Registration Dossier
Registration Dossier
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EC number: 807-365-2 | CAS number: 127961-54-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 9, 1998 - Nov. 15, 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study in humans, but not done according to OECD Guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 33 people were exposed to 100%, 50%, and 0% test substance on patches on the back or upper arm for 24 hrs in order to determine the skin irritantcy of the test substance. Readings were taken immediately, 24 hrs, and 48 hrs after removal of the patches.
- GLP compliance:
- yes
- Remarks:
- Study was performed in accordance with Good Clinical Practice for Trials on Medicinal Products in the European Community.
Test material
- Reference substance name:
- Sucrose tetrastearate triacetate
- IUPAC Name:
- Sucrose tetrastearate triacetate
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 20 to 59 years (average 37 years)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: corn oil
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: approx. 30 mg
- Concentration: All test subjects were exposed to 100% , 50%, and 0% test substance.
VEHICLE
- Concentration: 100%, 50%, and 0% - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- At 0, 24, and 48 hrs after patch removal
- Number of animals:
- 33 (7 males, 26 females)
- Details on study design:
- TEST SITE
- Area of exposure: upper back or arm
- Type of wrap if used: HAL test strip
SCORING SYSTEM: 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- 24/48/71 h reading time point corresponds to 0/24/48h in the study report
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- 24/48/71 h reading time point corresponds to 0/24/48h in the study report
- Irritant / corrosive response data:
- 3 people were exposed to 100%, 50%, and 0% test substance on patches on the back or upper arm for 24 hrs in order to determine the skin irritantcy of the test substance. Readings were taken immediately, 24 hrs, and 48 hrs after removal of the patches. No test subjects showed a reaction at any concentration.
Any other information on results incl. tables
Individual Results
| Subject | 100% | 50% | Corn Oil |
| 97297 | 0 | 0 | 0 |
| 98522 | 0 | 0 | 0 |
| 94265 | 0 | 0 | 0 |
| 98609 | 0 | 0 | 0 |
| 97336 | 0 | 0 | 0 |
| 98526 | 0 | 0 | 0 |
| 97116 | 0 | 0 | 0 |
| 96174 | 0 | 0 | 0 |
| 92179 | 0 | 0 | 0 |
| 95179 | 0 | 0 | 0 |
| 91598 | 0 | 0 | 0 |
| 98602 | 0 | 0 | 0 |
| 91799 | 0 | 0 | 0 |
| 99207 | 0 | 0 | 0 |
| 98002 | 0 | 0 | 0 |
| 97333 | 0 | 0 | 0 |
| 96084 | 0 | 0 | 0 |
| 96120 | 0 | 0 | 0 |
| 98529 | 0 | 0 | 0 |
| 96175 | 0 | 0 | 0 |
| 99171 | 0 | 0 | 0 |
| 98106 | 0 | 0 | 0 |
| 98006 | 0 | 0 | 0 |
| 94202 | 0 | 0 | 0 |
| 95270 | 0 | 0 | 0 |
| 98020 | 0 | 0 | 0 |
| 97338 | 0 | 0 | 0 |
| 91329 | 0 | 0 | 0 |
| 95014 | 0 | 0 | 0 |
| 97003 | 0 | 0 | 0 |
| 95012 | 0 | 0 | 0 |
| 97115 | 0 | 0 | 0 |
| 97161 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
- Conclusions:
- No signs of irritation were seen in any test subjects after exposure to the test substance. The test substance is not irritating to skin.
- Executive summary:
33 people were exposed to 100%, 50%, and 0% test substance on patches on the back or upper arm for 24 hrs in order to determine the skin irritantcy of the test substance. Readings were taken immediately, 24 hrs, and 48 hrs after removal of the patches. No test subjects showed a reaction at any concentration. The test substance in not irritating to skin.
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