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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:

Data for the definitive conclusion on the PBT or vPvB properties of fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2008) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

Persistence (P) Assessment:

The screening criterion for Persistence (P) is the potential of a substance to be readily biodegradable. As fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) is readily biodegradable, the substance is not fulfilling the criteria for persistence and is thus not “P” and not “vP”.

Bioaccumulation (B) Assessment:

An evaluation of the bioaccumulation potential of fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) is presented in IUCLID chapter 5.3 and chapter 4.3 in the Chemical Safety Report (CSR) indicating that bioaccumulation is expected to be low due to a calculated BCF of 0.89 L/kg wet weight (Arnot-Gobas). Thus, the substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria and can therefore considered not to be bioaccumulative.

Toxicity (T) Assessment:

Long-term toxicity testing with Daphnia magna resulted in a NOELR (15 d) of ≥ 2570 mg/L (nom.). Furthermore, fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) shows no acute toxicity on all three trophic levels (fish, aquatic invertebrates, algae) in the range of water solubility The test substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). Therefore, fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) does not meet the T criterion set out in Annex XIII of Regulation (EC) No. 1907/2006.