Registration Dossier
Registration Dossier
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EC number: 218-216-0 | CAS number: 2082-79-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 22,1982 - March 2,1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD guideline with acceptable restrictions (24 h exposure, occlusive dressing)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive dressing, 24 h exposure
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
- GLP compliance:
- no
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Details on test material:
- - Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin
- Weight at study initiation: 2-3 Kg
- Housing: single
- Diet (e.g. ad libitum): standard rabbit food - NAFAG, No. 814, Gossau SG
- Water (e.g. ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Before treatment the flanks of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified.
- Area of exposure: Gauze patches of 2.5 x2.5 cm with 0.5 g of the test material were applied to the prepared abraded and intact skin.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0.94
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Irritation score (intact skin)
Time period |
Erythema |
Edema |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
|
|
24 h |
0 |
2 |
1 |
0 |
2 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
|
48 h |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
24-72 h |
0.0 |
1.33 |
0.33 |
0.0 |
1.33 |
0.33 |
0.0 |
0.33 |
0.0 |
0.0 |
0.33 |
0.0 |
|
Total Mean |
0.56 |
0.11 |
|
||||||||||
Irritation score (abraded skin)
Time period |
Erythema |
Edema |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
|
|
24 h |
0 |
2 |
2 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
|
48 h |
0 |
2 |
1 |
0 |
2 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
|
72 h |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
|
4 d |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
24-72 h |
0.0 |
1.33 |
1.33 |
0.0 |
2.0 |
1.0 |
0.0 |
0.33 |
0.0 |
0.0 |
1.0 |
0.0 |
|
Total Mean |
0.94 |
0.22 |
|
||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present experiment the test article was found to cause no irritation when applied to intact and abraded rabbit skin.
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