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EC number: 233-566-4
CAS number: 10236-47-2
A study was conducted to assess the embryotoxic, fetotoxic, and
teratogenic potential of the oral administration of the analogue
substance neohesperidin dihydrochalcone in rats by a method according to
OECD 414 (GLP study). Starting from day 0 of gestation, 28 mated female
Wistar Crl:(WI)WU BR rats per group received experimental
diets containing the analogue substance at levels of 0 (control), 1.25,
2.5, and 5%. The top dose was selected on the basis of previous studies
conducted. Maternal examinations performed included detailed clinical
observations, body weights, food consumption and compound intake, gross
necropsy, and organ weights. The fetuses were removed from the uterus,
dried of amniotic fluid, weighed, sexed by observing the anogenital
distance, and examined for gross abnormalities. The placentas of the
live fetuses were weighed and examined for macroscopic abnormalities.
Early and late resorptions and dead fetuses were counted. Half of the
fetuses randomly selected from each litter were eviscerated, partly
skinned, fixed in 70% ethanol, cleared in potassium hydroxide, and
stained with Alizarin Red S for examination of the skeleton. The
remaining fetuses were fixed in Bouins fluid for subsequent visceral
examination. All examinations for fetal abnormalities were performed
microscopically. Skeletal and visceral examinations were conducted on
fetuses of the control and high-dose group only. Based on the test
results, the test item, at a dietary level of up to 5% (corresponding to
an intake of about 3.3 g/kg bw/day) did not exhibit any maternal
toxicity, fetotoxicity, embryotoxicity, or teratogenicity in Wistar
Crl:(WI)WU BR rats. Therefore, the NOAEL of the analogue substance
neohesperidin dihydrochalcone in rats was set at 3300 mg/kg bw/d.
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