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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 20-22, 2010
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 439.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: OECD TG 439
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate
EC Number:
Molecular formula:
sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

Test animals

Details on test animals or test system and environmental conditions:
- Supplier: SkinEthic Laboratories (Nice, France).
- Source: culturing adult human keratinocytes on a polycarbonate filter in conditions which permit their terminal differentiation

Test system

not required
Amount / concentration applied:
16 mg
Duration of treatment / exposure:
42 min
Details on study design:
The study was performed according to OECD TG 239.

Results and discussion

In vitro

Irritation / corrosion parameter:
other: other: tissue viability
Remarks on result:
Basis: mean. Time point: 42 min. Remarks: 106.6 %. (migrated information)

In vivo

Irritant / corrosive response data:
The tissue viability after treatment with the test material was higher than 50 % (mean viability: 106.6 %). Therefore, the test material is not considered to possess an irritant potential
Other effects:
For details see executive summary

Any other information on results incl. tables

For details see executive summary

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: OECD GHS
Under the experimental conditions reported, the test material is not irritant to skin.
Executive summary:

Study Design

This in vitro study was performed to assess the irritation potential of the test material by means of the Human Skin Model Test. The test consisted of a topical exposure of the test item to a human reconstructed model followed by a cell viability test. Cell viability was measured by dehydrogenase conversion of MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict skin irritation potential.
Triplicates of the human skin model RHE (Reconstructed Human Epidermis model) were treated either with the test item, the negative or the positive control for 42 minutes. 16 µL of either the negative control (PBS-buffer) or the positive control (5% Sodiumdodecylsulphat-solution) were applied to each tissue. Before adding the test item, 10 µL of deionised water was spread to the epidermis surface to improve further contact between the test item and the epidermis. Afterwards, 16 mg of the test item were applied to each tissue.


Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the treatment interval thus ensuring the validity of the test system.
After treatment with the negative control the absorbance values reached the required acceptability criterion of a mean optical density (OD) > 1.2 for the treatment interval thus showing the quality of the tissues.
The tissue viability after treatment with the test item was higher than 50 % (mean viability: 100.6 %). Therefore, the test item is not considered to possess an irritant potential.


Under the experimental conditions reported, the test item is not irritant to skin.