Registration Dossier
Registration Dossier
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EC number: 619-079-3 | CAS number: 949109-75-5
Endpoint summary
Administrative data
Description of key information
In a published study (Hepburnet al., 1999), phytosterol esters (PE) were added to the diet of male and female Wistar derived rats over a period of 90 days, to give concentrations of 0.16, 1.6, 3.2, and 8.1% (w/w) equivalent to phytosterol concentrations of 0.1, 1.0, 2.0, and 5.0 % (w/w) respectively. (Similar to OECD 408 test guideline, Rel. 2)
The results of this study showed there to be no clinical signs or effects on survival attributed to the administration of the test material. A NOEL of 8.1% (PE) was identified in the study, which is equivalent to a dose of 6.6 g/kg/bw/day PE or 4.1 g phytosterol/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 4 100 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- NOAEL > 4100 mg/kg/day.
Additional information
In a published study (Hepburnet al., 1999), phytosterol esters (PE) were added to the diet of male and female Wistar derived rats over a period of 90 days, to give concentrations of 0.16, 1.6, 3.2, and 8.1% (w/w) equivalent to phytosterol concentrations of 0.1, 1.0, 2.0, and 5.0 % (w/w) respectively. (Similar to OECD 408 test guideline, Rel. 2).
The results of this study showed there to be no clinical signs or effects on survival attributed to the administration of the test material. A NOEL of > 8.1% (PE) was identified in the study, which is equivalent to a dose of 6.6 g/kg/bw/day PE or 4.1 g phytosterol/kg bw/day.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Based on a well conducted 90 day oral feeding study in rats
Justification for classification or non-classification
Experimental evidence indicates that there is no requirement for classification for repeated dose toxicity.
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