Registration Dossier
Registration Dossier
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EC number: 943-350-8 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Based on the experimental data and the read-across consideration, no bioaccumulation is expected.
An in vitro encymatic Lipase Assay with the target substance is available.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The toxicokinetics and metabolism profile of Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers (target chemical) can reasonably be derived based on in-vitro experimental data and on the read-across approach using Polyclycerin polyricinoleate (PGPR) as a source chemical.
The underlying scientific rationale is that both chemicals are of comparable structural feature and chemical functionality and can be characterized as an ester of polyglycerols and fatty acid. The metabolism of both chemicals is assumed to be similar by ester-bond cleavage to release polyglycerols and fatty acid and the released metabolites are of comparable toxicological properties. The metabolic fate of polyglycerol fatty acid esters after ingestion is extensively investigated (Howes et al., 1998; Michael and Coots, 1971) and can be summarized:
- When applied orally, the compound is bioavailable only after ester bond cleavage in intestine, otherwise fecal excretion occurs.
- The liberated polyglycerols are excreted unchanged. The lower glycerols (n= 2, 3) are more readily absorbed and are excreted in the urine, while the higher glycerols are less easily absorbed and are excreted in the feces.
- The liberated fatty acids are to be incorporated into the normal fatty acid metabolism.
The hydrolysis of the target chemical Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers, catalyzed by pancreas lipases is proven in an in vitro test system (Hoeppner, 2014). It could be shown that Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers is subject to fatty acid releasing hydrolysis by porcine pancreas lipase (PPL). These findings suggest that metabolism of the esters of the Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers occur initially via enzymatic hydrolysis, leading to release of polyglycerols and the corresponding fatty acids. The liberated fatty acids will be incorporated into the fatty acid metabolism.
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