Registration Dossier
Registration Dossier
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EC number: 700-242-3 | CAS number: 62037-80-3
Exposure related observations in humans: other data
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:
- 2 017
- 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.
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