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Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
no
GLP compliance:
yes
Radiolabelling:
no
Species:
human
Sex:
female
Details on test animals or test system and environmental conditions:
Skin region: abdomen
BMI: 22.7-35.5
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.
Absorption in different matrices:
The mean amount of sodium laureth sulfate (SLS) removed from the skin surface (skin wash) ranged from 87.16% to 94.56% of the dose applied in the mean values of the 3 skin donors. This demonstrates that the SLS has mostly remained on the skin surface. The amounts in the receptor could not be quantified, since it was below the analytical lower limit of quantification (LLOQ). The mean recovery in the two first tape strips was 1.48% during all performed experiments. In the further 18 tape strips a mean recovery of 2.86% was documented. The recovery values for the cryocuts have accounted 0.56% in mean. The mean recovery values have varied from 90.90% to 100.21%, which complies to the acceptance criteria of 100 ± 15%.
The mean absorbed dose of SLS, sum of the amounts found in the viable epidermis, dermis and receptor medium was 0.56%.
Total recovery:
90.90% - 100.21%
Dose:
10%
Parameter:
percentage
Absorption:
< 1 %
Remarks on result:
other: 24 h
Remarks:
The mean absorbed dose of SLS, sum of the amounts found in the viable epidermis, dermis and receptor medium was 0.56%.
Conclusions:
The mean absorbed dose of sodium laureth sulfate (SLS), sum of the amounts found in the viable epidermis, dermis and receptor medium and the mean recovery of SLS found in the deeper skin layers sum up to 0.56%.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts
EC Number:
500-465-4
EC Name:
Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts
Cas Number:
160901-28-0
Molecular formula:
CnH2n+1(OCH2CH2)mOSO3Na; n = 9 - 11, m = 1 - 2.5
IUPAC Name:
Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts
Radiolabelling:
no

Test animals

Species:
human
Sex:
female
Details on test animals or test system and environmental conditions:
Skin region: abdomen
BMI: 22.7-35.5

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 sodium laureth sulfate (SLS) removed from the skin surface (skin wash) ranged from 87.16% to 94.56% of the dose applied in the mean values of the 3 skin donors. This demonstrates that the SLS has mostly remained on the skin surface. The amounts in the receptor could not be quantified, since it was below the analytical lower limit of quantification (LLOQ). The mean recovery in the two first tape strips was 1.48% during all performed experiments. In the further 18 tape strips a mean recovery of 2.86% was documented. The recovery values for the cryocuts have accounted 0.56% in mean. The mean recovery values have varied from 90.90% to 100.21%, which complies to the acceptance criteria of 100 ± 15%.
The mean absorbed dose of SLS, sum of the amounts found in the viable epidermis, dermis and receptor medium was 0.56%.
Total recovery:
90.90% - 100.21%
Percutaneous absorption
Dose:
10%
Parameter:
percentage
Absorption:
< 1 %
Remarks on result:
other: 24 h
Remarks:
The mean absorbed dose of SLS, sum of the amounts found in the viable epidermis, dermis and receptor medium was 0.56%.

Applicant's summary and conclusion

Conclusions:
The mean absorbed dose of sodium laureth sulfate (SLS), sum of the amounts found in the viable epidermis, dermis and receptor medium and the mean recovery of SLS found in the deeper skin layers sum up to 0.56%.