Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The copper slag is a complex metal containing substance. It mainly contains iron silicate and silicates of aluminum and calcium.. Traces of metals exist in metal, mineral form or included in silicate phases.

Classification derived based on rules for mixtures:

Skin sensitization: Not classified

Results from calculated classification are further supported (WoE) by consideration of physical chemical properties of the UVCB substance.

Chemistry and mineralogy of the slag (see IUCLID section 4.23 chemical and mineralogical characterization) were taken into account.

Water solubility (IUCLID section 4.8) and Sequential dissolutions (IUCLID 4.23 Chemical assays) furthermore confirmed species present and their solubility behavior.

Copper slag contains only minor constituents classified as skin sensitisers but their actual levels are much lower than < 1% thus copper slag is not classified for skin sensitization.

 

Ni in metallic or compound form present at concentration slightly above 0.1% in copper slags from secondary production ( see IUCLIDsection 1.2 and 4.3).

 

Therefore to further confirm the conclusions the solubility of Ni was assessed during an in-vitro bio-accessibility test in artificial sweat fluid in accordance with standardized test method (EN 1811). Results interpreted in the regulatory context of the EU Nickel Directive (94/27/EC ) which sets threshold for nickel release in artificial sweat of less than 0.5 µg Ni/cm2/week for products intended to come into direct and prolonged contact with the skin. (see section 7.1.Dermal absorption).

The amount of Ni released during the sweat tests of 2 copper slags is in the ranges between 1.9 to 2.5% or between 0.021 and 0.036 µg Ni/cm2/week. This information thus provides further evidence that there is no need to classify the copper slag substance for skin sensitisation

Migrated from Short description of key information:

Complex metal containing substance

Solubility of constituents in water is poor

Classification based on rules for mixtures

In vitro bio-accessability test in afrificial sweat fluid in accordance with EN 1811 (skin sensitisation)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The copper slag is a complex metal containing substance. It mainly contains iron silicate and silicates of aluminum and calcium. Traces of metals exist in metal, mineral form or included in silicate phases.

Classification derivedbased on rules for mixtures:

Respiratory sensitization: Not classified

Results from calculated classification are further supported (WoE) by consideration of physical chemical properties of the UVCB substance.

Chemistry and mineralogy of the slag (see IUCLID section 4.23 chemical and mineralogical characterization) were taken into account.

Water solubility (IUCLID section 4.8) and Sequential dissolutions (IUCLID 4.23 Chemical assays) furthermore confirmed species present and their solubility behavior.

Copper slag contains only minor constituents classified as respiratory sensitisers but their actual levels are much lower than < 1% thus copper slag is not classified for respiratory sensitization.

 

Migrated from Short description of key information:

Complex metal containing substance

Solubility of constituents in water is poor

Classification based on  rules for mixtures

Justification for classification or non-classification

Copper slag contains only minor constituents classified as skin or respiratory sensitisers but their actual levels are much lower than < 1% thus copper slag is not classified for skin or respiratory sensitization.