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Toxicological information

Dermal absorption

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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: see 'Remark'
Remarks:
GLP Guideline study. 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:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium laureth sulfate
- Ethoxylation degree: 2
- Physical state: Liquid
- Analytical purity: 70.1% a.i.
- Lot/batch No.: CE8290013
- Storage condition of test material: No data
Radiolabelling:
no

Test animals

Species:
human
Sex:
female
Details on test animals 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%.