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EC number: 208-933-7
CAS number: 547-67-1
Where data are not available for nickel
oxalate, data for other inorganic nickel compounds (i.e. structurally
related substances) that are expected to have similar toxicity can be
used for read across. For human health local effects endpoints, the
bioavailability of Ni2+at the target site determines the
potential occurrence and severity of the local effects to be assessed
for the read across of nickel substances. For local effects, inorganic
nickel substances of similar nickel ion release and similar physical
form can be used for read across. For nickel substances, the read-across
strategy is predicated on the assumed presence and bioavailability of a
common metal anion (e.g., Ni2+) at the target site. This is a
reasonable assumption for the majority of inorganic compounds and some
organic compounds (e.g., metal salts of some organic acids) (ICCM, 2007;
OECD, 2007; and ECHA, 2008), provided no significant effect of the other
constituents is expected. The oxalate ion is not of concern since
oxalate is not known to cause skin sensitization, but only skin
irritation (see IUCLID section 7.3).
Although it is not expected that all of the
nickel or oxalate ion would be released and bioavailable (based on low
water solubility and release of these ions in simulated human bodily
fluids [Kirby Memorial Health Center, 2010), the worst-case approach can
be taken where read across takes into account the soluble nickel
substances and oxalic acid as the ions released from nickel oxalate.
ECHA. 2008. Guidance on Information
Requirements and Chemical Safety Assessment, Chapter R.6: QSARs and
Grouping of Chemicals (Available from ECHA website:
ICMM [International Council on Mining and
Metals]. 2007. Health Risk Assessment Guidance for Metals (HERAG)
(available from ICMM website:
Kirby Memorial Health Center. 2010.
Bioaccessibility of nickel oxalate (soluble nickel analyses in simulated
gastric, interstitial, and lysosomal fluids). Study Sponsor:
Metallo-Chimique. Report Date: 2010-06-30.
OECD [Organisation for Economic Co-operation
and Development]. 2007. Guidance on Grouping of Chemicals. Series on
Testing and Assessment Number 80 (Available from the OECD website:
No data are available for nickel oxalate;
therefore, data for nickel sulphate and nickel sulphate hexahydrate are
used as read-across. Four studies are presented, three of which
demonstrate the skin sensitization potential of nickel compounds. In
FDRL (1986), all ten guinea pigs developed positive reactions at 24 and
48 hours. In Lammintausta et al. (1985), the lowest frequency of
positive reactions was 51.6% when guinea pigs were tested using three
different methods (GPMT, open epicutaneous and open epicutaneous with
Freund's Complete Adjuvant. In Nielsen et al. (1992), the lowest
frequency of positive reactions was 25% when guinea pigs were tested
with 3.0% nickel sulfate hexahydrate in hydroxypropyl cellulose. In
Seidnari et al. (1996), presented in 7.10.4 "Sensitisation data
(humans)", Individuals with no pre-existing history of Ni intolerance
underwent patch testing with 5, 10, and 20% nickel sulphate solutions.
Patches were removed after 24 hours and subjects were re-tested 30 days
later. Nickel sulphate solutions at concentrations up to 20% are not
irritant to the skin of non-nickel-sensitive subjects.
Taking all of the available information into
consideration and a classification of Xn; R43 and Skin Sens. Cat 1:H317 in
the 1st ATP to CLP, nickel oxalate is classified as Skin Sens. Cat 1:H317
and Xn; R43.
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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