Registration Dossier
Registration Dossier
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EC number: 700-536-1 | CAS number: 25628-08-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Test Method B.46
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439
- Principles of method if other than guideline:
- The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIiSystems, St. Katharinen, Germany)
- GLP compliance:
- yes
Test material
- Reference substance name:
- tetraethylazanium nonafluorobutane-1-sulfonate
- EC Number:
- 700-536-1
- Cas Number:
- 25628-08-4
- Molecular formula:
- C12H20F9NO3S
- IUPAC Name:
- tetraethylazanium nonafluorobutane-1-sulfonate
- Reference substance name:
- N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
- IUPAC Name:
- N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
- Details on test material:
- content: 97.7%
Constituent 1
Constituent 2
Test animals
- Species:
- other: not applicable - in-vitro 3D skin corrosion test
- Strain:
- other: not applicable - in-vitro 3D skin corrosion test
Test system
- Type of coverage:
- other: not applicable - in-vitro 3D skin corrosion test
- Preparation of test site:
- other: not applicable - in-vitro 3D skin corrosion test
- Vehicle:
- other: not applicable - in-vitro 3D skin corrosion test
- Controls:
- other: not applicable - in-vitro 3D skin corrosion test
- Duration of treatment / exposure:
- After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured
- Observation period:
- not applicable - in-vitro 3D skin corrosion test
- Number of animals:
- not applicable - in-vitro 3D skin corrosion test
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- 97.79
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: ca. 42h. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non irritant - scores in [%] viability. (migrated information)
In vivo
- Other effects:
- no data
Any other information on results incl. tables
Compound Cell viability [%] Classification*
Perfluorbutansulfonsäure-
Tetraethylammonium-Salz 98.79 Non irritant (NI)
Positive control 1.21 Irritant (I)
Negative control 100.00 Non irritant (NI)
*: Classification was done in accordance with EU Test Method B.46.
In vitro result In vivo prediction
mean tissue viability < 50 Irritant (I)
mean tissue viability > 50 Non-irritant (NI)
(I): Irritant , R38 = Skin irritation category 2, H315
(NI): Non – irritant = no skin irritation category
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
The experiment was carried out according to OECD 439 and EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).
Undiluted Tetraethylammonium perfluorobutanesulfonate was applied topically to the RHS model, i.e. 30mg per insert (plus 30µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates).
After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 98.79% in the MTT (Methylthiazoletetrazolium) conversion assay.
The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.
Thus, the results show that Tetraethylammonium perfluorobutanesulfonate is considered to have no skin irritation category.
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