Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The assessment of PBT/vPvB properties has been done on the basis of the data available from the previous notification programme at level 1-10 tpa as for EEC 92/32 and referring to the principles laid down in the “Guidance on information requirements and chemical safety assessment Part C: PBT Assessment and Chapter 11: PBT Assessment”.

An overall estimation of the available data/information discussed in the CSR lead to consider that they do not allow a direct comparison with all the criteria in Annex XIII but nevertheless indicate that the substance do not have these properties and finally the substance is not considered to be a PBT or vPvB. On the whole, using screening criteria, none of the three criteria is completely met. Persistence is not clearly expected in water and air, persistence in soil may occur but further testing may be needed only at higher levels; bioaccumulation is not of concern due to the experimental Po/w and toxic effect are not present (mammalians and aquatic organism).

The substance is not considered to biomagnify along the food chain on the basis of secondary poisoning argumentation as discussed in the specific paragraph.

 

The substance is produced at the 100 -1000 level and it is not deemed necessary for this level to perform additional studies to refine PBT, vPvB assessment.