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EC number: 206-761-7 | CAS number: 373-02-4
- 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
NOAEL (oral, systemic, animal): 175 mg/kg bw (42 mg Ni/kg bw/day) (EPSL, 2008)
LOAEL (oral, systemic, human data; read-across): 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; read-across): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009)
LOAEC (inhalation, local, animal; read-across): 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. See Appendix C3 for more information.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 550 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2.48 mg/m³ air
Additional information
One available study sufficiently characterizes lethality following oral exposure in rats (EPSL, 2008). An LD50 value of 550 mg/kg (with a 95% confidence interval of 191.7-1,680 mg/kg) was reported as a result of a guideline-based, GLP study that implemented the up and down procedure in rats. The result was based on a series of exposures in female rats to doses ranging from 175 mg/kg to 2,000 mg/kg.
Data on acute inhalation toxicity of Ni acetate are read-across from Ni sulphate (see read-across framework justification table above).Both inorganic nickel compounds are very similar in chemical structure and upon inhalation both transform (to similar extents) into a common soluble Ni2+ ion, the toxic moiety responsible for the acute toxicity of nickel compounds.A comprehensive read-across assessment was completed based on bioaccessibility data in synthetic lung fluids of various nickel compounds combined with in vivo verification data for three source nickel substances (Henderson et al., 2012a,b; 2014). The read-across paradigm presented in a summary document in Section 7.2.2 of IUCLID and in Appendix B2 of the CSR enables grouping of target Ni substances for classification purposes according to bioaccessibility in interstitial fluid as demonstrated. The outcome of this assessment indicates that Ni acetate 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) (EPSL, 2009). Therefore, application of this read-across confirms that Ni acetate 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, 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: In a GLP, guideline-based study, the acute oral LD50 of Ni acetate was determined in female rats using the up and down procedure. Statistical evaluation of mortality data resulting from exposures ranging from 175 to 2000 mg/kg indicated an oral LD50 of 550 mg/kg body weight and a NOAEL of 175 mg/kg bw (or 42 mg Ni/kg bw/day).
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 compounds indicates that Ni acetate 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).
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
A recent in vivo study confirms Ni acetate should be classified for acute oral toxicity as Acute Tox. 4: H302 (LD50=550 mg/kg).
Ni acetate is classified as Acute Tox. 4: H332 for acute inhalation toxicity according to the CLP. Background information regarding this classification has been provided in the discussion section above.
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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