Acute Oral Toxicity, Mutagenicity and Clastogenicity of Euphorbia hirta L.
Last Updated on: 2013-10-22 15:39:40
Registry ID: PHRR131014-000129
Secondary Identification Number: NIH 2012-008
UNIQUE URL
http://registry.healthresearch.ph//index.php?option=com_healthregistry&controller=registry&task=researchde
tails&id=517
SCIENTIFIC TITLE
Acute Oral Toxicity, Mutagenicity and Clastogenicity of the Crude Aqueous Extract of the Whole Plant of
Euphorbia hirta L. (Family Euphorbiaceae)
PROJECT DESCRIPTION
The decoction of the whole plant is used as a folkloric herbal treatment for Dengue Hemorrhagic Fever
(DHF) in the country (Apostal et al 2009). The plant is believed to have platelet increasing property. While
efforts are ongoing to determine the role of E. hirta for dengue, this study will focus on its safety. In
particular, the acute oral toxicity, mutagenicity and clastogenicity of the crude aqueous extract of the whole
plant will be determined in this study. The result of these preliminary studies will then become a part of a
database that is essential for the formulation of safety assessments for this plant. Acute toxicity using the
Up-and-Down procedure will be assessments to estimate the median lethal dose. The LD50 obtained after
acute oral administration will be used in setting dose levels for the mutagenicity tests included in this study
and for the future studies. Quercetin is one of the main phenolic constituents found in E. hirta (Tona et al.
1999,2004). Quercetin was found to be mutagenic (Czeczot et al. 1990; Bjeldanes and Chang 1977). To
date, studies conducted with regard to the mutagenic activity of E. hirta showed conflicting results (Cueme
et al. 2005; Loh, Er and Chen 2009). This study will therefore validate the mutagenic potential of the crude
aqueous extract using the Ames test without S-9 metabolic activation coupled with the micronucleus test.
The Ames test is a widely accepted short-term bacterial reverse mutation assay for the identification of
substances that can produce genetic damage that leads to gene mutations (Mortelmans and Zeiger 2000).
On the other hand, the micronucleus test is a method devised primarily for screening chemicals for
chromosome-breaking effects (Schmid 1975). The World Health Organization included genotoxicity among
the suggested tests needed to evaluate the safety of herbal medicines (WHO 2000). These tests are also
required to establish the non-mutagenicity of the herbal medicines for product registration as per
Administrative Order no. 172 (Guidelines on the Registration of Herbal Medicines)(DOH) 2004).
NUHRA DETAILS
NUHRA Regime
NUHRA Classification
NUHRA Priority
2010 - 2016
Health Technology Development
Drug Discovery and Development
PROJECT DURATION
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
Page 1
Start Date
Duration in Months
Target Completion Date
Actual Completion Date
2012-07-01
17
2013-12-01
2013-06-30
PROJECT STATUS
Completed
IMPLEMENTING AGENCY (PRIMARY SPONSOR)
Name of Institution
Classification
Region
University of the Philippines - Manila, College of Pharmacy
Government
NCR
LTO #
COOPERATING AGENCY (SECONDARY SPONSOR)
None
FUNDING AGENCY (SOURCES OF MONETARY OR MATERIAL SUPPORT)
1. National Institutes of Health - University of the Philippines - Manila
CONTACT FOR PUBLIC QUERIES
Name:
Francis R.
Capule
Email Address:
[email protected]
Phone
Number:
Postal Address:
5266115
University of the Philippines Manila,
College of Pharmacy, Department of
Pharmacy, Pedro Gil St. Cor. Taft
Ave., Ermita Manila, 1000
Phone
Number:
Postal Address:
5266115
University of the Philippines Manila,
College of Pharmacy, Department of
Pharmacy, Pedro Gil St. Cor. Taft
Ave., Ermita Manila, 1000
CONTACT FOR SCIENTIFIC QUERIES
Name:
Francis R.
Capule
Email Address:
[email protected]
INVESTIGATING TEAM
Name
Expertise
Affiliation
Francis R. Capule
Pharmacology
University of the Philippines - Manila,
College of Pharmacy
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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Roderick L. Salenga
Public Health, Epidemiology
University of the Philippines - Manila,
College of Pharmacy
HEALTH CONDITION(S) OR PROBLEM(S) STUDIED
Acute Oral Toxicity, Mutagenicity and Clastogenicity of the Crude Aqueous Extract of the whole Plant of
Euphorbia hirta L.
PRIMARY OUTCOMES
This study aims to determine the acute oral toxicity, mutagenicity and clastogenicity of the crude aqueous
extract of the whole plant of E. hirta. The acute oral toxicity study aims to determine the median lethal dose
(LD50)of the crude aqueous extract on adult Sprague-Dawley rats; to determine the toxidormes or
manifestations of toxicity of acute oral administration of the crude aqueous extract; to determine the lowest
observed adverse effect level (LOAEL) and no observed adverse effect level (NOAEL). On the other hand,
the mutagenicity aims to evaluate the mutagenic activity of the crude aqueous extract in a bacterial reverse
mutation system without a mammalian 5-9 activation component and to evaluate the clastogenic activity of
the crude aqueous extract in polychromatic erythrocyte stem cells in treated mice.
KEY SECONDARY OUTCOMES
None
DATE OF FIRST ENROLLMENT
2012-07-01
RECRUITMENT STATUS
Unspecified
COUNTRIES OF RECRUITMENT
Philippines
RESEARCH CLASSIFICATION
Non-clinical Studies
HAVE YOU APPLIED FOR INTELLECTUAL PROPERTY PROTECTION FOR YOUR PRODUCT?
No
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
Page 3
RESEARCH UTILIZATION
None
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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