Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result:
The substance is expected to be stable under the conditions of stomach and

duodenum and to pass the intestines unchanged and to be excreted directly via faeces. The absence of any liver effects in the course of the 28 day oral toxicity study supports the assumption that most of the test substance is not bioavailable. A bioaccumulation of the test item is not expected.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Functional groups relevant for hydrolysis

The substance contains an ether which is generally stable with regard to pH-dependent hydrolysis at pH values present in the gastrointestinal tract.

Functional groups relevant for elimination

The route of excretion is assumed to be via the biles using the glucuronic acid-conjugate pathway. Glucuronic acid conjugates are most likely formed with the phenolic -OH group. It is considered rather unlikely, that water-soluble metabolites would be formed by oxidation along the sidechain. Glucuronidated metabolites are generally known to be rapidly excreted.

Indication of uptake

In the intestines, due to its very low solubility in water and the large molecular weight only a small amount of the article is expected to be absorbed. Almost the entire ingested test item is expected to pass the intestines unchanged and to be excreted directly via faeces. With respect to the very small part of the substance resorbed, most is expected to become directly glucuronidated in the liver and excreted via the bile. This is likely as the substance has a free phenolic hydroxyl group.

Evaluation of the bioaccumulation potential

A bioaccumulation of the test substance is considered unlikely, due to the fact that in the course of a 28d study perfomed with a structural analogue at high doses, slight reversible liver induction was shown, which is indirect evidence that metabolism and excretion takes place.