Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Adequate data from a clinical study on volunteers show the substance is not irritant for the skin. See end-point 7.10.5
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Human single patch test using generally-accepted methods performed according to Good Clini cal Practice
Reason / purpose for cross-reference:
data waiving: supporting information
Type of study / information:
Acute skin tolerance on volunteers
Endpoint addressed:
skin irritation / corrosion
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin irritation potential of the test item was studied in volunteers using 48 hour single patch test and skin reactions were evaluated
GLP compliance:
no
Remarks:
Clinical study
Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
11 Volunteers of female and male sex from 20 to 68 years of age, with a normal skin , without any dermatological lesion on the experimental area should be included in the study
Exposure assessment:
measured
Details on exposure:
Single application of 25 μL of the studied test item, on the sacapular part of the back, maintained for
48 h in contact with the skin, with the help of an occlusive patch (Finn Chambers).
Results:
11 volunteers have been included. The average irritation index is 0
Conclusions:
The test item can be considered as non irritant after an application with the help of an occlusive patch for 48 h on 11 volunteers.
Executive summary:

In a single patch test, 11 volunteers (men and women) from 20 to 68 years of age, with a normal skin, without any dermatological lesion on the experimental area, have been included in the study. Single application of 25μL of the test item, on the sacapular part of the back, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Finn Chambers).

11 volunteers have been included and were analyzed. The average irritation index is 0.

Under the conditions employed in this study, test item was considered as non-irritant.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion