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EC number: 242-533-3 | CAS number: 18721-51-2
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
There are no skin sensitisation studies for [citric acid, nickel salt]. However, extensive data exist for the read-across substance nickel sulphate.
Parts of the data are taken from the EU-RAR for nickel sulphate, dated 2008.
A number of studies on skin sensitisation have been performed with nickel sulphate in guinea pigs and mice.
In a modified guinea pig maximization test (GPMT), nickel sulphate produced positive reactions in all tested animals at an induction concentration of 1% and challenge concentrations of 5, 2 and 1% (Ikarashi et al. 1996). Ikarashi et al. (1992) also showed the sensitising potential of nickel sulphate (10% solution) in a local lymph node assay (LLNA) conducted similar to OECD guideline 429. Furthermore, the same authors performed a sensitive mouse lymph node assay with nickel sulphate. In this assay, the intradermal treatment with a 2% solution and the topical application of a 5% solution resulted in a total stimulation index of 24.08.
In contrast, a LLNA performed with nickel sulphate solutions of up to and including 5% did not produce a positive response in the test animals (Ikarashi et al. 1992). Ambiguous results were reported in an interlaboratory validation study (Omori et al. 2008).
In conclusion, reliable studies using different protocols, either GPMT or LLNA, demonstrated that nickel sulphate is a skin sensitiser in guinea pigs and mice. In addition, numerous human data also show that soluble nickel salts are skin sensitisers (refer to EU RAR).
Migrated from Short description of key information:
The read-across substance nickel sulphate was sensitising in the guinea pig maximization test as well as in the local lymph node assay. Based on the analogy approach, the substance [citric acid, nickel salt] is also expected to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There are no animal data on respiratory sensitisation for [citric acid, nickel salt]. However, human case reports exist for the read-across substance nickel sulphate.
The available case reports (cited in the EU RAR for nickel sulphate, 2008) support the hypothesis that soluble nickel salts are capable of inducing hypersensitive reactions in the respiratory tract, e. g. asthma and/or rhinitis, after inhalation exposure (Block et al. 1982, Malo et al. 1982, Malo et al. 1985, McConnell et al. 1973, Novey et al. 1983, Niordson 1981).
References:
Block GT, Yeung M (1982): Asthma induced by nickel. JAMA 24711: 1600-1602.
Malo JL, Cartier A, Doepner M, Nieboer E, Evans S, Dolovich J. (1982): Occupational asthmatic caused by nickel sulphate. J. Allergy Clin. Immunology 69: 55-59.
Malo JL, Cartier A, Gagnon G, Evans S, Dolovich J. (1985): Isolated late asthmatic reaction due to nickel sulphate without antibodies to nickel. Clinical allergy 15: 95-99.
McConnell LH, Fink JN, Schlueter DP, Smith MG (1973): Asthma caused by nickel sensitivity. Annals of internal medicine 78: 888-890.
Niordson AM (1981): Nickel sensitivity as a cause of rhinitis. Contact dermatitis 7: 73-74.
Novey HS, Habib M, Wells ID (1983): Asthma and IgE antibodies induced by chromium and nickel salts. J.Allergy Clin. Immunol 72: 407-412.
Migrated from Short description of key information:
Case reports evidence the respiratory sensitisation by nickel sulphate in humans. Based on the analogy approach, the substance [citric acid, nickel salt] is also expected to be a respiratory sensitiser.
Justification for classification or non-classification
Based on the available data, the substance [citric acid, nickel salt] needs to be classified:
EU: R42/43
CLP: Category 1 respiratory sensitisation/ category 1 skin sensitisation
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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