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Information Library - Research - Safety


Layman's Introduction


Fulhold's primary concern in marketing CHD-FA for human use was to establish the safety of CHD-FA and CHD-FA products. To prove the safety of CHD-FA a thorough set of research projects has been completed. This section lists the reports from these research projects.

Fulhold has also undertaken the full set of tests required for certification under the REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Entities) programme in the European Union. These tests show that CHD-FA is safe and not hazardous to the environment.

Fulhold has conducted a Phase 1 safety trial in humans with no adverse effects noted at doses that were 6 times the recommended daily dose over extended periods. Human tests have also been carried out for topical uses of CHD-FA e.g. against eczema or rosacea. A wide range of animal tests have also confirmed the lack of toxicity for ingested or topical use.

The other tests listed show the safety of CHD-FA when applied to humans, animals and fish (a good proxy for environmental health).

The safety of CHD-FA has been confirmed in all the research to date.

Reach


The REACH Regulation (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) established a European Chemicals Agency. Other directives and this agency have determined safety and toxicity studies for authorisation and registration under the REACH regulation. Fulhold has completed all of these tests for REACH providing a comprehensive dossier of safety and toxicity information.

All of the REACH research was completed in Good Laboratory Practices (GLP) certified institutions that conform to OECD standards.

Mode of Action (MOA)


The mode of action of CHD-FA is being defined by work at the School of Dentistry at Glasgow University. This work indicates that bacteriocidal and fungicidal activity is the result of the CHD-FA breaking down the cell wall of the disease causing agent. This research is being published in the first part of 2011 and the peer reviewed journal publication will be added to the website as soon as published.

For anti-viral effectiveness early research indicated that the mode of action of CHD-FA was as an entry inhibitor i.e. viruses were prevented from entering target cells. The break down of the viral capsid may also be a mode of action and further research is being undertaken in this regard.

As an anti-inflammatory the mode of action appears to be via the suppression of signalling molecules that stimulate inflammation. Further research is being carried out to establish this conclusively and will be published on this website when available.

Absorption, Distribution, Metabolism, Excretion


It is important to know how substances that are ingested are processed in the body. Processing includes how and where substances are absorbed, where in the body they are distributed, how the substances are metabolised (used, broken down) and how much of the substances are excreted from the body over what time period. CHD-FA is systemically absorped as indicated by secondary clinical observations (e.g. pinpick wheal test, rat paw odoema model) but CHD-FA has not been detected in the blood serum. To try and determine the course of CHD-FA in the body research is being undertaken using advanced radio labelling techniques. The results of this research will be published in due course.

Toxicity and Safety Research


A great deal of research has been commissioned by Fulhold to ensure that CHD-FA is safe for ingested and topical use. The reports from this research are contained below;

AMES


The Ames test is a measure of the mutagenic (mutation causing) potential of CHD-FA. CHD-FA was found to be not mutagenic.

Micronucleus


The Micronucleus test similarly tests the potential for genotoxicity (mutation or carginogenic effect on genes). CHD-FA was found to be not mutagenic and non-genotoxic.

THM Safety data


Tri-halomethanes are carcinogenic compounds that may be found in water. Some research has shown that chlorinated water can combine with Fulvic Acid to produce THM's. To test for this possibility Fulhold commissioned the Umgeni Water Board to conduct tests. These tests showed that adding CHD-FA to chlorinated water lowered the total level of THM's in the water (the level was already so low as not to pose any danger).

Nagpur


The import of substances into India requires completion of toxicity tests before approval is granted. The report of the screening done by a certified laboratory in India can be downloaded here.

No negative effect on the growth of Megasphaera elsdenii NCIMB 41125 culture


Some types of bacteria that are important to the functioning of the body. An example of these types of bacteria are the Megasphaera Elsdenii that are important for digestion in cattle. In this test CHD-FA was shown not to affect these important and symbiotic bacteria.

ARC-LIVESTOCK BUSINESS DIVISION Testing of an antimicrobial agent called CHD-FA on the growth of Megasphaera elsdenii NCIMB 41125 culture.


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