Registration Dossier
Registration Dossier
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EC number: 234-829-6 | CAS number: 12035-72-2
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 subsulphide to cause irritation generally indicates that the compound is only slightly or mildly 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, 2009a). Three healthy female rabbits were exposed via the skin to Ni3S2 to determine if the test substance had the potential to produce irritation. Erythema was noted in two test animals at the 30-60 minute time point, one animal at the 24-hour and 48-hour timepoints, but not at the remaining time interval. The overall incidence and severity decreased with time, and the effects were fully reversible within 72 hours. No edema was observed during the study. The resulting Primary Dermal Irritation Index (PDII) was 0.3, indicating that nickel subsulphide was slightly irritating to the skin. 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, 2009b). In this study, Ni3S2 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 was observed in any of the animals, though all three treated eyes exhibited iritis and 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 7. 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 Ni3S2 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 or corrosives.
Collectively, these two studies provide reliable, adequate information to assess the irritant/corrosive properties of nickel subsulphide. The studies were specifically designed to evaluate the health hazard likely to arise from exposure by dermal or ocular application. Results demonstrated that nickel subsulphide 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 to be irritant/corrosive.
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, 2009a-b) 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
New in vivo studies confirm that Ni subsulphide should not be classified for dermal or eye irritation.
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.
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