Registration Dossier
Registration Dossier
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EC number: 259-217-6 | CAS number: 54549-24-5
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study. Reliability changed from "1" to "2" according to ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)."
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 68515-73-1
- Cas Number:
- 68515-73-1
- IUPAC Name:
- 68515-73-1
- Reference substance name:
- D-Glucopyranose, oligomers, decyl octyl glycosides
- EC Number:
- 500-220-1
- EC Name:
- D-Glucopyranose, oligomers, decyl octyl glycosides
- IUPAC Name:
- 500-220-1
- Reference substance name:
- D-Glucopyranose, oligomers, decyl octyl glycosides
- IUPAC Name:
- D-Glucopyranose, oligomers, decyl octyl glycosides
- Details on test material:
- - Name of test material (as cited in study report): Capryl glucoside
- Physical state: liquid
- Analytical purity: 62.8%
- Lot/batch No.: CE73510004
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Skin region: abdomen
BMI: 22.7-29.1
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: HBSS-buffer
- Duration of exposure:
- 24 h
- Doses:
- 10%
- No. of animals per group:
- 3 donors (n=2)
- Control animals:
- no
- Details on study design:
- According to Guideline.
Results and discussion
- Absorption in different matrices:
- The mean amount of CG removed from the skin surface (skin wash) ranged from 109.26% to 144.57% of the dose applied. The mean recovery (mean value for 6 Franz cells) in the two first tape strips was 0.52% during all performed experiments. In the further 18 tape strips a mean recovery of 0.30% was documented. The mean absorbed dose of CG, sum of the amounts found in the viable epidermis, dermis and receptor medium, were considered as 0.01%.
- Total recovery:
- 88.65% - 112.28%
Percutaneous absorption
- Dose:
- 10%
- Parameter:
- percentage
- Absorption:
- < 1 %
- Remarks on result:
- other: 24 h
- Remarks:
- The mean absorbed dose of CG, sum of the amounts found in the viable epidermis, dermis and receptor medium, were considered as 0.01%.
Applicant's summary and conclusion
- Conclusions:
- The mean absorbed dose of CG, sum of the amounts found in the viable epidermis, dermis and receptor medium, were considered as 0.01%.
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