Klor De 500 - 100 Chlorine Tablets for Disinfection and Cleaning Disinfectant for Hospital and Clinic Use

• The Ultimate Disinfectant for Hospital and Clinic Use. Now With Added Color
• A world 'first' in chlorine disinfection.
• Wide spectrum, multi purpose, disinfecting agent for hospitals and clinics with a colour indicator for SAFETY.
• Neutral chlorine oxidizer for powerful disinfection, in easy to handle tablet formulation.
• Non-toxic formulation which includes a pharmaceutically acceptable non toxic colour marker.
• With added surfactant – to clean as it disinfects.
• The surfactant breaks and penetrates the biofilm layer while the active chloroxidiser kills all the microorganisms.
• Rapid action against all types of microorganisms.

Instructions for use:

Add the tablets to the quantity of slightly warm water indicated in the above table. Wait until completely dissolved. The solution is ready for use. Make sure that the container with the solution is clearly labelled. • It is best to make a fresh solution each day. Rinse the container before filling with fresh solution. If there is a slight blue precipitate, shake gently to dissolve. • The patented Blue colour acts as an indicator that there is disinfectant solution present. To remove the disinfectant, rinse with sterile Water for irrigation until the blue colour disappears. (If the instrument does not need to be sterile potable water may be used for rinsing).

pH of 5.5 – 6.0, no irritation to skin.
Suitable for all surfaces and devices.
Easy to prepare - precise concentrations.
Extremely cost efficient.
Light blue color indicator = SAFE.
Environmentally friendly– Biodegradable.

KlorDeTM has a wide biocidal spectrum and are active against all forms of micro-organisms including pathogenic bacteria and spores, viruses, fungi and moulds, and mono-celled organisms such as amoebae. Troclosene sodium has been shown to be far superior in its biocidal activity to inorganic hypochlorite solutions. This in part is due to the much lower pH of the Troclosene solution [5.5 - 6.0] which enables the chlorine containing entity to remain in the undissociated form which is very much more biocidal than the dissociated forms. Troclosene has the added advantage that the immediate break down products formed from its biocidal action - donating a Chlorine atom - act a stabilisers for the undissociated Troclosene molecule remaining. The chlorine is present in a Latent form and this explains also why Troclosene solutions are less inactivated in the presence of organic matter.

V I R U S E S . In mammals one of the most problematic viruses is Hepatitis B. This virus in dried human plasma was exposed for 10 minutes at 20oC to 500 ppm Av.Cl' (Bond). A chimpanzee received the treated material IV (108 infectious doses per mL) and did not show any signs of infection after a post-innoculation period of 9 months. In a trial performed recently (oct. 2003) by the Ministry of Health Klor De was challenged against two viruses – Adeno virus & Polio virus type III. 1000ppm LAC of Klor De was used. After 11 min. there was an exponential reduction of 108.75 particles for the Polio virus. With the Adeno virus, there was a 104.5 reduction in less than 1 min. The Blue line shows the actual reduction of the Polio virus particles and the Red line shows the median of the retardation of the viruses. A study by the of the Ministry of Agriculture (1999) showed that 15 second contact with 2800 ppm Troclosene (Taharsept) obtained a 100% kill of the TMV virus, while 1400 ppm obtained a 90% kill. A test developed to assess the surface activity of disinfectants against viral preparations (Tyler et Ayliffe) included Troclosene sodium (NaDCC). 3 x 109 plaque forming units of Herpes simplex virus type I. After 1 minute using 2500 ppm LAC there was a 4.9 log reduction, and after 5 minutes no virus was recoverable. Using 1000 ppm LAC there was no recoverable virus after 5 minutes. The Troclosene sod. showed a 2-fold better log reduction than inorganic sodium hypochlorite after 5 minutes using the same numerical concentrations. Evaluation of the formulation of KlorDeTM according to the test criteria and methods approved by the US Environmental Protection Agency (EPA) for registration as a virucide was made in July - Nov 2001 using Herpes simplex virus type I, Hepatitis A virus, Human Immunodeficiency virus (HIV) type I, Polio virus type I, Canine Parvovirus, Newcastle disease virus and Pseudorabies virus. After an exposure time of 10 minutes, in the presence of an organic load, there was shown to be complete inactivation of all the viruses listed. Troclosene sod. is recommended by the WHO for treatment of HIV contamination in vitro. Investigation of viral suspensions (Bloomfield,Smith et Dalgleish) containing between 104 and 105 per mL in 0.9% saline, with and without 10% plasma to stimulate clean and dirty conditions. Using a concentration of 50 ppm a 4-5 log reduction was obtained in 2 minutes. A final concentration of 5000 ppm was sufficient to produce a total kill within 2 minutes. A residual chlorine level of 1 ppm is sufficient to cause better than a log 5 (99.999%} destruction of most viruses in 30 minutes at temperatures above freezing (Engelbrecht). Polio Virs reduction with 0.1% Troclosene Time - min. Log.

