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Toxicological information

Eye irritation

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Administrative data

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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Principles of method if other than guideline:
Collection of data based on scientifically acceptable methods.

Test material

Constituent 1
Chemical structure
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:
other: Estimation based on CAS number
Details on test material:
CAS number 97281-48-6
Specific details on test material used for the study:
For more details, please see attached weight of evidence document.

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Controls:
other: contralateral eye

Results and discussion

In vivo

Results
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.

Applicant's summary and conclusion

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.