Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: expert statement
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: expert statement

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

Direct toxicokinetic data are not available on the test item. Certain physico-chemical properties suggest potential absorption at a limited level. The two repeated dose oral administration studies resulted in some microscopic changes in liver and kidney in rats treated with 50 or 120 mg/kg bw/day. Recovery was evident after treatment was stopped. These biological effects provide qualitative evidence that in rats at least, intestinal absorption, and subsequent tissue distribution, cellular uptake and biological effects of the test item or its metabolites take place.