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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The PBT Assessment for Dipentaerythritol ester of nC5/iC9 acids is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

Persistence

Dipentaerythritol ester of nC5/iC9 acids is not readily biodegradable in a study according to OECD 301B (14% (DOC) in 28 days). Thus, the substance is considered to be persistent (P), but not very persistent (vP).

Bioaccumulation

Dipentaerythritol ester of nC5/iC9 acids exhibits a log Kow of > 6.2 (EU method A.8). However, the substance has a low potential to cross biological membranes. Bioaccumulation is very unlikely because most components of the substance have a very high molecular weight (> 800 g/mol).
T
hus, the substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity

No acute and chronic aquatic toxicity has been observed up to the limit of the water solubility of the substance. Besides, low bioavailability to aquatic organisms is expected due to the large molecular size and high molecular weight of the substance.
Moreover, the substance is not classified according to Regulation (EC) No. 1272/2008 (6th ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.