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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids 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

One study investigating the biodegradability of Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids is available. The study was conducted according to GLP and OECD guideline 301B under enhanced test conditions using non-acclimatized activated sludge from a municipal wastewater treatment plant as inocculum (BASF 2017). Based on CO2 consumption a degradation of 19 -28% was observed after 28 days and a biodegradation of 52 -59% after 60 days. Hence, the test substance is determined to be not readily biodegradable. However, the constantly increasing degradation curve indicate that the substance is inherently (ultimatively) biodegradable and thus not persistent in the environment. Thus, the test substance is not considered to be P or vP.

Bioaccumulation

No experimental data determining the bioaccumulation potential of Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids are available. A log Pow value calculated as ratio of the saturated water solubility (OECD 105) and saturated octanol solubility (no guideline currently available but based on the principles of OECD 105) was measured to be 3.6. This indicates that bioaccumulation cannot per se be excluded. Therefore, all relevant data to evaluate the bioaccumulation potential of the substance are combined in a Weight of Evidence (WoE) approach. These data comprise physico-chemical properties of the parent compounds and degradation products (e.g., log Pow, molecular weight, max diameter), ADME related data as well as calculated/experimental data for biodegradation and bioaccumulation. Based on this data Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids is not considered to be B or vB.

Toxicity

No conclusion can be reached based on available information