Registration Dossier

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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EU Test Method B.46
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
content: 97.7%

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.