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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-854-9 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Fatty acids C16-18 (even numbered), mono and diesters with sucrose (no CAS) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
Fatty acids C16-18 (even numbered), mono and diesters with sucrose (no CAS) is readily biodegradable according to the OECD criteria. Thus, the substance is not considered to be vP/P.
Bioaccumulation
The substance consists of sucrose esterified with palmitic or stearic acid (mono- and di-esterified). Since the components are characterized by different physico-chemical properties the components are grouped into two representative blocks in order to assess their bioaccumulation potential. The first block consists of C16- and C18-monoesters whereas the C16- and C-18-diester components were considered as the second block. In accordance with the guidance document the constituents in the first block are considered to have a low potential for bioaccumulation since the log Pow values are < 4.5 (3.4 - 3.99). Thus, constituents in the first block do not meet the B/vB-criteria. The constituents in the second block are characterized by log Pow values of 11.06 - 12.63. In accordance with the ECHA Guidance R.11 substances with a log Pow > 10 are unlikely to meet the B-criterion. Thus, it is concluded that the higher degree esters combined in the second block have a low potential for bioaccumulation and do not meet the B/vB-criteria.
Toxicity
The acute effect data for Fatty acids C16-18 (even numbered), mono and diesters with sucrose (no CAS) are > 0.1 mg/L. Moreover, the substance is not classified as H350, H340, H372, H373, H350i, H360, H361 and is readily biodegradable according to OECD criteria. Thus, in accordance with ECHA Guidance R.11 no T-assessment is necessary.
Conclusion
In conclusion, Fatty acids C16-18 (even numbered), mono and diesters with sucrose (no CAS) is not considered to be PBT or 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.
