Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

specific investigations: other studies
comparative study in rat and human hepatocytes to investigate the human relevance of the changes in rat thyroid hormone metabolism by UGT induction
Type of information:
other: Study planned

Data source

Materials and methods

Principles of method if other than guideline:
Primary cultures of cryopreserved hepatocytes from Wistar rat and three human donors will be cultured and incubated with the test item at different non-cytotoxic concentrations for different time points. A preliminary cytotoxicity study will determine the test item concentrations to be used in the main study. Positive controls samples will be added to the test design.
After treatment periods, the mRNA expression of Cyp2b1 and Cyp3a1 (rat) or CYP2B6 and CYP3A4 (human) and of UGT1A1, UGT1A5/6 (human and rat), UGT1A3, UGT1A9 (human), Ugt2B1 (rat) or UGT2B7 (human) will be measured to determine potential alterations at the transcriptional level.
GLP compliance:
Type of method:
in vitro

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:

Test animals

other: Primary cultures of cryopreserved hepatocytes from Wistar rat and human donors

Results and discussion

Applicant's summary and conclusion