Registration Dossier
Registration Dossier
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EC number: 235-227-6 | CAS number: 12136-45-7
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: Human observational study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Treatment of Molluscum contagiosum with potassium hydroxide: a clinical approach in 35 children.
- Author:
- Romiti R et al
- Year:
- 1 999
- Bibliographic source:
- Pediatric Dermatology, 16(3), 228-231
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Treatment of 32 children suffering of Molluscum contagiosm (a viral skin infection) with a topical 10% KOH aqueous solution, twice daily, during a period of 30 days,
- GLP compliance:
- no
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): KOH
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed: 32
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- Treatment of 32 children suffering of Molluscum contagiosm (a viral skin infection) with a topical 10% KOH aqueous solution, twice daily, during a period of 30 days, resulted in clearance of all lesions. The only side effects observed in 12 children were: severe stinging, transitory hypopigmentation, persistent hypo- and hyperpigmentation, hypertrophic scar and secondary infection.
Applicant's summary and conclusion
- Conclusions:
- topical 10% KOH solution, applicated 2 times daily for 30 days resulted in severe stinging, transitory hypopigmentation, persistent hypo and hyperpigmentation, hypertrophic scar and secondary infection in 12 out of 32 chlidren, indicating of potassium hydroxide being irritant.
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