Safety evaluation of certain food additives - ipcs inchem

428 ALKOXY-SUBSTITUTED ALLYLBENZENES
Table 4 (contd)
No. Flavouring agent End-point Test object Concentration Results References
Negative uu Kirkhart (1981)
1792 Safrole Micronucleus induction Mouse 4.11, 8.23 and 16.5 mg/kgr (0.003 75, 0.0075 and
0.015 ml/kg)
Negativeuu Tsuchimoto & Matter
(1981)
1792 Safrole Micronucleus induction Mouse 6.5, 13 and 26 mg/kg bwr (6,
12 and 24 μl/kg)
1792 Safrole Micronucleus induction Mouse 80% of LD50 Equivocal ccc Salamone et al. (1981)
CHO, Chinese hamster ovary; LD50, median lethal dose; LDH, lactate dehydrogenase; ppm, parts per million; SCE, sister chromatid exchange; UDS,
unscheduled DNA synthesis.
a Calculated from the relative molecular mass of elemicin = 208.26.
b Positive in a concentration-dependent manner at a maximum concentration of 104 μg/ml (500 μmol/l). At concentrations higher than 104 μg/ml
(500 μmol/l), marked cytotoxicity was observed through increased LDH leakage.
c Calculated from the relative molecular mass of estragole = 148.21.
d With and without metabolic activation.
e Estragole was toxic to cell growth at concentrations above 10 μmol/plate.
f With metabolic activation.
g Without metabolic activation.
h Marked cytotoxicity reported at concentrations greater than 10 3 mol/l.
i Calculated from the relative molecular mass of methyl eugenol = 178.23.
j Marked toxicity was noted.
k The highest level of UDS was detected at 10 μmol/l and decreased with increasing concentration up to 500 μmol/l.
l The authors of this study assert that UDS was marginally increased as compared with controls, and it does not reach statistical significance; thus,
they designate the overall result as equivocal.
m Calculated from the relative molecular mass of myristicin = 192.21.
n Cytotoxicity was reported at concentrations greater than 192 μg/ml (10 3 mol/l).
o Calculated from the relative molecular mass of safrole = 162.19.
p Positive only at the two higher concentrations of 10 and 25 μg safrole/ml.