Registration Dossier
Registration Dossier
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EC number: 240-841-2 | CAS number: 16812-54-7
Endpoint summary
Administrative data
Description of key information
Data regarding the irritation potential of Ni sulfide are read-across from Ni subsulfide since results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate nickel sulphide and nickel subsulphide release similar amounts of nickel ion. Nickel subsulphide has been shown not to be a skin irritant in animal studies and is not classified as a skin irritant. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.
Key value for chemical safety assessment
Additional information
No studies that characterized the potential for NiS to cause irritation or corrosion were identified. Data from another sulfidic nickel compound are being read-across to Ni sulphide since results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate nickel sulphide and nickel subsulphide release similar amounts of nickel ion. Nickel subsulphide has been shown not to be a skin irritant in animal studies and is not classified as a skin irritant. A comprehensive summary on this topic is provided inSection 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.
Information characterizing the potential for nickel subsulfide to cause irritation generally indicates that the compound is only slightly or mildly irritating. This indication is based on the results of two guideline-based, GLP studies recently conducted by Eurofins Product Safety Laboratory (EPSL, 2009a-b) evaluating eye and skin irritation potential. Collectively, these two studies provide reliable, adequate information to assess the irritant/corrosive properties of nickel subsulfide. The studies were specifically designed to evaluate the health hazard likely to arise from exposure by dermal or ocular application. Results demonstrated that nickel subsulfide can cause minor irritation in laboratory settings. However, all observed effects were fully reversible and generally classified as “slight” or “mild,” thus indicating a limited potential to be irritant/corrosive.
Justification for classification or non-classification
Ni sulfide is not classified for skin or eye irritation according to the 1st ATP to the CLP Regulation. No studies that characterized the potential for NiS to cause irritation or corrosion were identified. Data from another sulfidic nickel compound are being read-across to Ni sulphide since results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate nickel sulphide and nickel subsulphide release similar amounts of nickel ion. Nickel subsulphide has been shown not to be a skin irritant in animal studies and is not classified as a skin irritant. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.
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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