Benzalkonium chloride (BZK, BKC, BAK, BAC), also known as alkyldimethylbenzylammonium chloride (ADBAC) and by the trade name Zephiran,
is a type of
cationic surfactant
Surfactants are chemical compounds that decrease the surface tension between two liquids, between a gas and a liquid, or interfacial tension between a liquid and a solid. Surfactants may act as detergents, wetting agents, emulsifiers, foaming ...
. It is an organic
salt
Salt is a mineral composed primarily of sodium chloride (NaCl), a chemical compound belonging to the larger class of salts; salt in the form of a natural crystalline mineral is known as rock salt or halite. Salt is present in vast quantitie ...
classified as a
quaternary ammonium compound
In chemistry, quaternary ammonium cations, also known as quats, are positively charged polyatomic ions of the structure , R being an alkyl group or an aryl group. Unlike the ammonium ion () and the primary, secondary, or tertiary ammonium catio ...
. ADBACs have three main categories of use: as a
biocide
A biocide is defined in the European legislation as a chemical substance or microorganism intended to destroy, deter, render harmless, or exert a controlling effect on any harmful organism. The US Environmental Protection Agency (EPA) uses a slig ...
, a
cationic
An ion () is an atom or molecule with a net electrical charge.
The charge of an electron is considered to be negative by convention and this charge is equal and opposite to the charge of a proton, which is considered to be positive by convent ...
surfactant
Surfactants are chemical compounds that decrease the surface tension between two liquids, between a gas and a liquid, or interfacial tension between a liquid and a solid. Surfactants may act as detergents, wetting agents, emulsifiers, foaming ...
, and a
phase transfer agent
In chemistry, a phase-transfer catalyst or PTC is a catalyst that facilitates the transition of a reactant from one phase into another phase where reaction occurs. Phase-transfer catalysis is a special form of heterogeneous catalysis. Ionic re ...
. ADBACs are a
mixture
In chemistry, a mixture is a material made up of two or more different chemical substances which are not chemically bonded. A mixture is the physical combination of two or more substances in which the identities are retained and are mixed in the ...
of alkylbenzyldimethylammonium chlorides, in which the alkyl group has various even-numbered alkyl chain lengths.
Solubility and physical properties
Depending on purity, benzalkonium chloride ranges from colourless to a pale yellow (impure). Benzalkonium chloride is readily soluble in
ethanol
Ethanol (abbr. EtOH; also called ethyl alcohol, grain alcohol, drinking alcohol, or simply alcohol) is an organic compound. It is an Alcohol (chemistry), alcohol with the chemical formula . Its formula can be also written as or (an ethyl ...
and
acetone
Acetone (2-propanone or dimethyl ketone), is an organic compound with the formula . It is the simplest and smallest ketone (). It is a colorless, highly volatile and flammable liquid with a characteristic pungent odour.
Acetone is miscib ...
. Dissolution in water is ready, upon agitation. Aqueous solutions should be neutral to slightly alkaline. Solutions foam when shaken. Concentrated solutions have a bitter taste and a faint almond-like odour.
Standard concentrates are manufactured as 50% and 80% w/w solutions, and sold under trade names such as BC50, BC80, BAC50, BAC80, etc. The 50% solution is purely aqueous, while more concentrated solutions require incorporation of
rheology
Rheology (; ) is the study of the flow of matter, primarily in a fluid ( liquid or gas) state, but also as "soft solids" or solids under conditions in which they respond with plastic flow rather than deforming elastically in response to an appl ...
modifiers (
alcohol
Alcohol most commonly refers to:
* Alcohol (chemistry), an organic compound in which a hydroxyl group is bound to a carbon atom
* Alcohol (drug), an intoxicant found in alcoholic drinks
Alcohol may also refer to:
Chemicals
* Ethanol, one of sev ...
s,
polyethylene glycol
Polyethylene glycol (PEG; ) is a polyether compound derived from petroleum with many applications, from industrial manufacturing to medicine. PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), depending on its molecular we ...
s, etc.) to prevent increases in viscosity or gel formation under low temperature conditions.
Cationic surfactant
Benzalkonium chloride also possesses surfactant properties, dissolving the lipid phase of the tear film and increasing drug penetration, making it a useful
excipient
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...
, but at the risk of causing damage to the surface of the eye.
* Laundry detergents and treatments.
* Softeners for textiles.
Phase transfer agent
Benzalkonium chloride is a mainstay of phase-transfer catalysis, an important technology in the synthesis of organic compounds, including drugs.
