Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 604-608-2 | CAS number: 147853-32-5
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (CAS 147853-32-5) 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
Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (CAS 147853-32-5) is not readily biodegradable in a study according to OECD 301B (17% (CO2 evolution) in 28 days). Thus, the substance can be considered to be potentially fulfilling the criteria for Persistence (P) and (vP).
Bioaccumulation
Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (CAS 147853-32-5) exhibits a log Kow of > 6.5 (EU method A.8). However, due to the low water solubility (< 0.1 mg/L) exposure concentrations in the aquatic environment are expected to be very low, if the substance is present at all. Consequently the potential uptake of the substance by aquatic organisms is limited or even unlikely. Additionally, the substance has a low potential to cross biological membranes due to its molecular size. In case of uptake and absorption, rapid metabolism of fatty acids occurs. This is supported by the low calculated BCF value 0.893 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 of the Technical dossier for a detailed overview on bioaccumulation. Hence, the substance does not pose a risk to organisms in regard to bioaccumulation/biomagnification and is not considered to be B or vB.
Toxicity
Long-term toxicity testing with Daphnia magna resulted in a NOELR of 100 mg/LforFatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (CAS 147853-32-5) (OECD 211). No toxicity has been observed up to the limit of the water solubility of the substance (< 0.1 mg/L).
Moreover, the 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.
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.
