Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

ENDPOINT SUMMARY INFORMATION FROM THE 2008/2009 EU NICKEL COMPOUNDS RISK ASSESSMENT

There is considerable evidence for the in vitro genotoxicity of nickel compounds. Positive effects are generally seen in studies of chromosomal effects (chromosomal avìberrations, sister chromatoid exchanges), cell transformation tests and tests for DNA damage and repair. Whilst there are positive results for gene mutations, the positive results in at least some of these assays could possibly be due to genetic events other than point mutations.

FOR AN EXTENSIVE DISCUSSION, REFER TO THE NICKEL SULFATE DOSSIER WHICH IS BASED ON THE CONCLUSIONS EXPLAINED IN THE 2008/2009 EUROPEAN UNION EXISITING SUBSTANCE RISK ASSESSMENT OF NICKEL (EU RAR) (EEC 793/93)


Short description of key information:
There is clear evidence indicating that nickel fluoride is genotoxic in vitro, and in particular, it is clastogenic.
Moreovere, there are a number of in vivo studies in both animals and man performed mainly on Nickel sulfate. The study by Benson (2002) shows that nickel sulphate given by inhalation seems to induce inflammation and genotoxicity in lung cells at approximately the same concentrations. The results from some of the other animal studies are conflicting. Two recent micronucleus studies were negative: one study was a 2007 guidance compliant repeated dose oral study and the other study was via intraperitoneal administration. Evidence from human studies is limited.
There are no definitive studies on germ cells, and little evidence concerning hereditable effects.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Classification is valid for both the anhydrous and hydrated forms

The TC C&L has agreed to classify nickel sulfate, nickel chloride, nickel nitrate and nickel carbonates as Muta. Cat. 3; R68 and these classifications are included in the 30th ATP, which includes the statement H341, Mutagen category 3.

This classification is confirmed in 1st ATP of the CLP where nickel fluoride is listed as index 028 -029 -00 -4.

This classification is valid also for the tetrahydrated form of nickel difluoride.