Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
March - October 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: It is a well documented non-guideline study which was performed in compliance with GLP

Data source

Reference
Reference Type:
other: ECHA disseminated dossier
Title:
No information
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
yes
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels

Dose descriptor:
NOEL
Remarks:
effect on testosterone production in Leydig cells under hCG stimulation
Effect level:
1 other: mM

Applicant's summary and conclusion

Conclusions:
The test item was exposed to three cell culture systems such as isolated Leydig cells, Sertoli cells and Sertoli-germ cell co-cultures. The cell culture systems used are known to be responsive to some positive control compounds and the effects obtained used as reference values for the assessment of the test item. Cell parameters like protein content, lactate and pyruvate production, hormonally stimulated testosterone production and morphology depending on the cell culture type were analysed. Under the test conditions, the test item enhanced the lactate production (Sertoli cells) significantly in a dose-dependent manner and inhibited testosterone output (Leydig cells) but only in the presence of hormone at 5 hours. The no observed-effect level (NOEL) for this effect was established to be less than 1 mM. The test item thus showed only a small effect on the function of Leydig cells and no effect on Sertoli cells.