Genotoxicity and maternal-fetal safety of the dried extract of leaves of Azadirachta indica A. Juss (Meliaceae) in Wistar rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Azadirachta indica A. Juss (Meliaceae), popularly known as "neem", is used for the treatment of rheumatism, cancer, ulcers, diabetes, respiratory problems, among others. This species is present on six continents and contains more than 400 bioactive compounds. Practically all parts of the plant are used in the treatment of diseases. Although it is widely used, no study has evaluated the safety of this species throughout the gestational period in Wistar rats. AIM OF THE STUDY: To evaluate the genotoxicity and the effect of treatment with dried extract of leaves of Azadirachta indica on maternal toxicity and fetal development. MATERIALS AND METHODS: The dried extract of leaves of A. indica was obtained by spray drying after percolation of the plant material in 30% ethanol (w/w). The total flavonoids and rutin contents of the extract were determined by spectrophotometric method and HPLC-DAD, respectively. Pregnant Wistar rats (n = 40) were divided into four groups (n = 10/group): one control and three groups treated with dried extract of leaves of A. indica at doses of 300, 600 or 1200 mg/kg. Treatments were carried out from gestational day (GD) 0-20. During gestation, clinical signs of toxicity, weight gain, feed and water consumption of the dams were evaluated. On GD 21, rats were euthanized and cardiac blood was collected. Liver, kidneys, lung, heart, uterus, ovaries and bone marrow were collected. Reproductive performance parameters, histopathological analysis, biochemistry and genotoxicity were evaluated. Fetuses were evaluated for external morphology, skeletal and visceral changes. RESULTS: The total flavonoid content of the extract ranged from 2.64 to 3.01%, and the rutin content was 1.07%. There was no change in body mass gain, food and water consumption between the evaluated groups. There was also no difference between the groups in terms of biochemical parameters, reproductive performance, histopathological analysis of the mother's organs and genotoxicity. Supernumerary ossification sites of the sternum were observed, and other skeletal and visceral alterations were not significant. CONCLUSIONS: The treatment did not induce maternal toxicity, it was neither embryotoxic nor fetotoxic. The extract was not potentially genotoxic, and at a dose of 1200 mg/kg, it caused changes in the ossification of the sternum.

Assessing the safety of using the dry extract of Justicia pectoralis Jacq. (Acanthaceae) during pregnancy of Wistar rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Justicia pectoralis Jacq. (Acanthaceae), popularly known as tilo, chambá and anador, is widely used in folk medicine in Latin American countries as a sedative, anti-anxiety, reducing menopause symptoms and in the treatment of pathologies of the respiratory tract. Although J. pectoralis is widely used by the female population, there are no studies on the safety of using this species during pregnancy. AIM OF THIS STUDY: To evaluate the effects of prenatal treatment with dry extract from the aerial parts of J. pectoralis on maternal and developmental toxicity in Wistar rats. MATERIAL AND METHODS: Pregnant Wistar rats (n = 10/group) were treated from gestational day (GD) 0-20 with the vehicle (control group) or with the dry extract of J. pectoralis at doses of 300, 600 or 1200 mg/kg. During pregnancy, clinical signs of toxicity, maternal weight, feed and water intake were evaluated. On GD 21, rats were anesthetized and intracardiac blood was collected to evaluate biochemical parameters. During cesarean section, reproductive performance parameters were recorded. The liver, kidneys, uterus and ovaries were removed for histopathological analysis. Fetuses were examined for possible malformations and/or skeletal and visceral variations. RESULTS: Treatment with dry extract of J. pectoralis did not alter weight gain, feed intake or biochemical and maternal reproductive performance parameters There were also no significant histopathological changes in the maternal organs, as well as external, skeletal and visceral malformations in the fetuses. CONCLUSION: Oral administration of J. pectoralis dry extract during pregnancy did not induce maternal toxicity or embryotoxic and teratogenic effects.