Prenatal developmental toxicity study of an alkaloid-free Ageratum conyzoides extract powder in rats by oral administration

A prenatal developmental toxicological study was conducted to evaluate the safety of an alkaloid-free Ageratum conyzoides extract powder administration on pregnant female Wistar rats and on the development of the conceptus in accordance with OECD test guideline (no. 414). Pyrrolizidine alkaloids (PA...

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Vydané v:	Regulatory toxicology and pharmacology Ročník 117; s. 104748
Hlavní autori:	Subah, Silma, Bogoda, Nathasha, Glávits, Róbert, Venkatesh, Ruchitha, Murbach, Timothy S., Kolep-Csete, Kornélia
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Elsevier Inc 01.11.2020
Predmet:	Ageratum conyzoides Developmental Fetal Maternal NOAEL Prenatal Safety Toxicity Prenatal Developmental Maternal Toxicity NOAEL Ageratum conyzoides Fetal Safety
ISSN:	0273-2300, 1096-0295, 1096-0295
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Abstract	A prenatal developmental toxicological study was conducted to evaluate the safety of an alkaloid-free Ageratum conyzoides extract powder administration on pregnant female Wistar rats and on the development of the conceptus in accordance with OECD test guideline (no. 414). Pyrrolizidine alkaloids (PAs) naturally present in A. conyzoides have been shown to induce toxicity in past studies, particularly towards hepatic cells. Therefore our test item preparation of A.conyzoides extract (aerial part of the plant) consisted of the removal of PAs. There were no treatment related adverse effects found during maternal examinations (body weights, food consumption, numbers of pregnant and non-pregnant female rats, endocrine evaluation, gravid uterine weights, and number of corpora lutea), maternal/fetal examinations (numbers of implantation sites, pre-and post-implantation loss (%), dead and live fetuses (%), resorption sites), or fetal examinations (litter size and weights, number of fetuses, sex ratio, or external, visceral, and skeletal variations and malformations) in the Ageratum conyzoides extract powder groups at doses of 500, 1000 and 2000 mg/kw bw/day compared to vehicle control group. The no observed adverse effect level (NOAEL) determined for both maternal and developmental toxicity was 2000 mg/kg bw/day, which was the highest dose tested. •Toxicity of A.conyzoides has been postulated due to pyrrolizidine alkaloids.•The test item was an alkaloid-free ethanolic extract of A.conyzoides.•No treatment related maternal or fetal adverse effects of A.conyzoides extract were observed in rats.•The NOAEL for maternal and developmental toxicity was 2000 mg/kg bw/day, the highest dose tested.•This is the first study investigating the prenatal developmental toxicity of A.conyzoides in rats.
AbstractList	A prenatal developmental toxicological study was conducted to evaluate the safety of an alkaloid-free Ageratum conyzoides extract powder administration on pregnant female Wistar rats and on the development of the conceptus in accordance with OECD test guideline (no. 414). Pyrrolizidine alkaloids (PAs) naturally present in A. conyzoides have been shown to induce toxicity in past studies, particularly towards hepatic cells. Therefore our test item preparation of A.conyzoides extract (aerial part of the plant) consisted of the removal of PAs. There were no treatment related adverse effects found during maternal examinations (body weights, food consumption, numbers of pregnant and non-pregnant female rats, endocrine evaluation, gravid uterine weights, and number of corpora lutea), maternal/fetal examinations (numbers of implantation sites, pre-and post-implantation loss (%), dead and live fetuses (%), resorption sites), or fetal examinations (litter size and weights, number of fetuses, sex ratio, or external, visceral, and skeletal variations and malformations) in the Ageratum conyzoides extract powder groups at doses of 500, 1000 and 2000 mg/kw bw/day compared to vehicle control group. The no observed adverse effect level (NOAEL) determined for both maternal and developmental toxicity was 2000 mg/kg bw/day, which was the highest dose tested. •Toxicity of A.conyzoides has been postulated due to pyrrolizidine alkaloids.