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92 DISINFECTANTS


shear forces. Used as a thickener in hand gels, it can provide an agreeable skin feeling during rub-in, combined with prolonged contact time on the skin.


An additional desirable feature for hand


disinfection gels is crystal-clear transparency. This can be achieved by using a special clear solution grade of xanthan gum that provides all the stabilising and shear thinning properties of regular xanthan gum without imparting the typical turbidity. Jungbunzlauer’s xanthan gum can be used


as a natural-origin thickener in skin disinfectant gels with lower alcohol content, and can be combined with L(+)-lactic acid. Jungbunzlauer lactic acid, sodium lactate, potassium lactate and xanthan gum are all Ecocert- and COSMOS- approved raw materials for use in natural cosmetics and detergents. Whilst biocides have never been more


important in contributing to a safer and cleaner world, customers are increasingly looking for more natural, sustainable, gentle and safer formulations. The need for green alternatives is also driven by regulatory and safety developments. This article aims to share efficacy data on the antiviral activity of lactic acid, which Jungbunzlauer has also covered in other publications.5,6


Experimental part The EN14476 Phase 2/Step 1 quantitative suspension test is designed to evaluate the virucidal activity of chemical disinfectants and antiseptics, including those intended for use in the medical area. The protocol describes a method to determine the virucidal efficacy of biocidal active substances. It is one of the test protocols recommended in the ECHA Guidance on Regulation (EU) No. 528/2012, the Biocidal Products Regulation (BPR), especially for Product Types (PTs) 1 (human hygiene) and 2 (general disinfection).7 The set-up of the EN14476 test takes the


different virucidal classes into consideration and has model viruses for each class (Figure 1). EN14476 focuses on the antiviral activity evaluation of hand hygiene products, such as hygienic hand wash preparations or hand rubs, surface disinfectants, instruments and laundry disinfectants. Depending on the intended use of the biocidal product in question, additional EN test methods may be applicable, which will not be discussed here.8 Only disinfectants that pass for all virus


classes may carry the claim ‘virucidal’. As depicted in Figure 1, two weaker claims - ‘limited spectrum virucidal’ and ‘active against enveloped viruses’ - are available, which distinguish viruses according to their lipophilic character and the presence of an envelope, as described in the introduction. Murine norovirus and the adenovirus are examples more lipophilic viruses. A successful pass in tests against these permits the ‘limited spectrum virucidal’ claim.


Formulation


2.90% Lactic acid 0.90% Lactic acid


Contact time 60s PASS PASS


PERSONAL CARE November 2021 These results clearly prove the activity


of lactic acid against enveloped viruses. Since lactic acid is also registered as a biocide under the BPR, this opens the way to numerous formulations with a variety of other ingredients for disinfectant applications. Given the ongoing pandemic, there is an


urgent need for disinfectants that are potent against the enveloped virus SARS-CoV-2. Formulation A, containing 1.5% lactic acid and 44% ethanol plus 0.56% xanthan gum as thickener, was tested according to the full EN14476 method against MVA (Table 3). The pH of the formulation was set to 3.5 with potassium lactate. The lactate was used to add a moisturising


Figure 1: Claims for virucidal activity of products Here, the focus is on enveloped viruses with a


less lipophilic character. A model to test efficacy against this type of virus is the modified vaccinia virus Ankara (MVA, ATCC VR-1508). Passing this test permits a claim of ‘virucidal activity against enveloped viruses’.8


In each case, the set-up


offers a choice of two different conditions. Clean conditions use 3g/L of bovine serum albumin as the interfering substance, while dirty conditions are represented by this plus 3ml/L of erythrocytes. To pass the EN14476 test, a disinfectant or


disinfectant solution must be able to reduce the virus titre by at least four log steps within the given time period, at 20°C. This is equal to a 99.99% inactivation of the virus.8


All EN14476


tests were carried out at the laboratories of Dr Brill + Partner, Institute for Hygiene and Microbiology, in Bremen, Germany, which is accredited according to DIN EN ISO/IEC 17025.


Results & discussion A scheduled approach to determine usage levels of lactic acid in disinfectants with any kind of virucidal activity was set up. Since enveloped viruses are usually the easiest to inactivate, tests were started against MVA in accordance with EN14476. The more challenging (dirty) conditions, including sheep erythrocytes as the interfering substance, were selected. The results for the different solutions are given


in Table 1. Simple solutions of lactic acid diluted with water were used in this step. Even low concentrations of lactic acid seem to be able to inactivate the MVA. However, these preliminary results are not sufficient to substantiate a claim. As a second step, lower concentrations of


lactic acid were used in accordance with the full EN14476 test method. Again, dirty conditions were used. A positive result was obtained for low active concentrations of lactic acid, i.e. <1% active substance. The formulations given in Table 2 therefore avoid the need for classification, labelling and packaging (CLP) labelling while still offering an additional route to combat enveloped viruses like SARS-CoV-2.


TABLE 1: RESULTS OF SCREENING STEP 1 AGAINST VACCINIA VIRUS (MVA, DIRTY CONDITIONS, 20°C)


Contact time 5 min PASS PASS


Formulation


02.90% Lactic acid 0.45% Lactic Acid


benefit to the formula. Lactates are a component of the skin’s natural moisturising factor.3


This is highly relevant, because


solutions with high alcohol concentration can dry the skin.9


poor skin conditions can increase the risk of infections later on.10


Besides possible irritation, Topical application of


potassium lactate is able to restore the natural moisturising factor after it has been removed by water.4 As the results given in Table 4 show, the


active ingredients lactic acid and ethanol work well in combination with a skin moisturiser, potassium lactate, and a natural-origin thickener, xanthan gum, against enveloped viruses.


Regulations & safety In the EU, the BPR ensures that only approved active substances and authorised biocidal products are placed on the market. This applies to biocides of all kinds including disinfectants, which fall within the first of five main groups. PTs 1 and 2 are both relevant in this context. Since 2015, suppliers of active substances have to be listed in Article 95. L(+)-lactic acid is an approved active


substance for PTs 1, 2, 3 (veterinary hygiene) and 4 (disinfectants in the food and feed area). Approval for for PT 6 (preservation) is pending.11


The BPR includes only L-(+)-


lactic acid and ethanol as active substances of natural origin and ethanol is still in the approval phase. Since 2015, mixtures and final consumer


products also require adequate labelling in accordance with Regulation (EC) No. 1272/2008 on classification labelling and packaging of substances and mixtures. This Regulation also applies to biocides. For formulations containing L(+)-lactic


acid with a pH >2, hazardous labelling is required for concentrations >1%; at 1–3% the ‘harmful/irritant’ pictogram is required; and from ≥3% the ‘corrosive’ pictogram is mandatory. However, these are only default values, which can be overruled by in vitro testing.


TABLE 2: RESULTS OF FULL EN14476 AGAINST VACCINIA VIRUS (MVA, DIRTY CONDITIONS, 20°C)


Contact time 60s PASS FAIL


Contact time 5 min PASS PASS


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