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Toxicological information

Sensitisation data (human)

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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:
1999
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): KOH

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.