Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

There is no explicit requirement to generate toxicokinetic data under Regulation (EC) 1907/2006 (REACH). However, Annex I, Section 1.0.2 of REACH states that “the human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance”. Furthermore, REACH in Annex VIII, Section 8.8.1 mentions that one should perform “assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information”.

Reasons to consider relevant available information on toxicokinetic may be to interpret other human health data, to assist in developing a testing strategy and study design and to help optimising test designs. However, a UVCB substance consists of a wide range of constituents that were already tested and assessed in separate risk assessments. As such Toxicokinetic data of the individual constituent were fully discussed in the associated registration dossiers. Toxicokinetic data of the individual constituents are not presented here. Information considered relevant is reported in IUCLID Section 7 “Toxicological information”.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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