FulviSan-D. Product Applications: *food and beverage process plants, kitchens and serving establishments *live-stock farming: dairy, meat and poultry
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1 FulviSan-D Description: FulviSan-D is a dark brown concentrated liquid detergent, contains pure organic plant acids, designed for surface contact disinfectant requirements in the livestock, food processing and beverage industries. Suitable for floors, walls, ceilings and all types of food processing equipment. FulviSan-D produces visible stable acidic foam, which ensures maximum surface disinfectant contact time. FulviSan-D is suitable for use in hard and soft water. Product strengths: *excellent proven anti-microbial efficacy *excellent residual antimicrobial activity - stay *safe for human and animals should incidental ingestion result *not hazardous to environment *no effect on safety of food when contact occurs *powerful detergent *stable effective foam *suitable for all food and meat processing factories *suitable for hard & soft water and mixes readily with water Product Applications: *food and beverage process plants, kitchens and serving establishments *live-stock farming: dairy, meat and poultry Application solution: Active ingredients: Fulvic Acid and Organic Plant Acids Concentration: % ph- value: ( final solution-ready to use) Antimicrobial: % (5 Log order reduction) Appearance: dark brown liquid with herbal odour Storage stability: 25 C/65%RH 36 months Solubility: Freely soluble in water еϲ: > 3800 us.cm Heavy Metal: <5 ppm Temp. and light: Ambient and not light sensitive IMELDA JORDAAN 1
2 Directions: General detergent use: Dilute 1:25 and allow a contact time of 5 to 10 minutes Yeast & Mould disinfection: Dilute 1:16 and allow a contact time of 15minutes Listeria disinfection: Dilute 1:10 and allow a contact time of 5 minutes. Corrosion: Comply with SANS 1828:2017 Version 2.1 Safety Ecology Packing: Storage: Warning: FulviSan-D is not corrosive. It contains pure organic plant acids, totally safe for animal and human contact. FulviSan-D is a totally organic detergent that is not harmful to the environment. Fulvic Acid is the principle component and is composed of highly active (unspent) carbon, hydrogen, molecular oxygen, an organic form for maximum bio-availability. 25L Store in original sealed container Protect from extremes of temperature Store below 25 C Out of direct sunlight. May cause slight irritation to eyes. QUALITY ASSURANCE This product is manufactured by Fulvimed (PTY)Ltd, a c-gmp certified facility, who conforms with NSF Food Safety System Certification 22000:2011 in compliance with ISO 2000:2005 and ISO/TS :2009 (certificate number ), accredited by COFRAC# for ECOCERT Organic Standard Certification ZA1600z1e (EOS) and registered with U.S. FDA Registration No: IMELDA JORDAAN 2
3 MICROBIOLOGY Efficacy : FulviSan-D has been found to be effective against a broad spectrum of organisms including the following: Absidia corymbifera Malassezia globose Acinetobacter baumanii Aspergillus flavus Aspergillus fumigatus Aspergillus niger Aspergillus terreus Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Candida isolates Citrobacter freundi Cholera Clostridium difficile Enterobacter aerogenes Enterobacter cloacae Enterococcus faecium Epidermophyton Escherichia coli Escherichia coli biofilm Fusarium solani G.capitatum Herpes Simplex virus type 1 Klebsiella pneumoniae Malassezia dermatis Malassezia furfur Malassezia pachydermatis Megasphaera elsdenii Microsporum canis Mycobacterium smegmatis Porphyromonas gingivalis Proteus mirabilis Pseudomonsa aeruginosa Penicillium chrysogenum Penicillium marneffei Rhizopus oryzae Rhod. Mucilaginosa Salmonella entiritidis Salmonella typhimurium Staphylococcus aures Scedosporium Methicillin Resist Staph. Aureus MRSA Methicillin Susceptible Staph aureus Staph aureus Neg. Coagulate Staphylococcus epidermidis Streptococcus pyogenes Trichophyton rubrum Trichophyton mentagrophytes T. mentagrophytes interdigitale T.asahii Zygomycetes IMELDA JORDAAN 3
