Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

The PBT Assessment for Multi constituent ester of pentaerythritol 2-ethylhexanoate is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012d).

Persistence

The substance Multi constituent ester of pentaerythritol 2-ethylhexanoate is considered to be readily biodegradable. The assessment is based on an OECD 301B test, resulting in 60-63% degradation in one parallel in two experiments, respectively. Thus, the substance is not considered to be P or vP.

Bioaccumulation

The bioaccumulation potential of Multi constituent ester of pentaerythritol 2-ethylhexanoate is expected to be low. The bioavailability of the substance is presumably to be low due to the assumed environmental fate. Furthermore the substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF/BAF values calculated for the main components of the substance (diester component BCF/BAF: 12.49 L/kg; triester component: 1.1 L/kg; tetraester component: 0.89 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.

Toxicity

The substance of Multi constituent ester of pentaerythritol 2-ethylhexanoate is considered to be not toxic. The assessment is based on a long-term toxicity study towards Daphnia magna resulting in a NOEL reproduction (21d) of 5.8 mg/L. Furthermore the substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is considered to be not T.