Potassium methanolate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

Potassium methanolate

EC Number:

212-736-1

EC Name:

Potassium methanolate

Cas Number:

865-33-8

Molecular formula:

CH4O.K

IUPAC Name:

potassium methanolate

In vitro test system

Test system:

artificial membrane barrier model

Source species:

other: artificial

Cell type:

other: not applicable

Cell source:

other: not applicable

Source strain:

other: not applicable

Details on animal used as source of test system:

not applicable

Justification for test system used:

The Corrositex® assay is a standardized in vitro corrosion test to determine the corrosive potential of test substances. The Corrositex® assay kit is commercially available from InVitro International (Irvine CA, USA).

Vehicle:

unchanged (no vehicle)

Details on test system:

SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: yes
- Components: Reagents required for qualification and categorization screen, biobarrier matrix powder and diluent, membrane discs and vials containing the Chemical Detection System.
- Apparatus and preparation procedures: 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). Thus, the Corrositex® assay was evaluated on the basis of the color change of the CDS. The assay is therefore limited to testing those materials which cause detectable pH changes in the CDS. The time that a color change was observed was recorded manually (electronic time clocks) and the break through times of four replicates were used to determine the corrosive potential of the test substance. The assay ran in a fume hood.

WAS THE COMPATIBILITY TEST PERFORMED: yes

WAS THE TIMESCALE CATEGORY TEST PERFORMED: yes

METHOD OF DETECTION
- Chemical detection system

NUMBER OF REPLICATES: 4

Control samples:

not specified

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

Until a color change of the CDS was observed.

Duration of post-treatment incubation (if applicable):

not applicable

Number of replicates:

4

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

mean

Value:

7.07

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Corrosive potential was determined on the basis of the average time recorded for the test substance to produce a change in the CDS.

Executive summary:

Based on the observed results and applying the evaluation criteria it was concluded, that K-Methylat krist. 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 7 minutes and 4 seconds.