Phosphatidylcholines, soya, hydrogenated

Endpoint summary

Description of key information

One study exists on the substance for skin irritation. 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.

No study is available for eye irritation and a weight of evidence assessment was therefore perfomed. Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation. No classification as eye irritating should apply for the substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

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)

Specific details on test material used for the study:

Phospholipon® 90H
014569 Batch 294008-01/ 096

Species:

other: human

Details on test animals or test system and environmental conditions:

healthy adults

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

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

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.

Reference 2

Endpoint:

skin irritation / corrosion, other

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Principles of method if other than guideline:

occlusive plastic test chambers (Imtradex Germany)
48 hours of exposure and expection emidiatly after removal and again at 72 hours
20 human voluntiers (11 female/9 male, age 16-60 years)

GLP compliance:

no

Species:

other: human volunteers

Details on test animals or test system and environmental conditions:

age: 16-60 years

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Amount / concentration applied:

0.5, 1.0 and 3 .0 mg/cm2 skin

Duration of treatment / exposure:

48h

Observation period:

from time 48h to 72h

Number of animals:

20 human volunteers

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Max. score:

0.2

Reversibility:

not specified

Score of irritance ± SD

0.5 mg phospholipid/cm2 skin              0.1                         0.30                        

1.0 mg phospholipid/cm2 skin              0.05                      0.22

3.0 mg phospholipid/cm2 skin              0.2                         0.52

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, it can be said, that under the chosen circumstances the 3 different concentrations of liposomes (0.5; 1.0 and 3.0 mg phospholipid/cm2 skin) were tolerated well.

Executive summary:

The irritant potential of different solutions of liposomes was investigated in 20 dermatologically healthy volunteers by means of occlusive patch testing.

The group of subjects consisted of 11 women and 9 men between the age of 16 and 60 years.

In conclusion, it can be said, that under the chosen circumstances the 3 different concentrations of liposomes (0.5; 1.0 and 3.0 mg phospholipid/cm2 skin) were tolerated well.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

other: Weight of evidence analysis based on expert evaluated data on the group of lecithins

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: based on expert group reviews and published data

Justification for type of information:

Data on this endpoint are not available for Phosphatidylcholines, soya, hydrogenated.
In order to assess the eye irritation of hydrogenated phosphatidylcholines, the potential eye irritation of the hydrogenated lecithins in general as well as non-hydrogenated phosphatidylcholines (lecithins) can be considered. In order to combine data on several similar substances an overall weight of evidence approach is used for the assessment.

Principles of method if other than guideline:

Collection of data based on scientifically acceptable methods.

Specific details on test material used for the study:

For more details, please see attached weight of evidence document.

Species:

rabbit

Strain:

not specified

Controls:

other: contralateral eye

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds.

Other effects:

In one test, a positively charged liposome preparation significantly increased the number of blinks after application. Please see attached document for details.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are indications for mild eye irritation potential for these tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation. No classification as eye irritating should apply for the substance.

Executive summary:

The ocular irritation potential of hydrogenated lecithin is reported in final report on the safety assessment of lecithin and hydrogenated lecithin reviewed by the Cosmetic Ingredient Review Expert Panel. Hydrogenated lecithin produced minimal conjunctival irritation. All signs of irritation were cleared by day 2. The study concludes that hydrogenated lecithin is not a primary ocular irritant.

The European Lecithin Manufacturers association (ELMA) has also provided a statement that neither hydrogenated lecithin, nor lecithin should carry a hazard warning for this endpoint.

A number of studies on ocular irritation of lecithin and lecithin-containing cosmetic products have been tested in Draize tests using rabbits. The content of lecithin in the tested products was 2.25 to 3 % of Lecithin 65%. Lecithin 65% was also tested alone. The results ranged from non-irritating to moderate irritation, with the majority of the tests resulting in minimal irritation.

Two other tests of ocular irritating potential of neutral and positively charged lecithin from egg liposome preparations are also described in Fiume (2001). In one test the responses did not exceed “practically non-irritating” and immediately decreased to non-irritating. No lesions were found at microscopic examination. In the other test, the positively charged liposome preparation significantly increased the number of blinks.

Based on the studies described above on both hydrogenated lecithin and lecithin, the CIR panel concluded that lecithins and hydrogenated lecithins are not primary ocular irritants, and further the panel evaluated the substances to be safe for use in rinse off products and leave on products at concentrations ≤ 15%.

Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation. No classification as eye irritating should apply for the substance.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

One study exists on the substance for skin irritation. 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.

No study is available on eye irritation. A weight of evidence analysis was therefore performed. Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation.

No classification as skin or eye irritating should apply for the substance.