Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
other: Assessment based on physico-chemical and available experimental data
Adequacy of study:
supporting study
Reliability:
other: not applicable

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

The repeated dose toxicity data shows both adaptive and adverse effects on liver, so it is proven that at least some of the components of the UVCB substance are taken up and transported into the liver after ingestion. Representative components are shown in the figure below. Depending on the location and possible sterical hindrance, oxidative metabolism at the secondary amine is possible. Based on textbook knowledge of xenobiotic metabolism, both ring-hydroxylation and side-chain hydroxylation are possible. Coupling in phase II metabolism would result in more soluble metabolites that could be eliminated both via bile and kidney. Actual rate of uptake and elimination will depend on the grade and type of alkylation as this affects solubility and type of metabolism.

Applicant's summary and conclusion