Registration Dossier
Registration Dossier
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EC number: 235-715-9 | CAS number: 12607-70-4
Endpoint summary
Administrative data
Description of key information
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
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 OECD Guideline 404 (Acute Dermal Irritation / Corrosion) 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 conclude that nickel hydroxycarbonate is slightly irritating to the skin, but these results do not meet the criteria for classification as a skin irritant for CLP. However, the existing harmonized classification of Skin Irrit. 2: H315 in the 1st ATP to the CLP is carried forward in this registration file since the animal study for nickel sulphate was negative (EPSL, 2009c), while human studies demonstrated skin irritation for nickel sulphate (Frosch and Kligman, 1976; Seidenari et al, 1996). Therefore, animal data cannot be relied upon solely for lack of classification for nickel substances, though animal data has been shown to reflect current classification in the case of nickel nitrate. In the case of nickel dihydroxide, the low solubility in synthetic sweat and negative animal and bioaccessibility data support no classification for skin irritation for nickel dihydroxide (see Appendix B3).
The same laboratory also reported the results of an eye irritation study OECD Guideline 405 (Acute Eye Irritation / Corrosion) (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, leading to a classification of Eye Irritant 2 using CLP criteria.
These two guideline studies indicate that nickel hydroxycarbonate is a slight to moderate irritant to the skin and eye, respectively, but does not meet the criteria for classification as skin irritant.
The following information is taken into account for any hazard / risk assessment:
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 skin irritation do not meet the classification criteria for this endpoint. However, the existing harmonized classification of Skin Irrit. 2: H315 in the 1st ATP to the CLP is carried forward in this registration file since animal data has been shown to not be as reliable as human data for some nickel substances and bioaccessibility data has not been validated for skin irritation. The results for eye irritation meet the criteria for Eye Irrit. 2 (H319).
Justification for classification or non-classification
Ni hydroxycarbonate is currently classified as Skin Irrit. 2; H315 according to the 1st ATP to the CLP. The results of a recently completed guideline-based, GLP study do not meet the classification criteria for this endpoint. However, the existing harmonized classification of Skin Irrit. 2: H315 in the 1st ATP to the CLP is carried forward in this registration file since animal data has been shown to not be as reliable as human data for some nickel substances and bioaccessibility data has not been validated for skin irritation. 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 and Section 5.3 of this CSR, as well as Appendix B3.
A new in vivo study demonstrates that Ni hydroxycarbonate should be classified for eye irritation (Eye Irrit. 2; H319).
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