B A C T E R I O P H A G E S Evaluation of Trocloseneeffervescent tablets according to the accepted European (French) standard NF T 72 - 181 has been made for the following bacteriophages: T2 and E.coli B, MS2 and E.coli Hfrh, öX 174 and E.coli ATCC 13706, lactic No.66 ad Strep. lactis diacetyllactis IL 561. The tests were made using hard water with a 30 minute contact and all results were acceptable according to NF T 140 which requires a 4 log reduction. B A C T E R I A KlorDeTM containing Troclosene is a potent rapidly acting bactericide. Even at very low concentrations of 10 ppm there was a kill rate of 99.9% after 10 minutes exposure time for Staph. aureus, Strept. faecalis Salmonella typhi and Brucella abortis (Baker). Tests carried out at the Kimron veterinary institute showed that there was a complete kill in less than one minute in the dirty conditions, 5% milk, using Troclosene at 1400 ppm against Staph. aureus, Strept. uberis, Pseudomonas aeruginosa and E.coli. Troclosene was evaluated (1996) in accordance with the very stringent AFNOR (NFT 72 171) standards which are accepted throughout the European Union (and world wide). Troclosene passed tests for effectiveness against all the pathogenic test bacteria - E.coli, Pseudomonas, Staph. aureus, Enterococcus faecium and Mycobacterium smegmatis, - and also against the fungi Candida albicans. The NFT tests demand a 99.999% kill of the micro-organisms in suspension within 5 minutes at the test concentration and within 30 minutes when stuck onto glass Troclosene killed under the test conditions in less than 10 minutes. Using the AOAC use dilution method the formulation of KlorDeTM at 1000ppm no growth could be demonstrated in any of the 10 primary subculture tubes after 0 minutes exposure for Klebsiella. pneumoniae, Staph. Epidermidis, E.coli, Staph. aureus, Clostridium difficile. This test proved the U.S. EPA performance requirements for a disinfectant label claim. Similar AOAC use dilution method tests were also performed on the same formulation, on a separate occasion, against Pseudomonas aeruginosa, Salmonella choleraesuis, and Staph aureus, demonstrated the efficacy of 1000 ppm to act as sterilant with an exposure time of 10 minutes. B A C T E R I A L S P O R E S KlorDeTM contains the powerful chlorine donor Troclosene. Chlorine has been shown by Kelsey to be potent in its action against bacterial spores. Far superior to glutaraldehyde. Using a Modified Kelsey Sykes method to test against 106 or 104 per mL spore suspensions in distilled water of B. subtilis, B. pumilis, Clostridium tetani and Clostridium bifermentans with a 3 hour contact time, optimum recovery broths and 7 days incubation; several 10% antiseptic solutions were tried. All failed (including the Iodophors and aqueous glutaraldehyde) only an alcoholic spore suspension was killed by the glutaraldehyde in 3 hours whereas the Chlorine containing solution killed both aqueous and alcoholic spore suspensions in 8 Minutes . Kelsey therefore recommends using an alcoholic solution of the Chlorine donor for spore sterilisation. {see table of uses on page 2 }. The formulation of KlorDeTM produced by Medentech was tested for sporicidal activity using the European (French) method NF T 72 301 against the following: Baccillus cereus, Bacc. subtilis var. niger and Clostridium sprorogenes. "Practical conditions of use" are simulated by using a suspension medium of Bovine albumin with yeast extract. A contact time of 60 minutes was sporicidal. T U B E R C U L O S I S The formulation of KlorDeTM produced by Medentech was successfully tested for Tuberculoidal activity in 2001 using the AOAC Tuberculoidal activity test method by ViroMed Labs (Minneapolis). The AOAC test requires a kill of 10 out of 10 tests against Mycobacterium bovis - BCG. The test concentration was 1000 ppm LAC. The same formulation was tested using the official European (French) method NF T 72 190 for surface disinfection using a 15 minute contact time on glass with Mycobacterium smegmatis. The KlorDeTM formula was found to be bactericidal.

