Registration Dossier
Registration Dossier
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EC number: 200-313-4 | CAS number: 57-11-4
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: Reliable without restriction, test procedure according to national standards (DIN, etc.)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
- Reference Type:
- secondary source
- Title:
- Final report of the safety assessment for oleic acid, lauric acid, palmitic acid, myristic acid, stearic acid
- Author:
- CIR
- Year:
- 1 987
- Bibliographic source:
- JACT, 6(3): 321-401
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test / Revised (1964) Federal Hazardous Substance Act
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- stearic acid
- Details on test material:
- - Analytical purity: no data given
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- Fur was removed from the back of each of six rabbits by clipping the saddle of the trunk area. One area of skin was abraded by making minor incisions with a hypodermic needle. 0.5 ml of test material was applied to 1 in2 gauze patches. The patches were placed on both intact skin and abraded skin of each rabbit and secured with adhesive tape, rubber dental damming secured with staples, and gauze wound loosely around the trunk. The animals were then immobilized for 24 hours in wooden stocks. After 24 hours, the patches were removed and the skin cleaned by gently sponging with a moistened towel. The skin was examined immediately after removal of the patches (24 hr reading) and again at 72 hrs. At each examination the skin was scored for presence and severity of erythema/eschar formation and edema formation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other:
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not effects noted
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects noted
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects noted
- Irritant / corrosive response data:
- No signs of skin irritation were observed on intact or abraded sites at either scoring time point.
Any other information on results incl. tables
Material (0.5 ml) was applied via a one-inch-square surgical gauze patch to intact and abraded-skin sites. Patches were held in place for 24 hours. Reactions were scored immediately after patch removal and two days later (72 hours).
Scores for Skin Irritation
Rabbit No. |
24 hrs |
72 hrs |
|
43 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
44 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
45 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
46 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
47 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
48 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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