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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:
2009
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

Constituent 1
Reference substance name:
68515-73-1
Cas Number:
68515-73-1
IUPAC Name:
68515-73-1
Constituent 2
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
Constituent 3
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
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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