Biocompatibility

Hypochlorous acid is a weak, highly unstable acid which can only exist in a solution.[1]  Aquaox LLC produces hypochlorous acid by electrolysis of a dilute salt solution passing through an electrolytic cell.   At an acidic to neutral pH, the predominant chemical species is hypochlorous acid (HOCl). [2]  Hypochlorous acid has demonstrated antimicrobial activity against numerous bacterial, viral and fungal pathogens, including antibiotic-resistant strains.[3]

Hypochlorous acid has a history of safe use as a disinfectant in numerous applications including household, hospital, food preparation, industrial and pharmaceutical applications.  Hypochlorous acid is approved by the FDA for direct patient tissue contact as a wound care agent. It has also been used in root canal therapy.[4]

Aquaox LLC manufactures a number of electrochemically generated hypochlorous acid products at concentrations up to 0.0525% (525 ppm free available chlorine) for multiple uses. Some of our clients, we supply bottled solutions as one-step cleaners and disinfectants for general cleaning and disinfecting hard, non-porous surfaces.[5]  These products can be applied using a mop/bucket, a trigger spray bottle or a pressurized spray system. Some of our clients choose to have Aquaox LLC install a device within their facility to produce on-site solution for the same. Some of our clients, obtained FDA approval for bottling Hypochlorous acid solutions used for topical applications. Some of our clients use bottled or on-site generated Hypochlorous acid for water treatment or in food preparation.

This review was conducted to evaluate the risk of daily applying Hypochlorous acid on skin, for e.g. disinfecting people by spraying them when entering buildings.

Aquaox LLC has evaluated AQUAOX Disinfectant 275/525, its most concentrated hypochlorous acid product, in a series of preclinical toxicology studies which were conducted in compliance with the ISO 10993 Standards.  Testing included the evaluation of cytotoxicity, acute oral toxicity, repeat dose (28 day) dermal toxicity, dermal sensitization, acute inhalation toxicity as well as skin and eye irritation.

The results of these studies confirmed that AQUAOX Disinfectant 275/525, and by extrapolation all AQUAOX Disinfectant products marketed at hypochlorous acid concentrations less than 0.0525% are not cytotoxic, nor do they demonstrate signs of acute systemic toxicity or irritation following oral or inhalation exposure. AQUAOX Disinfectant 275/525 is not a dermal sensitizer nor is it a skin or eye irritant.  It failed to exhibit any signs of local or systemic toxicity following 28 days of repeated dermal administration to intact and abraded skin.[6]

The preclinical testing described above has demonstrated that AQUAOX Disinfectant 275/525, and by extrapolation all AQUAOX Disinfectant products marketed at hypochlorous concentrations less than 525 ppm are not irritants following inhalation, dermal or ocular exposure.  Based on these findings AQUAOX Disinfectant products are not considered to represent a risk to the health of applicators, patients or other potentially exposed individuals by daily skin contact.

[1] National Center for Biotechnology Information―NCBI (2015) Hypochlorous Acid, PubChem 867 Compound Database; CID=24341, https://pubchem.ncbi.nlm.nih.gov/compound/24341 868 (accessed Aug. 9, 2015).

[2] Sansebastiano, G. et al. Page 262 in Food Safety: A Practical and Case Study Approach (Ed: R. J. Marshall) 2006, Springer Science & Business Media, Berlin.

[3] Wang TX, Kelly MD, Cooper JN, Beckwith RC, Margerum DW. Equilibrium, kinetic, and UV-spectral characteristics of aqueous bromine chloride, bromine, and chlorine species. Inorg Chem. 1994; 33:5872– 5878.

[4] European Union Risk Assessment Report, Sodium Hypochlorite, CAS No: 7681-52-9, EINECS No: 231-668-3, Final Report, November 2007.

[5] http://www.aquaox.com/sustainable-cleaning-disinfecting-sanitizing-products/

[6] AQUAOX LLC., Technical Summary – Aquaox On-Site Generated Disinfectants. http://www.aquaox.com/wp-content/uploads /2017/04/ Technical-Summary_On-site_Disinfectants_vf.pdf