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Pre-clinical in vitro and in vivo safety evaluation of Cimicifuga heracleifolia
- Source :
- Regulatory toxicology and pharmacology : RTP. 73(1)
- Publication Year :
- 2015
-
Abstract
- The rhizomes of Cimicifuga species, including Cimicifuga heracleifolia (CH), have been widely used as antipyretic, analgesic, and anti-inflammatory agents in oriental countries. However, information regarding its toxicity, especially long-term toxicity and genotoxicity, is limited. Therefore, we performed the subchronic toxicity and genotoxicity assays of the CH extract in accordance with the test guidelines published by the Organization for Economic Cooperation and Development. In a 13-week repeat-dose oral toxicity study, the CH extract did not influence body weight, food/water consumption, mortality, clinical signs, and urinalysis throughout the study. Noteworthy, the CH extract groups exhibited increased liver weights along with serum alanine transaminase activity rise at doses of 667 and 2000 mg/kg in females. No-observed-adverse-effect-level of the CH extract administered orally was concluded to be 2000 mg/kg body weight/day for male rats and 222 mg/kg body weight/day for female rats. The CH extract did not exert a mutagenic or clastogenic effect in Ames test, in vitro chromosome aberration assay and in vivo micronucleus assay. Overall findings of the subchronic toxicity study indicate for the first time that the CH extract may possess hepatotoxic potential in female rats, suggesting that further mechanistic studies should be performed to have more conclusive results on hepatotoxic potential of the CH extract.
- Subjects :
- Male
Cimicifuga
No-observed-adverse-effect level
Pharmacology
Toxicology
medicine.disease_cause
Chromosome aberration
Ames test
In vivo
medicine
Animals
Chromosome Aberrations
No-Observed-Adverse-Effect Level
Micronucleus Tests
biology
Dose-Response Relationship, Drug
Chemistry
Mutagenicity Tests
Plant Extracts
Body Weight
Toxicity Tests, Subchronic
General Medicine
Organ Size
biology.organism_classification
Rats, Inbred F344
Rats
Micronucleus test
Toxicity
Female
Genotoxicity
Subjects
Details
- ISSN :
- 10960295
- Volume :
- 73
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Regulatory toxicology and pharmacology : RTP
- Accession number :
- edsair.doi.dedup.....315b53a436af7da1d8805b2558c08da0