F U N G I Troclosene is used on a regular basis for the control of fungal and algal growth. Work carried out by Endo and Takaturi in Japan has shown that Troclosene is effective for controlling the following organisms which include Mastitic yeast infectives: Candida spp. (albicans, albicans shibata, guilliermindii, tropicalis, crusei) Cryptococcus neoformans, Trichosporon cutaneum, Torulopsis spp., Prototheca zopfii, Kluyvermyces bulgaricus, Pichia fluxum and P.haplophilia and Saccharomyces italicus. During re-evaluation in 1996 for AFNOR standards (which are accepted throughout the European Union and world wide). Troclosene passed tests for effectiveness against Candida according to the United States official FDA standards. This requires a kill in the presence of 1% milk ( i.e 20mL of milk in our 2Lt sterilising box!). Troclosene killed under the test conditions in less than 10 minutes. {see table on the following page}. Using the AOAC use dilution method the formulation of KlorDeTM at 1000ppm no growth of Trichophyton mentagrophytes could be demonstrated against after a 10 minute contact in any of the 10 tests, thus complying with the EPA requirements. (Dec 2001) Rozenzweig et al found chlorine to be effective in low concentrations for contact periods of between 10 to 30 minutes. Aspergillus fumigatus was completely eradicated in 10 minutes using 10 ppm. Candida showed a 5 log reduction at 100 ppm in less than 1 minute. With longer contact times, as for example drinking water purification, a level of 5 ppm will destroy all water born algae. In concentrations of 100 ppm Troclosene may be used as a mouthwash for mycotic infections of the buccal cavity and concentrations of up to 1500 ppm are used against dermatophytes.

Up to the present it was only possible to produce Effervescent solution tablets containing Troclosene sodium to produce a colourless solution. These formulations were highly successful and products such as Klorsept and Klor De 800 (without colour). That the solutions were colourless was sometimes a problem as a marker was often needed to know when the post disinfecting rinse was complete, and also to prevent the solutions from being mistaken for Water, saline etc. As Troclosene is a chlorine donor it also acts as a bleach and it was thought that this made permanent colouration of the solution infeasible, let alone formulating a stable effervescent tablet. ConRaDTM is proud to have achieved a world 'first' in solving this problem and this invention has patent pending status in most of the industrialised world. Klor-DeTM Disinfecting tablets, have a completely new non-toxic formulation which includes a pharmaceutically acceptable non toxic dye. Formulation Chemistry Klor-DeTM Disinfection is based on the organic chlorine donor compound Troclosene sodium. Chemically Troclosene is a ring structure with alternating carbon and nitrogen atoms, where the two latently available chlorine atoms are bonded to the nitrogens at the 1 and 3 positions. The description of the molecule is: 1,3 dichloro -1,3,5 triazine 2,4,6 trione. This molecule contains about 60% Latently available chlorine [L.A.C.]. When added to the required amount of water the tablet effervesces and dissolves in the water producing a solution with a pH of between 5.5 and 6. An equilibrium system is soon established in accordance to the simplified equation.

Factors affecting biocidal action

a. Effect of pH As explained above, the pH of the solution is very slightly acid (from neutral) [5.5 - 6.0] . If compared to hypochlorite solutions the free available chlorine [Av.Cl'] is the sum of the dissociated and nondissociated ions together, ie HOCl + [OCl]'. This is normally expressed in mg per litre of chlorine, and is equivalent to parts per million - [ppm]. However, as the [OCl]' ion has only 1/100th of the biocidal efficacy of [HOCl], and the proportions of these two forms are pH related it can be seen that the biocidal capacity is dependent on the pH. Hypochlorites may therefore have a very high concentration, but a very low biocidal potential.

b. Effect of Concentration The higher the concentration (measured in ppm LAC) the greater the biocidal activity, provided that the temperature and pH are constant.

c. Effect of Temperature Increasing the temperature of the solution will increase the biocidal activity.

d. Time lapse An increase in the concentration or the temperature or both, will shorten the time required to kill the organisms.

e. Water Hardness Water hardness does not affect the biocidal activity of Klor-DeTM .The product contains stabilising elements which eliminate the effect of water hardness.

f. Organic matter Klor-DeTM Disinfecting Tablets are much less susceptible to the interfering effect of organic matter on their biocidal activity than are other chlorine compounds. This has been shown repeatedly in experimental evidence. There appears to be a qualitative difference between living organic matter, which does not affect the action of the chloroxidiser and non-living organic matter which may reduce its action when present in substantial quantities. As recorded previously, organic matter in the form of 5% milk, or 2% yeast, showed no interference in biocidal activity. Reports in the literature have shown that the presence of serum in concentrations of up to 18% also did not compromise the effectiveness of troclosene. This is especially important in the hospital and clinic setting.

