Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Human patch test
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
Justification for type of information:
The aim of the study is to evaluate the potential skin irritation after contact with the substance according to a 48 hours closed patch test under occlusion on human volunteers.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Human patch test under occlusion
Deviations:
no
Principles of method if other than guideline:
The specific patch (Finn Chambers) contaning the product (quantity: 20µl, diluted at 10%) is applied on the back skin of 25 human volunteers. The product is left in contact with the skin during 48 hours. The potential side effects (skin erythema and oedema reactions) are evaluated by a dermatologist 15 minutes, 1 hour and 24 hours after the removal of the patch.
GLP compliance:
not specified
Remarks:
The laboratory is ISO 9001. The test is in conformity with the Declaration of Helsinki, EU 2001/20/EC of 4/4/2001, Directive of the Ministry of Health of 2/5/2012 on good clinical practice and the Directive of the Ministry of Health of 22/5/2013 on GLP.

Test material

Constituent 1
Reference substance name:
Grape, red, ext.
EC Number:
284-511-6
EC Name:
Grape, red, ext.
Cas Number:
84929-27-1
IUPAC Name:
Palmitoyl grapevine shoot extract
Test material form:
solid

Test animals

Species:
other: human
Strain:
not specified

Test system

Type of coverage:
occlusive
Controls:
yes, concurrent negative control
Amount / concentration applied:
20µl, diluted at 10%
Duration of treatment / exposure:
48 hours
Observation period:
15 minutes, 1 hour and 24 hours.
Number of animals:
25

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: Human 1 to 25
Time point:
other: 15 minutes
Score:
ca. 0.04
Max. score:
1
Reversibility:
other: Not applicable as non-irritating
Remarks on result:
no indication of irritation
Remarks:
For mean human 1 to 25
Irritation parameter:
edema score
Basis:
other: Human 1 to 25
Time point:
other: 15 minutes
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable as non-irritating
Remarks on result:
no indication of irritation
Remarks:
For mean human 1 to 25
Irritation parameter:
erythema score
Basis:
other: Human 1 to 25
Time point:
other: 1 hour
Score:
ca. 0.04
Max. score:
1
Reversibility:
other: Not applicable as non-irritating
Remarks on result:
no indication of irritation
Remarks:
For mean human 1 to 25
Irritation parameter:
edema score
Basis:
other: Human 1 to 25
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable as non-irritating
Remarks on result:
no indication of irritation
Remarks:
For mean human 1 to 25
Irritation parameter:
erythema score
Basis:
other: Human 1 to 25
Time point:
24 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable as non-irritating
Remarks on result:
no indication of irritation
Remarks:
For mean human 1 to 25
Irritation parameter:
edema score
Basis:
other: Human 1 to 25
Time point:
24 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable as non-irritating
Remarks on result:
no indication of irritation
Remarks:
For mean human 1 to 25

Applicant's summary and conclusion

Interpretation of results:
other: The test item is not irritant for skin
Conclusions:
The potential skin irritation of the product has been assessed according to amended Draize classification. On the basis of the data obtained, the test item Palmitoyl grapevine shoot extract is deemed to be non irritating "dermatologically tested".
Executive summary:

Refer to attached study report.