Registration Dossier
Registration Dossier
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EC number: 940-803-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
- EC Number:
- 940-803-1
- Molecular formula:
- This is a multi-constituent susbstance there is no molecular formula or molecular weight range available
- IUPAC Name:
- Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot # W17033003. 28% active emulsion in water.
Thetawet FS-8250 is a 28% actives aqueous emulsion, water dispersible, low foam anionic fluorosurfactant
The active components are ammonium salts of [Mono & Di] 2-(Perfluorohexyl)ethyl-Phosphate. Found at ca. 10% and 18% respectively in the final product.
The substance is not possible to isolate from water and if attempted, there is decomposition with a loss of ammonia. The substance is also functionally surface active, forming emulsions in water and oil
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: cultured human cells
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 89.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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