Benzalkonium Chloride: Best Alternative to Triclosan

Triclosan (sometimes abbreviated as TCS) is an antibacterial and antifungal agent present in some consumer products, including toothpaste, soaps, detergents, toys, and surgical cleaning treatments. It is similar in its uses and mechanism of action to triclocarban. Its efficacy as an antimicrobial agent, the risk of antimicrobial resistance, and its possible role in disrupted hormonal development remains controversial. Additional research seeks to understand its potential effects on organisms and environmental health. Triclosan was developed in 1966. In 2016, the FDA ruled companies couldn’t sell triclosan-containing consumer products such as antibacterial soaps anymore. They stated these products haven’t proven to be any more effective than plain soap and water. Scientists are still studying the health effects of triclosan.

Triclosan (5-chloro-2-(2,4-dichlorophenoxy) phenol) is either banned or under scrutiny due to its possible effect in the disruption of hormonal development and the environment.

At equivalent antimicrobial efficacy, Benzalkonium Chloride (BKC/BAC/BAK/BZK) is a safer alternative with superior properties, including better water solubility and wider pH range of activity.

The regulatory situation

ECHA has assessed Triclosan as PBT (Persistent, bio accumulative, and Toxic) and ED (Endocrine disrupting). In 2016, the US FDA banned it from OTC healthcare antiseptic products without premarket review.

For these reasons, you may be looking for safer alternatives.

For healthcare uses like surgical scrubs and handwashes, topical antiseptics, coating in medical devices, etc. Triclosan can be replaced by Benzalkonium Chloride (BKC/BAK/BZK).

BKC can replace Triclosan 1:1

Benzalkonium Chloride (BKC) is as effective as Triclosan in killing a wide range of microorganisms, with few variations in MIC concentrations.

The table below shows results from a test performed by the Danish Serum Institute, where colonies were suspended to a turbidity of 0.5 McFarland or 0.13 on a colorimeter, and further diluted in a broth to 1×106 CFU/ml and incubated overnight at 370C. The antimicrobial concentration range was 0.00001 to 0.01%.

  • Minimum Inhibitory concentration (MIC)
  • Mean results in % or µg/ml

Supported by these results, an existing product can be re-formulated with BKC using an equal concentration as Triclosan.

As an additional tool, here is information on BKC compatibility and incompatibility:

Benzalkonium Chloride is a safer alternative

EU and US authorities report that there is no indication that BKC has MCR effects (mutagenic, carcinogenic, reproductive).

EU/ECHA: Benzalkonium Chloride is REACH registered, also as a biocide (e.g. Benzyl-C12-14-alkyldimethylammonium chlorides) with no specific safety concerns.

EU/EMA: Approved for use in pharmaceutical formulations without restrictions.

Approved in both OTC and Rx pharmaceuticals, globally.

Comparison of antimicrobials

Wondering how BKC and Triclosan compare to other antimicrobials? The table below summarizes the characteristics of several antimicrobial ingredients found on the market.

Why choose Benzalkonium Chloride?

  • Proven bactericide against a broad spectrum of microorganisms: Gram + and – & acid-fast bacteria, yeast, molds, enveloped viruses.
  • Effective through a wide pH range (4-10/11).
  • Very stable at various temperatures and pH.
  • Non-volatile.
  • Cost effective due to activity at low concentration.
  • Strong surfactant can support active ingredient delivery and offers residual activity.
  • Safe to use, non-flammable and widely available.
  • Does not add color or odor to finished formulations.
  • Soluble in water (Triclosan is poorly soluble in water).

References:

https://thedermreview.com/

https://journals.sagepub.com/

https://pmc.ncbi.nlm.nih.gov/

https://my.clevelandclinic.org/

Category of posts