317) according to the 1st ATP to the CLP Regulation. However, the results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate that Ni dihydroxide releases significantly less nickel (II) ion compared to nickel substances known to be skin sensitizers, including nickel sulphate and nickel metal. This suggests that nickel dihydroxide may not be a skin sensitizer. However, the bioaccessibility method has not yet been validated in vivo so the classification for skin sensitization can be read-across from nickel sulphate or nickel oxide, since both are classified as skin sensitizers. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.
- Reproductive Toxicity. A comprehensive read-across program based on bioaccessibility data in synthetic fluids and in vivo acute oral toxicity data has been conducted on a series of Ni substances including Ni dihydroxide. The results of this program suggest that Ni dihydroxide should not be classified as Repr. 1B; H360D. While no change to the existing classification is proposed within this registration file, a complete summary of the testing program including results and discussion are provided in Section 7.8 of IUCLID and as Appendix B1 in this CSR.
Related composition
- Related composition:
- Nickel dihydroxide
- Nickel dihydroxide - LE composition 1
Classificationopen allclose all
Explosives
- Reason for no classification:
- data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
- Reason for no classification:
- data conclusive but not sufficient for classification
Aerosols
- Reason for no classification:
- data conclusive but not sufficient for classification
Oxidising gases
- Reason for no classification:
- data conclusive but not sufficient for classification
Gases under pressure
- Reason for no classification:
- data conclusive but not sufficient for classification
Flammable liquids
- Reason for no classification:
- data conclusive but not sufficient for classification
Flammable solids
- Reason for no classification:
- data conclusive but not sufficient for classification
Self-reactive substances and mixtures
- Reason for no classification:
- data conclusive but not sufficient for classification
Pyrophoric liquids
- Reason for no classification:
- data conclusive but not sufficient for classification
Pyrophoric solids
- Reason for no classification:
- data conclusive but not sufficient for classification
Self-heating substances and mixtures
- Reason for no classification:
- data conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
- Reason for no classification:
- data conclusive but not sufficient for classification
Oxidising liquids
- Reason for no classification:
- data conclusive but not sufficient for classification
Oxidising solids
- Reason for no classification:
- data conclusive but not sufficient for classification
Organic peroxides
- Reason for no classification:
- data conclusive but not sufficient for classification
Corrosive to metals
- Reason for no classification:
- data lacking
Desensitized explosives
- Reason for no classification:
- data lacking
Acute toxicity - oral
- Hazard category:
- Acute Tox. 4
- Hazard statement:
- H302: Harmful if swallowed.
Acute toxicity - dermal
- Reason for no classification:
- data conclusive but not sufficient for classification
Acute toxicity - inhalation
- Hazard category:
- Acute Tox. 4
- Hazard statement:
- H332: Harmful if inhaled.
Skin corrosion / irritation
- Hazard category:
- Skin Irrit. 2
- Hazard statement:
- H315: Causes skin irritation.
Serious eye damage / eye irritation
- Reason for no classification:
- data conclusive but not sufficient for classification
Respiratory sensitisation
- Hazard category:
- Resp. Sens. 1
- Hazard statement:
- H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Skin sensitisation
- Hazard category:
- Skin Sens. 1
- Hazard statement:
- H317: May cause an allergic skin reaction.
Aspiration hazard
- Reason for no classification:
- data lacking
Reproductive toxicity
- Hazard category:
- Repr. 1B
- Hazard statement:
- H360D: May damage the unborn child.
- Specific effect:
- Perinatal mortality
Effects on or via lactation
- Reason for no classification:
- data conclusive but not sufficient for classification
Germ cell mutagenicity
- Hazard category:
- Muta. 2
- Hazard statement:
- H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Carcinogenicity
- Hazard category:
- Carc. 1A
- Hazard statement:
- H350i: May cause cancer by inhalation.
- Route of exposure:
- inhalation
1. Specific target organ toxicity - single (STOT-SE)
- Reason for no classification:
- data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated (STOT-RE)
- Hazard category:
- STOT Rep. Exp. 1
- Hazard statement:
- H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
- Affected organs:
- lungs
- Route of exposure:
- inhalation
Hazardous to the aquatic environment (acute / short-term)
- Hazard category:
- Aquatic Acute 1
- Hazard statement:
- H400: Very toxic to aquatic life.
Hazardous to the aquatic environment (long-term)
- Hazard category:
- Aquatic Chronic 1
- Hazard statement:
- H410: Very toxic to aquatic life with long lasting effects.
- M-Factor acute:
- 1
- M-Factor chronic:
- 1
Hazardous to the ozone layer
- Reason for no classification:
- data conclusive but not sufficient for classification
Labelling
- Signal word:
- Danger
Hazard pictogram
- GHS07: exclamation mark
- GHS08: health hazard
- GHS09: environment
Hazard statements
- H350i: May cause cancer by inhalation.
- H360D: May damage the unborn child.
- Perinatal mortality
- H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
- H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
- Respiratory effects only
- H332: Harmful if inhaled.
- H302: Harmful if swallowed.
- H315: Causes skin irritation.
- H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
- H317: May cause an allergic skin reaction.
- H410: Very toxic to aquatic life with long lasting effects.
Notes
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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