Registration Dossier

Administrative data

Description of key information

SKIN: Tested in rabbits, nickel fluoride tetrahydrated provoked irritation, still visible in 2/3 rabbits after 72 hours. Fully recovery after 7 days

EYE: Nickel fluoride is extremely iirritating to eyes

RESPIRATORY: The available data do not allow any conclusion on respiratory irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

In the Risk Assessment report of Nickel compounds, it is demonstrated that the response for different Nickel compounds are not consistent, being the sulfate not irritant and the nitrate much more active. In the text it is mentioned that: "The TC C&L has agreed to classify nickel nitrate as a severe eye irritant: Xi; R41 on the basis of experimental data, whilst no classification is suggested for the other nickel compounds. It should be noted that for these local effects, the Nickel ion alone may not be entirely responsible for the effects as the counter ion may itself show irritant properties."

For this reason, it was decided to further investigate the effect of nickel fluoride, as no existing data were found. The two studies performed for the assessment of skin and eye irritation demonstrated that nickel fluoride is moderately irritating to the skin and extremely irritating to the eyes.

The available data do not allow any conclusion on respiratory irritation. The criteria for classification for respiratory irritation are mainly based on human experience, which is lacking. There is a concern for respiratory irritation. However, this concern is considered to be more appropriately covered by the proposed classification for chronic effects (T; R48/23) with a specific concentration limit lower than the general limit in the Preparations Directive (EC, 1999).

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The studies that was performed to assess the skin/eye irritation potential of Nickel fluoride, based the conclusion on the US pesticide labelling requirements.

As the raw data were available, it was possible to transpose the conclusion into CLP requirements, which are:

Skin irritant, Category 2 H315 (R38 according to Directive 67/548) and Eye irritant Category 1 H318 (R41 according to Directive 67/548)