Registration Dossier

Administrative data

Description of key information

Value used for CSA: sensitizing (skin)

Value used for CSA: sensitizing (respiratory)

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No information characterizing sensitization associated with nickel sulphamate was identified. The Ni2+ ion is considered exclusively responsible for the immunological effects of nickel (Menné ,1994). Data on the potential to cause dermal sensitization are being read-across from Ni sulphatesince results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate nickel sulphate and nickel sulphamate release similar amounts of nickel ion (Henderson et al., 2014). Nickel sulphate has been shown to be a dermal sensitizer in animal and human studies. A comprehensive summary on this topic is provided in Appendix B3. New testing for dermal sensitization in animals is therefore waived for Ni sulphamate.

 

In addition to animal data for nickel sulphate, information on human dermal sensitization to nickel sulphate is summarized in the Nickel Sulphate IUCLID dossier Section 7.10.4. One of these studies, a meta-analysis of published patch test studies by Fischer et al. (2005) has been used as the basis for the derivation of a DNEL for dermal elicitation/sensitization with nickel sulphate as described in Section 5.11. The aim of the study by Fischer et al. (2005) was to assess thresholds of response by making a statistical analysis of available dose-response studies with a single occluded exposure and comparing the results to thresholds from other modes of exposure. Eight occluded Ni dose-response studies were selected based on statistical considerations. The statistical analysis showed that 5% of a sensitized population reacts to 0.44 µg Ni/cm2 and 10% react to 1.04 µg Ni/cm2. In another study with a single open application, 7.8% of sensitized persons responded to a dose 6x higher than the dose to which 10% reacted in occluded exposure. The NOAEL of 0.00044 mg Ni/cm2 from the Fischer et al. (2005) study is carried forward as the basis for the derivation of DNEL for dermal elicitation/sensitization for nickel sulphate and read-across to nickel sulphamate based on similar solubilities in bioaccessibility testing in synthetic sweat. A comprehensive summary on this topic is provided in Appendix B3.

The following information is taken into account for any hazard / risk assessment:

Ni sulfamate is classified as Skin Sens. 1:H317 in the 1st ATP to the CLP Regulation. Data on the potential to cause dermal sensitization are being read-across from Ni sulfate, since results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate nickel sulphate and nickel sulphamate release similar amounts of nickel ion. Nickel sulphate has been shown to be a dermal sensitizer in animal and human studies. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Data on the potential to cause respiratory sensitization are being read-across from Ni sulphate. A few case reports in 1970s and 1980s suggest that nickel sulphate may be a respiratory sensitiser in humans. Considering the number of workers that have been exposed to soluble nickel compounds in the refining and metal finishing industry over the years, the number of reported cases is very small. No data regarding respiratory sensitisation in animals have been located. A recent comprehensive review of the available literature regarding the potential of soluble Ni compounds to induce respiratory sensitization can be found in the attached background document entitled, "Background-Soluble Nickel Respiratory Sensitization" (Section 7.4.2 of IUCLID) and in Appendix B5 of the CSR.

The following information is taken into account for any hazard / risk assessment:

Data on the potential to cause respiratory sensitization are being read-across from Ni sulphate. Based on a recent literature review (Appendix B5), the available data for Ni sulphate may not be sufficient for classification of either compound as a respiratory sensitizer.

Justification for classification or non-classification

Ni sulphamate is classified as Skin Sens. 1;H317 in the 1st ATP to the CLP Regulation. Data on the potential to cause dermal sensitization are being read-across from Ni sulfate, since results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate nickel sulphate and nickel sulphamate release similar amounts of nickel ion. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.

Ni sulphamate is classified as Resp. Sens. 1; H334 in the 1st ATP to the CLP Regulation. A comprehensive review of the available literature regarding the potential of soluble Ni compounds to induce respiratory sensitization can be found in the attached background document entitled, "Background-Soluble Nickel Respiratory Sensitization" (CSR Appendix B5).