Plant Sterols

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 540 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

Reliability 2

NOAEL > 1540 mg/kg bw/day (expressed as phytosterol)

Additional information

In a well conducted OECD 416 oral feeding study in rats (with some deviations from the test guideline) a nominal dietary PE concentration of > 8.1% (equivalent to a dose of 2.5 -9.1 g Phytosterol Esters/kg body weight/day or 1.54 – 5.62 g phytosterol/kg/body weight/day, dependent on the phase of the study) was considered to be the no observed adverse effect level in this study. (1540 mg/kg bw/day expressed as phytosterol is the lowest value in the range that was given in the report and is taken as the NOAEL for this study). It should be noted that there were no treatment related effects on reproduction, on the development of the offspring, or on sexual maturation.

Short description of key information:
In a well conducted OECD 416 oral feeding study in rats (with some deviations from the test guideline) a nominal dietary Phytosterol Esters concentration of > 8.1% (equivalent to a dose of 2.5 -9.1 g Phytosterol Esters/kg body weight/day or 1.54 – 5.62 g phytosterol/kg/body weight/day, dependent on the phase of the study) was considered to be the no observed adverse effect level in this study.There were no effects on reproduction, on the development of the offspring, or on sexual maturation.

Justification for selection of Effect on fertility via oral route:
Well conducted OECD 416 oral feeding study in rats.

Effects on developmental toxicity

Description of key information

No adverse treatment-related maternal or foetal developmental effects were produced following ingestion of a diet containing up to 8.76% plant stanol fatty acid esters. This diet provided up to 5% of total dietary stanols equivalent to 2.4-3.5 g stanols/kg bw/day depending on the (days 0 -7: 3.5 g total stanols/kg bw/day, days 7 -14: 3.6 g total stanols/kg/bw/day, days 14 -21: 2.4g total stanols/kg/bw/day)
 
No significant differences were seen in reproductive performance, maternal and foetal body weights, sex distribution, or visceral or skeletal malformations, anomalies, and variations. Vegetable oil-derived stanol fatty acid esters are concluded not to be developmental toxicants and did not produce any embryotoxic, foetotoxic, or teratogenic effects in Wistar rats under the conditions of the study.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

2 400 mg/kg bw/day

Study duration:

chronic

Species:

rat

Quality of whole database:

Reliability 1
NOAEL > 2400 mg/kg bw/day (expressed as stanols)

Additional information

In a well conducted OECD 414 compliant study, no adverse treatment-related maternal or foetal developmental effects were produced following ingestion of a diet containing up to 8.76% plant stanol fatty acid esters. This diet provided up to 5% of total dietary stanols equivalent to 2.4-3.5 g stanols/kg bw/day depending on the (days 0 -7: 3.5 g total stanols/kg bw/day, days 7 -14: 3.6 g total stanols/kg/bw/day, days 14 -21: 2.4g total stanols/kg/bw/day)

 

No significant differences were seen in reproductive performance, maternal and foetal body weights, sex distribution, or visceral or skeletal malformations, anomalies, and variations. Vegetable oil-derived stanol fatty acid esters are concluded not to be developmental toxicants and did not produce any embryotoxic, foetotoxic, or teratogenic effects in Wistar rats under the conditions of the study. NAOEL is set as being greater than 2400 mg total stanols/kg (bw)

Justification for selection of Effect on developmental toxicity: via oral route:
A well conducted (rel 1) OECD 414 study in rats.

Justification for classification or non-classification

On the basis of the results of two well conducted reproductive toxicity and developmental toxicity studies in rats where no treatment related effects were observed, no classification will be required under the Dangerous Substances Directive (67/548/EEC) and CLP Regulation (1207/2008).