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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 substance is not PBT/vPvB.

The PBT Assessment for Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistence Assessment

The substance is not readily biodegradable according to OECD criteria. The substance is thus expected to be not rapidly degradable by microorganisms in both the aquatic and terrestrial environments and may therefore potentially fulfil the P/vP criterion.

Bioaccumulation Assessment

The bioaccumulation potential of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid is expected to be low. This assumption is based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. The high molecular weight of the substance significantly reduces the absorption due to steric hindrance to cross biological membranes. It can be concluded that the bioaccumulation potential of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid is negligible. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also support this assumption (BCF values all well below 2000 L/kg). Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the substance is not considered to be B or vB.

Toxicity Assessment

Due to the low water solubility of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid (WS < 0.15 mg/L at 20 °C), all aquatic toxicity tests were performed using water accommodated fractions (WAFs) of the substance. This resulted in acute EL50/LL50 values of > 100 mg/L (fish, aquatic invertebrates, algae) and chronic effect levels (algae, daphnia) of NOELR > 1 mg/L, all based on nominal loading rates. Therefore, no aquatic toxicity was observed up to the limit of water solubility. With respect to mammalian toxicity, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. With regard to environmental fate, the substance is not readily biodegradable and has low potential for bioaccumulation. Therefore, 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.

In conclusion the target may fulfill the P/vP criterion but not the B/vB or T criteria.