Registration Dossier
Registration Dossier
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EC number: 273-749-6 | CAS number: 69012-50-6 Product of blowing smelted nickel ore in a converter to lower the iron content.
Carcinogenicity
Administrative data
Description of key information
Carcinogenitcity is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in summaries in Sections 7.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Ni matte is currently classified for carcinogenicity according to the 1st ATP to the CLP (Carc 1: H350). Further to this, Ni matte is a UVCB with a variable composition that consists of nickel subsulfide (CAS #12035 -72 -2; See IUCLID Section 1.2) classified for carcinogenicity. Classification with mixtures rules calculations confirmed the existing classification for carcinogenicity.
· See furthermore attached documents:
Please refer to IUCLID section 13 or CSR Appendix I (attached) for detailed MeClas printouts with the specified input concentrations and resulting classification. Please visit www.meclas.eu for more information about the tool.
.Additional information
Nickel matte has a harmonized EU CLP classification. Nickel matte does carry a classification for carcinogenicity in the 1st ATP to the CLP Regulation. No toxicological studies have been identified that clearly indicate the potential of Ni mattes to cause carcinogenicity by relevant routes of exposure. Studies of nickel refinery workers contain data onexposures to mixed nickel species. Exposure to sulphidic nickel compounds has been shown to increase the risk of lung and nasal tumors. Nickel matte contains sulphidic nickel in the form of nickel subsulphide, so data on nickel subsulphide is relevant for assessing carcinogenicity of nickel matte. Epidemiological and animal data exist that provide strong evidence that nickel subsulphide should be considered as carcinogenic to the respiratory tract of humans after inhalation, and nickel subsulphide, like nickel matte, carries a classification for carcinogenicity in the1st ATP to the CLP Regulation.
To confirm the existing carcinogenicity classification, the UVCB classification was calculated by applying the CLP mixture rules based on the classification of the known or worst-case speciation of each constituent and worst-case constituent concentration in the UVCB (i.e. the maximum value of the maximal concentration reported by the individual legal entities), using the MeClas tool. Nickel matte is classified by mixtures rules for carcinogenicity driven by nickel subsulphide.
The following information is taken into account for any hazard / risk assessment:
Results from calculated classification (using mixture toxicity rules) indicate that all nickel matte compositions are classified for carcinogenicity by inhalation, but not by oral or dermal routes of exposure. This is consistent with the EU CLP classifications of nickel matte.
Value used for CSA:Carcinogenicity: Category 1 H350 (triggered by nickel subsulphide)
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