Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 306-549-5
CAS number: 97281-48-6
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
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
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).
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again