Matte, nickel

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitisation

Nickel matte has a harmonized EU CLP classification. Nickel matte does carry a classification for skin sensitisation 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 studies have been identified evaluating the potential of nickel mattes to cause dermal sensitization. As the currently available animal models for evaluating potential dermal sensitizers are thought to be insufficient for assessing nickel-containing compounds, no new testing has been undertaken as part of this REACH registration. Rather, testing for this endpoint in being waived as nickel matte is already classified for dermal sensitization according to the1st ATP to the CLP Regulation. In addition, nickel matte is a UVCB with a variable composition that can consists of several nickel substances that are considered to be dermal sensitizers (e. g., sulphidic and metallic nickel). Nickel subsulphide, which is a major component of nickel matte, is classified as R43 and Skin Sens. 1;H317 in the 1st ATP to the CLP Regulation. No animal or human studies were identified characterizing skin sensitization following exposure to nickel subsulphide. The Ni2+ion is considered exclusively responsible for the immunological effects of nickel (Menné 1994). The results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various nickel compounds indicate that nickel subsulphide releases less nickel (II) ion compared to water soluble nickel substances known to be skin sensitizers (including nickel sulphate and nickel chloride), but releases similar amounts of nickel ion to nickel metal, which is also a known skin sensitizer. This suggests that nickel subsulphide is probably a skin sensitizer but with lesser potency than water soluble nickel compounds like nickel sulphate. Although the bioaccessibility method has not yet been validatedin vivo, the classification for skin sensitization for nickel subsulphide, and thus nickel matte, is appropriate to be read-across from nickel sulphate or nickel, since both are skin sensitizers.

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

No data are available regarding the potential of nickel matte to cause dermal sensitization. However, nickel matte is currently classified for this endpoint in the EU and is considered likely to be a dermal sensitizer based on the presence of other classified nickel substances.

Value used for CSA:Adverse effect observed (sensitising)

Migrated from Short description of key information:
No data are available regarding the potential of nickel matte to cause dermal sensitization. However, nickel matte is currently classified for this endpoint in the EU and is considered likely to be a dermal sensitizer based on the presence of other classified nickel compounds.

Respiratory sensitisation

Endpoint conclusion

Additional information:

Respiratory sensitisation

Nickel matte has a harmonized EU CLP classification. Nickel matte does not carry a classification for respiratory sensitisation in the 1st ATP to the CLP Regulation. No toxicological studies have been identified evaluating the potential of Ni mattes to cause respiratory sensitization. To assess this endpoint, 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. Cobalt is classified as a respiratory sensitizer. Nickel matte compositions containing ≥1% Co are classified as respiratory sensitisers. 

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

Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from physical and chemical properties of the UVCB substance.Nickel matte compositions containing ≥1% Co are classified as respiratory sensitisers.

Value used for CSA:No adverse effect observed (non-sensitising)

In the following mattes, no respiratory sensitizers are present in amounts > or equal 1%:

Nickel Sulphidic Matte with Copper >8% (including Cobalt 0.1 -<1%)

Nickel Sulphidic Matte (including Cobalt 0.1 -<1%)

Nickel Metallic Matte (including Cobalt 0.1 -<1%)

Value used for CSA:Adverse effect observed (sensitising)

The following mattes are classified as respiratory sensitizers since a respiratory sensitizer is present in amounts > or equal 1%:

Nickel Sulphidic Matte with Copper >8% (including Cobalt ≥1 - <3%)

Nickel Sulphidic Matte (including Cobalt ≥1 - <3%)

Nickel Metallic Matte (including Cobalt ≥1 - <3%)

Nickel Metallic Matte (including Cobalt ≥3%)

Migrated from Short description of key information:
Respiratory sensitisation
The following information is taken into account for any hazard / risk assessment:
Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from physical and chemical properties of the UVCB substance.
In none of the grades, respiratory sensitizer are present in amounts > or equal 1%.

Justification for selection of respiratory sensitisation endpoint:
Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from physical and chemical properties of the UVCB substance.
The following mattes are classified as respiratory sensitizers since a respiratory sensitizer is present in amounts > or equal 1%:
Nickel Sulphidic Matte with Copper >8% (including Cobalt ≥1 - <3%)
Nickel Sulphidic Matte (including Cobalt ≥1 - <3%)
Nickel Metallic Matte (including Cobalt ≥1 - <3%)
Nickel Metallic Matte (including Cobalt ≥3%)

Justification for classification or non-classification

Ni matte is currently classified as a dermal sensitizer according to the 1st ATP to the CLP (R43 and Skin Sens. 1; H317). 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) and other compounds classified as a dermal sensitizers. Classification with mixtures rules calculations determined that nickel matte compositions containing ≥1% Co are classified as respiratory sensitisers. 

·   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.