3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 13, 2013 to March 22, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid

EC Number:

248-580-6

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid

Cas Number:

27619-97-2

Molecular formula:

C8H5F13O3S

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-sulfonic acid

Test material form:

solid

Specific details on test material used for the study:

Purity: 30% Halogenated aliphatic acid

In vitro test system

Test system:

artificial membrane barrier model

Details on test system:

Principles of the Method
Corrositex® is an in vitro assay used to determine the skin corrosion potential of a test substance.
The assay is based on the ability of a corrosive test substance to pass through a biobarrier membrane and to cause a color change in the liquid Chemical Detection System (CDS). The proprietary biobarrier membrane consists of a reconstituted collagen mixture. The CDS is composed of water and pH indicator dyes. Corrositex® is conducted in three steps:

1. Qualification Step
The test substance is pre-qualified to establish compatibility with the assay. The test substance is placed directly into a vial containing the CDS. If a change in color or consistency occurs, the
test substance can be tested by using this assay.

2. Categorization Step
This step establishes the category of the test substance for use in the classification step. The test substance is placed into Vial A (containing an acid buffer) and Vial B (containing a base buffer),
and the vials are observed for a color change. A color change observed in either vial is matched to a color chart. The test substance is assigned to either Category 1 or Category 2 based on the
color change in each vial. Category 1 and Category 2 are indicative of the time scales used in the classification step.

3. Classification Step
This step determines if the test substance is a skin corrosive according to UN and DOT regulations and classifications. The test substance is applied on top of the proprietary biobarrier membrane. A color change or consistency change in the CDS beneath the membrane indicates that the test substance has passed through the membrane. The determination of corrosive/non-corrosive and the Packing Group assigned are based on the amount of time it takes the test substance to pass through the membrane. The time scales differ for Category 1 and 2.
The category assigned and the mean value of the breakthrough time for all 4 sample replicate vials determines the packing group. The following table is used to assign the appropriate
Packing Group by category and breakthrough time.

PACKING GROUP DESIGNATION

Corrositex times

Category 1 0 to 3 minutes > 3 to 60 minutes > 60 to 240 minutes > 240 minutes
Category 2 0 to 3 minutes > 3 to 30 minutes > 30 to 60 minutes > 60 minutes
Corrosive Packing Group I Corrosive Packing Group II Corrosive Packing Group III Non-Corrosive
> = greater than

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

42.42

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: The substance is corrosive Paking group III from category 2

Any other information on results incl. tables

Breakthrough of the biobarrier occurred as follows (hour:minute:second):

Vial 1 (Test Substance): 00:45:05

Vial 2 (Test Substance): 00:43:21

Vial 3 (Test Substance): 00:40:20

Vial 4 (Test Substance): 00:42:00

Mean Value: 00:42:42

Vial 5 (Positive Control): 00:01:15

Vial 6 (Negative Control): No breakthrough

The positive control and negative control performed as anticipated.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Under the conditions of this test, the substance is classified skin corrosive cat. 1B.

Executive summary:

The substance was evaluated for skin corrosion potential using the In Vitro International Corrositex®assay. The results of the assay were used to determine the United Nations and Department of Transportation corrosive packing group. Corrositex® is a standardized and quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system. An aliquot of 500 µL of H-30675 was applied to each of 4 membrane discs. The test substance passed through all 4 of the membranes. The mean breakthrough time for all 4 vials was 0 hours, 42 minutes, and 42 seconds. Under the conditions of this test, the substance is corrosive and is assigned to Packing Group III (minor danger).

Based on these results, the substance is classified as skin corrosive cat. 1B, in accordance with Regulation (EC) No 1272/2008 (CLP).