KlorDeTM Tablets contain Troclosene and are extremely safe in use. Troclosene is so safe that it is used world wide to purify water for drinking purposes.(Aquatabs and Taharmayim) If however a tablet is swallowed whole, or the prepared solution is drunk by accident, a glass of milk will neutralise any possible unpleasant effects. Risk assessment may therefore be based on the premise that Troclosene is widely used for the purification of drinking water. The use of chlorine for the purification of drinking water has been practised in all of the developed countries and many other parts of the world for well over 100 years. The safety of chlorine is therefore well known. KlorDeTM Cleaning & Disinfection Tablets contain Troclosene (a chlorinated triazine trione) together with surfactants and ConRaDye * . The breakdown products released by the Troclosene upon usage are Isocyanurates and cyanurates and then via biuret reaction to carbon dioxide and ammonia. The product is therefore extremely friendly to the environment. Various studies indicate that KlorDeTM Tablets exhibits very little toxicity. Troclosene sodium and its breakdown products were not carcinogenic, teratogenic, mutagenic, fetotoxic or oncogenic in the animals studied. Troclosene sodium has now been in use on open wounds in humans as a registered medicine for several years without incident. Chronic and sub chronic studies showed no significant toxicity. Since cyanurates are rapidly excreted from the body, adsorption through wounds can not build up in the tissues. The use of Troclosene sodium (NaDCC) is also listed by the World Health Organisation in their report "Water Supply Sanitation & Health in Rural Areas" published in 1991. Aquatabs is approved for use world wide for drinking water purification United Nations Common Coding System) UNCCS #856461 and has been in use for many years by western armies, and aid organisations such as the Red Cross, UNICEF and OXFAM. Risk assessment for the use of Troclosene sodium therefore best done by examining the toxicity of its breakdown products as follows: Troclosene -Isocyanurates: Acute Toxicity LD 50 = 1.67 Gm:Kg in Rats LD 50 = > 2 Gm:Kg in Rabbits LD 50 = 3.57 Gm:Kg in Humans * This means that for a 60 Kg adult the LD 50 = 214 Gm or more than 100 tablets of KlorDeTM would have to be eaten !! *Environment Protection Agency (EPA). TSCA Chemical Inventory , USA June 1990, 105810/11/12} Chronic Toxicity: 333 ppm given orally to dogs and rate for SIX months with no signs of toxicity Monosodium cyanurate: Acute Toxicity: LD 50 => 7.5 Gm:Kg in Rats LD 50 = 20 Gm:Kg in Rabbits LD 50 = 21.4Gm:Kg in Cats Chronic Toxicity 8% cyanurate mixed with the food of dogs was ingested for TWO years with no signs of toxicity Cyanurates are eliminated unchanged from the human body. The elimination half life is 1.5 to 2 hours.{Allen,1982} *ConRaDye Blue is Ferric Hexacyanoferrate produced in-in-situ and confirmed by UV adsorption to be a single peak Max.abs 694/358 nm. This dye is a permitted colour for Pharmaceutical preparations under US code of Federal regulations Title 21 pt 73 Section 73.2299. It is also allowed for this purpose under Ministry of Health regs (1995). The LD50 of Ferric Hexacyanoferrate is > 10 g/Kg Per Os. The risk involved in the use of KlorDeTM Tablets in any setting is therefore negligible. An MSDS is available upon request.

In hospitals and clinics KLOR - De with a color marker is the disinfectant to be preferred for surface and instrument disinfection. Formulated and produced using breakthrough technology, it is the natural successor to the highly successful KLOR - De which was formulated especially for the needs of Medical Organisations and has been in use for well over a decade. KLOR - De is an effervescent tablet formulated with the addition of a small amount of surfactant which enables better contact of the disinfecting agent Troclosene sodium with the surface and also removes dirt and grease. Up to the present it was only possible to produce Effervescent solution tablets containing Troclosene sodium which produced a colourless solution. The new KLOR - De contains a pharmaceutically safe dye which gives the disinfectant solution a light blue colouration. This is a safety factor which also acts as an indicator when it is necessary to flush equipment from antiseptic. The absence of colour indicating that the rinse is complete. This surfactant has been shown not to cause irritation of the users hands or any other untoward effects such as unpleasant odours etc.