Bioactive agents
Especially for its antimicrobial activity, benzalkonium chloride is an active ingredient in many consumer products:
* Pharmaceutical products such as
eye,
ear
An ear is the organ that enables hearing and, in mammals, body balance using the vestibular system. In mammals, the ear is usually described as having three parts—the outer ear, the middle ear and the inner ear. The outer ear consists of ...
and nasal drops or
sprays, as a preservative.
* Personal care products such as
hand sanitizers,
wet wipe
A wet wipe, also known as a wet towel or a moist towelette, disposable wipe, disinfecting wipe, or a baby wipe (in specific circumstances) is a small to medium-sized moistened piece of plastic or cloth that either comes folded and individually ...
s,
shampoo
Shampoo () is a hair care product, typically in the form of a viscous liquid, that is used for cleaning hair. Less commonly, shampoo is available in solid bar format. Shampoo is used by applying it to wet hair, massaging the product into the ...
s,
soap
Soap is a salt of a fatty acid used in a variety of cleansing and lubricating products. In a domestic setting, soaps are surfactants usually used for washing, bathing, and other types of housekeeping. In industrial settings, soaps are use ...
s, deodorants and cosmetics.
* Skin antiseptics and wound wash sprays, such as
Bactine
Benzalkonium chloride/lidocaine (trade name Bactine among others) is an antiseptic, first-aid treatment distributed by Wellspring Pharmaceutical Corporation. Bactine was developed in 1947 and first marketed in 1950 by Miles Laboratories. It is a ...
.
* Throat lozenges and
mouthwash
Mouthwash, mouth rinse, oral rinse, or mouth bath is a liquid which is held in the mouth passively or swilled around the mouth by contraction of the perioral muscles and/or movement of the head, and may be gargling, gargled, where the head is ti ...
es, as a biocide
*
Spermicidal creams.
* Cleaners for floor and hard surfaces as a disinfectant, such as
Lysol
Lysol (; spelled Lizol in India) is a brand of American cleaning and disinfecting products distributed by Reckitt, which markets the similar Dettol or Sagrotan in other markets. The line includes liquid solutions for hard and soft surfaces, ai ...
and
Dettol
Dettol is a cleaning disinfectant and antiseptic. It was introduced in 1932 by the British company Reckitt. In Germany, it is sold under the name Sagrotan.
Prior to 2002, some Dettol products were branded Dettox.
Dettol Antiseptic Disinfectant ...
antibacterial spray and wipes.
*
Algaecide
Algaecide or algicide is a biocide used for killing and preventing the growth of algae, often defined in a loose sense that, beyond the biological definition, also includes cyanobacteria ("blue-green algae"). An algaecide may be used for controlle ...
s for clearing of algae, moss, lichens from paths, roof tiles, swimming pools, masonry, etc.
Benzalkonium chloride is also used in many non-consumer processes and products, including as an active ingredient in surgical disinfection. A comprehensive list of uses includes industrial applications. An advantage of benzalkonium chloride, not shared by ethanol-based antiseptics or hydrogen peroxide antiseptic, is that it does not cause a burning sensation when applied to broken skin. However, prolonged or repeated skin contact may cause dermatitis.
During the course of the
COVID-19 pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identif ...
, from time to time there have been shortages of hand cleaner containing
ethanol
Ethanol (abbr. EtOH; also called ethyl alcohol, grain alcohol, drinking alcohol, or simply alcohol) is an organic compound. It is an Alcohol (chemistry), alcohol with the chemical formula . Its formula can be also written as or (an ethyl ...
or
isopropanol
Isopropyl alcohol (IUPAC name propan-2-ol and also called isopropanol or 2-propanol) is a colorless, flammable organic compound with a pungent alcoholic odor. As an isopropyl group linked to a hydroxyl group (chemical formula ) it is the simple ...
as active ingredients. The FDA has stated that benzalkonium chloride is eligible as an alternative for use in the formulation of healthcare personnel hand rubs. However, in reference to the FDA rule, the CDC states that it does not have a recommended alternative to ethanol or isopropanol as active ingredients, and adds that "available evidence indicates benzalkonium chloride has less reliable activity against certain bacteria and viruses than either of the alcohols." In November 2020 The Journal of Hospital Infection published a study on benzalkonium chloride formulations; it was found that laboratory and commercial disinfectants with as little as 0.13% benzalkonium chloride inactivated the SARS-CoV-2 virus within 15 seconds of contact, even in the presence of a soil or hard water.
