Registration Dossier
Registration Dossier
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PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment 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
The substance is not readily biodegradable (4% degradation after 28 d (O2 consumption, OECD 301F). Thus, it is considered to be potentially vP/P.Bioaccumulation
The substance Fatty acids C16-18 (even numbered), oligoesters with sucrose consists of sucrose esterified with palmitic or stearic acid (mono-, di-, triesters and/or higher esters). 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 higher esters 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 in aquatic organisms since the log Pow values are < 4.5 (3.4 - 4.38). Thus, constituents in the first block do not meet the B/vB-criteria for accumulation in aquatic organisms. However, according to ECHA Guidance R.11 (ECHA, 2017) there is indication that accumulation in air breathing organisms might occur based on the calculated log Koa of > 5 (22.60 - 23.34) in combination with the log Pow > 2. These screening values (Kow and Koa) referred to in the ECHA Guidance R.11 are a function of the modelled organisms, food webs and environments used to obtain these values. To develop this partition coefficient combination it was clearly indicated in the guidance that biomagnification potential is only assumed for substances with high chemical absorption efficiency from the diet, no biotransformation after absorption and negligible active transport (in or out).
Fatty acids C16-18 (even numbered), oligoesters with sucrose will be hydrolysed in the gastrointestinal tract to sucrose and the respective fatty acids (palmitic and stearic acid). There is no evidence of tissue accumulation of absorbed intact monoesters.Fatty acids mainly distribute into fat tissue, lymph nodes and liver, while sucrose is metabolised in the intestinal mucosa to glucose and fructose, which can then be incorporated in the standard metabolic pathways of glycolysis and gluconeogenesis. Fatty acids are degraded by mitochondrialβ-oxidation and used for energy generation. Sucrose esters, including Fatty acids C16-18 (even numbered), oligoesters with sucrose, are mainly excreted as CO2 in the expired air as a result of metabolism. Incompletely hydrolysed sucrose esters appear to be excreted in the faeces.
In conclusion, the trigger values for biomagnification in air-breathing (terrestrial) organisms as stipulated in the ECHA Guidance R.11 are likely to overestimate the potential for biomagnification in the food chain. The described metabolic and excretion pathways are very likely to minimize biomagnification in the food chain. For further details on the toxicokinetic behaviour please refer to IUCLID section 7.1.
The constituents in the second block are characterized by log Pow values of > 10. In accordance with the ECHA Guidance R.11 substances with a log Pow > 10 are unlikely to meet the B-criterion. Moreover, the higher esters (di-, tri-, tetra- and higher esters) are expected to be metabolised in the same way as described for the mono- and diesters and are further utilized for catabolic processes. 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
Currently, no toxic effects towards aquatic organisms were recorded up to a limit concentration/loading rate of 100 mg/L. Moreover, the substance is not classified according to the consolidated version of Regulation (EC) No 1272/2008 and all further amendments (ATPs). However, chronic testing data on aquatic invertebrates and fish are not available yet (testing planned in 2023 based on ECHA Decision Number TPE-D-2114576748-28-01/F). Therefore, the substance does not meet the T-criterion based on the currently available data.Conclusion
In conclusion, the substance is not considered to be PBT or vPvB.
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