Registration Dossier
Registration Dossier
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EC number: 205-031-5 | CAS number: 131-57-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Oxybenzone
- EC Number:
- 205-031-5
- EC Name:
- Oxybenzone
- Cas Number:
- 131-57-7
- Molecular formula:
- C14H12O3
- IUPAC Name:
- 2-benzoyl-5-methoxyphenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Animal strain in detail: Chbb:NZW
- Age at study initiation: approx. 9-13 weeks old
- Weight at study initiation: 2210 to 2440 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test item was applied to the right flank of each animal. A control gauze patch was applied to the other flank. Both patches were moistened before application with distilled water.
- Type of wrap if used: patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, Brugg, Switzerland).
SCORING SYSTEM: Draize system
-Reading time point: 1, 24, 48, and 72 hours after removing the gauze patches
OTHER
- The animals were checked daily for systemic symptoms and mortality. Bodyweight was recorded at study initiation and on day 3 of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No skin reactions were observed one hour after removal of the test patches as well as at reading time points 24 hours to 72 hours. Therefore, the observation period was ended after the 72 hours evaluation.
- Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oxybenzone was shown not to be irritant to rabbit skin in this test.
- Executive summary:
No effects in any of the animals were observed in this test and as a aconsequence the observation period was terminated after 3 days. The substance oxybenzone is considered not to be irritant to rabbit skin.
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