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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
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. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Justification for type of information:
refer to category justification provided in IUCLID section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid, not further specified
Radiolabelling:
no

Test animals

Species:
human
Sex:
female
Details on test animals 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
Key result
Time point:
24 h
Dose:
10%
Parameter:
percentage
Absorption:
0.01 %
Remarks on result:
other: 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%.