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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Contact sensitization to benzoyl peroxide
Author:
Leyden JJ and Kligman AM
Year:
1977
Bibliographic source:
Contact Dermatitis, 3:273-275

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Maximization test according to Kligman & Epstein procedure, 1975
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibenzoyl peroxide
EC Number:
202-327-6
EC Name:
Dibenzoyl peroxide
Cas Number:
94-36-0
Molecular formula:
C14H10O4
IUPAC Name:
benzoyl benzenecarboperoxoate
Details on test material:
Benzoyl peroxide (topical preparations for acne)

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
white, young
Route of administration:
dermal
Details on study design:
- A 1.0 cm² of non-wvoven cloth was liberally saturated with 0.3 grams or ml of the test material and applied occlusively for five 48-hour periods.
- First test: use of 5 and 10 % Benzoyl peroxide gels (Desquamex) (evaluation in 25 students)
- Second test: use of 5 (Johnson & Johnson) and 10 % (Panoxyl 10) Benzoyl peroxide gels (evaluation in 25 students),
- Since the substance is irritant, no sodium lauryl sulfate was required
- Challenge: 10 -14 days later by a 48 hours patch test
- Evaluation at 48, 72 and 96 hours
- Grading system: 0 : no reaction, 1 : mild sensitization (erythema with mild edema); 2 : moderate sensitization (erythema with infiltration, raised sepreading beyond the borders with or without vesiculation), 3: strong sensitization (large vesiculo-bullous, vividly red, infiltrated plaques)

Results and discussion

Results of examinations:
38 of 50 subjects developed a ++ or greater reaction. Sensitized subjects reacted equally to the 5 and 10% concentration.

Applicant's summary and conclusion

Conclusions:
Sensitising in humans
Executive summary:

Four formulation of benzoyl peroxide, two 5 % and two 10 % gel, were evaluated in a group of 50 white college students (human maximisation pacth test). The subjects were challenged 10 - 14 days later by a 48 hours patch test and the responses compared to pretesting with the same materials. The challenge site was evaluated at 48, 72, and 96 hours on a four point scale. The results showed that in human, dibenzoyl peroxide is clearly a sensitiser.