Phosphatidylcholines, soya, hydrogenated

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

Phosphatidylcholines, soya, hydrogenated

EC Number:

306-549-5

EC Name:

Phosphatidylcholines, soya, hydrogenated

Cas Number:

97281-48-6

Molecular formula:

C44H88NO8P

IUPAC Name:

[(2R)-2,3-di(octadecanoyloxy)propyl] 2-(trimethylazaniumyl)ethyl phosphate

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 or test system 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

Results

Results 1

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.

Results 2

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.