Phosphatidylcholines, soya, hydrogenated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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. The possible acute dermal toxicity of the substance is therefore assessed in the present weight of evidence analysis based on existing data on the group of lecithins. As the substance belongs to the group of lecithins that are commonly used in cosmetics and used as food ingredient, reviews and expert group assessments of the substances are considered the most valid data for the group of lecithins. In order to combine data on several similar substances, an overall weight of evidence approach is used for the assessment. For more details, please see attached weight of evidence document.

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:

The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. However, details on methods may vary.
Please refer to attached weight of evidence document.

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:

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

Species:

rat

Strain:

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

Sex:

female

Administration / exposure

Type of coverage:

not specified

Vehicle:

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

Results and discussion

Effect levels

Sex:

female

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality observed

Clinical signs:

other: No adverse reactions

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the information available in the present weight of evidence analysis it is concluded that the substance Phosphatidylcholines, soya, hydrogenated is not acutely toxic by dermal route.

Executive summary:

The acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenatedis assessed in a weight of evidence approach using available data on the group of lecithins.

Oral acute toxicity studies on Phosphatidylcholines, soya, hydrogenated in mice and rats determined low toxicity with LD50 > 10 g/kg. Furthermore, several studies of acute toxicity of lecithins and hydrogenated lecithins reported low acute toxicity with LD50 of more than 16,000 mg/kg bw in mice, more than 5,000 mg/kg bw in rats and 4,750 mg/kg bw in rabbits. In a study with phosphatidylserine administrated subcutaneously, the LD50 value was reported to be greater than 5 mg/kg bodyweight. Thus all available studies on acute toxicity by other routes show a low acute toxicity of phosphatidylcholines, soya, hydrogenated and lecithins, with a LD50 of more than 4000 mg/kg bw. Although a relatively high dermal absorption of lecithins have been shown, the potential of acute dermal toxicity is evaluated to be low due to the high LD50 values reported.

Based on the information available in the present analysis it is concluded that the substance Phosphatidylcholines, soya, hydrogenated has low potential for acute toxicity by the dermal route and thus, no classification applies for this end-point.