Dipotassium oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide In 2004 and 2006, new guidelines on in vitro tests were published (OECD TG 430, 431 and 435) . The described method is meeting the criteria required by the new OECD TG 431 guideline.

Data source

Reference

Reference Type:

publication

Title:

The ECVAM international validation study on in vitrol tests for skin corrosivity. 2. Results and evaluation by the management team.

Author:

Fentem JH, Archer GEB, Balls M, BothamPA, Curren RD, Earl LK, Esdaile DJ, Holzhütter HG and LIebsch M

Year:

1998

Bibliographic source:

Toxicol. In Vitro, 12, 483-524

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD TG 431 (In vitro skin corrosion: human skin model test), study was performed prior to the adoption of the test guideline

Principles of method if other than guideline:

The Skin² model ZK1350 : in vitro skin corrosion test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hydroxide

EC Number:

215-181-3

EC Name:

Potassium hydroxide

Cas Number:

1310-58-3

Molecular formula:

HKO

IUPAC Name:

potassium hydroxide

Details on test material:

- Name of test material (as cited in study report): potassium hydroxideWhen Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.When water is added to Potassium oxide, Potassium hydroxide is produced.K2O+H2O→KOH

Test animals

Species:

other: Three-dimensional human skin equivalent

Details on test animals or test system and environmental conditions:

SKIN MODEL
- Skin² model ZK1350
- type: human kertinocytes, multi-layered (epidermal, dermal and corneal layers) and fully differentiated
- medium: serum-free, chemically defined
- vessel: polycarbonate filter inserts
- shipment conditions: inserts embedded in agarose gel containing nutrient solution

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: positive (8 N KaOH) and negative (blank) controls

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 15 µl
- Concentration (if solution): 5% and 10%

Duration of treatment / exposure:

10 sec

Observation period:

60 min

Number of animals:

four replicates per test substance

Details on study design:

TEST PROTOCOL:
- temperature: 18-22°C
- pre-incubation period: 2h
- washing: yes, PBS
- extraction: with isopropanol
SCORING SYSTEM:
- endpoint: metabolic conversion
- observation method: metabolic reduction of MTT (yellow stain), determined by spectrophotometer
- scoring: relative viability of cells (percentage of viability of the negative controls)
- classification:
"highly corrosive" (R35) if relative cell viability < 10 %
"corrosive" (R34) if relative cell viability >10- 80%
"non corrosive" if relative cell viability > 80%

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: in vitro

Value:

4

Remarks on result:

other:

Remarks:

Basis: other: Skin² model ZK1350 in vitro skin corrosion test. Time point: no data. Max. score: 4.0. Reversibility: no data. Remarks: 10% KOH is classified as corrosive, 5% KOH is classified as non corrosive. (migrated information)

In vivo

Irritant / corrosive response data:

10% KOH is classified as "corrosive" (R34), 5% KOH as non corrosive based on the Skin² ZK1350 in vitro skin corrosion test.
this is the result of a validation study. The model failed to identify 57% of chemicals that are known to be corrosive (low sensitivity of the model).

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

10% KOH is classified as "corrosive" (R34), 5% KOH as non corrosive using The Skin² model ZK1350