Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Substance specific information for the UVCB substance "Lead bullion, Platinum Group metals rich" is not available for the endpoint “toxicokinetics”. However, there is no specific requirement to generate toxicokinetic data under Regulation (EC) 1907/2006 (REACH). Annex I, Section 1.0.2 of REACH regulation states that “the human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance” and REACH regulation announces in Annex VIII, Section 8.8.1 that one should perform “assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information”.


Nevertheless, for "Lead bullion, Platinum Group metals rich", the human health (HH) hazard assessment is driven by the hazard assessment of the individual UVCB constituents which are (i) classified for HH and (ii) with a content ≥ 0.1 %. For most of the relevant constituents, toxicokinetic data are fully assessed and included in each individual REACH registration file but have not been included in the registration file of "Lead bullion, Platinum Group metals" rich (see strategy of registration for UVCB substances – Precious Metals Refinables). Relevant hazard and risk assessment information for "Lead bullion, Platinum Group metals rich" can be found in IUCLID Section 7 “Toxicological information_ Lead bullion, Platinum Group metals rich”.