Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
other: Weight of evidence analysis based on expert evaluated data on the group of lecithins
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: based on expert group reviews and published data
Justification for type of information:
Experimental data on this endpoint are not available for Phosphatidylcholines, soya, hydrogenated. The toxicokinetics of the substance is therefore assessed in the present weight of evidence analysis based on existing data on similar compounds.
To assess the toxicokinetic potential of hydrogenated phosphatidylcholines, hydrogenated lecithins in general as well as non-hydrogenated phosphatidylcholines (lecithins) can be considered. In order to combine data on several similar substances an overall weight of evidence approach is used for the assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Principles of method if other than guideline:
The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. However, details on methods may vary. Please refer to attached weight of evidence document.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Estimation based on CAS number
Details on test material:
CAS number 97281-48-6
Specific details on test material used for the study:
For more details, please see attached weight of evidence document.

Results and discussion

Applicant's summary and conclusion

Conclusions:
No data exist on the toxicokinetics of phosphatidylcholines, soya, hydrogenated, however, several in vivo studies using radiolabelled lecithins are available in both animals and humans. The studies suggest that lecithin is either absorbed from the intestine intact or hydrolysed to yield lysophosphatidylcholine or choline. Besides the intestinal wall, the major target organ for distribution and metabolism of lecithins is the liver. Only small amounts of lecithins are excreted via urine and faeces instead it is anticipated that the majority of the lecithins undergo metabolism as for endogenous phospholipids.
Due to structural similarities it is anticipated that the toxicokinetics of phosphatidylcholines, soya, hydrogenated can be expected to be similar to what is described for lecithins in general.
Executive summary:

No data exist on the toxicokinetics of phosphatidylcholines, soya, hydrogenated, however, several in vivo studies using radiolabelled lecithins are available in both animals and humans. The studies suggest that lecithinis either absorbed from the intestine intact or hydrolysed to yield lysophosphatidylcholine or choline. Besides the intestinal wall, the major target organ for distribution and metabolism of lecithins is the liver. Only small amounts of lecithins are excreted via urine and faeces instead it is anticipated that the majority of the lecithins undergo metabolism as for endogenous phospholipids. Due to structural similarities it is anticipated that the toxicokinetics of phosphatidylcholines, soya, hydrogenated can be expected to be similar to what is described for lecithins in general.