Gutiérrez MA, Gámez MR, Mas FR, García CH, Bucarano LI, Goicochea CE

Language: Spanish
References: 22
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ABSTRACT

Introduction: D-004, is a lipid extract from the fruits of royal palm tree(Roystonea regia) that contains a reproducible mixture of fatty acids, mainly oleic, palmitic, lauric and mirystic. The oral treatment with D-004 prevents prostate hyperplasia induced with testosterone in rodents.
Objective: to assess the teratogenic toxic potential of D-004 in rabbits.
Methods: pregnant females were distributed at random into three groups: a control group treated with (Tween 65/water) as vehicle and two treated with D-004 (500 and 1 000 mg/kg). Animals were orally administered from day 6 up to the 18 day of gestation. Females were euthanized on gestational day 29 and fetuses were examined for external, visceral and skeletal malformations.
Results: no significant differences were observed among treated and control groups regarding maternal body weight gain and food consumption during pregnancy. Treated and control group were comparable in numbers of corpora lutea, implantation sites, reabsorptions, alive fetuses, fetal weight and sex ratio. Visceral malformations were found in three fetus , one from the control group and 2 fetuses from the group treated with 1000 mg/kg. No external or skeletal malformations were observed in any group.
Conclusions: D-004 orally administered to rabbits at 500 and 1 000 mg/kg during the organogenesis period did no cause embryotoxic nor teratogenic effects.

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