Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
clinical data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: patch test
Principles of method if other than guideline:
The raw material was applied, once, to the skin under patch. It was tested concurrently with other 6 raw materials. The panel of volunteers was representatibve of a large population. The monocentric study was performed in open. The subject was used as own control.
The skin compatibility of the raw material was checked, after patch removal and visual examination of the experimental area by the investigator or the responsible technician.
The skin compatibility of the raw material, after application under normal conditions of used, was assessed by extrapolation of the results obtained under these specific experimental conditions.
The results were mainly expressed as descriptibve data and did not require a statistical treatment. If the test raw material
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
other: Human
Strain:
other: Not Applicable
Details on test animals and environmental conditions:
The number of volunteers whose data had to be exploitable at the end of the study was 10. 10 volunteers were included in the study.
The specific inclusion criteria, defined in the protocol, were the following ones:
-age : 18 to 70
-sex : male and female
-phototype (Fitzpatrick) : I to V

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Not Applicable
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
160µL (approximately 160mg), kept in position by a non woven medical adhesive (surface : 400mm2)
Duration of treatment / exposure:
48h +/-5 hours
Observation period:
The patch removal had to be performed by the investigator or the responsible technician.
One deviation from the protocol concerning the contact time was noticed by the investigator and is the following one : one volunteer (reference 10) kept the patch for 41 hours 30.
This deviation was judged without effect on the results of the study by the Investigator.
Number of animals:
10 humans volunteers
Details on study design:
The experimental area was the back.
The site of application of the raw material was chosen by the investigator or by the technician in charge of the study. Skin appearance was taken into account and the areas of friction with clothes were avoided.
Many other raw materials were tested concurrently, so the concerned raw material was applied by the investigator or the responsible technician, to one of the sites localized by a clockwise distribution, altering of one rank from a subject to another.

This examination had to be performed visually under standard "daylight" source, approximateiy 15 minutes (or more if some redness appeared after patch removal), after patch removal.

The expression of the results of the skin examination and questioning was that defined for this type of study in accordance with the corresponding procedure.
In case of reactivity :
— the main visible signs were noted, i.e.
Erythema, Oederna, Vesicle, Bulla, Papule, Scab, Dryness, Coloration, Soap effect.

The intensity of the erythema and oedema was assessed according ta an ordinal scale : slight, moderate, severe.

The appearance of the erythema was specified : diffuse, punctuated, peripheral (around the application site).

The importance of the number of vesicles and papules was assessed according_to an ordinal scale : 1 to 2 vesicles or papules, more than 2 vesicles or papules.
Bullae, scab, dryness, coloration and soap effect were described.

The importance of the dryness and coloration was assessed according to an ordinal scale : slight, moderate, severe.
— the main sensations of discomfort were described, i.e. : Heating, Stinging, Pruritus (itching).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

Control time after
patch removal

Number of reactive
volunteers

Types of reaction

Meandally irritation
score
Mdis

% of reactive
volunteers

T 15 minutes

0

None

0

0%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a clinical study, the test material, diluted at 10% with Squalane, has a very good skin compatibility and is safe for human health when applied under normal or foreseeable conditions of use. Non irritant