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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other:
Adequacy of study:
other information
Study period:
From 29 Mar 2017 to 27 Oct 2017

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Type of study / information:
Bioanalytical study was to analyze study samples of EDTA human plasma for the determination of HFPO-DA.
Test guideline
Guideline:
other:
Version / remarks:
European Medicines Agency (EMA). Guideline on Bioanalytical Method Validation.
EMEA/CHMP/EWP/192217/2009. 21 July 2011
GLP compliance:
yes

Results and discussion

Results:
HFPO-DA levels in blood plasma from plant workers had concentrations of HFPO-DA in the range of <0.001 - 0.2ug/ml.

Applicant's summary and conclusion

Executive summary:

HFPO-DA levels in blood plasma from plant workers had concentrations of HFPO-DA in the range of <0.001 - 0.2ug/ml.  Workers had been using HFPO-DA for approximately three years.  These levels are not indicative of a substance with slow bioelimination.