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EC number: 227-873-2
CAS number: 6018-92-4
There are no skin sensitisation studies for Trinickel
dicitrate. However, extensive data exist for the read-across substance
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.
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).
no animal data on respiratory sensitisation for Trinickel dicitrate.
However, human case reports exist for the read-across substance nickel
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,
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.
Based on the available data, the substance Trinickel
dicitrate needs to be classified:
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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