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The objective of the study was to evaluate the potential toxicity of crude  n -hexane extract of  Alpinia malaccensis  rhizome. The  in vivo  acute oral toxicity was evaluated by administering a single oral dose of the extract at 0, 300, or 2000 mg/kg body weight to female Wistar rats according to modified OECD Test Guideline 423. For the  in vitro  cytotoxicity study, A549, HepG2, 3T3, and COS-7 cell lines were exposed to different doses of  A. malaccensis  extract and cell viability was assessed adopting MTT assay followed by AO/EB staining, Hoechst staining, and comet assay with a view to compare the cellular and molecular mechanisms underlying the toxicity, if any. It was found that administration of 2000 mg/kg bw dose in  in vivo  oral acute toxicity study did not produce significant toxicity or mortality. No significant ( p  < 0.05) differences were observed for body weight and hematological and biochemical parameters compared to control after 14 days of treatment. No changes in behavior, body weight, hematological and biochemical parameters, and aspects of histopathology were observed when compared to the control. Thus, the possible oral lethal dose for  A. malaccensis  extract is above 2000 mg/kg body weight. The  in vitro  cytotoxicity analysis showed nontoxicity concentrations of the extract to be 2, 1.4, 30, and 1.4  µ g/mL for A549, HepG2, 3T3, and COS-7 cells, respectively, where no apoptotic/necrotic cell death and DNA damage were observed. In conclusion, the extract of rhizome of  A. malaccensis  did not produce apparent cytotoxicity or acute oral toxicity, confirming the scope to use  A. malaccensis  as a safe food preservative and a natural therapeutic product after further subacute and chronic toxicity studies.

In Vivo and In Vitro Toxicity Profiles of Hexane Extract of Alpinia malaccensis Rhizome in Rat and Cell Line Models