Sodium 2-methylbutan-2-olate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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: GLP study conducted in compliance with OECD guidline TG 435, well documented.

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-methylbutan-2-olate

EC Number:

238-639-4

EC Name:

Sodium 2-methylbutan-2-olate

Cas Number:

14593-46-5

Molecular formula:

C5H12O.Na

IUPAC Name:

sodium 2-methylbutan-2-olate

Test animals

Species:

other: Corrositex® kit

Strain:

other: reconstituted collagen matrix

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: control vials with positive and negative control

Amount / concentration applied:

The test substance was applied undiluted. Approximately 300 mg of the test substance was added onto the membrane disc (=maximum applicable amount).

Duration of treatment / exposure:

The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier penetration) is recorded.

Observation period:

3 min until the first change in the indicator solution (up to 4 hours)

Number of animals:

other: 4 Vials

Details on study design:

The Corrositex® assay is a standardized in vitro corrosion test. The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). The Corrositex® assay is used to determine the corrosive potential of test substances. The assay is limited to testing those materials which cause detectable pH changes in the CDS

Following the acceptance of the positive control the Corrositex® assay is performed for the test substance. Four vials containing the CDS are used for the
test substance. In addition, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was
placed into one vial containing the CDS. Application of 500 mg was not possible due to the low specific weight of the test substance. Hence, approximately 300 mg of the test substance was added onto the membrane disc (=maximum applicable amount). An electronic time clock was started with the application.

The vial is observed for three minutes for any change in the CDS. If no color change is observed within three minutes, the remaining membranes are treated with the test substance. An electronic time clock is started with each application. The vials are observed continuously for the first ten minutes. Thereafter the vials are observed for approximately ten minutes around the time points relevant for evaluation or until break through of the test substance occurred.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: overall irritation score

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 8 minutes and 53 seconds. Remarks: mean breakthrough time. (migrated information)

In vivo

Irritant / corrosive response data:

Sodium-tert-amylate showed a mean break through time of 8 minutes and 53 seconds.

Other effects:

not applicable

Any other information on results incl. tables

Test substance	Vial 1	Vial 2	Vial 3	Vial 4	Mean
12/0112 -1	8:49	9:50	7:23	9:29	8:53

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the observed results and applying the evaluation criteria it was concluded, that the test substance shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean break through
time determined in the in vitro membrane barrier test was 8 minutes and 53 seconds.