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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: published data
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
C12 LAS; Linear Alkylbenzene Sulfonate (LAS)) is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.

Data source

Reference
Reference Type:
publication
Title:
Stratum corneum Lipid Removal by Surfactants: Relation to in vivo irritation
Author:
Froebe CL, Simion FA, Rhein LD, Cagan RH and Kligman A
Year:
1990
Bibliographic source:
Dermatologica, 181, 277-283

Materials and methods

Type of study / information:
The relationship between the in vivo irritation potential of sodium lauryl sulfate (SLS) and linear alkyl benzene sulfonate (LAS) and the ability of these two surfactants to remove lipid from the stratum corneum (SC) in vitro were investigated.
Endpoint addressed:
acute toxicity: dermal
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test method developed by Frosch and Kligman.
Panelist's skin was evaluated prior to treatment to ensure the absence of erythema. Aliquos (0.2 mL) of aqueous surfactant solutions were applied to the volar forearm of 8 female panelists for 24 h using occlusive patches. After removal patches, the skin was rinsed with warm tap water. The degree of the erythema was assessed by a trained evaluator using the 4-point scale as follows: 0=no redness; 1=mild redness; 2=moderate redness, and 3=intense redness.
Fresh samples were re-applied to the original test sites for an additional 6 h on each of the next 4 days. Erythema was evaluated prior to the application of each patch and, finally, 7 days after the beginning of the study, I.e. 72 h after removal of the final patch. Panelists producing a redness score of 3 were removed from the panel.
This study was performed 3 times, once using 1.0% surfactant and twice using 0.1% surfactant solutions.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
C12-LAS
IUPAC Name:
C12-LAS
Details on test material:
C12-LAS manufactured by Colgate-Palmolive

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
Aliquos (0.2 mL) of aqueous surfactant solutions were applied to the volar forearm of 8 female panelists for 24 h using occlusive patches. After removal patches, the skin was rinsed with warm tap water. The degree of the erythema was assessed by a trained evaluator using the 4-point scale as follows: 0=no redness; 1=mild redness; 2=moderate redness, and 3=intense redness.
Fresh samples were re-applied to the original test sites for an additional 6 h on each of the next 4 days. Erythema was evaluated prior to the application of each patch and, finally, 7 days after the beginning of the study, I.e. 72 h after removal of the final patch. Panelists producing a redness score of 3 were removed from the panel.
This study was performed 3 times, once using 1.0% surfactant and twice using 0.1% surfactant solutions.
Exposure assessment:
measured

Results and discussion

Results:
The erythema scores were occurred in the final evaluation of test sites, 72 h after removal of the last set of patches. The first study (1% surfactant) was concluded within a maximum of 48h of the start, because all panelists experienced moderate/intense erythema at this time. 0.1% LAS produced negligible or mild erythema by the end of the study

Any other information on results incl. tables

Table. Soap chamber test: in vivo erythema response to LAS

Surfactant

-

Final mean erythema score

study No.:

1

2

3

concentration:

1%

0.1%

0.1%

LAS

-

3a

3.0

2.0

a: Exposure to 1% surfactant induced moderate/intense erythema in all panelists within 2 days.

Applicant's summary and conclusion

Conclusions:
0.1% LAS produced negligible or mild erythema by the end of the study.

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