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EC number: 239-198-0 | CAS number: 15137-09-4
In the area pretreated with 10% EDTA in cetomacrogol cream FNA, only 3 of 17 patients showed a + positive reaction to 1% (2440 ppm) nickel sulphate. 3 patients showed no reaction to any concentration of nickel sulphate in either area. The reactivity to nickel sulphate in the area pretreated with 10% EDTA appeared to be far less than in the control area (rank sum test p < 0.01). No irritant reactions to the 10% EDTA cream were observed.
Many cobalt(II) compounds and cobalt are known for the fact, that they may cause an allergic skin reaction.
The following substances are, inter alia, classified with H317: cobalt (Index number 027-001-00-9), cobalt dichloride (Index number 027-004-00-5), cobalt sulfate (Index number 027-005-00-0), cobalt sulfide (Index number 027-003-00-X), cobalt di(acetate) (Index number 027-006-00-6), cobalt dinitrate (Index number 027-009-00-2) and cobalt oxide (Index number 027-002-00-4).
In addition, the harmonized classification of the above-mentioned cobalt(II) compounds did not include the category H314 (Causes severe skin burns and eye damage) or H315 (Causes skin irritation). Also in the published dossiers on the ECHA website of the mentioned cobalt(II) compounds and cobalt bis(2-ethylhexanoate) (EC 205-250-6) no classification as skin corrosive or skin irritant was made.
Nevertheless, there are some indications that cobalt(II) compounds lead to skin irritation but this often results from strong allergic skin reactions.
Furthermore, it could be shown, that sodium EDTA does not act as skin irritant but as an useful reagent which inhibit allergic skin reaction by complexation of the irritant metal 2 + source like nickel sulfate. In an additional study it could complementary be shown that EDTA-Na2 is non-irritant and has not to be classified according to the regulation (EC) No 1272/2008 (CLP-regulation).
As in the target substance cobalt disodium ethylenediaminetetraacetate the cobalt(II) center is chelated by EDTA no classification as skin irritant will be done.
In regard to the eye-irritating properties it could be shown that EDTA-Na2 is not classified as eye irritant. But it must be considered that EDTA has a harmonised classification as substance which causes serious eye irritation (H319) according to Annex VI of the regulation (EC) No 1272/2008 (CLP Regulation). Therefore the complex EDTA-CoNa2 will also be considered as eye irritant (H319).
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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