This resulted in a growing consensus that BZK sanitizers are just as effective as alcohol-based sanitizers despite the CDC guidelines. As a hand sanitizer, use of BZK may be advantageous over ethanol in some situations because it has significantly more residual antibacterial action on the skin after initial application. Benzalkonium chloride has demonstrated persistent antimicrobial activity for up to four hours after contact whereas ethanol-based sanitizer demonstrate skin protection for only 10 minutes post-application.
Medicine
Benzalkonium chloride is a frequently used preservative in
eye drops
Eye drops or eyedrops are liquid drops applied directly to the surface of the eye usually in small amounts such as a single drop or a few drops. Eye drops usually contain saline to match the salinity of the eye. Drops containing only saline ...
; typical concentrations range from 0.004% to 0.01%. Stronger concentrations can be caustic
and cause irreversible damage to the
corneal endothelium
The corneal endothelium is a single layer of endothelial cells on the inner surface of the cornea. It faces the chamber formed between the cornea and the iris.
The corneal endothelium are specialized, flattened, mitochondria-rich cells that li ...
.
Avoiding the use of benzalkonium chloride solutions while contact lenses are in place is discussed in the literature.
Due to its antimicrobial activity when applied to skin, some topical
medications
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and rel ...
for
acne vulgaris
Acne, also known as ''acne vulgaris'', is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles. Typical features of the condition include blackheads or whiteheads, pimples, oily skin, and po ...
have benzalkonium chloride added to increase the products’ efficiency or shelf-life.
Benzalkonium Chloride is scientifically proven to be a successful spermicide. In Russia and China, benzalkonium chloride is used as a
contraceptive
Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unwanted pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth contr ...
. Tablets are inserted vaginally, or a gel is applied, resulting in local
spermicidal contraception. It is not a wholly reliable method, and can cause irritation.
Beekeeping
It is used in beekeeping for the treatment of rotten diseases of the brood.
Adverse effects
Although historically benzalkonium chloride has been ubiquitous as a preservative in ophthalmic preparations, its ocular toxicity and irritant properties, in conjunction with consumer demand, have led pharmaceutical companies to increase production of preservative-free preparations, or to replace benzalkonium chloride with preservatives which are less harmful.
Many mass-marketed inhaler and nasal spray formulations contain benzalkonium chloride as a preservative, despite substantial evidence that it can adversely affect
cilia
The cilium, plural cilia (), is a membrane-bound organelle found on most types of eukaryotic cell, and certain microorganisms known as ciliates. Cilia are absent in bacteria and archaea. The cilium has the shape of a slender threadlike projecti ...
ry motion,
mucociliary clearance
Mucociliary clearance (MCC), mucociliary transport, or the mucociliary escalator, describes the self-clearing mechanism of the airways in the respiratory system. It is one of the two protective processes for the lungs in removing inhaled particl ...
, nasal mucosal histology, human
neutrophil
Neutrophils (also known as neutrocytes or heterophils) are the most abundant type of granulocytes and make up 40% to 70% of all white blood cells in humans. They form an essential part of the innate immune system, with their functions varying in ...
function, and
leukocyte
White blood cells, also called leukocytes or leucocytes, are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from mult ...
response to local
inflammation
Inflammation (from la, wikt:en:inflammatio#Latin, inflammatio) is part of the complex biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or Irritation, irritants, and is a protective response involving im ...
.
Although some studies have found no correlation between use of benzalkonium chloride in concentrations at or below 0.1% in nasal sprays and
drug-induced rhinitis,
others have recommended that benzalkonium chloride in nasal sprays be avoided. In the United States,
nasal steroid preparations that are free of benzalkonium chloride include
budesonide
Budesonide, sold under the brand name Pulmicort among others, is a medication of the corticosteroid type. It is available as an inhaler, nebulization solution, pill, nasal spray, and rectal forms. The inhaled form is used in the long-term mana ...
,
triamcinolone acetonide
Triamcinolone acetonide, sold under the brand name Kenalog among others, is a synthetic corticosteroid medication used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and by injection into joints to trea ...
,
dexamethasone
Dexamethasone is a glucocorticoid medication used to treat rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, eye pain following eye surgery, superior vena cav ...
, and Beconase and Vancenase aerosol inhalers.
Benzalkonium chloride is an irritant to middle ear tissues at typically-used concentrations. Inner ear toxicity has been demonstrated.
