Title of article :
Safety evaluation of phytosterol esters. Part 8. Lack of genotoxicity and subchronic toxicity with phytosterol oxides
Author/Authors :
Lea، نويسنده , , L.J and Hepburn، نويسنده , , P.A and Wolfreys، نويسنده , , A.M. and Baldrick، نويسنده , , P، نويسنده ,
Issue Information :
روزنامه با شماره پیاپی سال 2004
Pages :
13
From page :
771
To page :
783
Abstract :
Vegetable oil spreads containing phytosterol-esters are marketed as a cholesterol-lowering functional food in more than 20 countries worldwide. An extensive package of safety data has shown phytosterol-esters to be safe for human use. However, even though phytosterols are very stable molecules, oxidation may occur at low levels under extreme heating conditions, resulting in phytosterol oxides. As there is some suggestion of adverse biological effects in the literature for the related cholesterol oxidation products, safety data have been generated for phytosterol oxides. A phytosterol oxide concentrate (POC) was generated by prolonged heating of phytosterol-esters in the presence of oxygen. The genotoxicity and subchronic toxicity of this mixture was assessed in a series of in vitro genotoxicity assays (bacterial mutation, chromosome aberration and micronucleus) and a subchronic feeding study in the rat. Results showed that a phytosterol oxide concentrate containing approximately 30% phytosterol oxides did not possess genotoxic potential and no obvious evidence of toxicity when administered in the diet of the rat for 90 consecutive days. In the latter study, a NOEL was established at an estimated dietary level of phytosterol oxides of 128 mg/kg/day for males and 144 mg/kg/day for females. In conclusion, these materials have been shown to raise no obvious concerns for human safety.
Keywords :
Phytosterol oxides , oxysterols , Phytosterols
Journal title :
Food and Chemical Toxicology
Serial Year :
2004
Journal title :
Food and Chemical Toxicology
Record number :
2117873
Link To Document :
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