Registration Dossier
Registration Dossier
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EC number: 682-238-0 | CAS number: 1190931-27-1
Specific investigations: other studies
Administrative data
- Endpoint:
- cytotoxicity
- Remarks:
- Effects on FRTL5 rat thyroid cell lines and normal human thyroid cells (NHT)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The new generation PFAS C6O4 does not produce adverse effects on thyroid cells in vitro
- Author:
- Coperchini F., L. Croce, P. Pignatti, G. Ricci, D. Gangemi, F. Magri, M. Imbriani, M. Rotondi, L. Chiovato
- Year:
- 2 020
- Bibliographic source:
- Journal of Endocrinological Investigation 44(8):1625-1635
Materials and methods
- Principles of method if other than guideline:
- - Principle of test: rat and human thyroid cell lines were incubated with a range of concentrations of the test substance
- Short description of test conditions: treatment period of 24, 48, 72, and 144h.
- Parameters analysed / observed: cell viability, cell proliferation, ROS production - GLP compliance:
- no
- Type of method:
- in vitro
- Remarks:
- Assessment of cytotoxicity of compound on FRTL5 rat thyroid cell lines and Normal human thyroid cells (NHT), using WST-1 assay, Annexin V-FITC Apoptosis Detection, Crystal Violet release, and ROS production.
- Endpoint addressed:
- other: cell viability (mitochondrial respiration), cell proliferation, apoptosis, Reactive Oxygen Species (ROS) production
Test material
- Reference substance name:
- ammonium 2,2-difluoro-2-{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate
- EC Number:
- 682-238-0
- Cas Number:
- 1190931-27-1
- Molecular formula:
- C6H4F9NO6
- IUPAC Name:
- ammonium 2,2-difluoro-2-{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate
- Test material form:
- not specified
Constituent 1
Administration / exposure
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 24, 48, 72, 144 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: ng/ml
- Dose / conc.:
- 0.01 other: ng/ml
- Dose / conc.:
- 0.1 other: ng/ml
- Dose / conc.:
- 1 other: ng/ml
- Dose / conc.:
- 10 other: ng/ml
- Dose / conc.:
- 100 other: ng/ml
Results and discussion
- Details on results:
- Results are summarised in the table below.
C6O4 had no significant effects on the parameters assessed in both the rat thyroid cell line and human primary thyroid cells: no change in cell viability (based on mithochondrial respiration), cell proliferation, apoptotic effects, and no induction of ROS production were observed.
As a comparison, both PFOA and PFOS caused a significant reduction in cell viability after 72 and 144 hours and a significantly reduced cell proliferation in the FRTL-5 cells, as well as cell death.
In the human thyroid cells, only PFOS caused a significant reduction in cell viability and cell proliferation in both the FRTL-5 and NHT cells, at all time points, as well as cell death.
Any other information on results incl. tables
Summary of results in rat thyroid cell line (FRTL-5) and Normal Human Thyroid cells (NHT) treated with C6O4, PFOA or PFOS.
| Treatment | C6O4 | C6O4 | PFOA | PFOA | PFOS | PFOS |
| cell type | FRTL-5 | NHT | FRTL-5 | NHT | FRTL-5 | NHT |
| Cell viability (mitochondrial respiration) | no effect | no effect | Reduced 72h** 144h*** | no effect | Reduced 24h** 48h to 144h*** | Reduced 24h to 144h* |
Apoptotic effects (Annexin V/PI assay) | no effect | no effect | cell death | no effect | cell death | cell death |
| Cell proliferation | no effect | no effect | Reduced* | no effect | Reduced** | Reduced** |
| ROS production short exposures (10,20,30 min) | no | no | NA | NA | NA | NA |
| ROS production long exposure (24h) | no | no | NA | NA | NA | NA |
| Cytotoxicity (PI staining) | no effect | no effect | NA | NA | NA | NA |
ANOVA test: * p<0.05, ** p<0.001, *** p<0.0001
NA: not assessed
Applicant's summary and conclusion
- Conclusions:
- The potential effects of C6O4 were assessed in vitro in rat thyroid cell line FRTL-5 and in normal human thyroid primary cells, and compared with effects of PFOA and PFOS. Treatment (0 to 100 ng/ml) with C6O4 did not induce any effect on cell viability, prolideration, apoptosis or ROS production, contrary to PFOA and PFOS treatments applied under same conditions.
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