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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-736-6 | CAS number: 540-10-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment of Hexadecyl palmitate (CAS 540-10-3) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment”.
Persistence
Hexadecyl palmitate (CAS 540-10-3) is readily biodegradable according to the OECD criteria in a study according to OECD 301 C (75.3% BOD after 28 d). Therefore, the substance does not meet the screening criterion for persistence and is not rated P or vP.
Bioaccumulation
Hexadecyl palmitate (CAS 540-10-3) has an estimated log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. However, a significant uptake and bioaccumulation of the substance in aquatic organisms is not expected based on the low water solubility, rapid biodegradation and metabolization via enzymatic hydrolysis, which produces free fatty acids and alcohols.
It is well known from literature that in fish, these hydrolysis products will be effectively metabolized and excreted (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 dw (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Overall, taking all information into account, the substance is not considered to be B or vB.
Toxicity
Neither long-term test with aquatic algae and aquatic invertebrates nor short-term toxicity tests with representative species from three trophic levels resulted in any toxic effects of hexadecyl palmitate (CAS 540-10-3) up to the limit of water solubility. Furthermore, the substance is not classified according to Regulation (EC) No 1272/2008. Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and it is concluded that the substance is not T.
In conclusion, the substance is not PBT/vPvB.
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.
