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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance with a recognized scientific procedure for analyzing the primary dermal irritation of a test material in experimental animals, but the animals were observed for only three day.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation period: 3 days versus 14 days.
Principles of method if other than guideline:
Method: other
GLP compliance:
not specified

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:
Purity: 78 percent; white granules (remainder water)

Test animals

Species:
rabbit
Strain:
other: New zealand, albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male/female weighting 2643 - 2952 grams

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
other: none used
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 500 mg of benzoyl peroxide
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours after the begining of the exposure
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap: gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing : with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: all rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The skin on the six rabbits appeared unaffected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Benzoyl peroxide (concentration at 78%) is neither a primary skin irritant nor a corrosive substance.
Executive summary:

ln a rabbit study in which 78 % granular benzoyl peroxide was applied to the back of 3 males and 3 females, the substance was held in place for 4 hours with a gauze bandage. After 4 hours, the bandages were removed and the exposed areas washed with lukewarm water. The skin was examined for any injury or irritation according to Draize scale at 4, 24 and 72 hours. No signs of skin irritation were observed at 1, 3 days after 4 hr exposure.