Registration Dossier
Registration Dossier
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EC number: 617-941-3 | CAS number: 86960-46-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzoic acid, 4-[ (1-oxodecyl) oxy]-
- EC Number:
- 617-941-3
- Cas Number:
- 86960-46-5
- Molecular formula:
- C17H24O4;
- IUPAC Name:
- Benzoic acid, 4-[ (1-oxodecyl) oxy]-
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
- Age at study initiation: 13 weeks (male), 10 weeks (females)
- Weight at study initiation: 2506, 2062, 2019 grams
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g moistened with approximately 0.5 mL of purified water
- Duration of treatment / exposure:
- The duration of treatment was 4 hours
- Observation period:
- The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm x 4 cm
- Type of wrap if used: gauze patch / semi-occlusive dressing / wrapped with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours (flushed with lukewarm tap water)
SCORING SYSTEM: scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 1,2,3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Irritation parameter:
- edema score
- Basis:
- animal: # 1,2,3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Irritant / corrosive response data:
- not staining, not corrosive, no skin reactions
- Other effects:
- no clinical signs
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria, the test item is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. 0.5 g of the test item moistened with purified water was applied by topical semi-occlusive application of to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.
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