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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct 20-22, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to OECD TG 439.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 439

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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:

700-540-3

Molecular formula:

C27H28F21NaO12S

IUPAC 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

Test animals

Details on test animals or test system and environmental conditions:

CELL CULTURE
- Supplier: SkinEthic Laboratories (Nice, France).
- Source: culturing adult human keratinocytes on a polycarbonate filter in conditions which permit their terminal differentiation

Test system

Controls:

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

Results

Irritation / corrosion parameter:

other: other: tissue viability

Remarks on result:

other:

Remarks:

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

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

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.

Results

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.

Conclusions

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