Registration Dossier
Registration Dossier
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EC number: 215-181-3 | CAS number: 1310-58-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: According to the SIDS document for potassium hydroxide (30 January 2002), a Klimisch score of 3 was assigned since test protocol has significant methodological deficiences and no post-exposure assessment was performed.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute toxicity and skin corrosion data for some organic and inorganic compounds and aqueous solutions
- Author:
- Vernot EH, MacEwen JD, Haun CC, and Kinkead ER
- Year:
- 1 977
- Bibliographic source:
- Toxicology and Applied Pharmacology, 42, 417-423
Materials and methods
- Principles of method if other than guideline:
- Draize test, test areas are evaluated for visible tissue destruction. When severe skin damage occured in at least 2 of 6 rabbits, the material was classified as corrosive. There was no post-exposure assessment of the lesion.
- GLP compliance:
- not specified
Test material
- 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 hydroxide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Controls:
- other: OECD 404: untreated area of the test animal serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 1% and 2% - Duration of treatment / exposure:
- 4 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: clipped 24 hr prior to exposure, 6 areas on the back, 3 on each side per rabbit
- % coverage: entire area covered with a latex rubber film secured with Elastoplast tape
- Type of wrap if used: 1 inch square surgical gauze 2 layers thick held in place with Elastroplast tape
SCORING SYSTEM:
Test areas are evaluated for visible tissue destruction. When such severe skin damage occured in at least 2 of 6 rabbits, the material was classified as corrosive.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 1%: not corrosive; 2%: corrosive
- Irritant / corrosive response data:
- 1%: not corrosive
2%: corrosive
Applicant's summary and conclusion
- Conclusions:
- 1% KOH was classified as "not corrosive" and 2% was classified as "corrosive" using a Draize test
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