Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.6 µg/L
Assessment factor:
2
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.36 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
8.6 µg/L
Assessment factor:
2
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.33 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
29.9 mg/kg soil dw
Assessment factor:
2
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
8.2 mg/kg food
Assessment factor:
30

Additional information

The approach for deriving PNEC values was used in the 2008/2009 European Union Existing Substances Risk Assessment of Nickel (EU RAR) (EEC 793/93). The EU RAR was jointly prepared by the Danish Environmental Protection Agency (DEPA), which served as the Rapporteur of the Existing Substances Risk Assessment of Nickel, and the Nickel Producers Environmental Research Association (NiPERA), which represented the Nickel Industry in this process. The complete Environment section of the EU RAR can be found in the pdf linked to the following URL:

 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/nickelreport311.pdf

 

All of the approaches described were discussed by the Technical Committee for New and Existing Substances (TC NES), and received final approval at the TC NES I meeting in April, 2008.

 

Common effects assessment basis:

 

The ecotoxicity databases on the effects of soluble nickel compounds to aquatic, soil- and sediment-dwelling organisms are extensive. It should be noted that the effects assessments of Nickel Fluoride is based on the assumption that adverse effects to aquatic, soil- and sediment-dwelling organisms are a consequence of exposure to the bioavailable Ni-ion, as opposed to the parent substances. The result of this assumption is that the ecotoxicology will be similar for all soluble Ni substances used in the ecotoxicity experiments. Therefore, data from soluble nickel substances are used in the derivation of chronic ecotoxicological NOEC and L(E)C10 values. If both NOEC and L(E)C10 data are available for a given species, the L(E)C10 value was used in the effects assessment.

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)

Conclusion on classification

In the first ATP of the CLP regulation, NiF2 is classified as H400, very toxic to aquatic life and H410, very toxic to aquatic life with long lasting effects. The estimated PNECs fully justify those values for both the anydrous and the hydrated forms