UNIVERSIDAD DE
DEPARTMENT OF CHEMICAL SCIENCES
Ciudadela Universitaria ¨Dr. Salvador Allende¨
Telephone: 2293680, E-mail: fcquimic@ug.edu.ec
FINAL REPORT - SUMMARY
CODE:
18-05
TITLE:
Study of the Acute Oral Toxicity of Cumanda, originating from NUTRAMEDIX Laboratories, LLC,
Florida,
OBJECTIVES:
To study adverse side effects produced by the
administration of Cumanda on body weight and different body systems.
description of the dosage, administration method
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 would be expected
to ingest 20 drops, or approximately 0.6 ml dissolved in 120 ml of water. This means 0.005 ml per 60 kg of body
weight, or 0.0000833 ml per kilo of body weight. The mouse therefore receives 240,963
times the expected human dosage, which suggests the innocuousness of the
product under study.
Conclusions:
1- Clinical symptoms were observed
in the animals, presumably due to the alcoholic content of the preparation.
2- Autopsies revealed no affects
to selected organs.
3- The product did not affect
weight gain of the animals in the study.
4- No toxic effects are produced
when administering Cumanda in an acute form to the animals.
5- Cumanda is a compound whose
potential for toxicity is very low based on the fact that its security margin
is very high. LD50 cannot be
calculated because the maximum dose that can be administered to a mouse is 4 ml
per 200 grams of body weight, the dosage used in this experiment. In addition, the dosage used in humans
is diluted in 120 ml of water, unlike with the mice that received an undiluted
dosage. All this means that, taking
into account that the total dissolved solids (1.5 mg/ml) that were administered
per 30mg of animal weight, and that humans consume only 1.2 x 10-4
mg, the innocuousness of the product is confirmed.
6- The LD50 of Cumanda is much higher than the 30
mg/kg administered to the mice, which in turn is much higher than what humans
receive, again confirming the safety of the product.
GENERAL CONCLUSIONS:
Cumanda did not produce toxic effects when used in accordance
to the guidelines described in OECD TG 423, thus the product is considered practically
innocuous for humans when administered in the acute form. Therefore studies of acute toxicity at
higher doses in humans are not necessary.
Date: 05/09/05