Registration Dossier

Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
endocrine system modulation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
28.11.2012 - 05.12.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: recent study conducted according to reliable in-house protocol

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: according to P. Sohoni and J.P. Sumpter (1998)
Principles of method if other than guideline:
The aim of the study was to determine the androgenic and antiandrogenic potential of the test item. The yeast cells used in the yeast androgen screening (YAS) assay have been stably transformed with genes for the human androgen receptor and the ß-galactosidase reporter gene. Andregenie as weil as antiandrogenic potentials of the test substances mediated by receptor binding or blocking can be determined using this assay, respectively.
GLP compliance:
no
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Triphenyl phosphite
- Physical state: Liquid, yellowish
- Storage condition of test material: Room temperature

Administration / exposure

Vehicle:
DMSO

Results and discussion

Details on results:
ln this study, the test substance showed no androgenic activity in comparison to dihydrotestosterone. ln this study, the test substance showed clear antiandrogenic activity at 10E-05 mol/L in comparison to hydroxyflutamide. No cytotoxicity was observed.

Applicant's summary and conclusion