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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 PBT Assessment for 2-ethylhexyl stearate (CAS No. 22047-49-0) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).

Persistence

The read-across substance 2-ethylhexyl palmitate is readily biodegradable in one study according to OECD 310 (80.8% (CO2 evolution) after 28 d). Thus, 2-ethylhexyl stearate does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

Due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the SCAE C2-C8 category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). This is supported by the low calculated BCF value of 1.01 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the SCAE C2-C8 Category members.

Toxicity

Long-term toxicity testing withDaphnia magnaresulted in a NOEC of ≥ 100 mg/L for the read-across substance isopropyl myristate (CAS No. 110-27-0) (OECD 211). Moreover, 2-ethylhexyl stearate 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 2-ethylhexyl stearate is not considered to meet the T criterion.