Registration Dossier
Registration Dossier
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EC number: 952-655-5 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for cocoyl olivate (EC No 952-655-5) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
The substance is considered to be readily biodegradable in two studies according to OECD 301C (67% and 75 % (BOD) after 28 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
Bioaccumulation
The substance has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the LCAE (Long Chain Aliphatic 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 the free alcohol. From literature it is well known, that these hydrolysis products will be metabolized and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973). This is supported by low calculated BCF values of 0.89 - 14.07 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 LCAE Category members. Thus, taking all information into account, the test substance is not considered to be B or vB.
Toxicity
Long-term toxicity testing with Pseudokirchneriella subcapitata resulted in a NOELR of ≥ 100 mg/L (OECD 201; nominal). All available short-term toxicity data did not result in any toxicity up to the water solubility limit. Moreover, cocoyl olivate is not classified according to Regulation (EC) No. 1272/2008. Thus, 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.
Conclusion
In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.
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