•The test item was an alkaloid-free ethanolic extract of A.conyzoides.•No treatment related maternal or fetal adverse effects of A.conyzoides extract were observed in rats.•The NOAEL for maternal and developmental toxicity was 2000 mg/kg bw/day, the highest dose tested.•This is the first study investigating the prenatal developmental toxicity of A.conyzoides in rats. A prenatal developmental toxicological study was conducted to evaluate the safety of an alkaloid-free Ageratum conyzoides extract powder administration on pregnant female Wistar rats and on the development of the conceptus in accordance with OECD test guideline (no. 414). Pyrrolizidine alkaloids (PAs) naturally present in A. conyzoides have been shown to induce toxicity in past studies, particularly towards hepatic cells. Therefore our test item preparation of A.conyzoides extract (aerial part of the plant) consisted of the removal of PAs. There were no treatment related adverse effects found during maternal examinations (body weights, food consumption, numbers of pregnant and non-pregnant female rats, endocrine evaluation, gravid uterine weights, and number of corpora lutea), maternal/fetal examinations (numbers of implantation sites, pre-and post-implantation loss (%), dead and live fetuses (%), resorption sites), or fetal examinations (litter size and weights, number of fetuses, sex ratio, or external, visceral, and skeletal variations and malformations) in the Ageratum conyzoides extract powder groups at doses of 500, 1000 and 2000 mg/kw bw/day compared to vehicle control group. The no observed adverse effect level (NOAEL) determined for both maternal and developmental toxicity was 2000 mg/kg bw/day, which was the highest dose tested.A prenatal developmental toxicological study was conducted to evaluate the safety of an alkaloid-free Ageratum conyzoides extract powder administration on pregnant female Wistar rats and on the development of the conceptus in accordance with OECD test guideline (no. 414). Pyrrolizidine alkaloids (PAs) naturally present in A. conyzoides have been shown to induce toxicity in past studies, particularly towards hepatic cells. Therefore our test item preparation of A.conyzoides extract (aerial part of the plant) consisted of the removal of PAs. There were no treatment related adverse effects found during maternal examinations (body weights, food consumption, numbers of pregnant and non-pregnant female rats, endocrine evaluation, gravid uterine weights, and number of corpora lutea), maternal/fetal examinations (numbers of implantation sites, pre-and post-implantation loss (%), dead and live fetuses (%), resorption sites), or fetal examinations (litter size and weights, number of fetuses, sex ratio, or external, visceral, and skeletal variations and malformations) in the Ageratum conyzoides extract powder groups at doses of 500, 1000 and 2000 mg/kw bw/day compared to vehicle control group. The no observed adverse effect level (NOAEL) determined for both maternal and developmental toxicity was 2000 mg/kg bw/day, which was the highest dose tested.
ArticleNumber	104748
Author	Venkatesh, Ruchitha Subah, Silma Murbach, Timothy S. Bogoda, Nathasha Kolep-Csete, Kornélia Glávits, Róbert
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Cites_doi	10.1016/j.jep.2014.07.005 10.4103/0973-8258.41171 10.1002/path.1700770220 10.3390/ijms19061668 10.1016/j.reprotox.2019.02.006 10.1002/19960404NT3 10.1590/S0102-695X2013005000028 10.1016/j.yrtph.2019.01.027 10.1016/j.brainresrev.2011.02.001 10.1076/phbi.39.5.336.5891 10.2903/j.efsa.2011.2406 10.1016/j.jfda.2018.05.005 10.1016/S0367-326X(01)00364-1 10.1080/19440049.2010.541288 10.1002/bdrc.20098
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Snippet	A prenatal developmental toxicological study was conducted to evaluate the safety of an alkaloid-free Ageratum conyzoides extract powder administration on...
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SubjectTerms	Ageratum conyzoides Developmental Fetal Maternal NOAEL Prenatal Safety Toxicity
Title	Prenatal developmental toxicity study of an alkaloid-free Ageratum conyzoides extract powder in rats by oral administration
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