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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
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 toxicity to reproduction and development from 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

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

Details on species / strain selection:
Studies were reported for mice, rats and rabbits.
Sex:
female
Details on test animals or test system and environmental conditions:
Gravid animals

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: For more details, please see attached weight of evidence document.
Details on study schedule:
For details, please see attached weight of evidence document.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
For more details, please see attached weight of evidence document.

Effect levels (P0)

Remarks on result:
not determinable due to absence of adverse toxic effects

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Description (incidence and severity):
For more details, please see attached weight of evidence document.

Effect levels (F1)

Remarks on result:
not determinable due to absence of adverse toxic effects

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
Based on the information available in the present weight of evidence analysis it is concluded that the substance Phosphatidylcholines, soya, hydrogenated is not a reproductive/developmental toxicant, and thus no classification for this endpoint should apply..
Executive summary:

The reproductive/developmental toxicity of the substancePhosphatidylcholines, soya, hydrogenatedis assessed in the present weight of evidence assessment.

Due to lack of specific data on the substance, existing data on lecithins and other phosphoglycerides are used. As phosphatidylcholine belongs in the group of lecithins and differences in possible effects on human health due to the hydrogenation is considered minimal,the use of data on lecithins and other phosphoglyceridesis considered acceptable for the present substance.

No reproductive toxicity data is available. The toxicity of lecithins described in subchronic and chronic studies are low, and no reports of effects on the reproductive organs have been described in the scientific expert reports (Fiume Z 2001; CIR 2015; EFSA 2017). The reproductive toxicity of lecithins and Phosphatidylcholines, soya, hydrogenated, is therefore considered to be low.

Developmental studies with mice, rats and rabbits are reported for lecithins. In the studies, gravid animals were dosed orally on days 6 to 15 of gestation for mice and rats and days 5 to 18 of gestation for rabbits. Necropsy of mice, rats and rabbits was done on day 17, 20 and 29 respectively. No significant effects were observed on maternal and foetus survival, nidation, body weight and abnormalities were observed in doses up to 1600 mg/kg for mice and rats and up to 475 mg/kg for rabbits.

These observations were supported in reproductive studies with rats and rabbits on soya phosphatidylcholine. In these studies, gravid animals were dosed orally on days 6 to 15 of gestation for rats, on days 1 to 6 of gestation and days 5 to 18 of gestation for rabbits. The lowest daily oral dose was reported to be >750, >1000 and > 500 mg/kg, respectively

Also, a lowest toxic daily oral dose of > 2800 mg/kg was reported for peri- and postnatal toxicity on rats dosed with lecithin from day 16 of gestation to the end of the third week postpartum.

Developmental studies with rats and rabbits are reported for phosphatidylserine. The test material was given by oral gavage to gravid rats in doses up to 200 mg/kg on days 6 to 15 of gestation and in doses up to 450 mg/kg to rabbits on days 6 to 18 of gestation. Necropsy was done on day 20 and 29, respectively. No adverse dosage-related effects were seen on maternal or litter values and embryonic and foetal development were not affected by treatment with phosphatidylserine.

Based on the available data, no developmental effects have been noted from lecithins when dosed orally to three species of gravid animals during gestation. No reproductive toxicity data is available, however based on data described scientific expert reports on subchronic and chronic no reports of effects on the reproductive organs have been reported (Fiume Z 2001; CIR 2015; EFSA 2017).

The overall conclusion based on presented data in this weight of evidence analysis, is therefore that there are no indications of reproductive or developmental toxicity of the substance Phosphatidylcholines, soya, hydrogenated. Derivation of a DNEL for reproductive toxicity for general population or for workers is not considered necessary as no hazard has been identified.