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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: see 'Remark'
Remarks:
GLP guideline study tested with the source substance Decyl octyl glycosides (CAS 68515-73-1). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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:
D-Glucopyranose, oligomers, decyl octyl glycosides
EC Number:
500-220-1
EC Name:
D-Glucopyranose, oligomers, decyl octyl glycosides
Cas Number:
68515-73-1
Molecular formula:
Not Applicable: UVCB
IUPAC Name:
D-Glucopyranose, oligomeric, C8-10 glycosides
Constituent 2
Reference substance name:
Reference substance 001
Cas Number:
68515-73-1
Test material form:
other: liquid, not further specified
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 in vitro test system (if applicable):
SKIN PREPARATION
- Source of skin: human
- Ethical approval if human skin: yes
- Type of skin: fresh abdominal skin
- Preparative technique: skin sections were prepared from the full-thickness skin samples using an Aesculap GA 630 dermatome.
- Thickness of skin (in mm): 0.5
- Membrane integrity check: yes
- Storage conditions: full-thickness skin was stored at -20 °C.

PRINCIPLES OF ASSAY
- Diffusion cell: Franz diffusion cell
- Receptor fluid: Hank´s buffered salt solution (HBSS) without glucose, pH 6.5
- Solubility of test substance in receptor fluid: yes
- Static system: yes
- Test temperature: 32 ± 2 °C,
- Occlusion: yes. Franz diffusion cells were kept covered with Parafilm®
- Reference substance(s): caffeine

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:
- Total recovery: 88.65-112.28%
- Recovery of applied dose acceptable: 100 ± 20%
- Limit of quantification (LOQ): 0.088 μg/mL in KRB pH 7.4 without HEPES and glucose
Percutaneous absorption
Dose:
10%
Parameter:
percentage
Absorption:
0.01 %
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%.