Registration Dossier

Administrative data

Description of key information

The results of two guideline-based, GLP studies recently conducted by Eurofins Product Safety Laboratory (EPSL, 2008a-b) evaluating eye and skin irritation potential indicate that the compound is only moderately or mildly irritating, respectively.  The results for eye irritation meet the criteria for Eye Irrit. 2 (H319). The results for skin irritation do not meet the classification criteria for this endpoint.  

Key value for chemical safety assessment

Additional information

Due to the structural similarities of Pentanickel Octahydroxide Carbonate and Nickel Hydroxycarbonate, all information in this section is relevant for Pentanickel Octahydroxide Carbonate (see section 13 for full discussion of read-across strategy).

Two studies were available to characterize skin and eye irritation in laboratory animals following exposures to nickel hydroxycarbonate. Both studies were OECD guideline studies carried out under GLP.

The skin irritation/corrosion study assessed dermal irritation in three rabbits following a single topical application of nickel hydroxycarbonate paste (EPSL, 2008a). Slight erythema was observed shortly after exposure termination, but the severity and incidence of irritation decreased over time, leading the investigators to classify nickel hydroxycarbonate as slightly irritating to the skin. The same lab also reported the results of an eye irritation study (EPSL, 2008b). Three rabbits were exposed to nickel hydroxycarbonate via direct instillation and observed for seven days. Initial irritation was evidenced by iritis, corneal opacity, and conjunctivitis, in addition to a high mean irritation score of 22.0 for the first day after exposure, though these sequelae were resolved by the study’s termination. These observations led to the conclusion that nickel hydroxycarbonate was moderately irritating to the eye.

These two guideline studies indicate that nickel hydroxycarbonate is a slight to moderate irritant to the skin and eye, respectively.

Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Ni hydroxycarbonate is currently classified as Xi;38 and Skin Irrit. 2;H315 according to the 1st ATP to the CLP. However, the

results of a recently completed guideline-based, GLP study do not meet the classification criteria for this endpoint. While no change to the existing classification is proposed within this registration file, a complete summary of the testing program including results and discussion are provided in IUCLID Section 7.3.1.

A new in vivo study demonstrates that Ni hydroxycarbonate should be classified for eye irritation (Eye Irrit. 2; H319).