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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 fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) 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, 2012) 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, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) 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, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) 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 - 18.94 L/kg wet weight (Arnot-Gobas) and further reliable information on the metabolism of the substance.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 (21 d) of ≥ 0.11 g/L (nom.). Furthermore, fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) 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, tall-oil, triesters with trimethylolpropane does not meet the T criterion set out in Annex XIII of Regulation (EC) No. 1907/2006.