Safety evaluation of certain food additives - ipcs inchem

ALKOXY-SUBSTITUTED ALLYLBENZENES 359
150 and 300 mg/kg bw groups, but not in the lower dose groups, suggest that
metabolic saturation is achieved during this time interval at higher dose levels. At
all dose levels, females displayed only small dose-dependent increases in AUCs
compared with naive animals, whereas males at 37, 75 and 150 mg/kg bw exhibited
more significant AUC increases relative to undosed animals, suggesting that
metabolic enzymatic induction plays a more important role in males. An increase in
AUCs with time suggests a decrease in the capacity to metabolize methyl eugenol
with age (National Toxicology Program, 2000). For mice administered 35, 75 or
150 mg/kg bw per day orally for 2 years, absorption was also rapid. Cmax was
reached after 5 min and increased with increasing dose for both males and females.
Elimination half-lives increased with dose, suggesting that the elimination was
saturated for both sexes.
More than 95% of a single 200 mg/kg bw dose of methyl eugenol and 56–
66% of a 100 mg/kg bw dose of estragole administered as a 1% suspension to male
rats by stomach tube were excreted in the urine within 24 h. When the same dose
levels were administered by intraperitoneal injection, >85% of the methyl eugenol
dose and 77–87% of the estragole dose were excreted in the urine after 24 h
(Solheim & Scheline, 1973).
Blood and urine were collected at regular intervals from male F344/N rats
given [ring- 14 C]methyl eugenol at 118 mg/kg bw orally by gavage. More than 72%
was eliminated in the urine, 13% in the faeces and