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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for Reaction products resulting from the esterification of Sorbitol with C8-18 (even) and C18unsaturated fatty acids in the ratio 1:1 (EC 931-434-7) 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 substances Sorbitan stearate (CAS No. 1338-41-6) and Sorbitan oleate (CAS No. 1338-43-8) are readily biodegradable according to OECD 301 C (88% (O2 consumption) after 28 d) and OECD 301 B (84.5% (CO2 evolution) after 28 days), respectively. Thus, Reaction products resulting from the esterification of Sorbitol with C8-18 (even) and C18unsaturated fatty acids in the ratio 1:1 (EC 931-434-7) does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation

Due to the rapid environmental biodegradation and metabolism via enzymatic hydrolysis of the Sorbitan esters category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and D-glucitol. 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 low calculated BCF values of 0.9 - 36.5 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic) for the category members. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the Sorbitan esters category members.

Toxicity

No effects on reproduction occurred in the long-term toxicity test with Daphnia magna (OECD 211) up to the limit of water solubility of the test substances with the read-across substances Sorbitan, octanoate (2:3) (CAS No. 91844-53-0), Sorbitan stearate (CAS No. 1338-41-6) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS No. 8007-43-0). The lowest NOEC (for algae) was 10 mg/L. Moreover, Sorbitan laurate 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 Reaction products resulting from the esterification of Sorbitol with C8-18 (even) and C18unsaturated fatty acids in the ratio 1:1 (EC 931-434-7) is not considered to meet the T criterion.