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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
diphenylperoxyanhydride
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.