Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

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

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

In case of Grade 1 Scale/slag-type materials, the substance is a solid, and massive (only WC crushed sample show ca 40% below 20µm sized particulates, no other route than oral to consider). For Grade 2 dross-type material, the substance is solid with fine to grain or massive portions (WC powder forms of species relevant for classification were taken into account when applying Mixture Toxicity rules). See furthermore pictures in IUCLID section 1.4 "sampling protocol" and granulometry tests in IUCLID section 4.5. Water solubility (IUCLID section 4.8) and Sequential dissolutions (IUCLID 4.23 Chemical assays) furthermore confirmed species present and their solubility behaviour.


Migrated from Short description of key information:
- complex metal containing substance
- solubility of constituents in water is poor
- classification based on mixture toxicity rules

Respiratory sensitisation

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

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

In case of Grade 1 Scale/slag-type materials, the substance is a solid, and massive (only WC crushed sample show ca 40% below 20µm sized particulates, no other route than oral to consider). For Grade 2 dross-type material, the substance is solid with fine to grain or massive portions (WC powder forms of species relevant for classification were taken into account when applying Mixture Toxicity rules). See furthermore pictures in IUCLID section 1.4 "sampling protocol" and granulometry tests in IUCLID section 4.5. Water solubility (IUCLID section 4.8) and Sequential dissolutions (IUCLID 4.23 Chemical assays) furthermore confirmed species present and their solubility behaviour.

Migrated from Short description of key information:
No respiratory sensitisation derived based on Arche CLP tool (calcualtion based on mixture toxicity); WoE from physico-chemical data demonstrate no presence of species with respiratory sensitizing properties.

Justification for classification or non-classification

Skin Sensitization: not classified

Respiratory Sensitization: not classified

The above classification is applicable to Copper scales Grade 1 (scale type matrial), Grade 2 and 4 (dross type materials with max Ni<1%)  

Skin Sensitization: cat 1 H317

Respiratory Sensitization: not classified

The above classification is applicable to Copper scales Grade 3 (dross-type material, with Ni> or equal 1%)

 

See end-records and discussions above for detailed justifications

 The tested sample was representative for a Typical across industry (for both grades), defined within the concentration ranges outlined under IUCLID section 1.2

Self-classification of the UVCB substance (IUCLID Section 2.1 & 2.2) was performed based on below outline:

1. Characterization

The material is accurately described from its elemental composition (typical concentrations and concentration ranges across production sites –IUCLID Section 1.2), and the specific speciation data (mineralogical information) obtained from a representative sample (IUCLID Section 4, in particular 4.23). This information is enough to initiate the classification process.

2. Classification by the Mixture Approach

The UVCB is treated as a complex metal containing substance with a number of discrete constituting compounds (metals, metal compounds, non-metal inorganic compounds). The hazard classifications of each compound are then factored into a combined classification of the UVCB as a whole. For health endpoints, UVCB classifications are based on the combined hazards of the compounds whereby additivity or key cut off levels, specified in look-up tables are used, depending on the endpoint and amount of information available for the constituting compounds. For environmental endpoints, additivity and/or summation algorithms are applied to quantitatively estimate the mixture’s toxicity to aquatic organisms. These concepts and rules are incorporated in easy to use IT tools, which can be used to classify the UVCB.

3. Bridging or Read-Across

(Eco)-toxicological data are not available for the specific UVCBs being evaluated. Considering the knowledge and variability in composition, read-across and bridging is done by using  a "representative" mineralogical/speciation analysis"  combined with the  "worst case" metal concentration (across companies)  as a basis for the classification of the UVCB substance (chemical and mineralogical surrogates with similar origin/production process and physical/chemical properties –see IUCLID 1.4 for information on Sampling procedure).

4. Eventual correction

No correction for (bio)availability was made

 See furthermore attached documents: Arche CLP tool version June 2010; Incorporated to tool (or attached): how elemental composition is translated into Mineralogical composition relevant for classification (i.e. “ input sheets” and iuclid 4.23)