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Repeated Intramuscular-dose Toxicity Test of Watersoluble Carthami Flos (WCF) Pharmacopuncture in Sprague-Dawley Rats.

Choi YM, Jung DJ, Kim SH, Kim JU, Yook TH - J Pharmacopuncture (2015)

Bottom Line: No toxicological meanings, except localized changes, were noted.WCF solution has no significant toxicological meaning, but does produce localized symptoms.No observed adverse effect level (NOAEL) of WCF in male and female rats is expected for doses over 0.5 mL/animal/day.

View Article: PubMed Central - PubMed

Affiliation: Department of Acupuncture & Moxibustion Medicine, Woosuk University Hospital of Korean Medicine, Jeonju, Korea.

ABSTRACT

Objectives: Water-soluble carthami flos (WCF) is a new mixture of Carthami flos (CF) pharmacopuncture. We conducted a 4-week toxicity test of repeated intramuscular injections of WCF in Sprague-Dawley rats.

Methods: Forty male and 40 female rats were divided into 4 groups of 10 male and 10 female SD rats: The control group received 0.5 mL/animal/day of normal saline whereas the three experimental groups received WCF at doses of 0.125, 0.25, and 0.5 mL/animal/day, respectively. For 4 weeks, the solutions were injected into the femoral muscle of the rats alternating from side to side. Clinical signs, body weights, and food consumption were observed; opthalmological examinations and urinalyses were performed. On day 29, blood samples were taken for hematological and clinical chemistry analyses. Then, necropsy was conducted in all animals to observe weights and external and histopathological changes in the bodily organs. All data were tested using a statistical analysis system (SAS).

Results: No deaths were observed. Temporary irregular respiration was observed in male rats of the experimental group for the first 10 days. Body weights, food consumptions, opthalmological examinations, urinalyses, clinical chemistry analyses, organ weights and necropsy produced no findings with toxicological meaning. In the hematological analysis, delay of prothrombin time (PT) was observed in male rats of the 0.25- and the 0.5- mL/animal/day groups. In the histopathological test, a dose-dependent inflammatory cell infiltration into the fascia and panniculitis in perimuscular tissues was observed in all animals of the experimental groups. However, those symptoms were limited to local injection points. No toxicological meanings, except localized changes, were noted.

Conclusion: WCF solution has no significant toxicological meaning, but does produce localized symptoms. No observed adverse effect level (NOAEL) of WCF in male and female rats is expected for doses over 0.5 mL/animal/day.

No MeSH data available.


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Body weights of female Sprague-Dawley rats.
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Figure 004: Body weights of female Sprague-Dawley rats.

Mentions: During the four weeks of the experiment, no deaths were observed. As a result, calculating the lethal dose for 50 percent kill (LD50) of WCF was impossible. However, we were able to verify that a repeated intramuscular dose of WCF at 0.5 mL/animal/day caused no deaths. No significant clinical signs were caused by injections into the female rats of the experimental groups, but three, two, and five male rats from groups G2, G3, G4, respectively, were found to have irregular respiration after WCF injection from day 1 to day 10. However, they soon recovered and no significant changes, such as weight loss compared to the control group were observed. Thus, the toxicity of WCF was not considered to be a cause of the irregular respiration. In addition, wounds, granulations and crust formations were observed on a male rat of the control group from day 13 to day 28 (Table 2). No significant changes in mean body weight (Figs. 3,4) and the mean food consumption between the experimental groups and the control group were noted.


Repeated Intramuscular-dose Toxicity Test of Watersoluble Carthami Flos (WCF) Pharmacopuncture in Sprague-Dawley Rats.

Choi YM, Jung DJ, Kim SH, Kim JU, Yook TH - J Pharmacopuncture (2015)

Body weights of female Sprague-Dawley rats.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4379474&req=5

Figure 004: Body weights of female Sprague-Dawley rats.
Mentions: During the four weeks of the experiment, no deaths were observed. As a result, calculating the lethal dose for 50 percent kill (LD50) of WCF was impossible. However, we were able to verify that a repeated intramuscular dose of WCF at 0.5 mL/animal/day caused no deaths. No significant clinical signs were caused by injections into the female rats of the experimental groups, but three, two, and five male rats from groups G2, G3, G4, respectively, were found to have irregular respiration after WCF injection from day 1 to day 10. However, they soon recovered and no significant changes, such as weight loss compared to the control group were observed. Thus, the toxicity of WCF was not considered to be a cause of the irregular respiration. In addition, wounds, granulations and crust formations were observed on a male rat of the control group from day 13 to day 28 (Table 2). No significant changes in mean body weight (Figs. 3,4) and the mean food consumption between the experimental groups and the control group were noted.

Bottom Line: No toxicological meanings, except localized changes, were noted.WCF solution has no significant toxicological meaning, but does produce localized symptoms.No observed adverse effect level (NOAEL) of WCF in male and female rats is expected for doses over 0.5 mL/animal/day.

View Article: PubMed Central - PubMed

Affiliation: Department of Acupuncture & Moxibustion Medicine, Woosuk University Hospital of Korean Medicine, Jeonju, Korea.

ABSTRACT

Objectives: Water-soluble carthami flos (WCF) is a new mixture of Carthami flos (CF) pharmacopuncture. We conducted a 4-week toxicity test of repeated intramuscular injections of WCF in Sprague-Dawley rats.

Methods: Forty male and 40 female rats were divided into 4 groups of 10 male and 10 female SD rats: The control group received 0.5 mL/animal/day of normal saline whereas the three experimental groups received WCF at doses of 0.125, 0.25, and 0.5 mL/animal/day, respectively. For 4 weeks, the solutions were injected into the femoral muscle of the rats alternating from side to side. Clinical signs, body weights, and food consumption were observed; opthalmological examinations and urinalyses were performed. On day 29, blood samples were taken for hematological and clinical chemistry analyses. Then, necropsy was conducted in all animals to observe weights and external and histopathological changes in the bodily organs. All data were tested using a statistical analysis system (SAS).

Results: No deaths were observed. Temporary irregular respiration was observed in male rats of the experimental group for the first 10 days. Body weights, food consumptions, opthalmological examinations, urinalyses, clinical chemistry analyses, organ weights and necropsy produced no findings with toxicological meaning. In the hematological analysis, delay of prothrombin time (PT) was observed in male rats of the 0.25- and the 0.5- mL/animal/day groups. In the histopathological test, a dose-dependent inflammatory cell infiltration into the fascia and panniculitis in perimuscular tissues was observed in all animals of the experimental groups. However, those symptoms were limited to local injection points. No toxicological meanings, except localized changes, were noted.

Conclusion: WCF solution has no significant toxicological meaning, but does produce localized symptoms. No observed adverse effect level (NOAEL) of WCF in male and female rats is expected for doses over 0.5 mL/animal/day.

No MeSH data available.


Related in: MedlinePlus