Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Boundary composition
Type of composition:
boundary composition of the substance
State / form:
Reference substance:
Boundary composition
PBT status:
the substance is not PBT / vPvB

The submission substance fulfils the P- and T-criterion (not degradable according to biodegradation screening test; classified as STOT RE Cat. 2), but does not fulfil the vB/B criterion (BCF < 2000): Reliable QSAR based data on BCF for fish (QMRF demonstrating validity of QSAR model; QPRF demonstrating (1) applicability of QSAR model on submission substance, (2) reliability of the prediction, as well as (3) relevance of the prediction for the regulatory purpose) allow for a safe conclusion that the submission substance is not bioaccumulative (BCF 141 L/kg whole body wet weight; worst case BCF implying maximum underestimation from 14 similar compounds: 269 L/kg whole body wet weight). This conclusion is confirmed by two relevant supporting models based on very different methodology.

Therefore, the submission substance is assessed to be not PBT / vPvB acc. to Annex XIII of Regulation (EC) No 1907/2006.

Likely routes of exposure:

Exposure considerations not required as the substance is not PBT / vPvB.