UNIVERSIDAD DE GUAYAQUIL

DEPARTMENT OF CHEMICAL SCIENCES

Ciudadela Universitaria ¨Dr. Salvador Allende¨

Telephone: 2293680, E-mail: fcquimic@ug.edu.ec

Guayaquil, Ecuador

FINAL REPORT

 

 

CODE: 28-05

 

 

TITLE:

Study of the Acute Oral Toxicity of Samento, originating from NUTRAMEDIX Laboratories, LLC, Florida, USA

 

 

OBJECTIVES:

To study adverse side effects produced by the administration of Samento 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 kg would be expected to ingest a maximum of 15 drops, or approximately .45 ml dissolved in 120 ml of water.  This means 6.25 x 10 –5 ml per kg of body weight assuming that the solids present in the medication are 1.5 mg/ml.  Therefore each animal received 30 mg per kg while a human ingests 9.3 x 10–5 mg,. The mouse therefore receives 320,000 times the expected human dosage, which indicates that the safety margin is very high. 

 

 

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 Samento in an acute form to the animals. 

 

5-   Samento 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 20 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 9.8 x 10-5 mg, the innocuousness of the product is confirmed. 

 

6-   The LD50  of Samento 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:

Samento 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:  05/08/05