UNIVERSIDAD DE GUAYAQUIL
DEPARTMENT OF CHEMICAL SCIENCES
Ciudadela Universitaria ¨Dr. Salvador Allende¨
Telephone: 2293680, E-mail: fcquimic@ug.edu.ec
Guayaquil, Ecuador
FINAL REPORT - SUMMARY
TITLE:
Study of the acute oral toxicity of Quina, originating from NUTRAMEDIX Laboratories, LLC, Florida, USA
OBJECTIVES:
To study adverse side effects produced by the administration of Quina on body weight and different body systems.
description of the dosage, administration method and duration of the experiment:
The experiment was conducted following the guidelines of OECD TG 423.
The method of administration was oral, using an intra-gastric canella.
The experiment lasted 19 days (5 of acclimation and 14 of testing).
It is important to realize that this experiment was carried out using a volume of 20 ml per kilogram of body weight. In comparison, a human of 60 kilogram of weight would be expected to ingest a maximum of 20 drops, or approximately 0.6 mL dissolved in 120 mL of water, this means the human will ingest 0.005 mL per 60 kg, therefore for each kilogram of weight he will be ingesting 0.0000833 mL and since the animal received 20 mL per kilogram, the animal therefore receives 240,963 times the expected human dosage, which indicates that the safety margin of the product is very high.
Conclusions:
1- Autopsies revealed no affects to selected organs.
2- The product did not affect weight gain of the animals in the study.
3- No toxic effects are produced when administering Quina in an acute form to the animals.
4- Quina is a compound whose potential for toxicity is very low based on the fact that its security margin is very high. In addition, it was administered undiluted, in contrast to suggested human use, in which it is diluted in 120 ml of drinking water.
GENERAL CONCLUSIONS:
Quina did not produce toxic effects when used in accordance to the guidelines described in OECD TG 423, using a volume of 20 mL/kg. This study demonstrates the innocuousness of the mentioned product.
Date: 07/26/05