Evaluation of General Toxicity and Genotoxicity of the Silkworm Extract Powder

The silkworm extract powder contain 1-deoxynojirimycin (DNJ), a potent alpha-glycosidase inhibitor, has therapeutic potency against diabetes mellitus. Therefore, natural products containing DNJ from mulberry leaves and silkworm are consumed as health functional food. The present study was performed to evaluate the safety of the silkworm extract powder, a health food which containing the DNJ. The repeated toxicity studies and gentic toxicity studies of the silkworm extract powder were performed to obtain the data for new functional food approval in MFDS. The safety was evaluated by a single-dose oral toxicity study and a 90 day repeated-dose oral toxicity study in Sprague-Dawley rats. The silkworm extract powder was also evaluated for its mutagenic potential in a battery of genetic toxicity test: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration test, and in vivo mouse bone marrow micronucleus assay. The results of the genetic toxicology assays were negative in all of the assays. The approximate lethal dose in single oral dose toxicity study was considered to be higher than 5000 mg/kg in rats. In the 90 day study, the dose levels were wet at 0, 500, 1000, 2000 mg/kg/day, and 10 animals/sex/dose were treated with oral gavage. The parameters that were monitored were clinical signs, body weights, food and water consumptions, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathological examination. No adverse effects were observed after the 90 day administration of the silkworm extract powder. The No-Observed-Adverse-Effect-Level (NOAEL) of silkworm extract powder in the 90 day study was 2000 mg/kg/day in both sexes, and no target organ was identified.

Single Oral Dose Toxicity Study of Prebrewed Armeniacae Semen in Rats

Armeniacae semen (AS) has been considered a toxic herb in the Korean medicine as it contains hydrogen cyanide and amygdalin, especially in its endocarp. Therefore, prebrewed AS that is devoid of endocarp has been traditionally used. In the present study, amygdalin content of the prebrewed AS was significantly lower (2.73 +/- 0.32 microg/ml; p < 0.01) than the content in the extract that contained the endocarps (28.50 +/- 6.71 microg/ml); amygdalin content corresponded to 10% of the extract in the present study. Because of single oral dose toxicity of prebrewed AS according to the recommendation of Korea Food and Drug Administration Guidelines (2009-116, 2009), which was based on single oral dose toxicity study of prebrewed AS, mortality due to toxic principles was significantly reduced. In this study, 2,000 mg/kg of prebrewed AS led to death of 1 female rat and 1 male rat at the end of 2 hr of administration. Based on these results, the 50% lethal dose in both male and female rats was determined to be 9279.5 mg/kg. Seizure, loss of locomotion, and increases in respiration and heart rate were observed as prebrewed AS treatment-related toxicological signs; these signs were restrictedly manifested in the prebrewed AS (2,000 mg/kg)-treated rats. In addition, no changes were observed in body weight, organ weight, gross features, and histopathological parameters with 2,000 mg/kg of AS in both male and female rats. These findings serve as direct evidence that amygdalin in AS is the toxic principle, which can be reduced by the traditional prebrewing method involving the exclusion of endocarp.

Mouse Single Oral Dose Toxicity Test of Bupleuri Radix Aqueous Extracts

The aim of this study was to evaluate the single oral dose toxicity of Bupleuri Radix (BR) aqueous extracts, it has been traditionally used as anti-inflammatory agent, in male and female mice. BR extracts (yield = 16.52%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principal organs were examined. As the results, no BR extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs were detected up to 2,000 mg/kg in both female and male mice, except for soft feces and related body weight decrease detected in male mice treated with 2,000 mg/kg. Therefore, LD50 (50% lethal dose) and approximate LD of BR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg, respectively. Although it was also observed that the possibilities of digestive disorders, like soft feces when administered over 2,000 mg/kg of BR extracts in the present study, these possibilities of digestive disorders can be disregard in clinical use because they are transient in the highest dosages male only.

Biological Activity and Single Oral Dose Toxicity of Dansam-samultang / 한국실험동물학회지

In this study, we investigated the in vitro antioxidative effects, antimicrobial activities and single oral dose toxicity of the extracts from Dansam-samultang to evaluate its use as a functional ingredient in cosmetics. In the antioxidative effect, the ethanol extract from Dansam-samultang (DSE) had higher antioxidant values of 92.0% at 1,000 microg/mL than that of water extract from Dansam-samultang (DSW, 86.0%) when evaluated by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging activity. The superoxide dismutase-like activity of DSW and DSE were 16.3% and 21.3% at 1,000 microg/mL in concentration, respectively. Xanthine oxidase inhibition activity of the DSE was higher 51.5% than that of the DSW (21.4%). This study was also undertaken to test the in vitro antimicrobial activity with the extracts of Dansam-samultang. In general, the DSE showed the significant antimicrobial activity against Staphylococcus aureus, Staphylococcus epidermiders and Escherichia coli. In single oral dose toxicity study, in vivo, there were no differences between control and treated groups in clinical signs, body weight gains, and gross finding. The results indicated that DSE did not show any toxic effects at 10 mL/kg in mice, and the LD50 of DSE was found to be higher than 10 mL/kg in this experiment. In conclusion, the extracts from Dansam-samultang may act as a natural subsistence for functional cosmetics.

Investigations of Samwhang-sasimtang Extracts on Biological Activities In Vitro and Vivo / 한국실험동물학회지

In this study, we investigated the in vitro antioxidative effects, antimicrobial activities and single oral dose toxicity of the extracts from Samwhang-sasimtang to evaluate its use as a functional ingredient in cosmetics. In the antioxidative effect, the ethanol extract from Samwhang-sasimtang (SSE) had higher antioxidant values of 91.9% at 1,000 microgram/mL than that of water extract from Samwhang-sasimtang (SSW, 77.0%) when evaluated by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging activity. 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS) radical cation decolorization of SSE was 82.2%, higher than that of the SSW (55.0%) and the antioxidant protection factors (APF) of SSW and SSE were 1.64 and 1.62 at 1,000 microgram/mL in concentration, respectively. This study was also undertaken to test the in vitro antimicrobial activity with the extracts of Samwhang-sasimtang. In general, the SSE showed the significant antimicrobial activity against Staphylococcus aureus and Staphylococcus epidermidis. In single oral dose toxicity study, there were no differences in vivo were observed between control and treated groups in clinical signs, body weight gains, and gross finding. The results indicated that SSE did not show any toxic effects at 10 mL/kg in mice, and the LD50 of SSE was found to be higher than 10 mL/kg in this experiment. In conclusion, the extracts from Samwhang-sasimtang may act as a natural subsistence for functional cosmetics.