Registration Dossier
Registration Dossier
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EC number: 812-963-1 | CAS number: 178436-06-1
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- Irritation potential on healthy human skin
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- unknown
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Type of study / information:
- Test to determine the irritation potential on healthy human skin.
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 0.01 g of the test sample was placed in a finn chamber (EPITEST Ltd. Oy.) and a 24-hour occlusive application on the flexor side of the subject's upper arm was conducted. After 24 hours the test sample was removed and the skin condition was examined, both 1 hour and 24 hours after removal.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ceramide IIIB
- IUPAC Name:
- Ceramide IIIB
- Test material form:
- liquid: viscous
- Details on test material:
- CERAMIDE IIIB (5% vaseline solution)
Constituent 1
- Specific details on test material used for the study:
- 5 % vaseline solution
Method
- Ethical approval:
- not specified
- Details on study design:
- Subjects: A total of 44 subjects, 19 males and 25 females with ages between 20 to 52.
Amount applied: 0.01 g - Details on exposure:
- 0.01 g of the test sample was placed in a finn chamber and a 24-hour occluxive application on the flexor side of the subject's upper arm was conducted. After 24 hours the test sample was removed and the skin condition was examined, both 1 hour and 24 hours after removal.
Results and discussion
- Results:
- The results of the patch test conducted on 44 subjects:
No reactions were observed 1 hour after the removal of the test sample. No reactions were observed
24 hours after removal of the test sample also.
No abnormalities were observed.
Applicant's summary and conclusion
- Conclusions:
- The results of the patch tests were negative in all cases; thus it is concluded that the test item does not cause skin irritation.
- Executive summary:
Patch tests were performed in 44 healthy humans to determine the irritation potential of Ceramide IIIB.
The results were negative in all cases; thus it is concluded that there is little possibility that Ceramide IIIB can cause irritation.
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