Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

There is no specific requirement to generate Toxicokinetic information according to REACH Regulation (EC) No 1907/2006. Annex I, Section 1.0.2 states that “the human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance”. Furthermore, REACH 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”. The toxicokinetic behaviour derived from available data but also taking in great consideration the physicochemical properties of the substance. Further testing is not considered as necessary since the toxicological profile of the substance can be predicted/ evaluated. The assessment of TK profile (absorption, metabolism, distribution, excretion) is therefore assessed to the extent that can be derived from the relevant available information.