Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials
Acer tegmentosum Maxim., commonly known as Manchurian stripe maple, is a deciduous tree belonging to the family of Aceraceae and has been traditionally used in folk medicine for its remedial effects in liver diseases and traumatic bleedings. With a growing body of experimental evidence for its pharm...
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| Format: | Article |
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Frontiers Media S.A.
2021-08-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2021.687261/full |
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| author | Jin-Sung Park Jin-Sung Park Euna Kwon Yun-Soon Kim Sang-Moo Kim Dae-Sun Kim Ja-June Jang Jun-Won Yun Byeong-Cheol Kang Byeong-Cheol Kang Byeong-Cheol Kang Byeong-Cheol Kang |
| author_facet | Jin-Sung Park Jin-Sung Park Euna Kwon Yun-Soon Kim Sang-Moo Kim Dae-Sun Kim Ja-June Jang Jun-Won Yun Byeong-Cheol Kang Byeong-Cheol Kang Byeong-Cheol Kang Byeong-Cheol Kang |
| author_sort | Jin-Sung Park |
| collection | DOAJ |
| description | Acer tegmentosum Maxim., commonly known as Manchurian stripe maple, is a deciduous tree belonging to the family of Aceraceae and has been traditionally used in folk medicine for its remedial effects in liver diseases and traumatic bleedings. With a growing body of experimental evidence for its pharmacological efficacies, such as neuroprotective, hepatoprotective, antioxidant, and anti-inflammatory activities, A. tegmentosum has gradually gained popularity as a health supplement and functional food. However, the large part of essential toxicity information still remained lacking despite the possibility of mutagenic potentials as previously suggested, posing safety concerns for human consumption. In this study, we evaluated 90-day repeated oral toxicity of A. tegmentosum Maxim. water extract (ATWE) in SD rats with acute toxicity assessment in beagle dogs, and reevaluated genotoxicity using a combination of in vitro and in vivo assays. During the oral study period, ATWE did not cause toxicity-related clinical signs and mortality in rodents without adverse effects observed in the analysis of hematology, serum biochemistry, and histopathology, establishing >5,000 mg/kg BW as the NOAEL. In addition, doses up to 5,000 mg/kg BW did not cause acute toxicity in beagle dogs. When assessed for genotoxicity using bacterial reverse mutation, chromosome aberration, and micronucleus formation, ATWE showed lack of mutagenicity and clastogenicity. These results demonstrated that AWTE was safe in the present preclinical study for systemic toxicity and genotoxicity at the tested doses, providing a guideline for safe use in humans. |
| first_indexed | 2024-12-21T19:20:23Z |
| format | Article |
| id | doaj.art-1165e905b6994c8d914e75a31e600032 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-21T19:20:23Z |
| publishDate | 2021-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-1165e905b6994c8d914e75a31e6000322022-12-21T18:52:58ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122021-08-011210.3389/fphar.2021.687261687261Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic PotentialsJin-Sung Park0Jin-Sung Park1Euna Kwon2Yun-Soon Kim3Sang-Moo Kim4Dae-Sun Kim5Ja-June Jang6Jun-Won Yun7Byeong-Cheol Kang8Byeong-Cheol Kang9Byeong-Cheol Kang10Byeong-Cheol Kang11Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, South KoreaGraduate School of Translational Medicine, Seoul National University College of Medicine, Seoul, South KoreaDepartment of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, South KoreaDepartment of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, South KoreaPharm Cross., Ltd, Chuncheon, South KoreaPharm Cross., Ltd, Chuncheon, South KoreaDepartment of Pathology, Seoul National University College of Medicine, Seoul, South KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon, South KoreaDepartment of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, South KoreaGraduate School of Translational Medicine, Seoul National University College of Medicine, Seoul, South KoreaBiomedical Center for Animal Resource and Development, Seoul National University College of Medicine, Seoul, South KoreaDesigned Animal and Transplantation Research Institute, Institute of GreenBio Science Technology, Seoul National University, Pyeongchang-gun, South KoreaAcer tegmentosum Maxim., commonly known as Manchurian stripe maple, is a deciduous tree belonging to the family of Aceraceae and has been traditionally used in folk medicine for its remedial effects in liver diseases and traumatic bleedings. With a growing body of experimental evidence for its pharmacological efficacies, such as neuroprotective, hepatoprotective, antioxidant, and anti-inflammatory activities, A. tegmentosum has gradually gained popularity as a health supplement and functional food. However, the large part of essential toxicity information still remained lacking despite the possibility of mutagenic potentials as previously suggested, posing safety concerns for human consumption. In this study, we evaluated 90-day repeated oral toxicity of A. tegmentosum Maxim. water extract (ATWE) in SD rats with acute toxicity assessment in beagle dogs, and reevaluated genotoxicity using a combination of in vitro and in vivo assays. During the oral study period, ATWE did not cause toxicity-related clinical signs and mortality in rodents without adverse effects observed in the analysis of hematology, serum biochemistry, and histopathology, establishing >5,000 mg/kg BW as the NOAEL. In addition, doses up to 5,000 mg/kg BW did not cause acute toxicity in beagle dogs. When assessed for genotoxicity using bacterial reverse mutation, chromosome aberration, and micronucleus formation, ATWE showed lack of mutagenicity and clastogenicity. These results demonstrated that AWTE was safe in the present preclinical study for systemic toxicity and genotoxicity at the tested doses, providing a guideline for safe use in humans.https://www.frontiersin.org/articles/10.3389/fphar.2021.687261/fullAcer tegmentosum Maxim.salidrosiderepeated oral toxicityrodentsbeagle dogsgenotoxicity |
| spellingShingle | Jin-Sung Park Jin-Sung Park Euna Kwon Yun-Soon Kim Sang-Moo Kim Dae-Sun Kim Ja-June Jang Jun-Won Yun Byeong-Cheol Kang Byeong-Cheol Kang Byeong-Cheol Kang Byeong-Cheol Kang Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials Frontiers in Pharmacology Acer tegmentosum Maxim. salidroside repeated oral toxicity rodents beagle dogs genotoxicity |
| title | Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials |
| title_full | Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials |
| title_fullStr | Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials |
| title_full_unstemmed | Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials |
| title_short | Safety Assessment of Acer tegmentosum Maxim. Water Extract: General Toxicity Studies in Sprague–Dawley Rats and Beagle Dogs With Re-evaluation of Genotoxic Potentials |
| title_sort | safety assessment of acer tegmentosum maxim water extract general toxicity studies in sprague dawley rats and beagle dogs with re evaluation of genotoxic potentials |
| topic | Acer tegmentosum Maxim. salidroside repeated oral toxicity rodents beagle dogs genotoxicity |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2021.687261/full |
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