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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. 
Relevant information on the individual UVCB constituents is reported in endpoint summaries for each consitutent in Section 7.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Nickel matte has a harmonized EU CLP classification. Nickel matte does carry a classification for repeated dose toxicity in the 1st ATP to the CLP Regulation. To confirm this 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 typical concentration reported by the individual legal entities), using the MeClas tool.  

No toxicological studies have been identified evaluating the potential of Ni mattes to cause repeated dose toxicity. The UVCB substance is a complex metal containing substance. Each individual (metal) constituent of this UVCB substance can release soluble ions that can contribute (as ‘relevant’ component) to the mixture toxicity. With knowledge of the elemental composition (IUCLID section 1.4 & 1.2) and, mineralogical information on the groups of nickel matte compositions was used to calculate the Classification of the UVCB substance by mixture rules (EU CLP Guidance Annex I: 3.9.3.4, and cut-off). Nickel matte is classified by mixtures rules for repeated dose toxicity driven by nickel substances.

 The following information is taken into account for any hazard / risk assessment:

No data are available regarding the potential of nickel matte to cause repeated dose toxicity. However, nickel matte is currently classified for this endpoint in the EU. Results from calculated classification (using mixture toxicity rules) support this classification. 

Value used for CSA:

Specific Target Organ Toxicity (repeated): Cat 1 H372. Organ affected: lungs; Route of exposure: inhalation

Justification for classification or non-classification

Ni matte is currently classified for repeated dose toxicity according to the 1st ATP to the CLP (STOT RE 1: H372). Further to this, Ni matte is a UVCB with a variable composition that consists of nickel subsulfide and nickel metal (See IUCLID Section 1.2) which are classified for repeated dose toxicity. Classification with mixtures rules calculations confirmed the existing classification for repeated dose toxicity. 

·   See furthermore attached documents:

Please refer to IUCLID section 13 or CSR Appendix I for detailed MeClas printouts with the specified input concentrations and resulting classification. Please visit www.meclas.eu for more information about the tool.