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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 criteria given in the ‘Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment’ (ECHA, 2012) are used as surrogate information to decide whether Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4) may fulfil the PBT or vPvB criteria.

 

Persistence Assessment

Based on the available data, Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4) is considered to be readily biodegradable. Thus, the substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

 

Bioaccumulation Assessment

The bioaccumulation potential of Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4) is expected to be low. This assumption is based on a very low bioavailability of the substances due to its ready biodegradability, high adsorption potential, high log Kow and low water solubility. Furthermore, the substance is rapidly metabolised and excreted by organisms and thus significant accumulation is not expected. This is supported by calculated low BCF/BAF values of 0.8931 - 0.8947 L/kg ww (Arnot-Gobas estimate, upper trophic), respectively. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the test substance is not considered to be B or vB.

 

Toxicity Assessment

Long-term toxicity testing with aquatic algae resulted in no effects up to the limit of water solubility. All available short-term toxicity data did not result in any toxicity up to the water solubility limit as well. A long-term study with aquatic invertebrates is currently on-going and the Toxicity Assessment will be updated accordingly once this study is available.
Moreover, Tetraesters of pentaerythritol with heptanoic acid and 3,5,5-trimethylhexanoic acid (List number 805-289-4) 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.