Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts

Dermal absorption

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

Guideline:

OECD Guideline 428 (Skin Absorption: In Vitro Method)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

68891-38-3 (purity 70.1%)

IUPAC Name:

68891-38-3 (purity 70.1%)

Details on test material:

- Name of test material (as cited in study report): Sodium laureth sulfate
- Ethoxylation grade: 2
- Physical state: liquid
- Analytical purity: 70.1%
- Lot/batch No.: CE8290013

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 (NLS) 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 NLS 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 NLS, 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 NLS, 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 (NLS), sum of the amounts found in the viable epidermis, dermis and receptor medium and the mean recovery of NLS found in the deeper skin layers sum up to 0.56%.