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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
study in human
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Principles of method if other than guideline:
The study has been performed in human. This is a single-blind within subject comparison study conducted in 30 healthy volunteers of either sex to evaluate the comparative skin irritation of the substance following cutaneous patch applications. Patches consisted of 2 sets of 5 Webril disks fixed along the midline of 5cm wide strips of occlusive Blenderm tape. Patches were applied for four 23 hours periods with assessment 1 hour after the removal of each patch.
GLP compliance:
yes
Remarks:
Good Clinical Research Practice here

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
no indication of irritation

Any other information on results incl. tables

The mean irritation scores are given below:

 

Mean irritation scores

Concentration of the substance in Sodium lauryl sulfate (%)

Day 1

(n = 30)

Day 2

(n = 30)

Day 3

(n = 30)

Day 4

(n = 30)

Overall

(n = 30)

0

0.6167

1.3500

1.9833

2.0333

5.9833

0.3

0.5167

1.2833

1.9333

1.9333

5.6667

1

0.7333

1.5833

2.0167

2.1500

6.4833

10

0.8167

1.6667

2.1333

2.3000

6.9167

20

0.7167

1.6333

1.9167

2.0500

6.3167

40

0.7833

1.5667

2.0333

2.1333

6.5167

60

0.4500

0.7500

1.2833

1.6167

4.1000

80

0.7833

1.1500

1.4333

1.5500

4.9167

99

0.6167

1.0833

1.2500

1.2000

4.1500

100

0.2000

0.5833

0.8667

0.8333

2.4833

p-values

0.0010

<0.0001

<0.0001

<0.0001

<0.0001

The p-values were derived from a Friedman rank analysis

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The substance was tested at different concentrations in sodium lauryl sulfate in 30 healthy volunteers. The substance didn't show any adverse effects or reactions during the study and was therefore not irritant to the skin of the subjects.