D-Glucose, reaction products with alcohols C16-18 (even numbered)

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

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

Test material information

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, oligomers, decyl octyl glycosides

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%
- Results adjusted for incomplete recovery of the applied dose:
- Limit of quantification (LOQ): 0.088 μg/mL in KRB pH 7.4 without HEPES and glucose

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%.