Occupational exposure to benzalkonium chloride has been linked to the development of asthma. In 2011, a large clinical trial designed to evaluate the efficacy of hand sanitizers based on different active ingredients in preventing virus transmission amongst schoolchildren was re-designed to exclude sanitizers based on benzalkonium chloride due to safety concerns.
Benzalkonium chloride has been in common use as a pharmaceutical preservative and antimicrobial since the 1940s. While early studies confirmed the corrosive and irritant properties of benzalkonium chloride, investigations into the adverse effects of, and disease states linked to, benzalkonium chloride have only surfaced during the past 30 years.
Toxicology
RTECS lists the following acute toxicity data:
Benzalkonium chloride is a human skin and severe eye irritant. It is a respiratory toxicant, immunotoxicant, gastrointestinal toxicant, and neurotoxicant.
Benzalkonium chloride formulations for consumer use are dilute solutions. Concentrated solutions are toxic to humans, causing corrosion/irritation to the skin and mucosa, and death if taken internally in sufficient volumes. 0.1% is the maximum concentration of benzalkonium chloride that does not produce primary irritation on intact skin or act as a sensitizer.
Poisoning by benzalkonium chloride is recognised in the literature.
A 2014 case study detailing the fatal ingestion of up to 8.1 oz (240 ml) of 10% benzalkonium chloride in a 78-year-old male also includes a summary of the currently published case reports of benzalkonium chloride ingestion. While the majority of cases were caused by confusion about the contents of containers, one case cites incorrect pharmacy dilution of benzalkonium chloride as the cause of poisoning of two infants. In 2018 a Japanese nurse was arrested and admitted to having murdered approximately 20 patients at a hospital in Yokohama by injecting benzalkonium chloride into their intravenous drip bags.
Benzalkonium chloride poisoning of domestic pets has been recognised as a result of direct contact with surfaces cleaned with disinfectants using benzalkonium chloride as an active ingredient.
Biological activity
The greatest biocidal activity is associated with the C12 dodecyl and C14
myristyl alkyl derivatives. The mechanism of
bactericidal
A bactericide or bacteriocide, sometimes abbreviated Bcidal, is a substance which kills bacteria. Bactericides are disinfectants, antiseptics, or antibiotics.
However, material surfaces can also have bactericidal properties based solely on their ...
/
microbicidal action is thought to be due to disruption of intermolecular interactions. This can cause dissociation of
cellular membrane
The cell membrane (also known as the plasma membrane (PM) or cytoplasmic membrane, and historically referred to as the plasmalemma) is a biological membrane that separates and protects the interior of all cells from the outside environment (th ...
lipid bilayer
The lipid bilayer (or phospholipid bilayer) is a thin polar membrane made of two layers of lipid molecules. These membranes are flat sheets that form a continuous barrier around all cells. The cell membranes of almost all organisms and many vir ...
s, which compromises cellular permeability controls and induces leakage of cellular contents. Other biomolecular complexes within the bacterial cell can also undergo dissociation.
Enzyme
Enzymes () are proteins that act as biological catalysts by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as products. A ...
s, which finely control a wide range of respiratory and metabolic cellular activities, are particularly susceptible to deactivation. Critical intermolecular interactions and tertiary structures in such highly specific biochemical systems can be readily disrupted by cationic surfactants.
Benzalkonium chloride solutions are fast-acting biocidal agents with a moderately long duration of action. They are active against bacteria and some viruses, fungi, and protozoa. Bacterial spores are considered to be resistant. Solutions are
bacteriostatic
A bacteriostatic agent or bacteriostat, abbreviated Bstatic, is a biological or chemical agent that stops bacteria from reproducing, while not necessarily killing them otherwise. Depending on their application, bacteriostatic antibiotics, disinfect ...
or
bactericidal
A bactericide or bacteriocide, sometimes abbreviated Bcidal, is a substance which kills bacteria. Bactericides are disinfectants, antiseptics, or antibiotics.
However, material surfaces can also have bactericidal properties based solely on their ...
according to their concentration.
Gram-positive
In bacteriology, gram-positive bacteria are bacteria that give a positive result in the Gram stain test, which is traditionally used to quickly classify bacteria into two broad categories according to their type of cell wall.
