Registration Dossier

Administrative data

Description of key information

- complex metal containing substance. - water solubility of the substance is poor (for metal constituents)  - oral and dermal bio-accessibility   - particle size distribution and potential for inhalation toxicity of molten liquid, solid massive and/or solid powder - classification based on mixture toxicity rules 

Key value for chemical safety assessment

Additional information

Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from physico- chemical properties of the UVCB substance.

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

Substance is a massive solid at Room Temperature RT (see picture in IUCLID section 1.4 "sampling protocol") which particle size distribution (IUCLID section 4.5) for a WC sample (ie samples crushed and grinded prior to testing) showed D50 > or equal 832µm, with particles <20µm less than 4% (WC). Routes for exposure to consider are therefore oral for massive material (and inhalation for molten material), and oral and inhalation in case of solid powders. Water solubility (IUCLID section 4.8) furthermore demonstrated that substance is poorly soluble in water, except at high loading and after long period for Cu, S, Si, Zn, K, and Na. The pH of the test solutions ranged for all representative samples between 5.8 and 9.7 (ie no extreme pH <2 or >11.5).

Water solubility (IUCLID section 4.8) and Sequential dissolutions (IUCLID 4.23 Chemical assays) as well as Transformation/Dissolution and bio-elution tests (IUCLID 5.6) furthermore confirmed species present and their solubility behaviour. The Meclas tool was used to automatically calculate the classification of the intermediate. The tool is based on a database containing the human and environmental classification for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) and oral/dermal bio-accessability is furthermore incorporated into the tool, so that the elemental composition (in % Total element) is automatically converted into % w/w of bio-accessible compounds that are relevant for applying the mixture rules

Justification for classification or non-classification

Acute toxic: not classified (Grade 1 and 2)

The classification derived is applicable to all Copper Matte.

See end-point record and discussion above for detailed justifications.  

The tested samples were representative for the typical across industry, defined within the elemental concentration ranges (maximum of the typical) outlined under IUCLID section 1.2 for Grades 1, and Grade 2, respectively.