4 TOXICOLOGY (ACUTE) Harlan Laboratories LTD, Shardlow, Derbyshire, UK, concluded that an acute oral median lethal dose (LD50) of 4.39% concentrated Fulvic acid for Wistar rats is estimated to be >2g/kg bw. Harlan Laboratories LTD, Derbyshire, UK concluded that the repeated oral dosing of FULVIC ACID (± %) when diluted to 10% in water and administered at different volumes to this dose concentration will not have any adverse systemic health effects on Wistar (RccHan :WIST) strain rats. NOEL 1g/kg bw was established. Harlan Laboratories LTD in Derbyshire, UK concluded that the Fulvic Acid acute dermal median lethal dose (LD50) is >2g/kg bw for Wistar strain rats Harlan Laboratories LTD in Derbyshire, UK concluded that exposed to a single 4 hours semioccluded application of 0.5g Fulvic Acid (ph5.5), applied directly to the skin New Zealand White strain rabbits caused no irritation or corrosive effects noticed on the skin, rendering Fulvic Acid non-toxic to direct contact with the skin TOXICOLOGY (SHORT TERM) The Drug Development Research Unit, Dept. of Pharmacology at the Univ. Pretoria determined that the topical application of 4% Fulvic Acid on Balb C mice over a 90day period is not toxic. NOEL 0.1g/ kg bw. Harlan Laboratories LTD in Derbyshire, UK concluded that FULVIC ACID is classified as a nonirritant to the New Zealand White (Hsdlf:NZW) rabbit skin as no corrosive effects were noted over a 72h test period. TOXICOLOGY (LONG TERM) Harlan Laboratories LTD in Derbyshire, UK, based on a local lymph node assay in female CBA/Ca strain mice concluded that 4.39% Fulvic Acid is not toxic when absorbed through the skin and safe for skin applications. The Department of Pharmacology, Faculty of Health Sciences, University of Pretoria, performed a 6 month chronic toxicity study and concluded that FULVIC ACID dosed for extended periods is not toxic to liver and kidney function. NOEL 0.1g/kg bw. GENOTOXICITY Harlan Laboratories LTD in Derbyshire, UK, conducted an In vitro Micronucleus Assay and indicated no genotoxicity above normal background levels for both in the filtered and unfiltered FULVIC ACID concentrations of 50, 100 and 150 µg/ml. (NOEL 0.15mg) Harlan Laboratories LTD in Derbyshire, UK, assessed the genotoxicity of FULVIC ACID [(filtered (3.3%) and unfiltered (3.6%)]in vitro on albino Hsd: ICR (CD-1 ) strain mice using a micronucleus assay. Dosage of FULVIC ACID was at the maximum tolerated dose (MTD) 1g/kg bw, 0.05g/kg bw and 0.025g/kg bw. and it was concluded that FULVIC ACID is non-genotoxic. NOEL< 0.05g/kg bw. REPRODUCTIVE TOXICITY Harlan Laboratories LTD in Derbyshire, UK, assessed the systemic toxicity and potential effects of FULVIC ACID (9.98% ) and concluded that the oral administration of 9.98% FULVIC ACID (9.98%) has no adverse effects on reproductive toxicity. No statistically significant changes on the reproduction (including offspring development), functional performance, sensory activity, mating and conception rates in Wistar Han :HsdRccHan : WIST strain rats were found. NOEL is 1.0g/kg bw/day IMELDA JORDAAN 4
5 OCULAR TOXICITY Harlan Laboratories LTD in Derbyshire, UK, tested eye irritancy in vivo caused by a 0.001g FULVIC ACID (5.5%) dosed directly into the conjunctiva sac of the right eye (left eye was left untreated as control) of New Zealand, White strain (Hsdlf:NZW) rabbits and concluded that FULVIC ACID should be classified non-irritant to the rabbit eye. HUMAN TOXICITY The Department of Pharmacology, Faculty of Health Sciences, University of Pretoria, performed an investigational, single centre, randomized, double blind, placebo controlled, study, over 43 days to assess the acute and sub-acute safe oral dosing of 3.8% FULVIC ACID and proof of concept efficacy when orally dosed performed in vivo on male subjects 18years. This study has demonstrated the safety and efficacy of FULVIC ACID. It proofed that FULVIC ACID, when applied externally to the human body, is well tolerated and safe to use. Derma Consult GmbH, Alfter, Germany assessed in vivo the dermal irritation from 1.0% FULVIC ACID when applied directly to the skin for an extended period in forty nine male and female subjects and classified FULVIC ACID harmless for skin irritations. The Dental School, School of Medicine, University of Glasgow, assessed the toxicity in an orally relevant epithelial cell line (OKF6/TERT2) to determine possible detrimental effects from FULVIC ACID (0.5%), ph2.0 and concluded that FULVIC ACID is not toxic to human consumption. IMELDA JORDAAN 5
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