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EC number: 306-082-7
CAS number: 95912-86-0
The PBT Assessment for Fatty acids, C8-10, C12-18-alkyl esters
(CAS 95912-86-0) is based on the criteria set out in the “Guidance on
information requirements and chemical safety assessment, Chapter R.11:
PBT Assessment” (ECHA, 2012).
Fatty acids, C8-10, C12-18-alkyl esters is readily biodegradable
in two studies according to OECD 301C (67 - 75.3% (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.
Fatty acids, C8-10, C12-18-alkyl esters has a log Kow of ≥ 8.72
(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 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.
Long-term toxicity testing with algae and daphnia resulted in no
effects up to the water solubility limit (OECD 201, OECD 211). All
available short-term toxicity data did not result in any toxicity up to
the water solubility limit as well. Moreover, Fatty acids, C8-10,
C12-18-alkyl esters 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 the test substance
is not considered to meet the T criterion.
In conclusion the substance is not considered to meet the criteria
to be classified as PBT or vPvB based on the available data.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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