Registration Dossier
Registration Dossier
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EC number: 202-327-6 | CAS number: 94-36-0
Skin irritation / corrosion
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:
- 1 973
- 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
- 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:
- Purity: 78 percent; white granules (remainder water)
Constituent 1
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.
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