Gram-positive bacte ...
bacteria are generally more susceptible than
gram-negative
Gram-negative bacteria are bacteria that do not retain the crystal violet stain used in the Gram staining method of bacterial differentiation. They are characterized by their cell envelopes, which are composed of a thin peptidoglycan cell wall ...
bacteria. Its activity depends on the surfactant concentration and also on the bacterial concentration (inoculum) at the moment of the treatment. Activity is not greatly affected by pH, but increases substantially at higher temperatures and prolonged exposure times.
In a 1998 study using the FDA protocol, a non-alcohol sanitizer with benzalkonium chloride as the active ingredient met the FDA performance standards, while
Purell
Purell is an American brand of hand sanitizer invented in 1988, and introduced to the consumer market in 1997, by GOJO Industries. Its primary component is ethyl alcohol (70% v/v), and is used by wetting one's hands thoroughly with the product, ...
, a popular alcohol-based sanitizer, did not. The study, which was undertaken and reported by a leading US developer, manufacturer and marketer of topical antimicrobial pharmaceuticals based on quaternary ammonium compounds, found that their own benzalkonium chloride-based sanitizer performed better than alcohol-based hand sanitizer after repeated use.
[ ]
Newer formulations using benzalkonium blended with various
quaternary ammonium
In chemistry, quaternary ammonium cations, also known as quats, are positively charged polyatomic ions of the structure , R being an alkyl group or an aryl group. Unlike the ammonium ion () and the primary, secondary, or tertiary ammonium cations ...
derivatives can be used to extend the biocidal spectrum and enhance the efficacy of benzalkonium based disinfection products. Formulation techniques have been used to great effect in enhancing the virucidal activity of quaternary ammonium-based disinfectants such as Virucide 100 to typical healthcare infection hazards such as
hepatitis
Hepatitis is inflammation of the liver tissue. Some people or animals with hepatitis have no symptoms, whereas others develop yellow discoloration of the skin and whites of the eyes (jaundice), poor appetite, vomiting, tiredness, abdominal pa ...
and
HIV
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
. The use of appropriate
excipient
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...
s can also greatly enhance the spectrum, performance and
detergency, and prevent deactivation under use conditions. Formulation can also help minimise deactivation of benzalkonium solutions in the presence of organic and inorganic contamination.
Degradation
![Biodegradation pathways of BAC](https://upload.wikimedia.org/wikipedia/commons/6/60/Biodegradation_pathways_of_BAC.jpg)
Benzalkonium chloride degradation follows consecutive debenzylation, dealkylation, and demethylation steps producing
benzyl chloride
Benzyl chloride, or α-chlorotoluene, is an organic compound with the formula C6H5CH2Cl. This colorless liquid is a reactive organochlorine compound that is a widely used chemical building block.
Preparation
Benzyl chloride is prepared indust ...
, an alkyl dimethyl amine,
dimethylamine
Dimethylamine is an organic compound with the formula (CH3)2NH. This secondary amine is a colorless, flammable gas with an ammonia-like odor. Dimethylamine is commonly encountered commercially as a solution in water at concentrations up to aroun ...
, a long chain alkane, and
ammonia
Ammonia is an inorganic compound of nitrogen and hydrogen with the formula . A stable binary hydride, and the simplest pnictogen hydride, ammonia is a colourless gas with a distinct pungent smell. Biologically, it is a common nitrogenous was ...
.
The intermediates, major, and minor products can then be broken down into CO
2, H
2O, NH
3, and Cl
–. The first step to the biodegradation of BAC is the fission or splitting of the alkyl chain from the quaternary nitrogen as shown in the diagram. This is done by abstracting the hydrogen from the alkyl chain by using a hydroxyl radical leading to a carbon centered radical. This results in
dimethylbenzylamine as the first intermediate and
dodecanal
Dodecanal, also known as lauraldehyde or dodecyl aldehyde, is an organic compound with the chemical formula CH3(CH2)10CHO. This colourless liquid is a component of many fragrances. It occurs naturally in citrus oils, but commercial samples are us ...
as the major product.
From here, dimethylbenzylamine can be oxidized to benzoic acid using the
Fenton process
Fenton's reagent is a solution of hydrogen peroxide (H2O2) with ferrous iron (typically iron(II) sulfate, FeSO4) as a catalyst that is used to oxidize contaminants or waste waters as part of an advanced oxidation process. Fenton's reagent can be us ...
