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EC number: 500-148-0
CAS number: 61788-89-4
The PBT Assessment for Fatty acids, C18-unsaturated, dimers, “Dimer”
(CAS No. 61788-89-4) 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, C18-unsaturated, dimers, “Dimer” showed not to be readily
biodegradable in four OECD 301 ready biodegradation studies (< 10% after
28 d). Due to the very low biodegradation in these studies, the low
solubility and high adsorption potential, it might be the case that the
test substance is persistent especially in soil. Thus, as possible worst
case, the persistence of the test substance in the environment is
The screening criterion for Bioaccumulation (B) stipulated in the
‘Guidance on information requirements and chemical safety assessment –
Chapter R.11: PBT Assessment’ (ECHA, 2008) is a Log Kow > 4. Even though
Log Kow values > 4 were estimated for the category members, no
significant bioaccumulation in animal tissue is expected due their low
potential to cross biological membranes and their metabolic fate in
organisms. Thus, the category members can neither be considered to be
bioaccumulative (B) nor very bioaccumulative (vB).
Long-term toxicity testing with Danio rerio resulted in no effects up to
the water solubility limit for a read-across substance (ISO/DIS
10229-1). Moreover, the test substance is
not classified according to Directive 67/548/EEC and Regulation (EC) No.
1272/2008 (2nd ATP). 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.
U.S. Environmental Protection Agency (2009). Risk-Based Prioritization
Document. Initial Risk-Based Prioritization of High Production Volume
(HPV) Chemicals – Fatty Acid Dimers and Trimer Category. pp 1-19. Report
date: April 2009.
Lipinski et al. (2001) Experimental and computational approaches to
estimate solubility and permeability in drug discovery and development
settings, Adv. Drug Del. Rev., 2001, 46, 3-26.
Hsieh, A. and Perkins, E.G. (1976). Nutrition and Metabolic Studies of
Methyl Ester of Dimer Fatty Acids in the Rat. Lipids, 11(10):763-768.
Paschke, R.F. et al. (1964). Dimer acid structures. The dehydro-dimer
from methyl oleate and Di-t-butyl peroxide. Journal of the American Oil
Chemists' Society 41(1):56-60.
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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