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Repeated dose 28-days oral toxicity study of Carica papaya L. leaf extract in Sprague Dawley rats.

ABSTRACT: Carica papaya L. leaves have been used in ethnomedicine for the treatment of fevers and cancers. Despite its benefits, very few studies on their potential toxicity have been described. The aim of the present study was to characterize the chemical composition of the leaf extract from 'Sekaki' C. papaya cultivar by UPLC-TripleTOF-ESI-MS and to investigate the sub-acute oral toxicity in Sprague Dawley rats at doses of 0.01, 0.14 and 2 g/kg by examining the general behavior, clinical signs, hematological parameters, serum biochemistry and histopathology changes. A total of twelve compounds consisting of one piperidine alkaloid, two organic acids, six malic acid derivatives, and four flavonol glycosides were characterized or tentatively identified in the C. papaya leaf extract. In the sub-acute study, the C. papaya extract did not cause mortality nor were treatment-related changes in body weight, food intake, water level, and hematological parameters observed between treatment and control groups. Some biochemical parameters such as the total protein, HDL-cholesterol, AST, ALT and ALP were elevated in a non-dose dependent manner. Histopathological examination of all organs including liver did not reveal morphological alteration. Other parameters showed non-significant differences between treatment and control groups. The present results suggest that C. papaya leaf extract at a dose up to fourteen times the levels employed in practical use in traditional medicine in Malaysia could be considered safe as a medicinal agent.

SUBMITTER: Afzan A

PROVIDER: S-EPMC6268730 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Repeated dose 28-days oral toxicity study of Carica papaya L. leaf extract in Sprague Dawley rats.

Afzan Adlin A Abdullah Noor Rain NR Halim Siti Zaleha SZ Rashid Badrul Amini BA Semail Raja Hazlini Raja RH Abdullah Noordini N Jantan Ibrahim I Muhammad Hussin H Ismail Zakiah Z

Molecules (Basel, Switzerland) 20120410 4

Carica papaya L. leaves have been used in ethnomedicine for the treatment of fevers and cancers. Despite its benefits, very few studies on their potential toxicity have been described. The aim of the present study was to characterize the chemical composition of the leaf extract from 'Sekaki' C. papaya cultivar by UPLC-TripleTOF-ESI-MS and to investigate the sub-acute oral toxicity in Sprague Dawley rats at doses of 0.01, 0.14 and 2 g/kg by examining the general behavior, clinical signs, hematolo ...[more]

PMID: 22491681

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Project description:Clinical research on herbal-based dentifrice +/- mouth rinse products is very limited compared with the plethora of research on conventional oral care products under normal oral hygiene conditions. The aim of this study was to determine the anti-inflammatory effects of a novel plant Carica papaya leaf extract (CPLE) on interdental bleeding in healthy subjects. In this randomized, single-blind parallel-design study, the eligible subjects were generally healthy non-smokers, aged 18⁻26, who exhibited healthy periodontal conditions upon study entry. The participants were equally randomized into the following four groups: CPLE dentifrice, CPLE dentifrice and mouthwash, sodium lauryl sulfate (SLS)-free enzyme-containing dentifrice and SLS-free enzyme-containing dentifrice with essential oil (EO) mouthwash. Subjects were instructed to brush their teeth twice a day without changing their other brushing habits. Interdental bleeding (BOIP) was measured from inclusion (T₀) until the fourth week (T₄) of the study. Clinical efficacy was assessed after one, two, three and four weeks of home use. The analyses compared BOIP between groups and were then restricted to participants with ≥70% and then ≥80% bleeding sites at T₀. Pairwise comparisons between groups were performed at T₀ and T₄, and a logistic regression identified correlates of gingival bleeding (T₄). Among 100 subjects (2273 interdental sites), the median percentage of bleeding sites per participant at T₀ was 65%. The bleeding sites dramatically decreased in all groups between T₀ and T₄ (relative variations from -54% to -75%, p < 0.01 for all). Gingival bleeding did not significantly differ between the CPLE dentifrice and the SLS-free dentifrice +/- EO mouthwash groups (from p = 0.05 to p = 0.86), regardless of the baseline risk level. Among the CPLE dentifrice users, fewer bleeding sites were observed when toothpaste and mouthwash were combined compared to bleeding sites in those who used toothpaste alone (21% vs. 32%, p = 0.04). CPLE dentifrice/mouthwash provides an efficacious and natural alternative to SLS-free dentifrice +/-EO-containing mouthwash when used as an adjunct to mechanical oral care to reduce interdental gingival inflammation.

Dataset Information

Repeated dose 28-days oral toxicity study of Carica papaya L. leaf extract in Sprague Dawley rats.

Publications

Repeated dose 28-days oral toxicity study of Carica papaya L. leaf extract in Sprague Dawley rats.

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