​  The Ultimate Alcohol Counteractor

TOXICITY REPORT ON DETRILUMINO® - ACTIVE INGREDIENT

​​STRICTLY PRIVATE & CONFIDENTIAL

​

ALCOHOL COUNTER-ACTOR

 

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The information contained herein is to be considered commercially confidential and sensitive and is covered by a related confidentiality agreement, or professional secrecy. This document is not to be copied or reproduced in any way, in part or in whole, without the express written consent of ANDRIE HANCKE.

 

TITLE

                                   

To determine whether there are toxic effects related to the ingestion of the Active Ingredient.

 

BACKGROUND

                       

The Active Ingredient is widely available commercially.  Informal studies have shown significant reductions in blood alcohol levels within thirty minutes of consuming 5g of the Active Ingredient. The reductions were approximately 30% greater than normal. The Active Ingredient is presently extensively used in drinking water purification, removal of harmful metabolites from water in aqua-culture applications, as animal feed additives and as soil conditioners.

 

AIM

                                   

To determine if there is any acute toxicity relating to the intake of massive quantities of the Active Ingredient.

 

METHOD

 

Ten adult Rattus norvegicus rats, of the wisteria strain were used.  They were divided into three groups as follows:

Four (4) animals (2 males and 2 females) were given 1g of the Active Ingredient (weight for weight the equivalent of 50 times the recommended dose for man).

Four (4) animals (2 male and 2 female) were given 0.5g of the Active Ingredient (approximately 25 times the recommended dose for man).

Two control animals (1 male and 1 female).

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All animals were fasted for 32 hours but had access to water.  They were examined and weighed.  Weight range was 200g – 296g.

Prior to dosing with the Active Ingredient, blood samples were taken for baseline renal and liver function tests. They were then fed the Active Ingredient mixed with water. This was administered as a single dose via a stomach tube.

                                   

Animals were observed before the procedure and then after the procedure at 4 hours, 8 hours, 16 hours and then daily for two days.

 On day 7 the animals were examined and blood samples were taken for liver and renal function tests.  Thereafter they were euthanized in a carbon dioxide box.

Autopsy examinations were performed on all animals and liver and kidney samples were removed for histological examination.

All blood samples were analyzed at the Laboratories. Histological slides were prepared by the Laboratories and stained with hematoxylin and eosin.

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RESULTS

 

All animals remained well for the duration of test. See tables below, which indicate that there was no compromise of kidney or liver functions.

 

​LIVER FUNCTION TABLE

 

ALB     =    albumin

ALP     =    alkaline phosphatase

ALT     =    alanine transaminase

AST     =    aspartate transaminase

DBILI   =    direct bilirubin

TBILI   =    total bilirubin

GGT    =    gamma glutamyl transferase

LDH     =    lactate dehydrogenase

TPRO  =    total protein

 

KIDNEY FUNCTION TABLE

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Creat         =     creatinine

NA             =    sodium

K                =    potassium

Cl               =    chloride

CO2          =    carbon oxide

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HISTOLOGICAL REPORT:

 

Sections of all ten liver samples showed:

 

Focal lobular collections of mononuclear cells and occasional entrapped hepatocyte.

No centrilobular hepatocyte necrosis.

No acute inflammatory cells.

 

Features are those of chronic focal lobular hepatitis.

 

Sections of all ten (10) kidney samples showed no abnormality of the tubules, blood vessels, glomeruli or interstitium.

 

DISCUSSION:

 

After massive ingestion of the Active Ingredient, equivalent of fifty (50) times and twenty five (25) times recommended for man, none of the animals showed any clinical, chemical or histological evidence of toxicity. The histological changes in the liver are unrelated to the ingestion of the Active Ingredient as they are chronic, in that they antedate the ingestion of the Active Ingredient and were also present in the control animals.

 

CONCLUSION:

 

There was no evidence of clinical, laboratory or histopathological evidence of toxicity to ingestion of massive doses of the Active Ingredient. Since the physiology in a rat is similar to that of a human, there is no evidence that consuming massive doses of the Active Ingredient is likely to be unsafe for human consumption.

 

NOTE

 

These experiments were conducted at a Bio-Medical Research Centre at a University where ethical approval was also granted. This work was performed together with a Professor of the Faculty of Medicine & Specialist Forensic Pathologist