Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Animal testing on UVCB with variable composition is not relevant. The toxicokinetics, metabolism and distribution are driven by the characteristics of the individual UVCB constituents. 

Key value for chemical safety assessment

Additional information

The toxicokinetics, metabolism and distribution are driven by the characteristics of the individual UVCB constituents.

The physico-chemical characterization of the UVCB (see relevant section in IUCLID) demonstrates that metal constituents are built into complex mineralogical structures consisting mainly: intermetallic, metal sulphates and metal oxides that are formed as a by-product from refining and smelting of lead containing materials. This resulted in relatively high solubilisation potential in water for most of the metals present in the UVCB (e. g. Cu, Ag, As).

Generally, the physical form and the physical-chemical properties of the UVCB substance are expected to limit the solubility of the UVCB constituents in biological fluids and subsequently to limit cellular absorption of the released metals. The toxicokinetics of the UVCB is therefore primarily related to the degree to which the metal mineral phases in the UVCB react with biological fluids and release soluble, potentially bio available species. The metals in the UVCB are considered fully soluble in water and therefore the bio-accessibility of the metal ion is considered as equivalent to the bio-accessibility/bio-availability of soluble metal compounds (Me sulfates and oxides).

In addition, the following requires to be taken into consideration:

Oral: the UVCB is a powder and needs to dissolve before it can be adsorbed. Relatively high absorption in gastro intestinal tract can therefore be expected due to (anticipated) full solubility of constituting species.

Inhalation: Two samples ware tested and a D50 of 38, resp. <20 µm was determined and thus contains the UVCB inhalable particles (particle size less than 100 µm), which are capable of entering the respiratory tract under realistic breathing conditions.

Dermal: the UVCB has to dissolve into the surface moisture of the skin before dermal uptake can begin. As the UVCB is highly soluble in water, it is expected to partition much to the epidermis, and thus likely resulting in substantial dermal uptake of some constituting (metal) species. The metals adsorbed after dermal exposure may also contribute to systemic metal doses and therefore have been considered for the (combined) toxicity assessement, as appropriate.

The “bio accessible” metal ions may enter the blood stream and exert its toxic action directly to the blood or in any target tissue or organ to which the circulatory system transports or distributes it. Information on toxicokinetics (absorption, distribution, metabolism and excretion) is available for key metal constituents in the UVCB. Metal-specific oral bio-availability of soluble compounds are therefore applicable to the UVCB.

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

Animal testing on UVCB with variable composition is not relevant. The toxicokinetics, metabolism and distribution are driven by the characteristics of the individual UVCB constituents.