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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
patch test method in humans
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010.04.27- 2010.04.29
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:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guidelines for the assessment of skin tolerance of potentially irritant cosmetic ingredients
Principles of method if other than guideline:
24 adult voluntiers
Single application on the back (for 48hours)
Product applied already diluted 10% under occuled patch
Quantity of product 0.02 ml
A dermatologist performs the clinical observation after the removal of the patches.Quantification of the skin irritation is given through a numerical scale (erythema, oedema, dryness, desquamation, vescicles) The average irritant score of the product to be tested is calculated from the average of the quotations obtained for each volunteer, allowing to rang the product from "non irritant to very irritant". Assessment is made by comparison with the "negative" control.
GLP compliance:
not specified
Remarks:
The study follows good clinical practices (GCP)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Phospholipon® 90H
014569 Batch 294008-01/ 096

Test animals

Species:
other: human
Details on test animals and environmental conditions:
healthy adults

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Remarks:
Already diluted
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.02 ml (10% diluted)
Duration of treatment / exposure:
48 hours
Observation period:
na
Number of animals:
24 human volunteers

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: All volunteers
Time point:
24/48/72 h
Score:
>= 0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
According to the experimental conditions of the study the product can be considered as non irritant regarding its primary skin tolerance.
Irritation parameter:
edema score
Basis:
other: All volunteers
Time point:
24/48/72 h
Score:
>= 0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
According to the experimental conditions of the study the product can be considered as non irritant regarding its primary skin tolerance.
Irritant / corrosive response data:
average irritant score of the product is 0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Average irritant score of the test item is 0.0. The test item is not considered an irritant
Executive summary:

The local skin tolerance of the test item was investigated after a single application on the skin on the back under occluded patch during 48 hours, on health adult volunteers.

Average irritant score ofter the application was 0.0. According to the experimental conditions of the study the test item can be considered as non irritant regarding its primary skin tolerance.