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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information
Toxicity to  reproduction is driven by the characteristics of the individual UVCB constituents. 
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.
Additional information

Results from calculated classification (using mixture toxicity rules) indicate that nickel matte compositions containing<3% Co are not classified for reproductive toxicity, while nickel matte compositions containing≥3% Co are classified as reproductive toxicants.

Reproductive toxicity: not classified

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%)

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

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

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

Reproductive toxicity: Category 2 H361 (triggered by Co content)

Nickel Metallic Matte (including Cobalt ≥3%)


Short description of key information:
Toxicity to reproduction (effect on fertility) is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.

Effects on developmental toxicity

Description of key information
Toxicity to  reproduction (developmental toxicity) is driven by the characteristics of the individual UVCB constituents. 
Relevant information on the individual UVCB constituents is reported in Section 7.

Toxicity to reproduction: other studies

Additional information

Nickel matte has a harmonized EU CLP classification. Nickel matte does not carry a classification for reproductive toxicity in the 1stATP to the CLP Regulation. No toxicological studies have been identified that clearly indicate the potential of Ni mattes to cause reproductive toxicity by relevant routes of exposure. A study of nickel refinery workers contain data onexposures to mixed nickel species. No effects were observed on a number of reproductive endpoints (genital malformations, spontaneous abortions, small-for-gestational-age newborns, and musculosketal effects in newborns of female refinery workers exposed to nickel (Vaktskjold et al., 2006, 2007, 2008a, 2008b).

To assess reproductive toxicity, the UVCB classification was calculated by applying the CLP mixture rules using the MeClas tool 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 company maxima concentration reported by the individual legal entities). Cobalt (CAS 7440-48-4) is self-classified by the Cobalt Development Institute for Reproductive toxicity: Category 2 H361 with a generic concentration limit of 3%. Therefore, the composition Nickel Metallic Matte (including Cobalt ≥3%) is classified for reproductive toxicity. 

 

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

Results from calculated classification (using mixture toxicity rules) indicate that nickel matte compositions containing<3% Co are not classified for reproductive toxicity, while nickel matte compositions containing≥3% Co are classified as reproductive toxicants.

Value used for CSA:

Reproductive toxicity: not classified

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%)

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

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

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

Reproductive toxicity: Category 2 H361 (triggered by Co content)

Nickel Metallic Matte (including Cobalt ≥3%)

Justification for classification or non-classification

Ni matte is a UVCB with a variable composition that contains cobalt (CAS 7440-48-4). Cobalt is self-classified by the Cobalt Development Institute for Reproductive toxicity: Category 2 H361 (with a generic concentration limit of 3%) and 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. Nickel matte compositions containing ≥3% Co are classified as reproductive toxicants.

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.

Additional information