Registration Dossier
Registration Dossier
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EC number: 478-920-0 | CAS number: 457632-32-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10. December 2007 - 18. January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 478-920-0
- EC Name:
- -
- Cas Number:
- 457632-32-5
- Molecular formula:
- C22H44O2.4 C20H38O4.1 (C3H8O3).20
- IUPAC Name:
- 1,20-bis({3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropyl}) icosanedioate
- Test material form:
- solid: pellets
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5-4-A
- Expiration date of the lot/batch: October 2008
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperater, light protected
- Stability under test conditions: stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 12 weeks (male) 11-12 weeks (female)
- Weight at study initiation: 2052 - 2147 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitim
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 14 or 16 pellets of Nomcort HKP, placed on surgical gauze patch to cover an area of approx. 6 cm2
- Duration of treatment / exposure:
- 4
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: not stated
- Type of wrap if used: semi-occlusive dressing, fixed with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours
(indicate if minutes, hours or days)
SCORING SYSTEM:
- Method of calculation: according to Guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Nomcort HK-P is not a skin irritant.
- Executive summary:
The primary skin irritation potential of Nomcort HK-P was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application on an area of approximately 6 cm2 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 reaction was performed 1, 24, 48 and 72 hours after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours afterpatch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
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 individual mean score for erythema/eschar and oedema for each of the three animals was therefore 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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