. The
trimethyl amine
Trimethylamine (TMA) is an organic compound with the formula N(CH3)3. It is a colorless, hygroscopic, and flammable tertiary amine. It is a gas at room temperature but is usually sold as a 40% solution in water. (It is also sold in pressurized ...
group in dimethylbenzylamine can be cleaved to form a benzyl that can be further oxidized to
benzoic acid
Benzoic acid is a white (or colorless) solid organic compound with the formula , whose structure consists of a benzene ring () with a carboxyl () substituent. It is the simplest aromatic carboxylic acid. The name is derived from gum benzoin, wh ...
. Benzoic acid uses
hydroxylation
In chemistry, hydroxylation can refer to:
*(i) most commonly, hydroxylation describes a chemical process that introduces a hydroxyl group () into an organic compound.
*(ii) the ''degree of hydroxylation'' refers to the number of OH groups in a ...
(adding a hydroxyl group) to form
p-hydroxybenzoic acid
4-Hydroxybenzoic acid, also known as ''p''-hydroxybenzoic acid (PHBA), is a monohydroxybenzoic acid, a phenolic derivative of benzoic acid. It is a white crystalline solid that is slightly soluble in water and chloroform but more soluble in polar ...
. Dimethylbenzylamine can then be converted into ammonia by performing
demethylation Demethylation is the chemical process resulting in the removal of a methyl group (CH3) from a molecule. A common way of demethylation is the replacement of a methyl group by a hydrogen atom, resulting in a net loss of one carbon and two hydrogen at ...
twice, which removes both methyl groups, followed by debenzylation, removing the benzyl group using
hydrogenation
Hydrogenation is a chemical reaction between molecular hydrogen (H2) and another compound or element, usually in the presence of a Catalysis, catalyst such as nickel, palladium or platinum. The process is commonly employed to redox, reduce or S ...
.
The diagram represents suggested pathways of the biodegradation of BAC for both the hydrophobic and the hydrophilic regions of the surfactant. Since
stearalkonium chloride is a type of BAC, the biodegradation process should happen in the same manner.
Regulation
Benzalkonium chloride is classed as a Category III antiseptic active ingredient by the United States
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA). Ingredients are categorized as Category III when "available data are insufficient to classify as safe and effective, and further testing is required”.
In September 2016, the FDA announced a ban on nineteen ingredients in consumer antibacterial soaps citing a lack of evidence for safety and effectiveness. A ban on three additional ingredients, including benzalkonium chloride, was deferred to allow ongoing studies to be completed.
Benzalkonium chloride was deferred from further rulemaking in the 2019 FDA Final Rule on safety and effectiveness of consumer hand sanitizers, "to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination" on whether it met these criteria for use in OTC hand sanitizers, but the agency indicated it did not intend to take action to remove benzalkonium chloride-based hand sanitizers from the market.
There is acknowledgement that more data are required on its safety, efficacy, and effectiveness, especially with relation to:
* Human pharmacokinetic studies, including information on its metabolites
* Studies on animal absorption, distribution, metabolism, and excretion
* Data to help define the effect of formulation on dermal absorption
* Carcinogenicity
* Studies on developmental and reproductive toxicology
* Potential hormonal effects
* Assessment of the potential for development of bacterial resistance
* Risks of using it as a contraceptive method.
See also
*
* – an alternative preservative for contact lens solutions
*
*
*
References
Further reading
*
* Thorup I: Evaluation of health hazards by exposure to Quaternary ammonium compounds, The Institute of Food Safety and Toxicology, Danish Veterinary and Food Administration
*
External links
International Programme on Chemical Safety, International Chemical Safety Card (ICSC) - Benzalkonium Chloride*
ttp://www.inchem.org/documents/pims/chemical/pimg022.htm International Programme on Chemical Safety, Poisons Information Monograph (PIMs) - Benzalkonium ChlorideHaz-Map Category Details - Benzalkonium ChlorideToxNet Human Safety Database - Benzalkonium Chloride CompoundsRecognition and Management of Pesticide Poisonings, United States Environmental Protection Agency, Office of Pesticide Programs, Sixth Edition, 2013*
ttp://datasheets.scbt.com/sc-227342.pdf Santa Cruz Biotechnology, Inc. MSDS*
ttps://web.archive.org/web/20141006101538/http://eu.spectrumlabs.com/lit/MSDS100104.pdf Spectrum Labs "Clear Bath" Algae Inhibitor MSDSNile Chemicals MSDSTCI America MSDSSciencelab.com, Inc. MSDS
{{DEFAULTSORT:Benzalkonium Chloride
Algaecides
Antiseptics
Benzyl compounds
Cationic surfactants
Chlorides
Disinfectants
Quaternary ammonium compounds