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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
March - October 1995
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 Type:
other: ECHA disseminated dossier
No information
Report date:

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Trifluoroacetic acid
EC Number:
EC Name:
Trifluoroacetic acid
Cas Number:
Molecular formula:
trifluoroacetic acid

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.