Registration Dossier

Administrative data

Description of key information

Value used for CSA: not irritating (skin or eye)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Only one study characterizing irritation/corrosion associated with nickel sulphamate was identified. The skin irritation study was conducted in rabbits according to OECD Test #404 - Acute Dermal Irritation/Corrosion guidelines (Safepharm Laboratoris (SPL), 1997). Three healthy female rabbits were exposed via the skin to Ni sulphamate-4 -hydrate to determine if the test substance had the potential to produce irritation. Very slight to well-defined erythema and very slight oedema were observed. Crust formation was also noted at one treated skin site. The overall incidence and severity decreased with time, and the effects were fully reversible within 24 hours. According to OECD Test #404 guidelines, compounds should be considered an irritant if responses persist to the end of the observation period; however, findings of this study indicated effects were fully reversible significantly prior to the end of the observation period

Data regarding eye irritition caused by Ni sulphamate are read-across from Ni sulphate because nickel sulphamate has similar water solubility to nickel sulphate. See read-across section.Ni sulphate has been demonstrated not to be an eye irritant in experimental animals (SLI, 1999).

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

An OECD-guideline compliant study conducted with Ni sulphamate-4-hydrate demonstrates that Ni sulphamate does not cause skin irritation (SPL, 1997). Data regarding eye irritation of Ni sulphamate are read-across from Ni sulphate. Ni sulphate has been demonstrated not to be an eye irritant in experimental animals. The available data do not allow any conclusion on respiratory irritation.

Justification for classification or non-classification

Ni sulphamate is not classified for skin or eye irritation according to the 1st ATP to the CLP Regulation. Background information can be found in the discussion section.