Safety evaluation of certain food additives - ipcs inchem

PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 135
Table 3. Concentrations of fat-soluble vitamins in plasma and liver following
administration of phytostanol esters to rats in the diet a
2.4.3 Genotoxicity
Mean concentration of vitamins in plasma b and liver
Male rat Female rat
% of phytostanols in the diet 0 0.2 1 5 0 0.2 1 5
WDPSE
% of phytostanol esters in the diet 0 0.34 1.7 8.4 0 0.34 1.7 8.4
-Carotene (μmol/l) 0.01 0.02 0.02 0.01 0.01 0.02 0.01 0.01
Vitamin A (μmol/l) 1.38 1.42 1.34 1.35 0.57 0.64 0.66 0.63
Vitamin E (μmol/l) 22.5 21.3 20.3 7.7** 23.2 25.3 24.8 11.4**
Vitamin D (nmol/l) 82 81 77 69** 122 123 119 102*
Vitamin K (nmol/l) 11.3 9.0 7.1 2.5** 7.5 12.3 9.9 3.1**
VODPSE
% of phytostanol esters in the diet 0 0.36 1.8 8.9 0 0.36 1.8 8.9
-Carotene (μmol/l) 0.01 0.01 0.02 0.01 0.01 0.02 0.01 0.02
Vitamin A (μmol/l) 1.38 1.36 1.41 1.28 0.57 0.71 0.66 0.65
Vitamin E (μmol/l) 22.5 21.1 19.9 7.6** 23.2 25.1 24.0 11.5**
Vitamin D (nmol/l) 82 80 78 68** 122 128 120 100**
Vitamin K (nmol/l) 11.3 7.2 7.1 2.4** 7.5 9.5 9.3 2.7**
Liver vitamin A NM NM NM NM 324 327 359* 338
Liver vitamin E NM NM NM NM 50.4 48.8 51.9 21.9**
Liver vitamin D NM NM NM NM 4.07 4.02 3.56 3.15*
a n = 10 rats per sex per group. * P < 0.05, ** P < 0.01. NM, not measured.
b Plasma collected at autopsy from the abdominal aorta of non-fasted rats.
Phytostanol esters from both wood (WDPSE) and vegetable oil (VODPSE)
were investigated in vitro in bacterial systems and mammalian cells for genotoxic
effects. Studies were carried out according to OECD Test Guidelines 471, 473 and
476. No genotoxic activity of any of the mixtures was observed in these studies,
which are summarized in Table 4.