Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-215-7 | CAS number: 1313-99-1
Endpoint summary
Administrative data
Description of key information
Value used for CSA:
Skin irritation / corrosion: not irritating
Eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Information characterizing the potential for nickel oxide to cause irritation/corrosion generally indicates that the compound is only slightly irritating. This indication is based on the results of two guideline-based, GLP studies recently conducted by Eurofins Product Safety Laboratory (EPSL) evaluating eye and skin irritation potential. The results for eye and skin irritation do not meet the classification criteria for either endpoint.
The skin irritation study was conducted in rabbits according to OECD Test #404 - Acute Dermal Irritation/Corrosion guidelines (EPSL, 2008f). Three healthy female rabbits were exposed via the skin to green nickel oxide to determine if the test substance had the potential to produce irritation. Erythema was noted in all test animals at the 30-60 minute time point (each animal was scored as 1), but not at the remaining time intervals (scored as 0). No edema was observed during the study (each animal scored as 0 at all time points). The overall incidence and severity decreased with time, and the effects were fully reversible within 24 hours. According to OECD Test #404 guidelines, compounds should be considered an irritant if responses persist to the end of the observation period; however, findings of this study indicated effects were fully reversible significantly prior to the end of the observation period.
The eye irritation study was also conducted in rabbits according to OECD Test #405 -Acute Eye Irritation/Corrosion guidelines (EPSL, 2008g). In this study, green nickel oxide was instilled into the right eye of three healthy female rabbits to determine the potential to produce irritation. In the treated eyes, no corneal opacity or iritis was observed in any of the animals, though all three treated eyes exhibited positive conjunctivitis one hour after instillation. All observed effects were reversible; incidence and severity of irritation decreased with time and all animals were free of ocular irritation by Day 4. Aside from eye irritation, no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior were observed in the animals. The results of the study indicated that nickel monoxide was mildly irritating to the eye under the conditions of the study. The OECD Test #405 guidelines state that extrapolation of these results to humans is only valid to a limited degree as in many cases the albino rabbit is more sensitive than humans to ocular irritants for corrosives.
Collectively, these two studies provide reliable, adequate information to assess the irritant/corrosive properties of green nickel oxide. The studies were specifically designed to evaluate the health hazard likely to arise from exposure by dermal or ocular application. Results demonstrated that green nickel oxide can cause minor irritation in laboratory settings. However, all observed effects were fully reversible and generally classified as “slight” or “mild, ” thus indicating a limited potential for irritant/corrosive potential, and do not meet the criteria for classification of skin or eye irritation.
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) evaluating eye and skin irritation potential indicate that the compound is only slightly or mildly irritating. The results for eye and skin irritation do not meet the classification criteria for either endpoint.
Justification for classification or non-classification
Recently completed in vivo skin and eye irritation studies confirm that Ni oxide should not be classified for either endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
