Evaluation of genetic toxicity, acute and sub-chronic oral toxicity and systemic safety of Agrimonia pilosa and Rhus gal
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Toxicol Res. https://doi.org/10.1007/s43188-020-00042-5
Toxicological Research
ORIGINAL ARTICLE
Evaluation of genetic toxicity, acute and sub‑chronic oral toxicity and systemic safety of Agrimonia pilosa and Rhus gall 50% ethanolic extract mixture (APRG64) in vitro and in vivo (rodent and non‑rodent animal models) Jong‑Hun Park1 · Jong‑Sung Ra2 · Jeong Eun Kwon2 · Yang‑Mi Her2 · Tae Hwan Choe2 · Yoon‑Seo Lee2 · Hee Ju Suh2 · Seung‑Yeon Shin2 · Dae Won Park2 · Ho‑Hyun Kwak1 · Heung‑Myong Woo1 · Hyelin Jeon3 · Se Chan Kang2 Received: 2 December 2019 / Revised: 15 January 2020 / Accepted: 18 February 2020 © Korean Society of Toxicology 2020
Abstract Agrimonia pilosa (AP) and Rhus gall (RG) are traditional medicinal plants. The bioflavonoid composition standardized by HPLC analysis was named APRG64. Despite many studies reported to beneficial bioactivities of AP and RG, very limited range of toxicity tests have documented. So, we did experiment diversely on the toxicity tests of the substance APRG64. Genotoxicity (mammalian chromosomal aberration test, micronoucleus test) against APRG64, acute and sub-chronic toxicity test from rodent/non-rodent, and systemic safety pharmacology test were conducted. As a result of the test, genotoxicity against APRG64 was not observed. The NOAEL of rodents was confirmed as 2000 mg/kg/day and non-rodents was confirmed as 500 mg/kg/day. In addition, systemic safety pharmacological toxicity (effects on respiratory system, central nervous system, cardiovascular system) following administration of APRG64 was not observed. Finally, we accomplished ten potential toxicity tests and evaluated extensive safety of APRG64. Consequently, APRG64 may be a promising material for nutraceuticals and natural medicines. Keywords Agrimonia pilosa · Rhus gall · Genotoxicity · Systemic safety pharmacological toxicity · Potential toxicity tests · Natural medicines · NOAEL Jong-Hun Park and Jong-Sung Ra made equal contributions to this work (co-first author). * Se Chan Kang [email protected]
Ho‑Hyun Kwak [email protected]
Jong‑Hun Park [email protected]
Heung‑Myong Woo [email protected]
Jeong Eun Kwon [email protected]
Hyelin Jeon [email protected]
Yang‑Mi Her [email protected]
1
College of Veterinary Medicine and Institute of Veterinary Science, Kangwon National University, 1, Kangwondaehak‑gil, Chuncheon‑si, Gangwon‑do 24341, Republic of Korea
2
Department of Oriental Medicine Biotechnology, Kyung Hee University, 1732, Deogyong‑daero, Giheung‑gu, Yongin‑si, Gyeonggi‑do 17104, Republic of Korea
3
Research Institute, Genencell. Co. Ltd, 120, Heungdeokjungang‑ro, Giheung‑gu, Yongin‑si, Gyeonggi‑do 16950, Republic of Korea
Tae Hwan Choe [email protected] Yoon‑Seo Lee [email protected] Hee Ju Suh [email protected] Seung‑Yeon Shin [email protected] Dae Won Park [email protected]
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Abbreviations AG Apigenin-7-O-β-glucuronide AP Agrimonia Pilosa APRG64 AP and RG of each 50% ethanolic extracts mixed 64 CHO-K1 Chinese hamster ovary EG Ethyl gallate FOB The functional observat
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